A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS

K032499 · A&D Engineering, Inc. · DXN · Oct 30, 2003 · Cardiovascular

Device Facts

• Record ID: K032499
• Device Name: A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The A&D LifeSource UA-704 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.

Device Story

The A&D LifeSource UA-704 is a digital blood pressure monitor for adult use. The device utilizes an upper-arm cuff inflated manually by the user via a bulb. It employs the oscillometric method to determine systolic and diastolic blood pressure and pulse rate. A preset mechanical valve controls the deflation rate, while a quick exhaust valve allows for manual deflation. Measurement results are displayed on an integrated LCD. The device is capable of detecting blood pressure and pulse rate during irregular heartbeats. It is intended for over-the-counter use by the patient. The device provides objective blood pressure and pulse rate data to assist users in monitoring their cardiovascular health.

Clinical Evidence

Bench testing only. The device demonstrated compliance with NIST/AAMI SP-10 standards for non-invasive blood pressure monitors, including electrical safety, pressure indicator accuracy, and system efficacy. No clinical data was provided.

Technological Characteristics

Oscillometric blood pressure measurement system. Components include an inflatable upper-arm cuff, manual inflation bulb, and preset mechanical deflation valve. Features an LCD display. Operates via battery power. Software is identical to predicate devices. Complies with NIST/AAMI SP-10 standards.

Indications for Use

Indicated for adults for the measurement of 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 UA-711 (K871718)
• A&D UA-767PC (K982481)
• A&D UA-787 (K012472)

Submission Summary (Full Text)

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# Attachment (D) 510(k) Summary

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## 1. DATE PREPARED

July 29, 2003

## 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 LifeSource UA-704 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 LifeSource UA-704 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 three devices: A&D UA-711, FDA 510(k) K871718. Issued on June 24, 1987

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

A&D UA-787, FDA 510(k) K012472. Issued on Feb. 15, 2002

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### TECHNOLOGICAL CHARACTERISTECS 6.

UA-704 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by pressing a bulb manually by the user. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff by pressing the quick exhaust valve. The measurement results are displayed on the LCD. UA-704 measures blood pressure and pulse rate even when an irregular heartbeat occurs.

#### 7. DEVICE TESTING

A&D LifeSource UA-704 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-704 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 & |
|-----------|-------------------------------------------------|----------------|
| Section # | | 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 | Conformed |

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, framing the emblem.

OCT 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A & D Engineering, Inc. c/o Mr. Jerry P. Wang Director of Engineering & QA 1555 McCandless Drive Milpitas, CA 95035

Re: K032499

Trade Name: LifeSource UA-704 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: September 29, 2003 Received: September 30, 2003

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. Jerry P. 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 Jetter 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/dsma/dsmamain.html

Sincerely vours.

Ona Heischur 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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# Attachment (B) Indications for Use Statement

510(k) Number (if known): k032499

Device Name: A&D Medical LifeSource UA-704 Digital Blood Pressure Monitors

Indications for Use:

Measure blood pressure (systolic and diastolic) and pulse rate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Dora Heemlu

(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K032499