(481 days)
Objective measurement device in "blocked nose" situations Deviated septums e.g. Allergic rhinitis Enlarged adenoids With the possibility of absolute and pre/post surgical or treatment comparisons.
A1 Acoustic Rhinometer
This document appears to be an FDA 510(k) clearance letter for the "A1 Acoustic Rhinometer", dated September 30, 1998. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about training/test sets, ground truth establishment, or expert involvement.
The letter primarily focuses on the regulatory aspects of substantial equivalence for marketing purposes, rather than detailing the technical validation study results. Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, sample sizes, or ground truth establishment based on the provided input.
To answer your request, you would need to provide the actual 510(k) submission document or a separate technical report detailing the performance testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures, possibly representing the department's focus on people and well-being.
SEP 3 0 1998
Eric Greig Managing Director G.M. Instruments, Ltd. Unit 6, Ashgrove Ashgrove Road Kilwinning, Ayrshire KA 13 6PU Scotland, UK
Re:
K972140 Al Acoustic Rhinometer Dated: August 18, 1998 Received: August 27, 1998 Regulatory class: II 21 CFR 868.1800/Procode: 73 BXQ
Dear Mr. Greig:
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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 obligation you might have under sections 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) 594-4613. 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.ida.gowcdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin, Ph.D.
Lillian Yin. Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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510(k) Number (if known): K972140
Device Name: A1 Acoustic Rhinometer
Indications For Use:
Objective measurement device in "blocked nose" situations
Deviated septums e.g. Allergic rhinitis Enlarged adenoids
With the possibility of absolute and pre/post surgical or treatment comparisons.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number
Image /page/1/Picture/10 description: The image shows the words "Prescription Use" in bold font. Underneath this text, the words "(Per 21 CFR 801.109)" are printed in a smaller font size. A check mark is present to the right of the words "Prescription Use".
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 868.1800 Rhinoanemometer.
(a)
Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.(b)
Classification. Class II (performance standards).