| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
|
Date of Entry 10/22/2018
|
|
FR Recognition Number
|
3-99
|
| Standard | |
AAMI TIR42:2010
Evaluation of Particulates Associated with Vascular Medical Devices |
|
Scope/Abstract| This technical information report (TIR) addresses vascular exposure to particles arising from the manufacturing environment for vascular medical devices and from the use of vascular medical devices. It is intended to assist vascular medical device manufacturers in determining the source of particulates, establishing product particulate limits, defining appropriate test methods, and assessing the clinical relevance of particulate contamination. |
|
| 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. |
|
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| FDA recognition of AAMI TIR42:2010 [Rec# 3-99] will be superseded by recognition of AAMI TIR42:2021 [Rec# 3-172].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. |
|
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, 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 |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry Coronary Drug-Eluting Stents¿ Nonclinical and Clinical Studies, Issued March 2008.
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, Issued May 2008.
|
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
