Download 17-3 Neur Neurosurgical Implants - Sterile, single

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).