EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS

K972994 · Integra Neurocare, LLC · JXG · Nov 3, 1997 · Neurology

Device Facts

• Record ID: K972994
• Device Name: EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
• Applicant: Integra Neurocare, LLC
• Product Code: JXG · Neurology
• Decision Date: Nov 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections. If an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure. 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 instructions for use. Prescription Use Only (Per 21 CFR 801.109)

Device Story

External CSF drainage management system; facilitates drainage and monitoring of intracranial pressure. Device functions via gravity-based drainage; intracranial pressure controlled by system height relative to patient. Used in clinical settings by physicians or qualified personnel. Output consists of CSF drainage and pressure monitoring data; allows healthcare providers to manage intracranial pressure and monitor for shunt failure. Benefits include controlled pressure relief and management of infections or hemorrhage. Not intended for drug administration.

Clinical Evidence

No clinical data provided. Determination of safety and efficacy is based on clinical history and substantial equivalence to legally marketed predicate devices.

Technological Characteristics

External CSF drainage and monitoring system. Materials are consistent with previously cleared Heyer-Schulte systems (K864676A). Operates via gravity-based fluid drainage; pressure control is dependent on system height adjustment. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring external cerebrospinal fluid (CSF) drainage for management of hydrocephalic shunt infections, pre-operative drainage, intraventricular hemorrhage, or post-operative intracranial pressure monitoring when internal shunts are not indicated.

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.

Predicate Devices

• P-S Medical Becker External Drainage and Monitoring System
• Codman External Drainage System II
• Heyer-Schulte/Camino Ventricular Drainage System (K932769)
• Heyer-Schulte Hermetic External CSF Drainage System (K864676A)

Submission Summary (Full Text)

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K972994

## SECTION 2 -510(k) SUMMARY

NOV - 3 1997

## 510(k) Summary:

The determination of safety and efficacy for the Heyer-Schulte NeuroCare External CSF Drainage Management Systems is based on years of clinical history with external drainage systems manufactured from the same materials beginning with the Heyer-Schulte Hermetic External CSF Drainage System (K864676A), which was approved by FDA for market in 1982.

The Heyer-Schulte NeuroCare External CSF Drainage Management Systems are substantially equivalent to other legally marketed products; the P-S Medical Becker External Drainage and Monitoring System, the Codman External Drainage System II. the Hever-Schulte/Camino Ventricular Drainage System (K932769) and the Heyer-Schulte Hermetic External CSF Drainage System (K864676A) with respect to functionality, design, placement and use.

Hydrocephalic patients with cerebrospinal fluid drainage systems must be kept under close observation for signs and symptoms of changing intracranial pressure due to shunt failure. These signs and symptoms may vary from patient to patient. Increasing intracranial pressure is characterized by headache, vomiting, irritability, listlessness, drowsiness, other signs of deterioration of consciousness and nuchal rigidity. In the infant, increased scalp tension at the anterior fontanelle and congestion of scalp veins will be noted.

Proper placement of the drainage system is critical. Intracranial pressure is controlled only by the height of the system. It is essential that neither the patient nor the drainage system be raised or lowered accidentally. Height changes should only be made by qualified personnel on the orders of the physician.

These products have not been tested for drug compatibility and are not intended for drug administration.

Heyer-Schulte NeuroCare determines substantial equivalence and safety and efficacy of the Hever-Schulte NeuroCare External CSF Drainage Management Systems based on predicate and currently marketed devices as noted in the summary above.

Jai L Hays
Lori L. Hays, MT(ASCP)

Lori L. Hays, MT(ASCP) Regulatory Submissions Specialist

August 11, 1997
Date

* The "K" numbers provided above refer to the 510(k)s previously approved by the FDA

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

NOV - 3 1997

Ms. Lori L. Hays Requlatory Submissions Specialist Heyer-Schulte Neurocare, L.P. 8401 102nd Street, Suite 200 P.O. Box 390 Pleasant Prairie, Wisconsin 53158-0390

Re: K972994 External CSF Drainage Management Systems Trade Name: Regulatory Class: II Product Code: 84JXG Dated: August 11, 1997 August 12, 1997 Received:

Dear Ms. Hays:

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 s 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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 Failure to comply with the GMP regulation may result in assumptions. 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

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Page 2 - Ms. Lori L. Hays

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.

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 at [phone].

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 8 - DEVICE INDICATIONS FOR USE

6972994 510(k) Number (if known):

Device Name: External CSF Drainage Management Systems

## Indications for Use:

The major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections.

lf an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure.

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 instructions for use.

Prescription Use Only (Per 21 CFR 801.109)