(34 days)
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No
The summary describes a standard digital blood pressure monitor using the oscillometric method and makes no mention of AI or ML.
No
The device is used for monitoring blood pressure and pulse rate, which is a diagnostic or monitoring function, not a treatment or therapeutic one.
No
Explanation: The device is described as a blood pressure monitor used to "monitor blood pressure (systolic and diastolic) and pulse rate." While monitoring is a component of healthcare, it doesn't inherently make the device diagnostic. Diagnostic devices typically identify or confirm the presence of a disease or condition, which is not stated as the primary function here. It provides physiological measurements, but the text doesn't indicate it interprets these measurements to diagnose a condition.
No
The device description explicitly states "Digital Blood Pressure Monitors," indicating a hardware device that uses the oscillometric method for measurement. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The A&D Medical LifeSource UA-779PC & UA-779T are blood pressure monitors. They measure blood pressure and pulse rate directly from the body using the oscillometric method. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use is to monitor blood pressure and pulse rate, not to perform diagnostic tests on biological samples.
Therefore, based on the provided information, this device falls under the category of a general medical device for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The A&D Medical LifeSource UA-779PC & UA-779T are designed to be used by end users who are eighteen (18) years and older at home and doctor/nuse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC &UA-779T uses the oscillometric method to conduct the measurement.
Product codes
DXN
Device Description
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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
eighteen (18) years and older
Intended User / Care Setting
end users...at home and doctor/nuse office
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 1999
A&D Engineering, Inc. c/o Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462
кадзава Re : A&D Medical, Models UA-779PC, UA-779T Requlatory Class: II (two) Product Code: DXN November 15, 1999 Dated: Received: November 16, 1999
Dear Mr. Mosenkis:
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, thereforc, 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 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 - Mr. Robert Mosenkis
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,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): ___ Kココラ888
Device Name: A&D Medical LifeSource UA-779PC & UA-779T Digital Blood Pressure Monitors
Indications for Use:
The A&D Medical LifeSource UA-779PC & UA-779T are designed to be used by end users who are eighteen (18) years and older at home and doctor/nuse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC &UA-779T uses the oscillometric method to conduct the measurement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use QI Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ ×
(Optional Format 1-2-96)
Dele K. Looper le
Division Sign-Off
Ivision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _ K993888
NIBP510(k) docs