(91 days)
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Not Found
No
The document describes a sensor amplifier and does not mention any AI or ML capabilities.
No
The device is described as an "amplifying interface" for sensor output and recording equipment, intended for "sleep labs." Its function is to provide a higher input signal for recording equipment, not to directly treat or diagnose a medical condition.
No
The device is described as an "amplifying interface" for sensor output and recording equipment, intended for "sound labs" where "recording equipment requires a higher input signal." It facilitates the recording of data but does not interpret or analyze that data to make a diagnosis or inform a diagnosis.
No
The device description is not found, but the intended use explicitly states it provides an "amplifying interface between Pro-Tech sensor output and customer recording equipment input." This strongly suggests the device is a hardware component (an amplifier) that processes a signal from a sensor, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "PROVIDE AN AMPLIFYING INTERFACE BETWEEN PRO-TECH SENSOR OUTPUT AND CUSTOMER RECORDING EQUIPMENT IN PUT." This describes a device that modifies or processes a signal from a sensor, not a device that is used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on the analysis of such samples.
- Function: The device acts as an amplifier for a sensor output, which is a signal processing function, not an in vitro diagnostic test.
Therefore, based on the provided text, this device does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 SUBJECTS (CHILDREN & ADULTS) WHERE THE RECORDING EQUIPMENT REQUIRES A HIGHER INPUT SIGNAL, THE DEVICE IS INTENDED FOR SLEEP LABS.
Product codes
84GWL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
CHILDREN & ADULTS
Intended User / Care Setting
SLEEP LABS
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle's head, represented by three curved lines.
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.
1
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | |
| Prescription Use | |
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
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