LUMBAR DRAINAGE ACCESSORY KIT

K970658 · Integra Neurocare, LLC · JXG · May 19, 1997 · Neurology

Device Facts

• Record ID: K970658
• Device Name: LUMBAR DRAINAGE ACCESSORY KIT
• Applicant: Integra Neurocare, LLC
• Product Code: JXG · Neurology
• Decision Date: May 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The major indication of external drainage is the management of hydrocephalic shunt infections. External drainage of cerebrospinal fluid (CSF) to control increased intercranial pressure may also be indicated if an internal shunt is not indicated or during the treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring. This device should only be used by a physician or qualified personnel under the direction of a physician.

Device Story

Lumbar Drainage Accessory Kit facilitates external drainage of cerebrospinal fluid (CSF). Used in clinical settings by physicians or qualified personnel to manage hydrocephalic shunt infections, control intracranial pressure, or monitor post-operative pressure. Device provides a pathway for fluid diversion when internal shunts are not indicated. System components assist in the drainage process; clinical utility relies on physician oversight to manage patient intracranial pressure and monitor fluid status. Benefits include therapeutic management of cerebral conditions and pressure regulation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Accessory kit for external CSF drainage. Materials and specifications not detailed in provided text. Non-electronic, mechanical drainage system.

Indications for Use

Indicated for patients requiring external cerebrospinal fluid (CSF) drainage for management of hydrocephalic shunt infections, control of increased intracranial pressure, pre-operative drainage, intraventricular hemorrhage, or post-operative pressure monitoring. For use by physicians or qualified personnel under physician direction.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 19 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Terry N. Layton, Ph.D.
Vice President, Chief Operations and Technical Officer
Heyer-Schulte NeuroCare™, L.P.
8401 102nd Street
Suite 200 - P.O. Box 390
Pleasant Prairie, Wisconsin 53158-0390

Re: K970658
Trade Name: Lumbar Drainage Accessory Kit
Regulatory Class: II
Product Code: 84JXG
Dated: February 19, 1997
Received: February 21, 1997

Dear Dr. Layton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Terry N. Layton, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# SECTION 8 - DEVICE INDICATIONS FOR USE

510(k) Number (if known): K970658

Device Name: Lumbar Drainage Accessory Kit

Indications for Use: The major indication of external drainage is the management of hydrocephalic shunt infections. External drainage of cerebrospinal fluid (CSF) to control increased intercranial pressure may also be indicated if an internal shunt is not indicated or during the treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring. This device should only be used by a physician or qualified personnel under the direction of a physician.

Care must be taken to ensure compliance with the manufacturer's procedures for use.

Prescription Use Only
(Per 21 CFR 801.109)

Thomas J. Callahan
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970658