DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 by NIHON SEIMITSU SOKKI CO., LTD.

The DS-181 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e., age 18 and above.

Device Description

The Nissei Model DS-181 is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of blood pressure and heart rate. The method of operation is the oscillometric method and the site of. measurement is the brachial artery in the arm. The system is microprocessor controlled and includes an air pump for automatic inflation; fuzzy logic to regulate opening cuff pressure, circuitry to detect and process minute pressure oscillations, an electromagnetic deflation-rate control valve, a six-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the seven most recent measurement results plus the computed average of the stored readings; error displays; a standard arm cuff; and an optional large arm cuff.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Nihon Seimitsu Sokki Co., Ltd. Model DS-181 Noninvasive Blood Pressure Measurement System

This document outlines the acceptance criteria and details of the study proving the Nihon Seimitsu Sokki Co., Ltd. Model DS-181 Digital Blood Pressure Monitor meets these criteria.

1. Acceptance Criteria and Reported Device Performance

The Model DS-181 system was evaluated against the accuracy criteria established in the ANSI/AAMI Standard SP10-1992. The document states that the device was "found to comply fully with the accuracy criteria established in the standard."

Acceptance Criteria (ANSI/AAMI Standard SP10-1992)	Reported Device Performance (Model DS-181)
Accuracy criteria as defined by ANSI/AAMI Standard SP10-1992 for noninvasive blood pressure measurement devices. (Specific numerical criteria are not detailed in the provided text but are implied by adherence to the standard).	Complies fully with the accuracy criteria established in the standard.

Note: The provided text does not explicitly state the numerical accuracy criteria from the ANSI/AAMI Standard SP10-1992. However, the FDA's acceptance of the 510(k) submission confirms that the device met the required accuracy for its intended use.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: The document indicates "clinical studies conducted in accordance with ANSI/AAMI Standard SP10-1992." While the exact number of subjects in the test set is not explicitly stated, adherence to this standard implies a sufficiently robust sample size as per the standard's requirements for clinical validation of blood pressure devices.
Data Provenance: The studies were described as "clinical studies," implying human subjects. The country of origin of the data is not explicitly stated in the provided text, but the company is based in Japan. It is not specified whether the studies were retrospective or prospective; however, clinical validation studies for medical devices are typically prospective.

3. Number and Qualifications of Experts for Ground Truth

The mechanism for establishing ground truth in clinical studies for blood pressure monitors typically involves comparison against a reference standard, often auscultation performed by trained clinicians.

Number of Experts: Not explicitly stated, but standard practice for ANSI/AAMI SP10-1992 compliance involves multiple trained observers to mitigate inter-observer variability.
Qualifications of Experts: Not explicitly stated. However, for blood pressure measurement validation, experts would typically be medical professionals (e.g., physicians, nurses, or trained technicians) with experience in accurate auscultatory blood pressure measurement using a mercury sphygmomanometer, often with specific training for validation studies.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described in the provided text. In a typical ANSI/AAMI SP10-1992 validation, multiple observers would take reference measurements, and the results would be averaged or reconciled to establish a robust ground truth, reducing individual observer bias.

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

An MRMC comparative effectiveness study, which typically evaluates the improvement of human readers with AI assistance versus without AI assistance, was not indicated. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The "measurement performance of the DS-181 system has been evaluated in clinical studies... and found to comply fully with the accuracy criteria established in the standard." This confirms the device's ability to accurately measure blood pressure independently of human interpretation of readings, demonstrating its standalone performance.

7. Type of Ground Truth Used

The ground truth used for the clinical validation of blood pressure monitors typically involves a reference method, such as:

Simultaneous auscultatory measurements performed by trained observers using a mercury sphygmomanometer (or other validated reference devices), which is considered the gold standard for non-invasive blood pressure measurement.
The ANSI/AAMI Standard SP10-1992 specifically outlines requirements for the reference method.

8. Sample Size for the Training Set

The document does not provide details about a separate "training set" in the context of machine learning. The Model DS-181 uses "fuzzy logic to regulate opening cuff pressure" and "a pressure measurement algorithm designed to detect, filter, process, and store pressure readings." While these algorithms would have been developed and refined, the text specifically focuses on the clinical studies for performance evaluation, which are typically validation studies rather than training set evaluations. If an internal training process using data was performed for the fuzzy logic or algorithms, its sample size is not disclosed.

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

As noted above, details about a distinct "training set" for the fuzzy logic or algorithms are not provided. However, generally, the ground truth for developing such algorithms would be established through:

Extensive experimental data collection, potentially involving human volunteers, alongside established reference blood pressure measurement methods.
Data could be derived from engineering tests, simulated physiological conditions, and early human subject measurements to optimize the algorithm's performance before final clinical validation.

Summary

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MODEL DS-181 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM

1. COMPANY INFORMATION. Name: Nihon Seimitsu Sokki Co., Ltd ("Nissei"). Address: 2508-13 Nakago, Komochi-Mura, Kitagunma-Gun, Gunma-Ken, 377-0293, Japan (011) 81-279-20-2311 Contact: Mr. I.Ishii, Quality Assurance Director Phone:
1. DEVICE IDENTIFICATION. Trade Name: Model DS-181 Digital Blood Pressure Monitor

Common Name and Classification Name: Noninvasive Blood Pressure Measurement System, 74 DXN

1. PREDICATE DEVICE. Model EBM-2050 Unisonic Electronic Digital Blood Pressure Monitor, Nihon Seimitsu Sokki Co., Ltd. - K850316, SE decision 4/16/85.
1. DEVICE DESCRIPTION, General: The Nissei Model DS-181 is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of blood pressure and heart rate. The method of operation is the oscillometric method and the site of. measurement is the brachial artery in the arm. The system is microprocessor controlled and includes an air pump for automatic inflation; fuzzy logic to regulate opening cuff pressure, circuitry to detect and process minute pressure oscillations, an electromagnetic deflation-rate control valve, a six-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the seven most recent measurement results plus the computed average of the stored readings; error displays; a standard arm cuff; and an optional large arm cuff.

Operation: If occlusion of the systolic pulse is not achieved by initial pressurization, cuff pressure is automatically increased incrementally 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 improper measurement procedures might result in inaccurate readings. If cuff pressure starts to exceed 330 mmHg, cuff pressure is exhausted automatically and an error signal is presented. . Power: The Model DS-181 is powered by four AA-size batteries. Power is shut down automatically if the unit remains idle for a period of approximately three minutes. An optional AC adaptor is also available.

1. INTENDED USES. The Model DS-181system is indicated for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, age 18 and above. The product is recommended for use by patients capable of understanding written and/or oral directions in a home care environment.
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1. COMPARISON WITH PREDICATE DEVICE. The Model DS-181 system has been compared with the Nissei Model EBM-2050 Unisonic Electronic Digital Blood Pressure cleared under 510(k) No. K850316. 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 DS-181 incorporates features designed to enhance measurement reliability -- fuzzy logic circuitry and an electromagnetic deflation control valve -as well as a memory function not found in the predicate device. The hour and minute clock function in the predicate device is not included in the subject 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 DS-181 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 10,000 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 has been evaluated and 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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized symbol that resembles a caduceus, which is a symbol of medicine.

DEC - 1 1999

Mr. Robert D. Waxham Submission Correspondent for Nihon Seimitsu Sokki Co., LTD. 222 Institute Street Smithfield, VA 23430-1136

K993890 Re : Digital Blood Pressure Monitor, Model DS-181 Regulatory Class:II(2) Product Code: DXN Dated: November 15,1999 Received: November 16,1999

Dear Mr. Waxham:

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 requlations 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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General (QS) regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 regulations.

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Page 2 - Mr. Robert D. Waxham

This letter will allow you to continue 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) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

toromper Ce

Celia M. Witten, Ph.D., M.D.
Acting Director
Office of Device Evaluation
Center for Devices and
Radiological Health

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510(k) Number (if known):

Device Name: Model DS-181 Digital Blood Pressure Monitor

Indications For Use:

The DS-181 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e., age 18 and above.

(PL.RASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

…………… Concurrence of CDRH, Office of Device Evaluation (ODE)

Ress R. Simpler

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K q d 3890

Prescription Use (Per 21 CFR 801.109) OR

ﻟﻨ Over - The-Counter Use

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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).