|Recognition List Number: 028 FR Publication Date: 03/16/2012
Part B: Supplementary Information
Recognition Number 17-4: ASTM F647-94 (Reapproved 2006), standard practice for evaluating and specifying implantable shunt assemblies for neurosurgical application. (Neurology)
Date of Standard: 1994.
|Address of Standards Development Organization:|
| ASTM International (ASTM)|
| 100 Barr Harbor Drive|
| West Conshohocken, PA 19428-2959 |
|CDRH Office and Division associated with recognized standards:|
|OFFICE OF DEVICE EVALUATION (ODE) |
|Neurological Shunt Assemblies for Neurological Applications|
|Processes Affected: |
|510(k), PMA, IDE, PDP, HDE|
|Type of Standard:|
| Test Methods, Vertical, National|
|Extent of Recognition:|
|Complete Standard except as noted below:
This standard covers requirements for the testing and specification of implantable shunts as related to resistance to flow, direction of flow, materials, radiopacity, mechanical properties, finish, sterility, and labeling of shunt assemblies. Components include, but are not limited to, those that are temporarily implanted to effect external drainage, or permanently implanted to effect shunting of fluid from a cerebral ventricle, a cyst, the subarachnoid space to the peritoneal cavity, the venous circulation, or some other suitable internal delivery site, and intracranial bypass.
1. The standard prescribes a test method for the evaluation of pressure/flow characteristics of shunts or shunt components but does not include specific pressure/flow requirements (pass/fail) criteria. Therefore, results of testing may be required with clearly defined (pass/fail) criteria. Furthermore, devices with pressure/flow characteristics or flow path design significantly different from current marketed shunts may require clinical data to support safe and effective claim.
2. The pressure/flow test is based on a constant flow model through the shunt or shunt component using distilled water. This model cannot address the issue of shunt obstruction, which is a major failure mode for these types of devices. Therefore, shunt valve design and shunt components that are significantly different from current marketed shunts may require additional testing based on any unique design features of the device to demonstrate that the device does not increase the risk to shunt obstruction.
3. This standard does not address the issue of siphoning due to hydrostatic pressure when a shunted patient is in the upright or standing position. New shunt valve designs will need to characterize their device with respect to siphoning effect. Shunt valves that claim anti-siphoning or siphon-prevention will need to provide performance data to demonstrate the device's effectiveness.
4. Biocompatibility requirements should be expanded to be in accordance with ANSI/AAMI/ISO 10993-1. Additional biocompatibility testing may be necessary using specialized tests for new materials in contact with brain parenchyma.
5. Pyrogenicity requirements need to be modified to reflect that the device is non-pyrogenic to a level of 0.06 EU/ml in accordance with FDA's LAL guideline.
6. Sterilant residues - there is no provision to assure that sterilization by EtO meet the minimum residue levels specified in ISO 10993-7.
7. Sterile packaging requirements should include expiration dating and data from testing may be needed to support the specified date.
|Related CFR Citations and Product Codes:|
||Instrument, Shunt System Implantation
||Shunt, Central Nervous System And Components
|Relevant Guidance: |
|Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1)
Guideline on Validation of the LAL Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices. Document issued prior to February 1997.
|FDA Technical Contact:|
| Joseph C. Hutter |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2458 |
| Silver Spring MD 20993 |
| 301/796-6499 |
| email: email@example.com|