(185 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and does not mention any AI or ML components or functionalities.
No
The device measures blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status, fitting the definition of a diagnostic device.
No
The device description explicitly mentions hardware components such as an inflatable cuff, internal pump, and electronic-controlled exhaust valve, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The A&D Medical UA-789 digital blood pressure monitor measures blood pressure and pulse rate directly from the patient's upper arm using an inflatable cuff and the oscillometric method. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
Therefore, the device's function and method of operation clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The A&D Medical UA-789 digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
Indications For Use: Measure blood pressure (systolic and diastolic) and pulse rate.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The A&D Medical UA-789 digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate. UA-789 uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal electronic-controlled exhaust valve. There is a quick exhaust mechanism so that the pressure of the cuff can be completely released. The arm distribution range is from 9.4" to 23.6" (24 cm to 60 cm). The accuracy and effectiveness of the extra large cuffs used in UA-789 have been validated through the ANSI/AAMI SP-10 standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adults with 12 years older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Attachment (D) 510(k) Summary
1. DATE PREPARED
July 14, 2006 (original). September 1, 2006 (revised).
JAN 1 9 2007
2. SPONSOR INFORMATION
A&D Engineering, Inc. Mr. Jerry Wang 1555 McCandless Drive, Milpitas, CA 95035 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang@aandmedical.com
3. DEVICE NAME
| Proprietary Name: | A&D Medical UA-789 Digital Blood Pressure Monitor |
|---|---|
| Common/Usual Name: | Blood Pressure Monitor |
| Classification name: | Non-invasive blood pressure measurement System |
| 21 CFR 870-1130, Class II, 74DXN. |
DEVICE DESCRIPTION AND INTENDED USE 4.
The A&D Medical UA-789 digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
5. PREDICATE DEVICE
A&D LifeSource model UA-787 digital blood pressure monitor with FDA 510(k) K012472.
6. TECHNOLOGICAL CHARACTERISTICS
UA-789 uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and
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diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal electronic-controlled exhaust valve. There is a quick exhaust mechanism so that the pressure of the cuff can be completely released. The arm distribution range is from 9.4" to 23.6" (24 cm to 60 cm).
The accuracy and effectiveness of the extra large cuffs used in UA-789 have been validated through the ANSI/AAMI SP-10 standard.
7. DEVICE TESTING
A&D Medical UA-789 digital blood pressure monitor meets the following standards:
- ANSI/AAMI SP-10 standard .
- . European Directive 93/42 EEC for Medical Products
- EN60601 General Safety Provisions .
- EN60601-2-30 Particular Requirements for the Safety of BP Monitor .
- EN60601-1-2 and EN55011 Electromagnetic Compatibility .
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A&D Engineering, Inc. c/o Mr. Jerry Wang Director of Engineering and QA 1555 McCandless Dr. Milpitas, CA 95035
JAN 1 9 2007
Re: K062027
Trade Name: A&D Medical LifeSource UA-789 Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: January 3, 2007 Received: January 4, 2007
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Wang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO62027
Attachment B
Indications for Use
510(k) Number (if known):
Device Name: A&D Medical LifeSource UA-789 Digital Blood Pressure Monitor
Indications For Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Syn Off
Division of Cardiovascular Devices
510(k) Number K062027
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