Recognition List Number: 023 Publication Date: 05/05/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-76: ASTM F2129-08, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. (Cardiovascular)
Date of Standard: 2008. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| (2) | OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Test Methods, Horizontal |
| Extent of Recognition: |
Complete standard
This test method assesses the corrosion susceptibility of small, metallic, implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization. Examples of device types, which may be evaluated by this test method include, but are not limited to, vascular stents, filters, support segments of endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth.
1.2 This test method is used to assess a device in its final form and finish, as it would be implanted. These small devices should be tested in their entirety. The upper limit on device size is dictated by the electrical current delivery capability of the test apparatus (see Section 6). It is assumed that test methods, such as Test Methods G 5 and G61 have been used for material screening.
1.3 Because of the variety of configurations and sizes of implants, this test method provides a variety of specimen holder configurations.
1.4 This test method is intended for use on implantable devices made from metals with a relatively high resistance to corrosion. |
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| Related CFR Citations and Product Codes: |
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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 |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.3375 |
Filter, Intravascular, Cardiovascular |
Class 2 |
DTK |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §882.5200 |
Clip, Aneurysm |
Class 2 |
HCH |
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| Relevant Guidance: |
Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, January 13, 2005.
Carotid Stent - Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications, October 26, 1996
Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff, January 13, 2005
Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final, February 5, 1998
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| FDA Technical Contact: |
| Terry O. Woods |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 2116 |
| Silver Spring MD 20993 |
| 301/796-2503 |
| Email: terry.woods@fda.hhs.gov |
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