(106 days)
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No
The summary describes a physiological signal amplifier and does not mention any AI or ML capabilities, image processing, or data analysis beyond signal acquisition and transmission.
No
Explanation: The device is described as an amplifier for the acquisition and transmission of physiological signals (EEG, polygraphy, polysomnography) for research and exams, not for treatment.
Yes
The device is described as acquiring signals for "recording of neurophysical/physiological research and exams," which implies the collection of data for diagnostic purposes (e.g., EEG, polygraphy, polysomnography signals to assess neurological and physiological conditions).
No
The intended use describes a "Physiological Amplifier family" which is a hardware device used for signal acquisition and transmission. While software is likely involved in processing and displaying the signals, the core function relies on a physical amplifier.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the acquisition and transmission of physiological signals (EEG, polygraphy, polysomnography) during neurophysical/physiological research and exams. This involves measuring signals from the body, not analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
IVDs are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is designed to capture electrical and other physiological signals directly from the body.
N/A
Intended Use / Indications for Use
The REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neurophysical/ physiological research and exams.
Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.
Product codes
GWL
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
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Intended User / Care Setting
by or under the direction of a physician
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 30 2006
TMS International BV % Mr. David W. Wagner U.S. Agent 7744 Swaps Trail Evergreen, Colorado 80439
Re: K060374
Trade/Device Name: REFA Physiological Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: May 12, 2006 Received: May 12, 2006
Dear Mr. Wagner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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
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Page 2 - Mr. David W. Wagner
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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
el-mee
Mark N. Melkerson 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
510(k) Number K060374:
Device Name: REFA Physiological Amplifier
The REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neurophysical/ physiological research and exams.
Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-counter use _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) 60-0 Division of General, Restorative and Neurological Devices
KO60374 510(k) Number_