(56 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor with data upload capabilities, and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks descriptions of training or test sets typically associated with AI/ML development.
No.
The device's stated intended use is to "Measure blood pressure (systolic and diastolic) and pulse rate," which is for diagnostic or monitoring purposes, not for treating a condition.
Yes
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly states it uses an inflatable cuff, an internal pump, and an electronic-controlled exhaust valve, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- Device Function: The A&D Medical UA-851THW blood pressure monitor measures blood pressure and pulse rate directly from the patient's upper arm. This is a non-invasive measurement performed on the living body.
- Lack of Specimen Analysis: The device does not analyze any biological specimens.
Therefore, based on its intended use and how it functions, the A&D Medical UA-851THW is a non-IVD medical device.
N/A
Intended Use / Indications for Use
The A&D Medical UA-851THW 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.
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-851THW 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-851THW 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. There is a maximum pressure safety setting at 300mmHg. The culT will inflate higher than 300mmHg. The arm distribution range is from 5.1" to 17.7" (13 cm to 45 cm). At the end of the measurement, the result can be uploaded to a PC with ActiLink USB transceiver and viewed by the Wellness Connected software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
October 17, 2008
NOV 1 3 2008
2. CONTACT INFORMATION
A&D Engincering, Inc. Mr. Jerry Wang 1756 Automation Parkway, Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang(@andmedical.com
3. DEVICE NAME
| Proprietary Name: | A&D Medical UA-851THW 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. |
4. DEVICE DESCRIPTION AND INTENDED USE
The A&D Medical UA-851THW 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-767PBT digital blood pressure monitor with FDA 510(k) K043217
A&D LifeSource model UA-789 digital blood pressure monitor with FDA 510(k) K062027.
Both devices are designed and manufactured by the same company and facility as the UA-851THW digital blood pressure monitor.
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TECHNOLOGICAL and OPERATIONAL CHARACTERISTICS 6.
UA-851THW 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. There is a maximum pressure safety setting at 300mmHg. The culT will inflate higher than 300mmHg. The arm distribution range is from 5.1" to 17.7" (13 cm to 45 cm). At the end of the measurement, the result can be uploaded to a PC with ActiLink USB transceiver and viewed by the Wellness Connected software.
7. SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Parameter | Predicate Devices
(UA-789 & UA-767PBT) | UA-851THW |
|-----------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------|
| Measurement
Method | Oscillometric Method | No change – the same |
| Measurement
Range | BP : 20 to 280 mmHg
Pulse : 30 to 200 pulse/min | No change – the same |
| Accuracy | BP : +/- 3mmHg or +/- 2% of
measured value, whichever is
greater
Pulse : +/- 5 % (pulse) | No change – the same |
| Pressurization
Source | Automatic internal pump | No change – the same |
| Cuff Deflation | Automatic constant speed
mechanical exhaust valve | No change – the same |
| Data Memory
Size with Time
& Date | 40 memories for UA-767PBT
60 memories for UA-789 | 51 memories |
| Irregular
Heartbeats
Detection | More than +/-25% to the mean
interval of all pulse intervals | No change – the same |
| Power Source | 6V DC, 4x1.5V AA batteries
or AC adapter as an option | No change – the same |
| Battery Life | 4 months with daily
measurement | No change – the same |
| Operating
Environment | 50°F (10°C) to 104°F (40°C) at
less than 85% RH | No change – the same |
| Storage
Environment | 14°F (-20°C) to 140°F (60°C)
at less than 85% RH | No change – the same |
| Dimensions | 80(H) x 110(W) x 120(L) mm | 160(H) x 150(W) x 125(L) mm |
Product Specification Comparison
2
| Cuff
Attachment
Method | By plastic hose connected to
monitor | No change – the same |
|------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------|
| Arm Size | UA-767PBT – 5.1" to 17.7"
(13 cm to 45cm)
UA-789 – 9.4" to 23.6" (24 cm
to 60 cm) | No change – the same as UA-
767PBT |
| Weight | UA-767PBT – 920 g (2.03 lb)
without batteries
UA-789 – 940 g (2.07 lb)
without batteries | 930 g (2.05 lb) without
batteries |
| Display Type | Liquid crystal display | No change – the same |
Major changes from the predicate devices:
- Replace the radio in the UA-767PBT with a new one into UA-851THW .
- Change the plastic molds from UA-789 to UA-851THW .
These changes do not affect the devices' intended use or alter the device's fundamental scientific technology. There is no significant difference that affects the safety or effectiveness of the intended device as compared to the predicate devices.
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Public Health Service
Image /page/3/Picture/2 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 wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2008
A & D Engineering, Inc. c/o Mr. Jerry Wang Director of Engineering 1756 Automation Parkway San Jose, CA 95131
Re: K082734
Trade/Device Name: A&D Medical LifeSource UA-851THW Digital Blood Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 17, 2008 Received: October 22, 2008
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, Frug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA). 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. 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
4
Page 2 - Mr. Jerry Wang
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 clectronic prochet 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 10gally 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 entilled, "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 Suall 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,
Duna D. Holmes
Bram D. Zuckerman, M.D. - Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment B
Indications for Use
510(k) Number (if known): اِک ه ک ی 34
Device Name: A&D Medical LifeSource UA-851THW 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)
Duma R. Varner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K082734
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