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Various examples of how registry data and real-world evidence (RWE) have been used in the FDA approval process for medical devices. It covers different types of studies, such as prospective, retrospective, and comparative analyses, and the use of data from registries, electronic medical records, and clinical trials. The document also mentions specific medical devices and their regulatory paths, including PMA, 510(k), and HDE-to-PMA conversions.
Typology: Summaries
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Example 6. PMA - Approval and Postmarket Surveillance of a Pediatric Ventricular Assist Device
Utilizing National Registry Data [13, 14]^ ................................................................................................. 30
Example 7. PMA - Approval and Postmarket Surveillance for a Left Ventricular Assist Device Using National Registry Data [15, 16, 17, 18]^ ........................................................................................................ 32
Example 8. PMA - Approval of a Heart Valve Replacement Using National Registry Data [12, 19]^ ....... 34
Example 9. PMA - Approval of a New PMA for an Endovascular System with a Post-approval Study using the Society for Vascular Surgery Vascular Quality Initiative (VQI) Registry [20, 21]^ ..................... 35
Example 10. PMA - Modification to Indications for Use Statement and Postmarket Surveillance for a Portable Normothermic Organ Perfusion, Ventilation and Monitoring Medical Device Using National Registry Data [22, 23, 24, 25]^ ........................................................................................................ 37
Example 11. PMA - Postmarket Surveillance of a Total Hip Replacement Using Two OUS National Registries [26, 27]^ .................................................................................................................................... 39
Example 12. PMA - Approval of an Indication Expansion for an Implanted Autonomic Nerve Stimulator for Epilepsy Based on OUS National Registry Data in a Bayesian Hierarchical Analysis [28, 29, 30] (^) ..................................................................................................................................................... 40
Example 13. PMA - Indication Expansions of Drug-Eluting Coronary Stents Using National Registry Data [31, 32]^ ............................................................................................................................................ 42
Example 14. PMA - Indication Expansion and Postmarket Surveillance of a DCB Percutaneous
Transluminal Angioplasty Catheter Approval Using National Registry Data [33, 34, 35]^ ......................... 43
Example 15. PMA - Postmarket Surveillance of a Superficial Femoral Artery Stent Utilizing a National Registry for Condition-of-Approval [36, 37]^ ............................................................................. 45
Example 16. PMA - Postmarket Surveillance of an Endovascular Graft for Aortic Aneurysms Utilizing a National Registry for Condition-of-Approval [38, 39]^ .......................................................................... 46
Example 17. PMA - Postmarket Surveillance of an Endovascular Graft for Aortic Aneurysms Utilizing a National Registry for Condition-of-Approval [40, 41]^ .......................................................................... 48
Example 18. PMA - Post-Approval Studies for an Implantable Cardioverter Defibrillator Utilizing a National Registry, the National Death Index, and a Sponsor Registry [42, 43, 44]^ ................................... 50
Subsection B. Examples of Registries as a Source of Real-World Evidence ....................................... 50
Example 19. 510(k) - Clearance of a Cryosurgical Tool Using Sponsor Registry Data [45]^ ................... 56
Example 20. 510(k) - Clearance of a Cryosurgical Tool Using Sponsor Registry Data [47]^ ................... 57
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Example 21. 510(k) - Modification to Indications for Use Statement for a Neurological Stereotaxic Instrument Supported by RWE from a Registry [48]^ ............................................................................ 58
Example 22. 510(k) - Modification to the Instructions for Use for a Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Using Registry Data [49, 50]^ .................. 59
Example 23. HDE - Approval for Vertebral Body Tethering System Using RWE from a Retrospective Review of Medical Records and to Satisfy Post-Approval Requirements [51, 52, 53, 54, 55]^ ...................... 61
Example 24. De Novo - Classification of an In Vivo Cured Intramedullary Fixation Rod Using the Medical Records from Sponsor’s OUS Registry [57]^ ............................................................................. 63
Example 25. PMA - Approval of a Permanent Pacemaker Electrode Following a Classification Order
Leveraging RWE from a Sponsor Registry and Device-Generated Data from Remote Monitoring [58]
............................................................................................................................................................ 64
Example 26. PMA - Approval of a Ventricular Support Device Using Supplemental Sponsor Registry Data [59]^ ................................................................................................................................................ 65
Example 27. PMA - Postmarket Surveillance of a Leadless Pacemaker Using a Sponsor Registry [60, 61, 62, 63] (^) ..................................................................................................................................................... 66
Example 28. PMA - Approval for a Total Ankle Replacement System using Outside-the-US RWE as a Primary Source of Clinical Evidence and RWE for a Post-Approval Study [64, 65]^ ................................. 67
Example 29. PMA - Approval of a Coronary Drug-Eluting Stent Leveraging Supplemental OUS Sponsor Registry Data [67, 68, 69, 70]^ ........................................................................................................ 69
Example 30. PMA - Postmarket Surveillance of a Ventricular Support Device Using Sponsor Registry Data [71]^ ................................................................................................................................................ 70
Example 31. PMA - Approval of an Indication Expansion and Postmarket Surveillance of a Ventricular Support Device Leveraging Sponsor Registry Data [72, 73]^ ................................................. 71
Example 32. PMA - Approval of an Indication Expansion and Postmarket Surveillance of a Ventricular Support Device Leveraging Sponsor Registry Data [74, 75]^ ................................................. 73
Example 33. PMA - Indication Expansion and Postmarket Surveillance of a Drug-Eluting Peripheral Transluminal Angioplasty Catheter Leveraging OUS Sponsor Registry Data [76, 77]^ ............................. 75
Example 34. PMA - Indication Expansion and Postmarket Surveillance of an Endovascular Graft for Aortic Aneurysms Leveraging Sponsor Registry Data [78]^ .................................................................... 77
Example 35. PMA - Postmarket Surveillance of a Ventricular Assist Device Leveraging a Sponsor Registry [79]^ .......................................................................................................................................... 79
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Example 49. PMA - Postmarket Surveillance of a Mitral Valve Repair Device Utilizing a National Registry and Claims Data for Condition-of-Approval [114, 115]^ ............................................................ 102
Example 50. PMA - Postmarket Surveillance of a Transcatheter Heart Valve Utilizing a National Registry and Claims Data for Condition-of-Approval [116]^ ................................................................. 103
Example 51. PMA - Postmarket Surveillance of a Transcatheter Heart Valve Utilizing a National Registry and Claims Data for Condition-of-Approval [117]^ ................................................................. 105
Example 52. Continued-Access Program Leveraging National Registry and Claims Data for Data Collection [45, 118]^ ................................................................................................................................ 106
Appendix Section IV. Examples Utilizing Medical Records as Real-World Evidence ....................... 107
Example 53. 510(k) - Clearance of New Robotically Assisted Surgical Device Using a Retrospective Review of Medical Records [119]^ ........................................................................................................ 110
Example 54. 510(k) - Clearance of a New Adjunct to Multiparameter Patient Monitor Using Data from Electronic Medical Records for Validation [120, 121, 122, 123]^ ......................................................... 111
Example 55. 510(k) - Modification to Indications for Use Statement for a Hemodialysis Catheter End Cap Using a Cluster-Randomized Trial with Data Abstracted from Electronic Health Records and National Healthcare Safety Network (NHSN) Dialysis Event Forms of Patients [124, 125, 126, 127]^ ......... 113
Example 56. 510(k) - Modification to Indications for Use Statement for a Robotic Surgical System Using Retrospective Reviews of Medical Records [128]^ ...................................................................... 115
Example 57. 510(k) - Modification to Indications for Use and Labeling for Magnetic Surgical
Instrument System Using a Retrospective Review of Medical Records [129]^ ..................................... 116
Example 58. 510(k) - Clearance of an Updated Percutaneous Catheter with Active Tip Using a
Retrospective Review of OUS Medical Records [130]^ ......................................................................... 117
Example 59. 510(k) - Modification to Indications for Use Statement and Labeling for 510(k) Dilation Catheter Using a Retrospective Review of Medical Records [131, 132, 133]^ ........................................... 118
Example 60. 510(k) - Modification to Indications for Use Statement for Embolic Protection System
Using a Retrospective Review of Medical Records [134]^ .................................................................... 119
Example 61. De Novo - Classification of High Velocity Nasal Insufflation Device for Neonates Using a
Retrospective Review of Medical Records [22, 135, 136]^ ........................................................................ 120
Example 62. De Novo - Classification of a Hemostatic Device for Intraluminal Gastrointestinal Bleeding Using Medical Records from OUS Postmarket Studies [15, 137]^ ............................................ 122
Example 63. De Novo - Classification of a Temporary Coil Embolization Assist Device Using Real- World Evidence from Retrospective OUS Case Series [138]^ ................................................................ 123
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Example 64. De Novo - Classification of a Radiological Computer-Assisted Triage and Notification Software Using A Secondary Analysis of Medical Records and Real-world Literature [139, 140]^ ......... 124
Example 65. PMA - Approval for Automated External Defibrillator Using Device-Generated Data and
for a Post-Approval Study After Call for PMA [141, 142, 143, 144]^ ............................................................. 126
Example 66. PMA - Modification to Indications for Use Statement for a Drug-Eluting Peripheral
Transluminal Angioplasty Catheter Supported by a Retrospective Review of Medical Records from
the Sponsor’s Database [145]^ .............................................................................................................. 128
Example 67. PMA - Approval of an Indication Expansion for a Transcatheter Pulmonary Valve Using
Medical Record Data [146]^ .................................................................................................................. 129
Appendix Section V. Examples Utilizing Other Sources of Real-World Evidence ............................ 130
Example 68. De Novo - Classification of an Endoscopic Electroscopic Clip Cutting System Using OUS
Compassionate Use Data [147]^ ............................................................................................................ 134
Example 69. De Novo - Classification of an Esophageal Cooling Device Using OUS Clinical Case Summaries and Temperature Charts [148]^ ......................................................................................... 135
Example 70. De Novo - Classification of a Scalp Cooling System Using Supplemental RWE from OUS Postmarket Surveillance Study [149]^ ................................................................................................... 136
Example 71. De Novo - Classification of a Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access Using OUS Commercial Use Data [150]^ ............................................ 137
Example 72. De Novo - Classification of a Web and Mobile-Based Software Application for Contraception Using Real-World Evidence from a Software Application with Patient-
Entered/Patient-Generated Data [151, 152]^ .......................................................................................... 138
Example 73. PMA - Postmarket Surveillance of an Intervertebral Disc Prosthesis Using an Explant
Retrieval Study [153]^ ............................................................................................................................ 139
Example 74. PMA - Approval for Automated External Defibrillator Using Device-Generated Data as a Primary Source of Clinical Evidence After Call for PMA [154, 155, 156, 157]^ .............................................. 140
Example 75. PMA - Approval for Automated External Defibrillator Using Device-Generated Data as a
Primary Source of Clinical Evidence After Call for PMA [158, 159, 160, 161]^ .............................................. 141
Example 76. PMA - Approval for Automated External Defibrillator Using Device-Generated Data as a
Primary Source of Clinical Evidence After Call for PMA [162, 163]^ ........................................................ 142
Example 77. PMA - Approval of an Indication Expansion of a Superficial Femoral Artery Drug-Eluting Stent Using Supplemental OUS Postmarket Surveillance Data [164, 165]^ ............................................. 143
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Real-world data (RWD) can be collected from a diverse array of sources, such as electronic health records, registries, administrative claims, pharmacy data and feedback from wearables and mobile technology. These data offer opportunities to generate evidence and better understand clinical outcomes. In support of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) mission to protect and promote public health by ensuring the safety and effectiveness of medical devices, while assuring patients have timely access to them, CDRH aims to foster the use of real-world evidence (RWE) to support regulatory decision-making. To further this goal, by developing a more complete understanding of RWE usage, CDRH has reviewed a sample of past decisions to identify examples leveraging RWE in premarket and postmarket decisions. We selected a set of 90 examples of submissions that illustrate the broad spectrum of RWE usage in support of regulatory decision-making from fiscal years 2012 through 2019.
The 90 examples come from the full continuum of clinical and device areas throughout all seven Offices of Health Technology in CDRH and across the medical device total product life cycle. These examples represent:
This report is organized into six sections separated by device type (therapeutic devices, in vitro diagnostics) and RWD source (Registries, Administrative Claims Data, Medical Records, Other Sources).
The examples demonstrate a diversity in the usage of RWE, where:
This report also includes examples from areas where innovative device technologies are being developed.
Finally, four studies leveraged RWD sources to abstract radiographic imaging data to address endpoints, and one example is included for a peripheral vasculature imaging device that utilized a clinical trial embedded in a national registry, with enrollment, randomization, and data collection conducted through the registry platform to support a premarket decision.
CDRH strongly encourages the continued and expanded use of RWE to provide new insights into the performance and clinical outcomes associated with medical device use over the total product lifecycle. Manufacturers planning to seek marketing authorization for devices are encouraged to consider RWE
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early on and communicate with FDA, as needed, to understand how to best utilize the RWE to support the marketing claims. Successful applications of RWE are most often achieved when principles of relevance and reliability are considered, as detailed in our guidance on Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. We are actively engaged with the medical device stakeholder community to address challenges and advance the science of RWE generation, through the establishment of the National Evaluation System for health Technology, or NEST, which is integrating data from clinical registries, electronic health records, and medical billing claims to gather more comprehensive evidence of medical device safety and effectiveness while seeking to reduce the time and cost of RWE generation.
The FDA currently defines real-world data (RWD) as the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can be derived from a variety of different sources, including electronic health records (EHRs), claims and administrative data, data from product and disease registries, patient-generated data, and device-generated data. Real-world evidence (RWE) is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.
RWD on patients’ experiences with medical devices are regularly collected for non-regulatory purposes during routine care and treatment. FDA recognizes that this resulting wealth of RWD can be leveraged to deliver further understanding of the performance, clinical outcomes, and benefit-risk profiles related to medical device use and to reduce the resources required to generate the necessary clinical evidence to support medical device submissions and fulfill postmarket surveillance requirements. If RWD are reliable and relevant to the regulatory question at hand, they may be considered valid scientific evidence supporting both premarket and postmarket regulatory decisions made by the FDA. To foster the use of RWE in device submissions, FDA issued the guidance document Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices in 2017 to explain how FDA assesses RWD to determine if they are sufficient for generating RWE that can be utilized in support of the FDA’s regulatory decision-making.
In continued support of its goal to increase both access to and use of RWE to support regulatory decision- making, CDRH has undertaken a retrospective review of past decisions to catalog and better understand examples of the use of RWE to support regulatory decisions. This review covered submissions with final decision dates from fiscal years 2012 through 2019, and initially encompassed De Novo Requests, original PMA applications and panel-track supplements, humanitarian device exemption applications, post-approval studies, and 522 postmarket surveillance studies. Beginning in 2018, 510(k) clearances were included in our retrospective review, while post-approval studies and 522 postmarket surveillance studies were omitted.
In our retrospective review, all submissions with final decisions in the date range, fiscal years 2012 through 2019, were selected for triage, although only those 510(k) submissions that included a clinical review were selected. The submissions were triaged to identify those in which the sponsor submitted RWD, with a more detailed review conducted of those submissions in which the RWD was considered important in supporting the final regulatory decision. The submissions identified from that review are included in this report. This effort resulted in a total of 90 examples of RWE used to support the final premarket or postmarket regulatory decision. These examples also demonstrate that the number of submissions and variety of device types supported by RWE have increased over time. The examples included in this report are not inclusive of all submissions or regulatory decisions that used RWE, but is
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Support Organization Registry were leveraged as a historical control that was propensity-score matched to the HDE IDE trial population, and also included RWE from post-HDE approval patients. Condition-of- approval postmarket surveillance was conducted through an all-comers surveillance registry with a follow-up of five years.
Sponsor or manufacturer registries represent another commonly utilized source of RWE. Included in this report are 19 examples of sponsor registries utilized as a source of premarket and postmarket clinical evidence. For a modification of the indications for use for a neurological stereotaxic instrument (K171257), registry data on patients treated with the device in standard practice served as the primary source of clinical evidence supporting a decision of substantial equivalence. Sponsor registry data were leveraged as both the primary source of clinical evidence supporting the approval of a total ankle replacement system (P160036) and as a source for deriving performance goals for the condition-of- approval postmarket study. For a modification of the indications for use for a vascular hemostasis device (P960043/S097), the sponsor’s registry tracked patients who were treated with the subject device as part of a continued access study after the conclusion of the previous randomized controlled trial of the device. Data from this registry were the sole source of clinical evidence supporting approval of the supplement seeking an indication expansion. Additionally, for two coronary drug-eluting stents (P160043/S012 and P110013/S088), two bundled modifications of indications for use were submitted. Data from the sponsor’s international registry were used to create a sub-cohort for analysis of the subject devices and served as a secondary source of clinical evidence supporting approval.
In Section II, there are two examples of submissions leveraging administrative claims data as RWE. For a pediatric contact lens (P180035), in order to fulfill the condition-of-approval, a post-approval study was required to evaluate the rate of microbial keratitis (MK) against a performance goal. Due to the low- prevalence of MK, this type of endpoint would be difficult to assess in a traditional clinical trial. Instead, FDA is working with the sponsor on a novel approach that will nest a cohort post-approval study into an integrated health care and coverage organization. Outcomes of interest will be extracted from electronic health records and claims data. For an indication expansion of a multifocal intraocular lens (P040020/S049), the post-approval study will utilize Medicare Beneficiary Encrypted Files as part of a retrospective study of all cataract surgeries in the Medicare population from 2011 to 2013, comprising approximately 180,000 surgeries, in order to estimate the background rate of post-surgical intraocular inflammation to compare to the subject device.
Included in this section are 12 examples that leverage a combination of national registries and administrative claims data. All but one of these examples leverage the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STC/ACC TVT) Registry with linkage to administrative claims data in CMS claims database to monitor long-term outcomes through five years after implantation of the subject devices. Two examples of transcatheter heart valves (P140031/S028 and P130009/S034) utilized STS/ACC TVT Registry data for both condition-of-approval postmarket surveillance and clinical evidence supporting approval of the indication expansions sought in both devices through PMA supplements. The transcatheter heart valve in P140031/S028 additionally relied on STS/ACC TVT Registry data as the sole source of clinical evidence in supporting expansion to include aortic and mitral valve-in-valve replacement. Finally, for an implantable cardioverter-defibrillator
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(P110042/S077), the condition-of-approval (CoA) postmarket surveillance study utilized multiple RWE sources to monitor the long-term performance of the subject device. The study leveraged existing national registry data from the American College of Cardiology National Cardiovascular Data Registry (ACC- NCDR) ICD Registry, remote-monitoring of device-generated data, public and private payer claims data from CMS and Truven MarketScan databases, and the National Death Index.
CDRH continues to review and make regulatory decisions on all types of submissions that use medical records as the primary or secondary source of clinical evidence. Medical records may serve as the primary source of clinical evidence for new submissions, as for a new version of a percutaneous catheter (K180986) which was supported solely by a retrospective medical record review of patients treated OUS, and for a new robotically assisted surgical device (K171120) to be cleared based on a retrospective analysis of medical records.
Utilizing medical records as a primary source of clinical evidence is common in submissions seeking an indication expansion. Other submissions illustrate use of RWE to support modifications to the indications for use statements for legally marketed devices. In most cases these modifications include use to treat a new disease or use in a new patient population or anatomic location. These submissions often incorporate systematic reviews or meta-analyses of existing literature to develop comparators or provide context for the real-world performance of the subject device. One example is for an indication expansion of a drug- eluting peripheral catheter (P140010/S037) to include treatment of longer lesions, primarily supported by a retrospective analysis of medical records from the sponsor’s database. Another example is for a modified indications for use statement for a hemodialysis catheter end cap (K180111), which FDA has cleared to include information related to the reduction of bloodstream infections. The sponsor performed a cluster-randomized clinical trial in 40 dialysis centers across the U.S. to compare the subject device and a comparator device using data abstracted from electronic health records (EHRs). Both devices were legally marketed, and dialysis centers were randomized to use one or the other device. Patients were treated according to the local standard of care, which includes routine blood culture specimen collection for blood infection surveillance and reporting to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN). Blood culture specimens were analyzed by a central laboratory and the results were then entered into the patient’s EHR and into NHSN Dialysis Event forms for routine surveillance reporting. Data were then abstracted from the EHR and from the NHSN forms for the purposes of the study.
Section V is comprised of examples of other sources of RWE. Included in this section are PMAs submitted in response to a classification order requiring premarket approval of automated external defibrillators (AEDs). In these three examples for AEDs (P160012, P160032, and P160033), the subject devices had been marketed in the U.S. for over 10 years, and the submissions drew on postmarket device- generated data on out-of-hospital use in order to support their approvals. In P160012, when EMS were called to an out-of-hospital cardiac arrest, study data collectors traveled to the scene, interviewed witnesses, recorded data on the circumstances of the cardiac arrest, and collected data recorded by the AEDs.
Real-world evidence is also starting to be used to support regulatory decision-making for digital health technologies. One example is for a software platform that computes a Rothman Index score from data extracted from patients’ electronic medical records (K172959). These RWD were used for development and validation of the device, as well as for comparing performance of the Rothman Index to the predicate patient status index when both were calculated from hospitals’ electronic medical record systems. Another example is a De Novo classification request for a radiological computer-assisted triage and
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decisions, one postmarket decision, and one example involving both premarket and postmarket use of RWE that spans the “total product life cycle” (TPLC). These examples include RWE from the sources described above, including medical records, published literature, and sponsor database data. One particularly innovative example included in this report is a newborn screening IVD utilizing dried blood specimens (DEN150035). The pivotal trial for the device was embedded in the Missouri State Public Health Laboratory’s routine screening program and evaluated the device performance on all samples submitted to this state laboratory. The Missouri Department of Health and Senior Services’ active surveillance program was also utilized to track reports of false negatives. This study served as the sole source of clinical evidence supporting the regulatory decision to grant the De Novo classification request. Another example is a De Novo classification request for a next generation sequencing-based tumor profiling test (DEN170058). Clinical data for this submission came from an electronic medical record database of advanced cancer patients with associated pathological and clinical data generated as part of routine workflow at Memorial Sloan Kettering Cancer Center. A retrospective analysis of the electronic medical records provided evidence to support a pan-cancer claim, to validate a test cut-off, and to provide data on somatic mutation prevalence. The original PMA submission for an IVD to assess risk of spontaneous preterm delivery by testing cervicovaginal secretions (P160052) is a total-product lifecycle example with patients’ medical records serving as the primary source of clinical evidence for both the premarket approval and post-approval study. The sponsor submitted an observational clinical study of patients tested with the subject device for premarket clinical evidence and as a condition-of-approval, and the sponsor will collect postmarket clinical evidence by conducting a confirmatory study in a larger population of patients tested with the subject device. These examples demonstrate how RWD sources can be leveraged to support clinical research and generate evidence for marketing submissions for IVDs, and further examples can be found in (^) Appendix Section I.
The tag definitions below are used for all examples:
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4 K173860 Volcano Corporation
s5/s5i/CORE/ CORE Mobile Precision Guided Therapy System
OUS randomized trial embedded in national registries (Swedish Coronary Angiography and Angioplasty Registry)
Premarket: For this 510(k) submitted to modify the subject device’s indication, the sponsor submitted clinical evidence from three studies, including a randomized controlled trial embedded in an OUS national registry.
Outside-the-US; Registry data; RWE as a primary source of clinical evidence;
5 H170001 ApiFix, Ltd. Minimally Invasive Deformity Correction (MID-C) System
Outside-the-US commercial use
Postmarket registry
Premarket: OUS commercial use provided the majority of clinical use cases for this submission. The RWE was used in combination with other clinical data from OUS studies.
Postmarket: The sponsor has agreed to perform a post-approval study (PAS) that will use registry- based data collection.
Outside-the-US; Pediatric RWE; Registry data; RWE as a primary source of clinical evidence; Total-Product Lifecycle Example;
6 P160035 Berlin Heart Inc.
EXCOR Pediatric Ventricular Assist Device
Real-world data from non- study patients, ELSO Registry, postmarket registry
Premarket: In this conversion of an HDE to a PMA, national registry data from the Extracorporeal Life Support Organization (ELSO) Registry was leveraged as a historical control that was propensity-score matched to the HDE trial population. RWE also served as a source of supplemental clinical evidence in the form of post- HDE patient data.
Postmarket: As a condition-of-approval, postmarket surveillance will be conducted through an all-comers registry for five years.
Pediatric RWE; Registry data; Total-Product Lifecycle Example;
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7 P100047 Medtronic, Inc.
HeartWare INTERMACS Registry Premarket: For this PMA, RWE from the INTERMACS Registry was utilized as a contemporaneous control for the sponsor's clinical trial data.
Postmarket: The INTERMACS Registry will be leveraged to compare outcomes through two years between patients receiving the subject device and other LVADs.
Registry data; Total-Product Lifecycle Example;
8 P150036 Edwards Lifesciences, LLC
INTUITY Elite Valve STS Adult Cardiac Surgery Database
Premarket: For this PMA, data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD) on mean aortic cross-clamp and cardiopulmonary bypass surgical times was leveraged as a comparison metric against data from the sponsor’s clinical trial.
Registry data;
9 P180001 William Cook Europe ApS
Zenith Dissection Endovascular System
Society for Vascular Surgery Vascular Quality Initiative (VQI) Registry
Postmarket: As a condition-of-approval for this PMA original application, the postmarket surveillance study will utilize the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry.
Registry data;
10 P160013/S002 TransMedics, Inc
Organ Care System (OCS) Lung System
United Network for Organ Sharing (UNOS) Registry
Sponsor Registry (Postmarket only)
Premarket: To support this PMA supplement for modifying the indications for use, the sponsor provided supplemental, match-run data from the United Network for Organ Sharing (UNOS) database.
Postmarket: The sponsor will conduct two post- approval studies as a condition of approval, one that follows current clinical trial patients for five years utilizing the UNOS database, and one that collects postmarket data in all-comers registry with some data collected from the UNOS registry.
Registry data; Total-Product Lifecycle Example;
