PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM

K953893 · Biomedical Sensors, Inc. · CCC · Nov 4, 1997 · Anesthesiology

Device Facts

• Record ID: K953893
• Device Name: PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
• Applicant: Biomedical Sensors, Inc.
• Product Code: CCC · Anesthesiology
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1150
• Device Class: Class 2

Device Story

The Fluorescent Paratrend 7 Intravascular Monitoring System (MPM7000S) is an intravascular monitoring device designed for continuous physiological measurement. It utilizes fluorescent sensing technology to monitor blood gas and pH parameters. The system is intended for use in clinical settings by healthcare professionals to provide real-time data, facilitating clinical decision-making regarding patient respiratory and metabolic status. The device provides continuous monitoring, potentially benefiting patients by allowing for rapid intervention in response to changes in blood chemistry.

Technological Characteristics

Intravascular monitoring system utilizing fluorescent sensing technology for blood gas and pH measurement. Operates as a Class III device under product code 73 CCC.

Regulatory Classification

Identification

An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

NOV - 4 1997

Food and Drug Administration

9200 Corporate Boulevard

Rockville MD 20850

Ms. Jan L. Walters
Diametrics Medical Limited
Short Street
High Wycombe
Bucks, HP11 2QH
ENGLAND

Re: K953893
Fluorescent Paratrend 7 Intravascular Monitoring System
(MPM7000S)
Regulatory Class: III (three)
Product Code: 73 CCC
Dated: September 19, 1997
Received: September 23, 1997

Dear Ms. Walters:

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 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. Jan L. Walters

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