A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR

K040371 · A&D Engineering, Inc. · DXN · May 19, 2004 · Cardiovascular

Device Facts

• Record ID: K040371
• Device Name: A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The A&D Medical UA-767BT digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.

Device Story

Digital blood pressure monitor for home use by adults. Device uses oscillometric method; cuff inflated by electrical air pump; deflation controlled by preset mechanical valve. Input: pressure oscillations from upper arm cuff. Output: systolic/diastolic blood pressure and pulse rate displayed on LCD; data transmitted via Bluetooth to PC, PDA, printer, or access point. Device uses identical software and pressure detection hardware as predicate UA-767PC. Healthcare providers or patients use stored/transmitted data for blood pressure monitoring. Benefits include convenient home tracking of cardiovascular metrics.

Clinical Evidence

Bench testing only. Device conforms to NIST/AAMI SP-10 standards for non-invasive blood pressure monitors, including electrical safety, pressure indicator accuracy, and system efficacy. No clinical data provided.

Technological Characteristics

Oscillometric measurement principle; electrical air pump; mechanical valve for deflation. Bluetooth wireless connectivity. Powered by batteries. Form factor: upper arm cuff (13.0-45.0 cm circumference). Software: identical to predicate (K982481).

Indications for Use

Indicated for adults 18+ years old for home monitoring of systolic/diastolic blood pressure and pulse rate. Arm circumference 13.0-45.0 cm. Contraindicated for users with common arrhythmias (atrial/ventricular premature beats, atrial fibrillation). Not for ambulatory use.

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 UA-767PC (K982481)

Submission Summary (Full Text)

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### MAY 1 9 2004

## Attachment (D) 510(k) Summary

#### 1. DATE PREPARED

February 10, 2004

#### 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-767BT 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-767BT digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.

#### 5. PREDICATE DEVCIE

It is substantially equivalent to the following device:

A&D UA-767PC, FDA 510(k) K982481. Issued on Jan. 13, 1999

#### 6. TECHNOLOGICAL CHARACTERISTECS

UA-767BT uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset

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mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff by pressing the blue "START" button. The measurement results are displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point.

#### DEVICE TESTING 7.

A&D Medical UA-767BT digital blood pressure monitor meets NIST/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance". Please refer to the table below for the list of AAMI SP-10 tests. UA-767BT is not clinically tested. It uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate.

| SP-10 | Section Title | Test Results &<br>Comments |
|-----------|-----------------------------------------------------------|----------------------------|
| Section # | | |
| 4.1.1 | General | Conformed |
| 4.1.2.1 | Device labeling | Conformed |
| 4.1.2.2 | Outer container | Conformed |
| 4.1.3 | Information manual | Conformed |
| 4.1.4.1 | Component replacement | Conformed |
| 4.1.4.2 | Power system labeling | Conformed |
| 4.1.4.3 | Labeling for battery-powered devices | Conformed |
| 4.2.1 | Storage conditions | Conformed |
| 4.2.2 | Operating conditions | Conformed |
| 4.2.3 | Vibration and shock | Conformed |
| 4.2.4.1 | Voltage range | Conformed |
| 4.2.4.2 | Life | Conformed |
| 4.3.1.1 | Maximum cuff pressure | Conformed |
| 4.3.1.2 | Cuff deflation | Conformed |
| 4.3.2 | Electrical safety | Conformed |
| 4.3.3 | Conductive components | Conformed |
| 4.4.1 | Pressure indicator accuracy | Conformed |
| 4.4.2 | Overall system efficacy | Conformed |
| 4.4.2.1 | Auscultatory method as the reference standard | Conformed |
| 4.4.2.2 | Intra-aeterial method as the reference standard | Not applicable |
| 4.4.3 | Battery-powered devices | Conformed |
| 4.5 | Requirements for devices with manual<br>inflation systems | Conformed |

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines resembling a bird or a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2004

A&D Engineering, Inc. c/o Mr Jerry Wang Director of Engineering & QA 1555 McCandless Drive Milpitas, CA 95025

Re: K040371

Trade Name: UA-767BT Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: May 05, 2004 Received: May 06, 2004

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 prodicate 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. 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); 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 may be obtained 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/dsma/dsmamain.html

Sincerely vours,

Neil Rf Ogden
Bram D. Zuckerman, M.D. for

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 Statement

510(k) Number (if known): __ K04037 |

Device Name: A&D Medical UA-767BT Digital Blood Pressure Monitors

### Indications for Use:

The UA-767BT is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. At the end of each measurement, the results will be stored in the UA-767BT memory. UA-767BT through its Bluetooth wireless communication port can also transfer the measurements stored in memory to other electronic devices, such as an Access Point, PC, a modem, or a printer. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UA-767BT uses the oscillometric method to conduct the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).

Nielko Ogl for DDR
(Division Sign Off)

of Cardiovascular Devi

510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

or