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I am sorry, but based on the provided document, I cannot describe the acceptance criteria or any study details that prove the device meets those criteria.
This document is a 510(k) clearance letter from the FDA for a device called "PRO2 Check Oxygen Indicator." It states that the device is substantially equivalent to legally marketed predicate devices. However, it does not include information about specific acceptance criteria for performance, nor does it detail any studies, performance metrics, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your request.
The letter focuses on regulatory approval based on substantial equivalence to existing devices, and not on presenting a detailed performance study like what would be found in a clinical trial report or a more comprehensive technical submission.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 22 1999
Mr. Donald W. Morrow, III Medical Technology Specialists 6290-D Warwick Road Richmond, VA 23224
Re: K983500 PRO2 Check Oxygen Indicator Regulatory Class: II (two) Product Code: 73 CCL Dated: February 25, 1999 Received: February 26, 1999
Dear Mr. Morrow:
This letter corrects our substantially equivalent letter of March 17, 1999, regarding the error in your 510(k) number.
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 leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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
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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.
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/dsma/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
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).