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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR 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 Development 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:
510(k), PMA, IDE, HDE
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
§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Draft Guidance for Industry - Coronary Drug-Eluting Stents: Nonclinical and Clinical Studies;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
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