SENSOR AMPLIFIER

K972515 · Pro-Tech Services, Inc. · GWL · Oct 2, 1997 · Neurology

Device Facts

• Record ID: K972515
• Device Name: SENSOR AMPLIFIER
• Applicant: Pro-Tech Services, Inc.
• Product Code: GWL · Neurology
• Decision Date: Oct 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1835
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

TO PROVIDE AN AMPLIFYING INTERFACE BETWEEN PRO-TECH SENSOR OUTPUT AND CUSTOMER RECORDING EQUIPMENT IN PUT. THE SENSOR ANPLIFIER IS TO BE USED WITH SUBTETS (CHILDRING E ADVES) WHERE THE RECORDING EQUIPMENT REQUIRES A HIGHER INPUT SIGNAL , THE DOVE IS INFENDED FOR SLOUD LABS.

Device Story

Sensor Amplifier serves as signal conditioning interface; connects Pro-Tech sensors to external recording equipment. Device receives low-level sensor signals; amplifies signal amplitude to meet input requirements of recording systems. Used in sleep labs; operated by clinical staff. Output allows clinicians to record physiological data from patients; facilitates diagnostic monitoring in sleep studies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Signal amplification interface; analog circuitry; designed for integration with Pro-Tech sensors and third-party recording equipment.

Indications for Use

Indicated for use in sleep labs with pediatric and adult subjects where recording equipment requires a higher input signal from Pro-Tech sensors.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 2 1997

Mr. Anthony Zaragoza Pro-Tech Services, Inc. P.O. Box 2165 12826 NE 178th Street, Suite A Woodinville, Washington 98072

K972515 Re: Trade Name: Sensor Amplifier Regulatory Class: II Product Code: 84GWL June 30, 1997 Dated: Received: July 3, 1997

Dear Mr. Zaragoza:

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 reqistration, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq 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. Michael Fowler

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

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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Kanasis/A'

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510(k) Number (if known):K97 2515

Device Name: SENSOR AMPLIFIER

Indications For Use:

TO PROVIDE AN AMPLIFYING INTERFACE BETWEEN PRO-TECH SENSOR OUTPUT AND CUSTOMER RECORDING EQUIPMENT IN PUT.

THE SENSOR ANPLIFIER IS TO BE USED WITH SUBTETS (CHILDRING E ADVES) WHERE THE RECORDING EQUIPMENT REQUIRES A HIGHER INPUT SIGNAL , THE DOVE IS INFENDED FOR SLOUD LABS.

7/11/97

ANTHONY ZARAGOZA

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Thomas J. Callahan*

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| Division of Cardiovascular, Respiratory, and Neurological Devices | |
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| Prescription Use | <div> <img alt="Checkmark" src="checkmark.png"/> </div> |
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| Over-The-Counter Use | |
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