Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-99: AAMI TIR42:2010, Evaluation of Particulates Associated with Vascular Medical Devices. (Cardiovascular)
Date of Standard: 2010. |
| Address of Standards Organization: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
|
| (2) | OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) |
|
| (3) | OFFICE OF COMPLIANCE (OC) |
|
|
| Devices Affected: |
| All vascular devices which can shed unintentional particulate matter |
|
| Processes Affected: |
|
| Type of Standard: |
| National |
| Extent of Recognition: |
| Recognize all sections of the TIR, except Section 8.0. Section 8.0 may be a helpful reference, but at this time the literature does not provide discreet thresholds to establish safety limits for the variety of vascular medical devices; therefore, further studies are necessary to determine safe levels of particulates. This standard is relevant for all vascular medical devices where particulate matter unintentionally generated from the device and introduced to the patient is a potential concern. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Coronary Drug-Eluting Stent |
Class 3 |
NIQ |
| 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 |
| |
|
| Relevant Guidance: |
Guidance for Industry and FDA Staff ? Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071863.htm
Draft Guidance for Industry - Coronary Drug-Eluting Stents: Nonclinical and Clinical Studies; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072196.pdf
Guidance for Industry and FDA Staff ? Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm225145.htm |
|
| FDA Technical Contacts: |
| Hina Pinto |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1106 |
| Silver Spring MD 20993 |
| 301/796-6351 |
| Email: hina.pinto@fda.hhs.gov |
|
| Dinesh Patwardhan |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 64, Room 4028 |
| Silver Spring MD 20993 |
| 301/796-2622 |
| Email: dinesh.patwardhan@fda.hhs.gov |
|
|
