VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD

K982702 · Camino Neurocare, Inc. · GWM · Sep 10, 1998 · Neurology

Device Facts

• Record ID: K982702
• Device Name: VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
• Applicant: Camino Neurocare, Inc.
• Product Code: GWM · Neurology
• Decision Date: Sep 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

This ICP catheter is indicated for use on patients that require continuous intracranial pressure monitoring.

Device Story

Ventrix Subdural Tunneling Pressure Monitoring Kit is a sterile, single-use device for continuous intracranial pressure (ICP) monitoring. The system consists of an ICP catheter designed for subdural placement. The device is used in clinical settings by healthcare professionals to monitor patients requiring ICP management. The catheter provides real-time pressure data to an external monitor, allowing clinicians to assess intracranial status and guide therapeutic interventions. The tunneling feature facilitates secure catheter placement, reducing the risk of dislodgement and infection. By providing continuous, accurate pressure readings, the device assists in the early detection of elevated ICP, enabling timely clinical decision-making to prevent secondary brain injury and improve patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Subdural ICP catheter kit; sterile, single-use; tunneling design for secure placement; intended for continuous pressure monitoring.

Indications for Use

Indicated for patients requiring continuous intracranial pressure (ICP) monitoring.

Regulatory Classification

Identification

An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

Ms. Jody J. Fleming Senior Regulatory Affairs Specialist Camino Neurocare, Inc. 5955 Pacific Center Blvd. San Diego, California 92121

Re: K982702

Trade Name: Ventrix™ Subdural Tunneling Pressure Monitoring Kit Regulatory Class: II Product Code: GWM Dated: July 23, 1998 Received: August 3, 1998

Dear Ms. Flemming:

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 (OS) 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. Jody J. Flemming

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,

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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510(k) Number (if known):

K982702

Ventrix Subdural Tunneling Pressure Monitoring Device Name: Kit

Indications For Use:

This ICP catheter is indicated for use on patients that require continuous intracranial pressure monitoring.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

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

(Division Sign-Off)
Division of General Restorative Devices/682707

510(k) Number .