Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
057
|
Date of Entry 12/20/2021
|
FR Recognition Number
|
3-180
|
Standard | |
ASTM F3505-21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance |
|
Scope/Abstract1.1 This standard addresses the kink resistance of stents and endovascular prostheses (for example, stent grafts). The standard may also be applicable to scaffolds.
1.2 Test methods presented herein address the kink resistance of stents and endovascular protheses when exposed to bending in a single plane. While concurrent influences (for example, torque) are recognized to influence kinking properties, test methods other than single-plane bending are not addressed.
1.3 Test methods presented herein do not specifically address kink resistance of branched (for example, bifurcated) or multicomponent endovascular prostheses, but some aspects of this standard may be applicable to their application.
|
|
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 |
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 |
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. |