| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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3-189
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| Standard | |
ASTM F2942-19
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents |
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Scope/Abstract1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.
1.2 This guide does not address flat plate, local crush durability, or multi-mode testing. Although this guide does not address multi-mode testing, the information included herein could be applicable to developing this type of test.
1.3 This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents (i.e., stents with a surface layer of an additional material(s)), monolithically polymeric stents, or absorbable stents, although the application of this standard to those products is not precluded.
1.4 This guide applies to endovascular grafts ("stent-grafts") and other conduit products commonly used to treat aneurismal disease, peripheral vessel trauma, or to provide vascular access. The information provided herein does not address all issues related to testing of these devices.
1.5 This guide is applicable to testing of stent(s) (or a representative portion of a stent). While durability testing of coupon samples (e.g., a scaled-up portion of the stent structure) can provide useful information, it is not within the scope of this guide.
1.6 This guide applies to in vitro modeling of stent durability from non-radial arterial motions. Such motions may arise from musculoskeletal activities, including walking and breathing, and cardiac motion. Test Methods F2477 addresses pulsatile (i.e., radial) durability of vascular stents. ... |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ASTM F2942-13 [Rec# 3-138] will be superseded by recognition of ASTM F2942-19 [Rec# 3-189]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-138] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 3-138] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| N/A |
Stent, Superficial Femoral Artery, Drug-Eluting
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Class 3
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NIU
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| N/A |
Iliac Covered Stent, Arterial
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Class 3
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PRL
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| N/A |
Stent, Iliac Vein
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Class 3
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QAN
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| N/A |
Stent Graft, Bypass, Superficial Femoral Artery
|
Class 3
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QWM
|
| N/A |
Stent, Coronary |
Class 3
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MAF
|
| N/A |
System, Endovascular Graft, Aortic Aneurysm Treatment |
Class 3
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MIH
|
| N/A |
Stent, Carotid |
Class 3
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NIM
|
| N/A |
Stent, Renal |
Class 3
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NIN
|
| N/A |
Stent, Iliac |
Class 3
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NIO
|
| N/A |
Stent, Superficial Femoral Artery |
Class 3
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NIP
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| N/A |
Coronary Drug-Eluting Stent |
Class 3
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NIQ
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| N/A |
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment |
Class 3
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PFV
|
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, issued April 2010.
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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