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

K043217 · A&D Engineering, Inc. · DXN · Mar 3, 2005 · Cardiovascular

Device Facts

• Record ID: K043217
• Device Name: A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 3, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The A&D Medical UA-767PBT 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; uses oscillometric method to measure systolic/diastolic pressure and pulse rate. Input: pressure signals from inflated arm cuff; electrical pump inflates cuff; mechanical valve controls deflation. Output: blood pressure/pulse rate values displayed on LCD; data transmitted via Bluetooth to PC, PDA, printer, or access point. Used by patients at home. Device detects irregular heartbeats. Healthcare providers use transmitted data for patient monitoring. Benefits include convenient home-based 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 trial data presented.

Technological Characteristics

Oscillometric measurement; electrical air pump; mechanical deflation valve; LCD display; Bluetooth wireless connectivity. Complies with NIST/AAMI SP-10 standards. Software-based processing for pressure detection and irregular heartbeat identification.

Indications for Use

Indicated for adults 18 years and older for home monitoring of systolic/diastolic blood pressure and pulse rate. Arm circumference range: 13.0 cm to 45.0 cm. 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)
• A&D UA-767BT (K040371)
• A&D UA-787 (K012472)

Submission Summary (Full Text)

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# Attachment (D) 510(k) Summary

#### DATE PREPARED 1.

February 4, 2005

# 2. SPONSOR INFORMATION

A&D Engineering, Inc. Mr. Jerry Wang 1555 McCandless Drive, Milpitas, CA 95035 Tel: [phone] Fax: [phone] Email: jwang(a)andmedical.com

# 3. DEVICE NAME

| Proprietary Name: | A&D Medical UA-767PBT 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-767PBT 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 A&D UA-767BT, FDA 510(k) K040371. Issued on May 19, 2004 A&D UA-787, FDA 510(k) K012472. Issued on Feb. 15, 2002

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# TECHNOLOGICAL CHARACTERISTECS 6.

UA-767PBT 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 arc determined by oscillometric method. The deflation rate is controlled by a presct 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 arc displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point. UA-767PBT measures blood pressure and pulse rate even when an irregular heartbeat occurs.

#### 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. It uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate.

| SP-10<br>Section # | Section Title | Test Results &<br>Comments |
|--------------------|--------------------------------------------------------|----------------------------|
| 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 inflation systems | Conformed |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.

MAR 3 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043217

Trade Name: UA-767PBT 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: February 04, 2005 Received: February 07, 2005

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 adultcration.

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, RDAAway 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 Flease of advised that I DTC issual.es sour device complies with other requirements of the Act that FDA has made a decemmandions administered by other Federal agencies. You must of any rederal statutes and regulations and limited to: registration and listing (21 comply with an the rive s requirements, on the manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients over device as described in your Section 510(k) I mis letter will anow you to organ manage of your device of your device to a legally premarket notineation: "The PDF intentigstification 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 If you desire specific at 100 is 100 [phone]. Also, please note the regulation entitled, Contact the Office of Come of Commarket notification" (21CFR Part 807.97) you may obtain. INflouranding of reference to prour responsibilities under the Act may be obtained from the Other general mionmation on your responsional 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 yours,

B.Zimmerman, MD

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): K043217

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

Indications For Use:

The UA-767PBT 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-767PBT memory. UA-767PBT 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. UA-767PBT 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).

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-
(21 C)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummen

Offision Sign-Off) Division of Cardiovascular Devices 510(k) Number Kost 201

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