COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR

K970769 · Aristo Medical · DQA · Aug 28, 1997 · Cardiovascular

Device Facts

• Record ID: K970769
• Device Name: COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
• Applicant: Aristo Medical
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Device Story

ComSat Pulse Oximeter Probes are sensors used for non-invasive monitoring of arterial oxygen saturation. The device functions by transmitting light through tissue and detecting the resulting signal to calculate oxygen saturation levels. It is intended for use in clinical settings by healthcare professionals for continuous or spot-check monitoring. The output is displayed on a compatible pulse oximeter monitor, assisting clinicians in assessing patient oxygenation status and guiding clinical decision-making regarding respiratory support or intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulse oximeter probe; utilizes optical sensing (light transmission/detection) for arterial oxygen saturation measurement. Form factor is a sensor probe compatible with pulse oximeter monitors.

Indications for Use

Indicated for continuous or spot monitoring of non-invasive arterial oxygen saturation in patients requiring such monitoring.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

AUG 28 1997

Mr. Lane F. Beard
Sensor Devices, Inc.
c/o Aristo Medical USA
1801-A Airport Road
Waukesha, Wisconsin 53188

Re: K970769
ComSat Oximeter Sensors
Regulatory Class: II (two)
Product Code: 74 DQA
Dated: June 30, 1997
Received: July 1, 1997

Dear Mr. Beard:

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 requirements, 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 - Mr. Lane F. Beard

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

Enclosure

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510(k) Number (if known): K970769

Device Name: ComSat Pulse Oximeter Probes

Indications for Use: Continuous or spot monitoring of non-invasive arterial oxygen saturation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)



OR

Over-The-Counter Use

(Optional Format 1-2-96)