A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR

K082734 · A&D Engineering, Inc. · DXN · Nov 13, 2008 · Cardiovascular

Device Facts

• Record ID: K082734
• Device Name: A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 13, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

The A&D Medical UA-851THW is a digital blood pressure monitor for adult use (12+ years). It uses an inflatable arm cuff and an internal pump to measure blood pressure via the oscillometric method. An electronic-controlled exhaust valve manages deflation. The device detects irregular heartbeats (defined as >+/-25% deviation from mean pulse interval). It stores 51 measurements. Data can be uploaded to a PC via an ActiLink USB transceiver for viewing in Wellness Connected software. The device is intended for over-the-counter use, allowing patients to monitor their own blood pressure and pulse rate at home, facilitating self-management of cardiovascular health.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and performance specifications consistent with predicate devices.

Technological Characteristics

Oscillometric measurement method; automatic internal pump; electronic-controlled exhaust valve; 300mmHg maximum pressure safety setting; LCD display; USB connectivity via ActiLink transceiver; 51-memory capacity; powered by 4x1.5V AA batteries or optional AC adapter.

Indications for Use

Indicated for adults aged 12 and older to measure systolic and diastolic blood pressure and pulse rate.

Regulatory Classification

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.

Predicate Devices

• A&D LifeSource model UA-767PBT digital blood pressure monitor (K043217)
• A&D LifeSource model UA-789 digital blood pressure monitor (K062027)

Submission Summary (Full Text)

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## 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: [phone] Fax: [phone] Email: jwang(@andmedical.com

#### 3. DEVICE NAME

| Proprietary Name: | A&D Medical UA-851THW Digital Blood Pressure<br>Monitor |
|----------------------|-------------------------------------------------------------------------------------|
| Common/Usual Name: | Blood Pressure Monitor |
| Classification name: | Non-invasive blood pressure measurement System<br>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<br>(UA-789 & UA-767PBT) | UA-851THW |
|-----------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------|
| Measurement<br>Method | Oscillometric Method | No change – the same |
| Measurement<br>Range | BP : 20 to 280 mmHg<br>Pulse : 30 to 200 pulse/min | No change – the same |
| Accuracy | BP : +/- 3mmHg or +/- 2% of<br>measured value, whichever is<br>greater<br>Pulse : +/- 5 % (pulse) | No change – the same |
| Pressurization<br>Source | Automatic internal pump | No change – the same |
| Cuff Deflation | Automatic constant speed<br>mechanical exhaust valve | No change – the same |
| Data Memory<br>Size with Time<br>& Date | 40 memories for UA-767PBT<br>60 memories for UA-789 | 51 memories |
| Irregular<br>Heartbeats<br>Detection | More than +/-25% to the mean<br>interval of all pulse intervals | No change – the same |
| Power Source | 6V DC, 4x1.5V AA batteries<br>or AC adapter as an option | No change – the same |
| Battery Life | 4 months with daily<br>measurement | No change – the same |
| Operating<br>Environment | 50°F (10°C) to 104°F (40°C) at<br>less than 85% RH | No change – the same |
| Storage<br>Environment | 14°F (-20°C) to 140°F (60°C)<br>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

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| Cuff<br>Attachment<br>Method | By plastic hose connected to<br>monitor | No change – the same |
|------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------|
| Arm Size | UA-767PBT – 5.1" to 17.7"<br>(13 cm to 45cm)<br>UA-789 – 9.4" to 23.6" (24 cm<br>to 60 cm) | No change – the same as UA-<br>767PBT |
| Weight | UA-767PBT – 920 g (2.03 lb)<br>without batteries<br>UA-789 – 940 g (2.07 lb)<br>without batteries | 930 g (2.05 lb) without<br>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

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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 [phone]. 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 [phone] or [phone] 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

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## 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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