TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP

K020780 · Medex, Inc. · GWM · May 20, 2002 · Neurology

Device Facts

• Record ID: K020780
• Device Name: TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
• Applicant: Medex, Inc.
• Product Code: GWM · Neurology
• Decision Date: May 20, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The TranStar Intracranial Pressure Transducer is intended for external monitoring of Intracranial pressures (ICP). Intracranial pressure waveforms are conducted from the patient to the transducer through a column of fluid. The fluid pressure waveforms are converted into electrical signals that can then be displayed using separate monitoring equipment.

Device Story

TranStar Intracranial Pressure Transducer monitors intracranial pressure (ICP). Device receives pressure waveforms from patient via fluid-filled column; converts fluid pressure into electrical signals. Output transmitted to separate monitoring equipment for display. Used in clinical settings (e.g., ICU, OR) by physicians or trained clinical staff. Provides real-time ICP data to assist in neurological patient management and clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intracranial pressure transducer; converts fluid-coupled pressure waveforms to electrical signals. Class II device (21 CFR 882.1620).

Indications for Use

Indicated for external monitoring of intracranial pressure (ICP) in patients requiring such monitoring. Prescription use only.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara Law Regulatory Affairs Manager Medex, Inc. · 6250 Shier Rings Road Dublin, Ohio 43016-1295

Re: K020780

Trade/Device Name: TranStar Intracranial Pressure Transducer Regulation Number: 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: March 8, 2002 Received: March 11, 2002

Dear Ms. Law:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a rowe and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are based or 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Barbara Law

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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## Indications for Use Statement

510(k) Number (if known):

K.020780.

TranStar Intracranial Pressure Transducer Device Name:

Indications for Use:

The TranStar Intracranial Pressure Transducer is intended for external monitoring of Intracranial pressures (ICP). Intracranial pressure waveforms are conducted from the patient to the transducer through a column of fluid. The fluid pressure waveforms are converted into electrical signals that can then be displayed using separate monitoring equipment.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020780

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use