UA-651 uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is inflated automatically by an internal pump of UA-651. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300mmHg. UA-651 will not inflate the cuff higher than 300mmHg. UA-651 will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the A&D Medical UA-651 Digital Blood Pressure Monitor. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance Study Information:

For a non-invasive blood pressure measurement system like the UA-651, the crucial acceptance criteria revolve around its accuracy in measuring blood pressure and pulse rate. The document indicates that the device's accuracy specifications are unchanged from its predicate devices, which suggests these specifications were previously found acceptable.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (Predicate Devices)	Reported Device Performance (UA-651)
Accuracy (BP)	+/- 3 mmHg or +/- 2% of measured value, whichever is greater	No change – the same (i.e., +/- 3 mmHg or +/- 2% of measured value, whichever is greater)
Accuracy (Pulse)	+/- 5 % (pulse)	No change – the same (i.e., +/- 5 % (pulse))
Measurement Range (BP)	20 to 280 mmHg	No change – the same (i.e., 20 to 280 mmHg)
Measurement Range (Pulse)	30 to 200 pulse/min	No change – the same (i.e., 30 to 200 pulse/min)
IHB Detection	More than +/-25% to the mean interval of all pulse intervals	No change – the same (i.e., more than +/-25% to the mean interval of all pulse intervals)

Important Note: The document consistently states "No change – the same" for the UA-651's performance characteristics compared to the predicate devices. This implies that the previous clearance of the predicate devices established these as acceptable performance criteria, and the current device meets them due to technological equivalence. The document does not provide new, specific test results for the UA-651 to explicitly prove it meets these criteria in this submission. Instead, it relies on the argument of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide details on a specific clinical test set for the UA-651 itself. Since the submission relies on demonstrating substantial equivalence to predicate devices, it asserts that the modifications (primarily cosmetic changes and removal of certain features) do not affect safety or effectiveness. Therefore, a new, comprehensive clinical study with a dedicated test set and sample size specifically for the UA-651's accuracy is not detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document as there is no description of a new clinical study to establish ground truth for the UA-651.

4. Adjudication Method for the Test Set:

This information is not provided in the document as there is no description of a new clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study is not mentioned or implied in this document. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. Blood pressure monitors are automated devices, and their performance is typically assessed through direct comparison to a reference standard, not through human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The blood pressure monitor is an inherently standalone device in terms of its measurement algorithm. It measures blood pressure without direct human real-time intervention in the measurement process itself (though a human initiates the measurement). The accuracy specifications (e.g., +/- 3 mmHg) inherently represent the standalone performance of its oscillometric algorithm. However, the document does not describe a new standalone study conducted for the UA-651. It relies on the standalone performance of its predicate devices.

7. Type of Ground Truth Used:

For blood pressure monitors, the gold standard (ground truth) is typically a sphygmomanometer (manual blood pressure measurement using a stethoscope and cuff), often performed by trained clinicians, or an invasive arterial line measurement. While the document doesn't explicitly state the type of ground truth a reference standard to which the predicate devices were compared, it's implicitly understood that such a reference standard was used in the original validation of the predicate devices to establish their accuracy claims. No new ground truth establishment is described for the UA-651.

8. Sample Size for the Training Set:

The concept of a "training set" is usually associated with machine learning algorithms where data is used to train a model. While the oscillometric method involves algorithms, they are typically based on established physiological principles and signal processing, rather than iterative machine learning training on a large dataset in the modern sense. Therefore, the document does not mention a specific training set size.

9. How the Ground Truth for the Training Set Was Established:

As above, the concept of a "training set" in the context of modern machine learning is not directly applicable or discussed. The underlying algorithms for oscillometric blood pressure measurement would have been developed and validated against established physiological principles and clinical data during the development of the predicate devices, likely using reference methods for ground truth (as described in point 7). The document does not detail this process for the UA-651 or its predicate devices' initial development.

In summary: The submission for the A&D Medical UA-651 hinges on the argument of "substantial equivalence" to its predicate devices. This means that instead of presenting new studies for the UA-651, it asserts that because the core technological and operational characteristics related to blood pressure measurement are unchanged, and the modifications are primarily aesthetic or involve the removal of non-critical features, the UA-651 is presumed to have the same performance as the already-cleared predicate devices. The details about sample sizes, experts, adjudication, and specific ground truth establishment are not provided for the UA-651 itself in this document, as those would have been part of the original predicate device clearances.

Summary

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol of a human figure, represented by three stylized profiles facing to the right, one behind the other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 7, 2014

A & D Engineering, Inc. Mr. Jerry Wang Director of Engineering 1756 Automation Parkway San Jose, CA 95131

Re: K141160

Trade/Device Name: A&D Medical UA-651Digital Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: September 5, 2014 Received: September 8, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Jerry 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For 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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Indications for Use

510(k) Number (if known): K141160

Device Name: A&D Medical UA-651 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

X ============================================================================================================================================================================ 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)

Page 1 of _ 1

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K141160

510(k) Summary

This summary of 510(k) safety and effective information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1. Date Prepared
  Octorber 03, 2014

2. Submitter's Information

A&D Engineering, Inc. Mr. Jerry Wang 1756 Automation Parkway, San Jose, CA 95131 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang@andonline.com

3. Device Information

Proprietary Name:	A&D Medical UA-651Digital 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. Predicate Devices

A&D Model UA-1000 Family Digital Blood Pressure Monitors with 510(k) number K111686

A&D Model UA-767PBT Digital Blood Pressure Monitor with 510(k) number K043217 Predicate devices are designed and manufactured by the same company and facilities as the modified devices UA-651.

ട്. Device Description - Technological and Operational Characteristics

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6. Intended Use & Indicator for Use

Indended use: The A&D Medical UA-651 family digital blood pressure monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.

Indications for Use: Measure blood pressure (systolic and diastolic) and pulse rate.

The intended user and the indication for use of A&D Medial UA-651 as described in the labeling are the same as their predicated devices, UA-1000 family and UA-767PBT.

7. Summary of Substantial Equivalence

Modifications made from the predicate devices:

Change the plastic molds so UA-651 has a different appearance ●
Reduce memory size and remove AM / PM function ●
Remove the following functions from UA-1000 family Voice, Tricheck, and ● AM/PM measurement average.
. Remove the Bluetooth wireless communication from UA-767PBT.

Parameter	Predicate Devices(UA-1000 family & UA-767PBT)	Modified Devices(UA-651)
Power source	4 AA size batteries and ACadaptor as an option	No Change – the same
Battery Life	4 months with daily measurement	No change – the same
MeasurementMethod	Oscillometric Method	No change – the same
MeasurementRange	BP : 20 to 280 mmHgPulse : 30 to 200 pulse/min	No change – the same
Accuracy	BP : +/- 3mmHg or +/- 2% ofmeasured value, whichever isgreaterPulse : +/- 5 % (pulse)	No change – the same
PressurizationSource	Automatic internal pump	No change – the same
Cuff DeflationMethod	UA-767PBT – Standard exhaustvalveUA-1000 family – Constant speedelectrical controlled exhaust valve(ECEV method)	No change – the same asUA-767PBT
Display Type	Liquid crystal display	No change – the same
Cuff AttachmentMethod	By plastic hose connected tomonitor	No change – the same
IHB (Irregular	More than +/-25% to the mean	No change – the same

Product Specification Comparison

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HeartbeatsDetection)	interval of all pulse intervals
OperatingEnvironment	50°F (10°C) to 104°F (40°C)30 %RH to 85% RH	No change - the same
StorageEnvironment	14°F (-20°C) to 140°F (60°C)10 %RH to 95% RH	No change - the same
Pressure Indicator	UA-1000 family (Yes) under USAJUC VII guideline	No change - the same
Data Memory Sizewith Time & Date	90 memories for UA-1000 family40 memories for UA-767PBT	Reduce to 30 memories
Pressure Sensor design	Static electricity capacity type	No change - the same
Dimensions in mm	UA-767PBT: 163.7 x 111 x 66.7UA-1000 Family: 140 x 60 x 105	190 x 83 x 165
Weight	UA-1010–265gUA-1020–285gUA-1030T–300g without batteries	300g without batteries
Cuff Design	UA-767PBT – D-ring cuffsUA-1000 family – U-shape cuffs	No change - the same asUA-767PBT
Arm Size	UA-289 small cuff : 16 to 24 cmUA-290 medium cuff : 23 to 37 cmUA-291 large cuff : 31 to 45 cm	No change
Clock (Time/Date)	Yes for UA-1020 and UA-1030T	Removed
Talking	Yes - UA-1030T, No - others	Removed
AM/PM	Yes – UA-1020 & UA-1030T	Removed
Wireless RadioConnectivity	UA-1000 family (No), UA-767PBT (Yes)	Removed
Personal PCAnalysis Software	UA-1000 family (No), UA-767PBT (Yes)	Removed

Key Features Comparison

Parameter	Predicate Devices(UA-1000 family & UA-767PBT)	Modified Devices(UA-651)
Field service	Not allowed	No Change - the same
Automatic zero at "START"	Yes	No Change - the same
Manual zero adjustment	Not allowed	No Change - the same
Calibration	Not allowed in the field	No Change - the same
Sterilization	Not needed	No Change - the same

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Substantial Equivalence Conclusion:

UA-651 Digital blood pressure monitors have the following similarities to the predicate devices, UA-1000 family and UA-767PBT digital blood pressure monitors, which previously received the 510(k) clearance.

Same intended use. ●
Same oscillometric method to determine the blood pressure & pulse rate
Same inflation method - automatic internal pump
Same deflation method - standard exhaust valve
Same materials, no new materials used
Same manufacturing processes at the same facility

As a conclusion, the intended use of the modified device, UA-651 as described in its labeling, has not changed as a result of the modifications. The fundamental scientific technology of the modified device, UA-651, has not changed, either. There is no significant difference that affects the safety or effectiveness of the modified device as compared to the predicate devices.

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).