A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR

K062027 · A&D Engineering, Inc. · DXN · Jan 19, 2007 · Cardiovascular

Device Facts

• Record ID: K062027
• Device Name: A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended 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.

Device Story

Digital blood pressure monitor; uses inflatable cuff wrapped around upper arm. Internal pump automatically inflates cuff; electronic-controlled exhaust valve manages deflation. Device employs oscillometric method to determine systolic/diastolic blood pressure and pulse rate. Designed for over-the-counter use by adults 12 years and older. Output displayed on device screen for user review. Facilitates home monitoring of blood pressure and pulse rate.

Clinical Evidence

Bench testing only. Accuracy and effectiveness of the extra-large cuffs were validated through the ANSI/AAMI SP-10 standard. Device also meets EN60601 safety and electromagnetic compatibility standards.

Technological Characteristics

Oscillometric measurement principle; internal pump and electronic-controlled exhaust valve; supports arm circumference 24 cm to 60 cm. Complies with ANSI/AAMI SP-10, EN60601-1, EN60601-2-30, and EN60601-1-2 standards.

Indications for Use

Indicated for adults 12 years 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-787 digital blood pressure monitor (K012472)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone] Email: [e-mail]

### 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<br>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 [phone]. 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 [phone] or [phone] 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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