The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or know hypertension in a home care environment as an adjunct to medical management.

Device Description

The Model DS-1901 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of systolic and diastolic blood pressure and pulse rate in adult patients in a homecare environment. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes an air pump for automatic cuff inflation, an electric valve, pushbutton controls, circuitry to detect and process minute pressure oscillations, an I.CD display of systolic and diastolic blood pressure readings and pulse rate, a wide-ranged arm cuff and a carrying case. The memory circuit stores the thirty most recent readings plus the computed average of the stored readings, which will be retained after power turn-off or battery removal and can be intentionally deleted. The system is powered by four AA-size batteries or, optionally, by a 6V AC adapter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nissei Model DS-1901 Digital Blood Pressure Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The primary standard referenced for performance and accuracy is the ANSI/AAMI Standard SP10-2002, Electronic or Automated Sphygmomanometers. While the document doesn't explicitly list specific numerical acceptance criteria values for this standard within the provided text, it states that the device meets the standard. The functional performance of the device is described as having the "same measurement accuracy for both blood pressure and pulse rate" as its predicate device (Nissei Model DS-181).

Acceptance Criteria (from ANSI/AAMI SP10-2002)	Reported Device Performance (DS-1901)
Measurement Accuracy for Blood Pressure	Meets ANSI/AAMI SP10-2002; Same measurement accuracy as predicate device (DS-181)
Measurement Accuracy for Pulse Rate	Meets ANSI/AAMI SP10-2002; Same measurement accuracy as predicate device (DS-181)
Arm Circumference Range Functionality	Evaluated for circumference of 23 to 43 cm with compensating algorithm
EMC/EMI Compliance	Meets IEC 60601-1-2, IEC 61000-4-x series
Safety and Effectiveness	Well recognized as safe and effective for intended use; Same operating principles and intended uses as predicate devices.

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

Sample Size: Not explicitly stated in the provided text. The document mentions "clinical evaluation" was performed, but the number of subjects is not provided.
Data Provenance: Not explicitly stated. Given the manufacturer (Nihon Seimitsu Sokki., Co., Ltd. from Japan) and the submission to the FDA in the US, the clinical evaluation could have been conducted in Japan, the US, or another country. The document does not specify if it was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For a blood pressure monitor, ground truth is typically established by trained medical professionals (e.g., physicians, nurses) using validated manual methods (like auscultatory measurements using a stethoscope) concurrently with the device being tested. No details are provided about these individuals.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not applicable to a standalone blood pressure monitor. The device itself is designed to perform the measurement, not assist a human in interpreting diagnostic images or data.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Standalone Performance: Yes, the entire clinical evaluation (e.g., against ANSI/AAMI SP10-2002) is a standalone performance assessment. The device is intended to provide blood pressure and pulse rate readings directly to the user (patient) or clinician without requiring real-time human interpretation of the measurement process itself. The accuracy metrics associated with the ANSI/AAMI standard directly reflect the standalone performance of the algorithm and hardware.

7. The Type of Ground Truth Used

Type of Ground Truth: The document implies that the ground truth for blood pressure and pulse rate measurements would have been established using validated reference methods, typically auscultatory blood pressure measurements performed by trained observers, as is standard practice for clinical validation of automated sphygmomanometers per ANSI/AAMI SP10. The text does not explicitly state "auscultation" but refers to the accuracy against the standard, which relies on such methods.

8. The Sample Size for the Training Set

Sample Size: Not applicable. The DS-1901 is a device that includes an algorithm for measurement and compensation, but it's not a machine learning or AI model trained on a large dataset in the typical sense that would have a separate "training set" and "test set" for algorithm development. Its "algorithm" is likely fixed logic and calculation based on biomedical engineering principles, not a learnable model. While it has a "personal mode" that determines inflation value from past measurements, this is a user-specific adaptation, not a global training process.

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

Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the machine learning sense for this device. The "ground truth" for developing the underlying measurement algorithms would be based on fundamental physiological and engineering principles, validated against established reference methods during the device's design and engineering phases.

Summary

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SAFETY & EFFECTIVENESS DATA SUMMARY

Submitters Name, Address & Phone Number: Nihon Seimitsu Sokki., Co., Ltd. (Nissei) 2508-13, Nakago, Komochi-Mura Kitagunma-Gun, Gunma-Ken 377-0293, Japan +81-0279-20-2311

Submission Correspondent:

Lyle Howard Corporation 203 Main Street, 166 Flemington, NJ 08822 USA Attention: Lynette Howard 908-788-4580

Classification Name: Common / Usual Name: Proprietary Name:

Noninvasive Blood Pressure Monitor Blood Pressure Monitor Model DS-1901 Digital Blood Pressure Monitor

Establishment Registration Number: 9610827

Classification: Class II, Reg. # 870.1130, DXN, Cardiovascular Devices Panel

Performance Standards: Sections 898 and 1010 of the Federal Food, Drug and Cosmetic Act

Substantial Equivalence:

The legally marketed device to which substantial equivalence will be demonstrated is the Nissei Model DS-181 Digital Blood Pressure Monitor. This device was cleared for marketing under 510(k) No. K993890, SE decision December 3, 1999.

The subject device is essentially an updating of the predicate device. As can be seen in Appendix S, many of the features and performance specifications are identical. Note particularly that both systems contain a built-in air pump for automatic cuff inflation. have the same measurement accuracy for both blood pressure and pulse rate, are powered by four "AA" batteries, and include an optional AC adaptor.

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The principal differences are that the new DS-1901 includes the circuit detecting arrr circumference and the algorithm revising it to compensate the measurement result and to embody the application of a cuff to arm with circumference of 23 to 43 cm, which the predicate device DS-181 did not and that while the predicate device takes blood pressure measurement during deflation, the subject device takes measurement during inflation. "Personal mode", which determines inflation value from past measurements, is employed with new device. The clock function is also added to the subject device.

Because the difference between the subject device and the predicate device represent functional improvements that have been evaluated through both bench testing and clinical evaluation, it is clear that these changes raise no new questions with respect to either safety or effectiveness.

Testing conducted or standards applied to assure safety and effectiveness includes but is not limited to:

Clinical Performance and Accuracy: ANSI/AAMI Standard SP10-2002, Electronic or Automated Sphygmomanometers, approved October 28, 2002.

Electromagnetic Compatibility: IEC 60601-1-2, 2001 with test procedures according to IEC 61000-4-2, 2001; IEC 61000-4-3, 2001; IEC 6100-4-4, 2001 with Amendment 1, 2000 and Amendment 2,2001; IEC 6100-4-6, 2001; IEC 61000-4-8, 2001; IEC 61000-4-11. 2001.

Electromagnetic Interference: IEC 60601-1-2, 2001.

Description of the new device:

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Intended Use:

Safety and Efficacy Information:

The DS-1901 Blood Pressure Monitors are well recognized as being safe and effective for the stated intended use. The Nihon DS-1901 Blood Pressure Monitors have the same operating principals and intended uses as the predicate Blood Pressure Monitor systems already in commercial distribution.

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Image /page/3/Picture/1 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 a stylized eagle or bird symbol with three curved lines representing its wings or feathers.

Public Health Service

MAR 2 5 7005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nihon Seimitsu Sokki, Co., Ltd. (Nissei) c/o Dr. J. A. van Vugt KEMA Quality B.V. Utrechtseweg 310, 6812 AR Arnhem P.O. Box 5185, 6802 ED Arnhem THE NETHERLANDS

Re: K050697

K050077
Trade Name: Model DS-1901 Digital Blood Pressure Monitor -Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 17, 2005 Received: March 18, 2005

Dear Dr. van Vugt:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantially interests a for use stated in the enclosure) the device interest predicate devices marketed in interstate for use stated in the encrosule) to regary manetoe province Amendments, or to commerce prior to May 28, 1776, the enactions of the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of capliation devices that have been recarsined in acceraance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merelore, market the device, beginer is for annual registration, listing of general controls provisions of the Hereas Capital of Childrens against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on Wa may be subject to suell additional combolis of the 21, Parts 800 to 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.

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Page 2 – Dr. J. A. van Vugt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuation of a backer complies with other requirements of the Act that I DA has made a actorinations administered by other Federal agencies. You must of ally it edical statutes and regalations and limited to: registration and listing (21 Comply with an the Act 3 requirements, not, good manufacturing practice requirements as set CFR I art 807), fabeling (21 OF R Part 820); and If applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product launation control pro herems (we wice as described in your Section 510(k) This letter with anow you to ogin mantoung your and equivalence of your device to a legally premaired notification: The PDA mailing of casting 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 If you desire specific advice ion your as (240) 276-0120. Also, please note the regulation entitled, contact the Office of Compunation in (21 m) (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

B. Zimmerman for

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

Enclosure

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Indications for Use

510(k) Number (if known):

Model DS-1901 Digital Blood Pressure Monitor Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Over-The-Counter Use (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)

A. Ammerman
Division Sign Off

Division Sign-Off) Division of Cardlovascular Devices 510(k) Number_ 050697

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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).