(83 days)
The Bortec Biomedical Analog Multiplexed cable Telemetry (AMT) electromyograph is intended for non-invasive use as a research or diagnostic sensing and processing instrument in studies of physiological signals. The AMT is indicated for use with active or passive adult or pediatric subjects in hospitals or clinics under the direction of a health care professional during electromyography, including bio-feedback, evoked potential, kinesiological, nerve conductance and sleep studies.
Analog Multiplexed cable Telemetry (AMT) electromyograph
The provided text is a 510(k) clearance letter from the FDA for the Bortec Biomedical, LTD. Analog Multiplexed Cable Telemetry (AMT) Electromyograph. This document is a regulatory approval and does not contain the acceptance criteria or details of a study proving the device meets those criteria, nor does it provide information about AI-specific performance metrics.
The letter states that the device has been reviewed and determined to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA found the new device to be as safe and effective as a device already on the market, but it does not require the submission of detailed performance studies in the same way a novel device might.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance studies based on the provided input. The document focuses on regulatory compliance and indications for use, not detailed technical performance data or specific study designs.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bortec Biomedical, LTD. Carl Youngman, Ph.D. c/o Regulatory Affairs Associates 936-11th Avenue East Seattle, Washington 98102
Re: K023147
Trade/Device Name: Analog Multiplexed Cable Telemetry (AMT) Electromyograph Regulation Number: 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: Class II Product Code: IKN Dated: September 18, 2002 Received: September 20, 2002
Dear Dr. Youngman:
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
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Page 2 - Dr. Carl Youngman
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 (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Muriam C. Provost
W Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BORTEC BIOMEDICAL AMT Electromyograph 510(k)
Indications for Use Statement
510(k) Number: Ko23147
Analog Multiplexed cable Telemetry (AMT) electromyograph Device Name:
Indications for Use:
The Bortec Biomedical Analog Multiplexed cable Telemetry (AMT) electromyograph is intended for non-invasive use as a research or diagnostic sensing and processing instrument in studies of physiological signals. The AMT is indicated for use with active or passive adult or pediatric subjects in hospitals or clinics under the direction of a health care professional during electromyography, including bio-feedback, evoked potential, kinesiological, nerve conductance and sleep studies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign-Off
ivision Sign-Off, Division of Guneral, Restorative nd Neurological Devices
Prescription Use (Per 21 CFR §801.109)
OR Over-The-Counter Use
Indications for Use Statement
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).