NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX

K990660 · Nmt Neurosciences Implants S.A. · JXG · Sep 23, 1999 · Neurology

Device Facts

• Record ID: K990660
• Device Name: NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
• Applicant: Nmt Neurosciences Implants S.A.
• Product Code: JXG · Neurology
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Control Unit: The NMT Neurosciences Control Unit is a portable, programmable system, designed for use with the NMT Disposable Drainage Line Kit, that controls cerebrospinal fluid (CSF) external drainage at the programmed pressure. Unlike other external drainage devices, the pressure setting is not dependent upon the patient's position. The system also allows for CSF sampling, collection, and for CSF pressure monitoring. Disposable Drainage Line Kit: The Disposable Drainage Line Kit is designed to be connected to the NMT Neurosciences Control Unit for cerebrospinal external drainage, sampling, collection and pressure monitoring.

Device Story

Portable, programmable control unit used with disposable drainage line kit for external cerebrospinal fluid (CSF) management. System regulates CSF drainage at programmed pressure, independent of patient position; enables CSF sampling, collection, and pressure monitoring. Operated by clinical staff in hospital settings. Provides automated pressure control to maintain drainage parameters; output used by clinicians to manage intracranial pressure and fluid drainage. Benefits include precise, position-independent pressure regulation for patients requiring external CSF diversion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, programmable electronic control unit; disposable fluid line kit. Features position-independent pressure regulation mechanism. System is prescription-only. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring external cerebrospinal fluid (CSF) drainage, sampling, collection, and pressure monitoring. System is prescription-only.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

Ms. Barbara Ramseyer Consultant NMT Neurosciences Implants S.A. 6011 Cellini Street Coral Gables, Florida 33146

Re: K990660

Trade Name: Control Unit Disposable Drainage Line Kit Regulatory Class: II Product Code: JXG Dated: June 30, 1999 Received: July 1, 1999

Dear Ms. Ramseyer:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 - Ms. Barbara Ramseyer

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,

Pcoéééfe

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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## NMT Neurosciences Implants

K990660 510(k) Number:

Device Name:

Control Unit Disposable Drainage Line Kit

## Indications for Use:

Control Unit:

The NMT Neurosciences Control Unit is a portable, programmable system, designed for use with the NMT Disposable Drainage Line Kit, that controls cerebrospinal fluid (CSF) external drainage at the programmed pressure. Unlike other external drainage devices, the pressure setting is not dependent upon the patient's position. The system also allows for CSF sampling, collection, and for CSF pressure monitoring.

Disposable Drainage Line Kit:

The Disposable Drainage Line Kit is designed to be connected to the NMT Neurosciences Control Unit for cerebrospinal external drainage, sampling, collection and pressure monitoring.

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription (Per CFR 801.109)

Over the Counter Use (Optional Format 1-2-96)

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