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

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. 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. 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criterion	Reported Device Performance
Blood pressure measurement accuracy (compliance with ANSI/AAMI Standard SP10-1992)	"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."
Electrical characteristics, mechanical and environmental integrity, high and low altitude performance, resistance to vibration and shock, life cycle testing, and intra-device variability	"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."
Biocompatibility of cuff materials	"The biocompatibility of cuff materials was evaluated favorably by TUV Product Service."
Electromagnetic interference (EMI)	"Electromagnetic interference studies have been conducted by ONETECH Testing & Evaluation Laboratories and found to comply with international standards."
Software verification	"Software verification have been performed and documented."

Study Details:

Sample size used for the test set and the data provenance:
- The document states "clinical studies" were conducted but does not specify the sample size of subjects used for the test set.
- The document does not specify the country of origin of the data.
- The document does not specify if the study was retrospective or prospective. However, typically, clinical validation studies for medical devices are prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide this information. The study was a clinical validation against a standard, not necessarily involving expert interpretation of data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not provide this information.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is a "Fuzzy Automatic Blood Pressure Monitor" and the studies focused on its standalone accuracy against a standard, not on human-AI interaction or improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The studies assessed the "measurement performance of the Meditec systems" (the devices themselves) against the ANSI/AAMI Standard SP10-1992, which is a standard for automated blood pressure devices. This inherently evaluates the algorithm's performance without human intervention in the measurement process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for blood pressure measurement accuracy was established by compliance with the ANSI/AAMI Standard SP10-1992. This standard defines reference methods for blood pressure measurement (e.g., auscultatory method with trained observers) against which automated devices are compared. The document does not go into the specifics of how the "true" blood pressure was determined during the clinical studies, but it would align with the established reference methods of SP10.
The sample size for the training set:
- The document does not specify a training set size. This device is a blood pressure monitor, and while it uses a "Fuzzy" algorithm, the primary validation is against established measurement standards, not necessarily through traditional machine learning training/testing paradigms with labeled patient data in the way an AI diagnostic tool would. It's more about hardware and algorithm calibration.
How the ground truth for the training set was established:
- Given the nature of the device and the standards it follows, the concept of a "training set" ground truth in the typical machine learning sense is not explicitly presented or relevant here. The device's "fuzzy" algorithm would likely have been developed and calibrated internally using a variety of blood pressure patterns, but the document does not detail this process or how the ground truth for such internal development was established. The focus of the regulatory submission is on the validation against a known standard.

Summary

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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 : (011) 82-342-707-2701 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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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing feathers and three tail feathers.

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 (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 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 (800) 638-2041 or (301) 443-6597 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.

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Concurrence of CDRH, Office of Device Evaluation(ODE)

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Buse Kemperle
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

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Over-The Counter Use $\underline{\hspace{1cm}}$

00021

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).