| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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3-172
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| Standard | |
AAMI TIR42:2021
Evaluation of Particulates Associated with Vascular Medical Devices |
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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. |
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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| FDA recognition of AAMI TIR42:2010 [Rec# 3-99] will be superseded by recognition of AAMI TIR42:2021 [Rec# 3-172]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-99] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 3-99] will not be accepted. |
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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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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