Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 17-3: ISO 7197:2006, Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components. (Neurology)
Date of Standard: 2006. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
Sterile, single use hydrocephalus shunts and components including:
a. one piece type,
b. multipiece type either assembled or in kit form,
c. individual shunt components or in combination.
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| Processes Affected: |
| 510(K), PMA, IDE, PDP, HDE |
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| Type of Standard: |
| International, Vertical, Test Methods |
| 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. The shunt system consists of three basic elements: an inflow (proximal) catheter, a valve which regulates the differential pressure or control flow through the system, and an outflow catheter. Additional components including specialized accessory devices, such as reservoirs, siphoning-preventing devices and on-off valves and filters, are added at the discretion of the physician to modify performance or adapt the basic system to the particular needs of the patient.
1. The standard prescribes a test method for opening and closing pressures of the valve
components of the system at a constant flow rate of 20 ml/h. Because there is no specific
requirement (pass/fail) criteria, results of testing may be required with clearly defined pass/pass
criteria.
2. The standard prescribes a test method for determining functional range (pressure/flow
characteristics of shunt). Because there is no specific pressure/flow characteristic
(pass/fail) criteria, 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 effectiveness claims.
3. 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.
4. The standard prescribes a test method for devices capable of siphon-prevention. Because
there is no specific performance requirement (pass/fail) criteria, results of testing may be
required with clearly defined (pass/fail) criteria.
5. The standard prescribes a test method for long-term (28 days) functional stability. This test
simulates the effect of aging and looks for changes in performance of the shunt such as leakage,
breaks, or change in pressure/flow characteristics due to "long term" usage. Because there are no
specific (pass/fail) criteria, results of these tests may be required with clearly defined (pass/fail) criteria.
Furthermore, because of the limitation of the simulated environment, new shunt system with significantly different flow path design or pressure/flow characteristics may require clinical data to support safe and effectiveness claims.
6. Biocompatibility requirements are in accordance with ISO 10993-1. Additional biocompatibility
testing may be necessary using specialized tests for new materials in contact with brain parenchyma.
7. 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.
8. Sterilant residues - there is no provision to assure that sterilization by EtO meet the minimum residue levels specified in ISO 10993-7.
9. Sterile packaging requirements should include expiration dating and data from testing may be needed to support the specified date. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §882.4060 |
Cannula, Ventricular |
Class 1 |
HCD |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §882.4100 |
Catheter, Ventricular |
Class 2 |
HCA |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §882.4545 |
Instrument, Shunt System Implantation |
Class 1 |
GYK |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §882.5550 |
Shunt, Central Nervous System And Components |
Class 2 |
JXG |
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| 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. |
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| 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: joseph.hutter@fda.hhs.gov |
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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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