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Neurosurgical Implants - Sterile, 17-3 Neur single-use hydrocephalus shunts and components 7197:2006 03/16/2012 ISO 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 SWITZERLAND CDRH Office and Division Associated with Recognized Standards: OFFICE OF DEVICE EVALUATION (ODE) 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. Processes Affected: 510(K), PMA, IDE, PDP, HDE 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. Related CFR Citations and Product Codes: Regulation Device Name Number Device Product Class Code §882.406021 Cannula, Ventricular Class 1 HCD22 Regulation Device Product Device Name Number Class Code §882.410023 Catheter, Ventricular Class 2 HCA24 Regulation Device Product Device Name Number Class Code §882.454525 Instrument, Shunt System Implantation Class 1 GYK26 Regulation Device Product Device Name Number §882.5550 27 Shunt, Central Nervous System And Components Class Code Class 2 JXG 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. [Code of Federal Regulations] [Title 21, Volume 8] 8 [Revised as of April 1, 2013] [CITE: 21CFR882.4060] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 882 -- NEUROLOGICAL DEVICES Subpart E--Neurological Surgical Devices Sec. 882.4060 Ventricular cannula. (a)Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle. (b)Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] [Code of Federal Regulations] [Title 21, Volume 8] 8 [Revised as of April 1, 2013] [CITE: 21CFR882.4100] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 882 -- NEUROLOGICAL DEVICES Subpart E--Neurological Surgical Devices Sec. 882.4100 Ventricular catheter. (a)Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b)Classification. Class II (performance standards). [Code of Federal Regulations] [Title 21, Volume 8] 8 [Revised as of April 1, 2013] [CITE: 21CFR882.4545] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 882 -- NEUROLOGICAL DEVICES Subpart E--Neurological Surgical Devices Sec. 882.4545 Shunt system implantation instrument. (a)Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin. (b)Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] [Code of Federal Regulations] [Title 21, Volume 8] 8 [Revised as of April 1, 2013] [CITE: 21CFR882.5550] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 882 -- NEUROLOGICAL DEVICES Subpart F--Neurological Therapeutic Devices Sec. 882.5550 Central nervous system fluid shunt and components. (a)Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt. (b)Classification. Class II (performance standards).