A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512

K042967 · A&D Engineering, Inc. · DXN · Dec 3, 2004 · Cardiovascular

Device Facts

• Record ID: K042967
• Device Name: A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The A&D LifeSource UB-511 & UB-512 digital blood pressure monitors are intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.

Device Story

Digital blood pressure monitors (UB-511/UB-512) for adult use; wrist-worn cuff; automatic inflation via air pump. Operates via oscillometric method to determine systolic/diastolic pressure and pulse rate; functions during irregular heartbeats. Displays results on LCD for one minute; categorizes results per WHO BP classifications (Optimal to Severe Hypertension). Device powers off automatically after one minute of inactivity. Used by patients in home or clinical settings. Output informs users of BP status and pulse; aids in monitoring cardiovascular health.

Clinical Evidence

Bench testing only. Conformance to NIST/AAMI SP-10 standards demonstrated, including pressure indicator accuracy, system efficacy, and electrical safety. No clinical data provided; equivalence established via identical software and hardware components to predicate devices.

Technological Characteristics

Wrist-worn oscillometric blood pressure monitor; automatic air pump inflation; LCD display. Powered by batteries. Software-based classification of BP results according to WHO standards. Complies with NIST/AAMI SP-10 standards for NIBP monitors.

Indications for Use

Indicated for adults 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 UB-401 (K002115)
• A&D UA-328 (K040229)

Submission Summary (Full Text)

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DEC - 3 2004

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# Attachment (D) 510(k) Summary

## DATE PREPARED 1.

Oct. 20, 2004

## 2. SPONSOR INFORMATION

A&D Engincering, 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 UB-511 & UB-512 Digital Blood Pressure<br>Monitors | |
|----------------------|-------------------------------------------------------------------------------------|--|
| 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 UB-511 & UB-512 digital blood pressure monitors are intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.

### PREDICATE DEVCIE 5.

It is substantially equivalent to the following three devices: A&D UB-401, FDA 510(k) K002115. Issued on July 25, 2000

A&D UA-328, FDA 510(k) K040229. Issued on June 30, 2004

## TECHNOLOGICAL CHARACTERISTECS 6.

UB-511 & UB-512 use an inflated cuff which is wrapped around the wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method while the cuff is inflated. The pressure of the cuff

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is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for one minute. The blood pressure results are compared with WHO (World Health Organization) BP classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. UB-511 & UB-512 measure blood pressure and pulse rate even when an irregular heartbeat occurs. After one minute without operation, UB-511 & UB-512 turns off automatically.

### 7. DEVICE TESTING

A&D LifeSource UB-511 & UB-512 digital blood pressure monitors meet 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. UB-511 & UB-512 are 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 |
| | inflation systems | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2004

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

Re: K042967

Trade Name: A&D Medical LifeSource UB-511 & UB-512 Digital Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: November 29, 2004 Received: November 30, 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 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 Wang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession on the requirements of the Act
that FDA has made a determination that your device complies with on any must that FDA has made a decemmation that your administered by other Federal agencies. You must or any Federal Statutes and regulations administered of registration and listing (21)
comply with all the Act's requirements, including, but not limited to: ref comply with all the Act 3 requirements, morading practice requirements as set CFR Part 807); labeling (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if app 1000-1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decloils of Pecifice in your Section 510(k)
This letter will allow you to begin marketing your device of war device to logol I his letter will anow you to oegin manxalig your antial equivalence of your device to a legally premarket nothleadon. The PDA miding of backand on 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 advice for your ac not on one one and the regulation entitled, conlact the Office of Comphanes at (2017) the Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) view difference "Misbranding by relefence to premaries noville is a may be obtained from the Other general information 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,

Bhimima for

am D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K042967

## Attachment (B) Indications for Use Statement

510(k) Number (if known):

Device Name: A&D Medical LifeSource UB-511 & UB-512 Digital Blood Pressure Monitors

Indications for Use:

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

Or

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B Summa