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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 3-86
Standard
ASTM  F2394-07 (Reapproved 2017)
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
Scope/Abstract
This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Figure 2.2 Bottom Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System
Figure 2.3 Top Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System
Figure 2.4 Alternative Test Tracking Fixture
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.

Figure 2.2 Bottom Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System conflicts with an existing published final guidance, see Section C2 of guidance listed below.

Figure 2.3 Top Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System conflicts with an existing published final guidance, see Section C2 of the guidance listed below.

Figure 2.4 Alternative Test Tracking Fixture conflicts with an existing published final guidance, see Section C2 of the guidance listed below.
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 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.

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 Contact
 Jhumur Banik
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-5239
  Jhumur.Banik@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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