| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
057
|
Date of Entry 12/20/2021
|
|
FR Recognition Number
|
3-171
|
| Standard | |
ASTM F2514-21
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading |
|
Scope/Abstract| 1.1 Purpose-This guide establishes recommendations and considerations for the development, verification, validation, and reporting of structural finite element models used in the evaluation of the performance of a metallic vascular stent design undergoing uniform radial loading. This standard guide does not directly apply to non-metallic or absorbable stents, though many aspects of it may be applicable. The purpose of a structural analysis of a stent is to determine quantities such as the displacements, stresses, and strains within a device resulting from external loading, such as crimping or during the catheter loading process, and in-vivo processes, such as expansion and pulsatile loading. ... |
|
| Extent of Recognition
|
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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| N/A |
Stent, Coronary |
Class 3
|
MAF
|
| N/A |
System, Endovascular Graft, Aortic Aneurysm Treatment |
Class 3
|
MIH
|
| 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
|
| N/A |
Stent, Superficial Femoral Artery, Drug-Eluting |
Class 3
|
NIU
|
| N/A |
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment |
Class 3
|
PFV
|
| N/A |
Iliac Covered Stent, Arterial |
Class 3
|
PRL
|
| N/A |
Stent, Iliac Vein |
Class 3
|
QAN
|
|
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. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
