| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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3-159
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| Standard | |
ISO 5910 First edition 2018-06
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
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Scope/Abstract1.1 This document applies to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus).
1.2 This document outlines an approach for verifying/validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification/validation tests and methods are derived from the risk assessment. The tests include assessments of the physical, chemical, biological, and mechanical properties of components and materials of heart valve repair systems. The tests also include preclinical in vivo evaluation and clinical investigation of the finished heart valve repair system to assess the safety and effectiveness of the heart valve repair system.
NOTE For the purposes of this document, effectiveness endpoint includes clinical performance and benefits.
1.3 This document defines operational conditions and performance requirements for heart valve repair systems where adequate scientific and/or clinical evidence exists for their justification.
1.4 This document excludes Cardiac Resynchronization Therapy (CRT) devices, paravalvular leakage closure devices, systems that do not leave an implant in place (e.g. ablation, radio frequency annuloplasty), apical conduits and devices with components containing viable cells. This Standard also excludes materials not intended for repairing and/or improving the function of human heart valves according to its intended use (e.g. patch material and sutures used in general surgical practice). |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Section 7.2.4.2 Structural component fatigue assessment
Section 7.2.5.3 Device durability assessment
Section 7.4.6 Statistical considerations including sample and duration
Annex N.3 Test parameters
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Section 7.2.4.2, Section 7.2.5.3, and Annex N3 conflict with section In Vitro Testing in reference #1 listed below.
Section 7.4.6 conflicts with section Pediatric Clinical Trial Design in reference #2 listed below. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| N/A |
Mitral Valve Repair Devices |
Class 3
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NKM
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Relevant FDA Guidance and/or Supportive Publications*
1. Fernando, A., Hillebrenner, M., Stewart, S., Swain, J., Hampshire, V., Zuckerman, B.(2011). U.S. Regulatory Considerations for Heart Valves Implanted by Minimally Invasive Surgery. Cardiovascular Engineering and Technology, 2(2): 62-5.
2. Yoganathan, A.P., Fogel, M., Gamble, S., Morton, M., Schmidt. P., Secunda, J., Vidmar, S., and Del Nido, P. (2013) A new paradigm for obtaining marketing approval for pediatric prosthetic heart valves. Journal of Thoracic and Cardiovascular Surgery, 146(4):879-86.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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