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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 3-172
Standard
AAMI TIR42:2021
Evaluation of Particulates Associated with Vascular Medical Devices
Scope/Abstract
This document provides information for defining appropriate test methods, determining the source of particulate, assessing the clinical risk of particulate, and establishing product particulate limits. Particulate could arise from many sources including materials, environment, and clinical use. This TIR is intended to offer guidance to the medical device industry when evaluating the tendency for medical devices to release particulate, identifying particulate sources, applying analytical methods for particulate testing, and developing particulate limits based on clinical risk.
Extent of Recognition
Complete standard
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
Unclassified Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Class 3 NWX
Unclassified Coronary Drug-Eluting Stent Class 3 NIQ
Unclassified Drug-Coated Peripheral Transluminal Angioplasty Catheter Class 3 PRC
Unclassified Drug-Eluting Peripheral Transluminal Angioplasty Catheter Class 3 ONU
Unclassified Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Iliac Vein Class 3 QAN
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
Unclassified Transcatheter Septal Occluder Class 3 MLV
Regulation Number Device Name Device Class Product Code
§870.5100 Catheters, Transluminal Coronary Angioplasty, Percutaneous Class 2 LOX
Regulation Number Device Name Device Class Product Code
§870.1330 Wire, Guide, Catheter Class 2 DQX
Regulation Number Device Name Device Class Product Code
§870.1250 Catheter, Angioplasty, Peripheral, Transluminal Class 2 LIT
§870.1250 Catheter, Percutaneous Class 2 DQY
§870.1250 Catheter, Percutaneous, Cutting/Scoring Class 2 PNO
Regulation Number Device Name Device Class Product Code
§870.1210 Catheter, Continuous Flush Class 2 KRA
Regulation Number Device Name Device Class Product Code
§870.1200 Catheter, Intravascular, Diagnostic Class 2 DQO
Relevant FDA Guidance and/or Supportive Publications*
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
 Dinesh Patwardhan
  FDA/OC/CDRH/OSEL/
  301-796-2622
  dinesh.patwardhan@fda.hhs.gov
 Eleni Whatley
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  301-796-6372
  Eleni.Whatley@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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