(108 days)
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Not Found
No
The summary focuses on signal acquisition and transmission, with no mention of AI, ML, or related concepts.
No.
Explanation: The device is described as an "amplifier" for "acquisition" and "transmission" of physiological signals for "research and exams," not for treating or diagnosing any condition.
Yes
The device is described as an amplifier for acquiring physiological signals (EEG, polygraphy, polysomnography) for "neuro-physical/physiological research and exams," which implies its use in diagnosing conditions based on these signals.
No
The device description is not found, but the intended use explicitly states the device is a "Physiological Amplifier" intended for the "acquisition" and "transmission" of physiological signals. This strongly implies the presence of hardware components for signal acquisition, which would disqualify it as a software-only device.
Based on the provided information, the Porti Physiological Amplifier 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, etc.) from a patient's body. This is a direct measurement of physiological processes within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The Porti Physiological Amplifier does not process such samples.
- Lack of IVD-related information: The provided text does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing performed on samples outside the body.
The device functions as a physiological signal amplifier and data acquisition system, which falls under the category of medical devices used for monitoring and recording physiological activity in vivo.
N/A
Intended Use / Indications for Use
The Porti Physiological Amplifier is intended to be use by or under the directions of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/physiological research and exams.
Polygraphy and polysmnography may besides EEG, include physiological information such as EMG, ECG, EGG, 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
Not Found
Intended User / Care Setting
by or under the directions 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)
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 consists of a stylized eagle-like symbol with three overlapping curved lines, representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TMS International BV c/o Mr. David W. Wagner Quality for Quality Consulting 7744 Swaps Trail Evergreen, CO 80439
MAR 2 2 2007
Re: K063599
Trade Name: Porti 7 Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: March 14, 2007 Received: March 19, 2007
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 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.
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Page 2 - Ms. Laetitia Cousin
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely v
For
Mark N. Melkerson
Director
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 K063599
The Porti Physiological Amplifier is intended to be use by or under the directions of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/physiological research and exams.
Polygraphy and polysmnography may besides EEG, include physiological information such as EMG, ECG, EGG, EGG, PH, Respiration, Temperature and Oxygen Saturation.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L063555
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-counter use
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