(223 days)
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Not Found
No
The description explicitly states the device uses a "manual method for detecting Knorokoff sounds" and is a "Genmed Aneroid Sphygmomanometer," which is a traditional, non-electronic blood pressure device. There is no mention of AI, ML, or any computational analysis of data.
No
The device is described as an "Aneroid Sphygmomanometer" intended for the "measurement of systolic and diastolic pressure". Its function is diagnostic (measurement), not therapeutic (treatment).
Yes
Explanation: The device is described as an "Aneroid Sphygmomanometer" intended for the "measurement of systolic and diastolic pressure on adults." This measurement provides information about a patient's health status, which is a diagnostic function.
No
The device description explicitly states "Genmed Aneroid Sphygmomanometer," which is a hardware device used for measuring blood pressure. The description also mentions manual attachment, inflation, and detection of Korotkoff sounds, all of which are physical actions associated with a hardware sphygmomanometer. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the measurement of systolic and diastolic blood pressure on adults. This is a physiological measurement taken directly from the patient's body.
- Device Description: It's an Aneroid Sphygmomanometer, a device used for measuring blood pressure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
Therefore, the Genmed Aneroid Sphygmomanometer is a medical device, but it falls under the category of devices used for direct physiological measurement, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
DXN
Device Description
Genmed Aneroid Sphygmomanometer
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
adults
Intended User / Care Setting
medical professionals or in the home / medical personnel or for home use
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
§ 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).
0
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:
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.
Pre scription
Bore R. Kemperle
-1011sion > Cardiovascular, Respiratory, ogical Devi 510(k) Nomber_