| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
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060
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Date of Entry 05/29/2023
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|
FR Recognition Number
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3-184
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| Standard | |
ASTM F2477-23
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
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Scope/Abstract1.1 These test methods cover the determination of the durability of a vascular stent or endoprosthesis by exposing it to diametric deformation by means of hydrodynamic pulsatile loading. This testing occurs on a test sample that has been deployed into a mock (elastically simulated) vessel. The test is conducted for a number of cycles to adequately establish the intended fatigue resistance of the sample.
1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys and endovascular prostheses with metal stents. This standard does not specifically address any attributes unique to coated stents, polymeric stents, or biodegradable stents, although the application of this test method to those products is not precluded.
1.3 These test methods may be used for assessing stent and endovascular prosthesis durability when exposed to blood vessel cyclic diametric change. These test methods do not address other cyclic loading modes such as bending, torsion, extension, or compression.
1.4 These test methods are primarily intended for use with physiologically relevant diametric change, however guidance is provided for hyper-physiologic diametric deformation (that is, fatigue to fracture).
1.5 These test methods do address test conditions for curved mock vessels, however might not address all concerns. |
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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| FDA recognition of ASTM F2477-07 (Reapproved 2013) [Rec# 3-87] will be superseded by recognition of ASTM F2477-23 [Rec# 3-184]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-87] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 3-87] 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 |
System, Endovascular Graft, Aortic Aneurysm Treatment
|
Class 3
|
MIH
|
| N/A |
Intracranial Neurovascular Stent
|
HDE
|
NJE
|
| N/A |
Intracranial Aneurysm Flow Diverter
|
Class 3
|
OUT
|
| N/A |
Stent, Coronary |
Class 3
|
MAF
|
| N/A |
Stent, Carotid |
Class 3
|
NIM
|
| N/A |
Stent, Renal |
Class 3
|
NIN
|
| N/A |
Stent, Iliac |
Class 3
|
NIO
|
| N/A |
Stent, Superficial Femoral Artery |
Class 3
|
NIP
|
| N/A |
Coronary Drug-Eluting Stent |
Class 3
|
NIQ
|
|
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.
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff, issued July 2021.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
