For the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e. 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.

Device Description

The Nissei Model DS-1862 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, an eleven-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the thirty most recent measurement results for two patients plus the computed average of the stored readings; error displays, a standard arm cuff, and an optional large arm cuff.

AI/ML Overview

The provided documents describe the Nihon Seimitsu Sokki Co. Ltd. (Nissei) Model DS-1862 Digital Blood Pressure Monitor and its substantial equivalence to a predicate device, the Nissei DS-181.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the performance specifications of the predicate device, which the new device (DS-1862) aims to match or improve upon. The reported device performance for the DS-1862 is stated as "SAME" across several key metrics, implying it meets or exceeds the predicate's specifications.

Acceptance Criteria (Predicate Device DS-181)	Reported Device Performance (DS-1862)
Operating Principle: Oscillometric method	SAME (Oscillometric method)
Indication for use: For noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e., age 18 and above.	SAME
Display: 7 Digit LCD	11 Digit LCD
Measurement Range: Sys 50-250 mm Hg (cuff press.) Dia 40 to 180 mm Hg Pulse rate 40 to 160 pulse/min	SAME
Accuracy: ±3 mm Hg (cuff press.) ±5% of reading (pulse rate)	SAME
Cuff arm circumference: 230 to 320 mm	170 to 350 mm
Power supply: Four AA size batteries	SAME
External dimensions: 160mm W x 100mm D x 52mm H	163mm W x 180mm D x 83mm H
Memory: 7 Measurement results, Computation of the average of stored data.	30 Measurement results x 2, Computation of the average of stored data.
Weight: 265 g. w/o batteries	420 g. w/o batteries

2. Sample Size Used for the Test Set and Data Provenance

The documents do not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). They only mention "bench and user testing" and "clinical testing data."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable in this context. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting results with and without AI assistance. The study focuses on the device's accuracy compared to a validated predicate.

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

A standalone study was effectively performed. The device itself is an automated system for measuring blood pressure. The "bench and user testing" and "clinical testing data" likely refer to the performance of the device's algorithm and hardware in isolation, as well as its use by individuals. The focus is on the device's intrinsic accuracy and functionality.

7. Type of Ground Truth Used

The ground truth for the accuracy assessment (±3 mm Hg for cuff pressure and ±5% for pulse rate) would typically be established by a validated reference measurement method. For blood pressure monitors, this usually involves:

Auscultation by trained observers: Using a mercury sphygmomanometer and stethoscope, where multiple trained observers independently take readings, and their consensus or average is used as the reference.
Invasive arterial pressure measurement: In a clinical research setting, direct intra-arterial pressure measurement can be used as the gold standard, though this is less common for routine validation of home-use devices.

The documents do not explicitly state which method was used, but the "Accuracy" specification (±3 mm Hg) is a standard requirement for blood pressure monitors and implies comparison against a highly accurate reference.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. While the device uses a "pressure measurement algorithm designed to detect, filter, process, and store pressure readings," the documents do not provide any information about a specific training set or its size. For older-generation oscillometric devices, the "algorithm" is often based on established mathematical models and signal processing techniques rather than a machine learning model that requires a distinct training phase with labeled data in the same way modern AI systems do.

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

Given the lack of information on a specific "training set" in the context of modern machine learning, this information is not provided and likely not applicable in the typical sense for this type of device and its submission. The algorithms for oscillometric blood pressure measurement are generally developed and refined based on engineering principles and physiological understanding, and then validated with clinical testing against established reference methods.

Summary

{0}------------------------------------------------

EXHIBIT 2

510K Summary Nihon Seimitsu Sokki Co. Ltd (Nissei) 2508-13 Nakago, Komochi-Mura, Kitagunma-Gun, Gunma-Ken 377-0293, Tokyo, Japan Phone: +81-0279-20-2311 Fax: +81-0279-20-2411 Contact: I. Ishii, Chief Engineer

1. Identification of the device Proprietary-Trade Name: Model DS-1862 Digital Blood Pressure Monitor Classification Names: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, Common/Usual Name: Noninvasive Blood Pressure Measurement System
1. Equivalent legally marketed devices This product is similar in function and design to predicate Nihon Seimitsu Sokki Co., Ltd. (Nissei) DS-181, K993890
1. Indications for Use (intended use). The DS-1862 Digital Blood pressure Monitor 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. The product is rccommended for use by patients capable of understanding written and/or oral directions in a home care environment.
1. Description of the Device The Nissei Model DS-1862 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, an eleven-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the thirty most recent measurement results for two patients 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 eitor 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-1862 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}------------------------------------------------

K040309
page 2 of 2

Safety and Effectiveness, comparison to predicate device 5.

The results of bench and user testing indicate that the new device is as safe and effective as the predicate device.

Designation	Nihon Seimitsu Sokki Co., Ltd.(Nissei) DS-181, K993890	Nihon Seimitsu Sokki Co., Ltd.(Nissei ) DS-1862
Operating Principle	Oscillometric method	SAME
Indication for use	For the noninvasivemeasurement of systolic anddiastolic blood pressure anddetermination of heart rate inadult patients, i.e. age 18 andabove.	SAME
Display	7 Digit LCD	11 Digit LCD
Measurement Range	Sys 50-250 mm Hg (cuff press.)Dia 40 to 180 mm HgPulse rate 40 to 160 pulse/min	SAME
Accuracy	±3 mm Hg (cuff press.)±5% of reading (pulse rate)	SAME
Cuff armcircumference	230 to 320 mm	170 to 350 mm
Power supply	Four AA size batteries	SAME
External dimensions	160mm W x 100mm D x 52mm H	163mm W x 180mm D x 83mm H
Memory	7 Measurement results,Computation of the average ofstored data.	30 Measurement results x 2,Computation of the average ofstored data.
Weight	265 g. w/o batteries	420 g. w/o batteries

6. Comparison matrix - new vs. Predicate device

7. Conclusion

After analyzing both bench and clinical testing data, it is the conclusion of Nissci that the "DS-1862" Digital Blood Pressure Monitor is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2004

Nihon Seimitsu Sokki Co. Ltd. c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O.Box 7007 Deerfield, IL 60015

K040309 Re:

Trade Name: Digital Blood Pressure Monitor, Model DS-1862 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: February 03, 2004 Received: February 09, 2004

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for too mated in the 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 -- Mr. Daniel Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read on as made a determination that your device complics with other requirements of the Act that I Drines intel to and regulations administered by other Federal agencies. You must or any I odotal blacked and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set SI It rate 877) stuces (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product raction comror provide in (seting your device as described in your Section 510(k) I his letter will anow you to ought maing of substantial equivalence of your device to a legally premarket notification "The stassification 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mornational and Consumer 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,

some R. Williner

O Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Nissei Model DS-1862 Blood Pressure Monitor

For the noninvasive measurement of systolic and diastolic blood Indications For Use: Indications I of '000' - 1 viration of heart rate in adult patients, i.e. age 18 and above, in a pl essure and the december of understanding the inderstanding the instructions for use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

the contraction of the control of the country

Orang 2_lodine 1

(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number K04030 G

Page 1 of 1

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).