FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800

K992328 · Meditec Co., Ltd. · DXN · Jul 21, 1999 · Cardiovascular

Device Facts

• Record ID: K992328
• Device Name: FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
• Applicant: Meditec Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Models MD-750, MD-770, MD-800 are intended for the noninvasive measurement of systelic and diastolic blood pressure and determination of heart rate in adult palients, age 18 and above. Because they are recommended for use in a home care environment, three models are intended to be used by patients capable of understanding written and/or oral directions.

Device Story

Oscillometric blood pressure monitor; uses built-in pump for automatic cuff inflation; constant air-rate deflation; circuitry detects/processes pressure oscillations; LCD displays systolic/diastolic pressure and heart rate; includes memory function. Used in home care environment by adult patients capable of following instructions. Powered by four AA batteries with auto-shutoff. Provides objective blood pressure and heart rate data to assist users in monitoring cardiovascular health.

Clinical Evidence

Clinical studies conducted per ANSI/AAMI SP10-1992; compliance with accuracy criteria confirmed. Additional bench testing included electrical, mechanical, environmental, altitude, vibration/shock, life cycle, and intra-device variability testing. Biocompatibility of cuff materials evaluated by TUV; electromagnetic interference testing performed.

Technological Characteristics

Oscillometric measurement system; battery-powered (4x AA); LCD display; built-in pump; pressure range 20-285 mmHg; deflation rate 2-3 mmHg/sec. Biocompatible cuff materials. Software-based pressure measurement algorithm.

Indications for Use

Indicated for noninvasive measurement of systolic/diastolic blood pressure and heart rate in adults (age 18+) in home care settings.

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

• Sein Blood Pressure Meters, Models SE-7000 (K952826)

Submission Summary (Full Text)

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JUL 21 1999

992-328

510(k) SUMMARY ( MODELS MD-750, MD-770, MD-800 )

### 1. COMPANY INFORMATION.

Name : Meditec Co., Ltd. Address : #206 Ga dong, Sungnam APT. Factory, 150 Yatap-dong Bundang-gu Sungnam-city Kyunggi-do 463-070, Korea Phone : [phone] Contact : Mr. D. H. Chang, President

# 2. DEVICE IDENTIFICATION.

a. Trade Name : (1) Fuzzy Automatic Blood Pressure Monitor Model MD-750 (2) Fuzzy Automatic Blood Pressure Monitor Model MD-770 (3) Fuzzy Automatic Blood Pressure Monitor Model MD-800

b. Common Name and Classification Name : Noninvasive Blood Pressure Measurement System.

## 3. PREDICATE DEVICE.

Sein Blood Pressure Meters, Models SE-7000, K952826

## 4. DEVICE DESCRIPTION.

- a. General : Three Meditec models are oscillometric systems intended for measurement of blood pressure and heart rate in a home care environment. Three models has a built-in pump for automatic inflation. Three Models include a constant air regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure and heart rate, and a memory function.
- b. Operation : Three models utilize a pressure measurement algorithm designed to detect, process, and store pressure readings. The pressure measurement range is 20 to 285 mmHg maintained within limits of 2 of 3 mmHg/sec to optimize measurement accuracy.
- c. Power : Three models are powered by four AA-size batteries and are equipped with a circuit that will automatically cut off power after about 3 minutes of non-use to conserve battery charge.

### 5. INTENDED USES.

Models MD-750, MD-770, MD-800 are intended for the noninvasive measurement of systelic and diastolic blood pressure and determination of heart rate in adult palients, age 18 and above. Because they are recommended for use in a home care environment, three models are intended to be used by patients capable of understanding written and/or oral directions.

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# 6. COMPARISON WITH PREDICATE DEVICE.

Meditec Models(MD-750. MD-770. MD-800) has been compared with the automatically inflated Sein Model SE-7000. The intended use of the three subject devices and the predicate device . is the same. The principle of operation(oscillometric measurement) is identical and there are no significant differences between the subject and predicate devices that raise new questions concerning either safety or effectiveness.

## 7. PERFORMANCE DATA.

The measurement performance of the Meditec systems has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-1992 and found to comply fully with the accuracy criteria established in the standard. Safety and functional testing including electrical characteristics, mechanical and environmental integrity under various operating and storage conditions, high and low altitude performance, resistance to vibration and shock, life cycle testing, and intra-device variability has been performed with satisfactory results. The biocompatibility of cuff materials was evaluated favorably by TUV Product Service. Electromagnetic interference studies have been conducted by ONETECH Testing & Evaluation Laboratories and found to comply with international standards. Software verification have been performed and documented. It is concluded that the subject devices comply with all relevant safety and performance standards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 1999

Meditec Co., Ltd.. c/o Ms. Carole Stamp Responsible Third Party Official/510K Program Manager TÜV Product Service Inc. 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112

Re: K992328 Fully Automatic Blood Pressure Monitor Models MD-750, MD-770 and MD-800 Requlatory Class: II (Two) Product Code: DXN Dated: July 8, 1999 July 12, 1999 Received:

Dear Ms. Stamp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Carole Stamp

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Call han, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________

Device Number : Noninvasive Blood Pressure Measurement system Models MD-750, MD-770 and MD-800

Indications For Use:

Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 18 and above, in a home care environment.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

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Buse Kemperle
(Division Sign-Off)

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Division of Cardiovascular, Respiratory, and Neurological Devices K992328 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

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