ANEROID SPHYGMOMANOMETER by GENMED, INC.

These devices are intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Knorokoff sounds. This device is indicated for use by medical personnel or for home use.

Device Description

Genmed Aneroid Sphygmomanometer

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a Genmed Aneroid Sphygmomanometer. It declares the device substantially equivalent to legally marketed predicate devices for the measurement of systolic and diastolic pressure on adults, for use by medical professionals or in the home.

However, the document does NOT contain information about:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size.
If a standalone performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

This is a regulatory clearance document, not a clinical study report or a technical performance evaluation. Therefore, it does not detail the specific performance metrics or studies used to demonstrate the device meets acceptance criteria, beyond the FDA's determination of "substantial equivalence" to a predicate device. Substantial equivalence typically relies on demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if it has different characteristics, that it does not raise different questions of safety and effectiveness. This often involves adherence to recognized standards and sometimes limited performance testing, but the specifics are not included in this letter.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three lines representing the branches of government.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ОСТ 7 1999

Leonard Frier, P.E. MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, MD 21230-3432

Re: K990638/S2 Genmed Aneroid Sphygmomanometer Requlatory Class: II (two) Product Code: DXN Dated: July 29, 1999 Received: August 2, 1999

Dear Mr. Frier:

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 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). 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 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 Requlation (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 requlatory 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Leonard Frier, P.E.

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" (21CFR 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

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510(k) NUMBER: K990638

DEVICE NAME: Genmed Aneroid Sphygmomanometer

INDICATIONS FOR USE STATEMENT:

Pre scription

Bore R. Kemperle

-1011sion > Cardiovascular, Respiratory, ogical Devi 510(k) Nomber_

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).