FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F

K983855 · Jawon Medical Co., Ltd. · DXN · Nov 17, 1998 · Cardiovascular

Device Facts

• Record ID: K983855
• Device Name: FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
• Applicant: Jawon Medical Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Models HD-1000S and HD-2000F are intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients. Because they are recommended for use in a home care environment, both models are intended to be used by patients capable of understanding written and/or oral directions.

Device Story

The Jawon HD-1000S and HD-2000F are compact, automatic, microprocessor-controlled sphygmomanometers for brachial blood pressure measurement. The device uses an air pump, electronic valve, and cuff to perform oscillometric measurements. It detects and processes pressure oscillations to calculate systolic/diastolic blood pressure and heart rate, displaying results on an LCD. The system is intended for home use by patients capable of following instructions. The HD-2000F includes a memory function. The device provides patients with a convenient method for monitoring blood pressure, facilitating self-management of health.

Clinical Evidence

Measurement performance evaluated in clinical studies per ANSI/AAMI SP10-1992; found to comply with accuracy criteria. Safety testing (electrical, environmental, vibration, shock) conducted by Underwriters Laboratories. Electromagnetic compatibility tested by ONETECH Testing & Evaluation Laboratories. Software verification and validation performed.

Technological Characteristics

Oscillometric measurement; microprocessor-controlled; electronic deflation valve (3-5 mmHz/sec); LCD display; pushbutton controls; powered by 4 AA batteries; battery low indicator. HD-2000F includes memory function.

Indications for Use

Indicated for noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients (age 15 and above) in a home care environment.

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 Model TM-2650 Automatic Blood Pressure Meter (K895429)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K 983855

## MODELS HD-1000S AND HD-2000F NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM

- 1. COMPANY INFORMATION. Name: Jawon Medical Co., Ltd. Address: 2F Seoil B/D, #1451-74, Seocho-Dong, Seocho-Ku, Seoul 137-070, Korea (011) 82-2-587-4056 Contact: Mr. J. N. Kim, Manager Phone:
- 2. DEVICE IDENTIFICATION. Trade Name: Models HD-1000S and HD-2000F Fuzzy Type Digital Blood Pressure Monitor Common Name and Classification Name: Noninvasive Blood Pressure Measurement System, 74 DXN
- 3. PREDICATE DEVICE. A&D Model TM-2650 Automatic Blood Pressure Meter, K895429, SE decision 11/28/89.
- 4. DEVICE DESCRIPTION. General: Both models of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. All measurements are performed using the oscillometric method. The display unit and the measurement cuff are interconnected by tubing. Both models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitty to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and pushbutton controls. Model HD-2000F includes a memory function.

Operation: The subject device employs a pressurement algorithm designed to detect, filter, process, and store pressure readings. The electronic deflation control valve maintains the deflation rate within limits of 3 to 5 mmHz/sec to optimize measurement accuracy.

Power: Both models are powered by four AA-size batteries and contain an indicator to alert the operator when battery charge is weak.

- 5. INTENDED USES. Models HD-1000S and HD-2000F are intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients. Because they are recommended for use in a home care environment, both models are intended to be used by patients capable of understanding written and/or oral directions.
6. COMPARISON WITH PREDICATE DEVICE. The two models of the Jawon device have been compared with the A&D Automatic Blood Pressure Meter, Model TM-2650, The intended use of the two systems is the same. The principle of operation (oscillometric measurement) and many operating features are identical. The only substantive difference between the subject and predicate devices is that the predicate device incorporates a thermal printer and the subject device does not. It is concluded that there are no technologic differences between the subject and predicate devices that raise new questions concerning either safety or effectiveness.

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- 7. PERFORMANCE DATA. The measurement performance of the Jawon 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 testing including electrical characteristics of the system and components, environmental integrity under various operating and storage conditions, and resistance to vibration and shock was conducted by Underwriters Laboratories with satisfactory results. Similarly, electromagnetic compatibility studies have been conducted by ONETECH Testing & Evaluation Laboratories and found to comply with international standards. Software verification and validation have been performed. It is concluded that the subject device complies with all relevant safety and performance standards.

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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 abstract image of an eagle or bird-like figure, represented by a series of curved lines.

NOV 17 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAWON Medical Co., LTD. c/o Carole Stamp Third Party Official TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

Re : K983855 Noninvasive Blood Pressure Measurement System Models HD-1000S and HD-2000F Requlatory Class: II (Two) Product Code: 74 DXN October 29, 1998 Dated: Received: October 30, 1998

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 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions,

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Page 2 - Ms. Carole Stamp

or other Federal laws or regulations.

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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/cdrh/dsmamain.html."

Sincerely yours,

DA Spyk

Thomas J. Callahan, 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 Name: Noninvasive Blood Pressure Measurement System Models HD-1000S and HD-2000F

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Indications For Use:

Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 15 and above, in a home care environment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Bette L Kemper a

(Division Sign-Off) Division of Ordiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

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OR

Over-The-Counter Use رسما

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