WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S by JAWON MEDICAL CO., LTD.

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.

Device Description

The Jawon Model HD-303S is a compact, automatic sphygmomanometer intended for measurement of blood pressure at the wrist. The method of operation is the oscillometric method. The control unit and the cuff are physically integrated into a single wrist-mounted unit. The system is microprocessor controlled and includes an air pump; fuzzy logic to regulate inflation, deflation, and measurement operations; circuitry to detect and process minute pressure oscillations; a six-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the previous eight measurement results; and two pushbutton controls.

AI/ML Overview

Acceptance Criteria and Device Performance for Jawon Model HD-303S Noninvasive Blood Pressure Measurement System

This document outlines the acceptance criteria and the study that demonstrates the Jawon Model HD-303S Noninvasive Blood Pressure Measurement System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states that the Jawon Model HD-303S was evaluated against the ANSI/AAMI Standard SP10-1992. This standard sets the accuracy criteria for automated sphygmomanometers. While the specific numerical criteria for systolic and diastolic blood pressure accuracy are not explicitly listed in the submission, the summary confirms full compliance.

Acceptance Criteria Category	Specific Criteria (from ANSI/AAMI Standard SP10-1992)	Reported Device Performance (Jawon Model HD-303S)
Blood Pressure Accuracy	Mean difference between device and reference measurement $\leq \pm 5$ mmHg. Standard deviation of difference $\leq 8$ mmHg. (General criteria for automated sphygmomanometers per SP10)	"found to comply fully with the accuracy criteria established in the standard." (Indicating compliance with the above metrics)
Safety Testing	Electrical characteristics, life testing, intra-device variability, environmental integrity (high/low altitude, vibration, shock)	"conducted with satisfactory results."
Electromagnetic Compatibility (EMC)	Compliance with relevant EMC standards (e.g., FCC Part 15)	"found to comply with all relevant standards."
Software Verification & Validation	Adherence to established software development and testing practices	"performed."

2. Sample Size and Data Provenance for the Test Set

The 510(k) summary explicitly states: "The measurement performance of the Jawon system has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-1992."

Sample Size for Test Set: The exact number of subjects or measurements in the clinical studies is not specified in the provided text. ANSI/AAMI SP10-1992 typically requires a minimum of 85 subjects for clinical validation.
Data Provenance: The country of origin of the data is implied to be Korea where Jawon Medical Co., Ltd. is located, but not explicitly stated. The studies are prospective clinical studies, as they were conducted to evaluate the device against a standard as part of its premarket submission.

3. Number of Experts and Qualifications for Ground Truth Establishment

The 510(k) summary does not specify the number or qualifications of experts used to establish the ground truth for the test set. However, a clinical study conducted in accordance with ANSI/AAMI SP10-1992 would typically involve at least two trained observers (often physicians or trained technicians) for auscultatory reference measurements performed simultaneously for comparison with the automated device. These observers would be specifically trained and certified for blood pressure measurement according to the standard's requirements.

4. Adjudication Method for the Test Set

The 510(k) summary does not explicitly state the adjudication method used. However, for clinical validation against ANSI/AAMI SP10-1992, the standard prescribes a specific method for establishing reference blood pressure. This typically involves simultaneous auscultatory measurements by two trained observers, with agreement criteria between their readings. If there is significant disagreement, a third observer might be involved, or the measurement might be discarded. This aligns with a form of expert consensus, often a "2+1" model if a third adjudicator is needed for discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or indicated. This type of study, comparing human readers with and without AI assistance, is not applicable to a standalone blood pressure monitor. The device is intended to provide a direct measurement, not to assist human interpretation of complex medical images or data that traditionally involve multiple human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The summary states, "The measurement performance of the Jawon system 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." This refers to the algorithm-only performance of the device in measuring blood pressure.

7. Type of Ground Truth Used

The ground truth used for the clinical studies in accordance with ANSI/AAMI SP10-1992 is expert consensus auscultatory blood pressure measurements. In these studies, a trained observer (or multiple observers) uses a stethoscope and a mercury or aneroid sphygmomanometer as the reference standard to manually measure blood pressure. This manual measurement, often involving consensus between two observers, serves as the "truth" against which the automated device's readings are compared.

8. Sample Size for the Training Set

The 510(k) summary does not provide specific details about a separate "training set" sample size. The device uses "fuzzy logic to regulate inflation, deflation, and measurement operations" and "a pressure measurement algorithm designed to detect, filter, process, and store pressure readings." While such algorithms are typically developed and refined using data (a training set), the submission focuses on the clinical validation using a separate test set as required by ANSI/AAMI SP10. The training data would have been internal and proprietary during the device's development phase.

9. How the Ground Truth for the Training Set was Established

Similar to point 8, the 510(k) summary does not explicitly describe how the ground truth for any internal training set was established. However, for the development of a blood pressure measurement algorithm, the ground truth for training data would almost certainly be established through expert auscultatory blood pressure measurements on subjects, similar to the method used for the validation test set. This data would be used to refine and optimize the fuzzy logic and measurement algorithms to accurately correlate oscillating pressure waves with systolic and diastolic blood pressure.

Summary

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510(k) SUMMARY

MODEL HD-303S NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM

1. COMPANY INFORMATION. Name: Jawon Medical Co., Ltd. Address: 7F Jeong Ju Bldg., #1451-38, Seocho-Dong, Seocho-Ku, Seoul 137-070, Korea (011) 82-2-587-4056 Contact: Mr. J. N. Kim, Manager Phone: -
1. DEVICE IDENTIFICATION. Trade Name: Model HD-303S Wrist Type Digital Blood Pressure Monitor Common Name and Classification Name: Noninvasive Blood Pressure Measurement System, 74 DXN
1. PREDICATE DEVICE. Model WS-200 Automatic Digital Electronic Wrist Blood Pressure Monitor, Nihon Seimitsu Sokki Co., Ltd. - K952494, SE decision 12/28/95.
1. DEVICE DESCRIPTION. General: The Jawon Model HD-303S is a compact, automatic sphygmomanometer intended for measurement of blood pressure at the wrist. The method of operation is the oscillometric method. The control unit and the cuff are physically integrated into a single wrist-mounted unit. The system is microprocessor controlled and includes an air pump; fuzzy logic to regulate inflation, deflation, and measurement operations; circuitry to detect and process minute pressure oscillations; a six-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the previous eight measurement results; and two pushbutton controls.

Operation: If occlusion of the systolic pulse is not achieved by initial pressurization, cuff pressure is automatically increased in 30 mmHg increments until a proper systolic measurement can be obtained. The device employs a pressure measurement algorithm designed to detect, filter, process, and store pressure readings. An error message is presented whenever results fail to satisfy preprogrammed accuracy criteria. If cuff pressure starts to exceed 320 mmHg, a high-speed exhaust valve is opened automatically.

Power: The Model HD-303S is powered by two AAA-size batteries. Power is shut down automatically if the unit remains idle for a period of approximately two minutes.

1. INTENDED USES. The Model HD-303S system is indicated for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, age 18 and above. Because the device is recommended for use in a home care environment, use should be limited to patients capable of understanding written and/or oral directions.
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1. COMPARISON WITH PREDICATE DEVICE. The Jawon device has been compared with the Nihon Seimitsu Sokki Co. Model WS-200 Wrist Blood Pressure Monitor. The intended use of the two systems is the same. The principle of operation (oscillometric measurement) and many operating features are identical. The principal differences are that the control unit and cuff are an integral unit in the subject device but separate, requiring that the cuff be connected by the operator in the predicate device, and that operation is controlled by fuzzy logic in the subject device but by conventional automatic methods in the predicate device. It is concluded that there are no technologic differences between the subject and predicate devices that raise new questions concerning either safety or effectiveness.
1. PERFORMANCE DATA. The measurement performance of the Jawon system 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, life testing over 10,005 operational cycles, intra-device variability, environmental integrity under various operating and storage conditions including high and low altitude extremes, and resistance to vibration and shock has been conducted with satisfactory results. Similarly, electromagnetic compatibility and FCC Part 15 compliance studies have been conducted by ONETECH Testing & Evaluation Laboratories, and the device was found to comply with all relevant standards. Software verification and validation have been performed. It is concluded that the subject device complies with all applicable safety and performance standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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JUN 1 1991 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jawon Medical Co., Ltd. c/o Ms. Carole Stamp Responsible Third Party Official 510(k) Program Manager TÜV Product Service Inc. 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

Re: K991688 Wrist Type Digital Blood Pressure Monitor, Model HD-303S Regulatory Class: II (Two) Product Code: DXN Dated: May 14, 1999 Received: May 17, 1999

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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 A substantially equivalent determination assumes compliance with 895. 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 requlation 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, or other Federal laws or requlations.

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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 Model HD-303S Wrist Type Digital Blood Pressure Monitor

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)

Otto K. Langurci

and Neurologica 510(k) Numbe

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use L

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Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).