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 known hypertension in a home care environment as an adjunct to medical management.

The device displays irregular pulse rhythm indication when it is detected during measurement.

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 LCD display of systolic and diastolic blood pressure readings, pulse rate and irregular pulse rhythm 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

The provided text is a 510(k) summary for the NIHON SEIMITSU SOKKI CO., LTD. Model DS-1901 Digital Blood Pressure Monitor. This document explicitly states that there is no difference in intended use and technology characteristics between the subject device and the predicate device (K050697). The reason for the 510(k) submission is to include detection and display of irregular pulse rhythm in the Indications for Use Statement, a feature already present in the predicate device.

Therefore, the study conducted for this specific 510(k) submission (K071384) primarily relies on the equivalency to the predicate device, K050697. The document does not describe a new, independent study with specific acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies for the DS-1901 device itself. Instead, it refers to the performance of the predicate device.

Based on the information provided, here's a best effort to address the prompt, acknowledging the limitations of the document for a direct answer to all questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Predicate)	Reported Device Performance (from Predicate)
Pressure: +/- 3 mmHg	Pressure: +/- 3 mmHg
Pulse rate: +/- 5% or reading	Pulse rate: +/- 5% or reading

2. Sample size used for the test set and the data provenance

The document for K071384 does not specify a distinct test set or its sample size. It states that the subject device (DS-1901) is equivalent to the predicate device (K050697). Therefore, the performance data is inferred from the predicate device. The provenance of the data for the predicate device is not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe a study involving experts to establish ground truth for this submission, as it relies on equivalency to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a study with an adjudication method.

5. 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

Not applicable. This device is a digital blood pressure monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone automatic blood pressure monitor. Its performance, as stated through equivalency to the predicate, is the "algorithm only" performance for blood pressure and pulse rate measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood pressure monitors, the "ground truth" (or reference standard) for accuracy is typically a manually performed auscultatory measurement using a mercury sphygmomanometer or another validated reference device, conducted by trained personnel. This information is not explicitly stated in the provided document but is the common standard for such devices.

8. The sample size for the training set

Not applicable. The document does not describe a training set for an algorithm development for this specific submission, as it relies on equivalency to a predicate device.

9. How the ground truth for the training set was established

Not applicable. The document does not describe a training set or how its ground truth would be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is an equivalency study to a previously cleared predicate device, Model 1901 Digital Blood Pressure Monitor (K050697). The 510(k) submission for the DS-1901 explicitly states: "There is not a difference of intended use and technology characteristic between the subject device and any predicate device (K050697)." The reason for the submission was to formally add "detection and display of irregular pulse rhythm" to the Indications for Use, a feature already present in the predicate. The performance specifications (accuracy of pressure and pulse rate measurement) are therefore directly inherited from the predicate device, which would have undergone its own validation testing to demonstrate these accuracies against a reference standard.

Summary

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K07 1384
510(k) Summary

as required by 807.92

1. Company Identification

NIHON SEIMITSU SOKKI CO., LTD. (Nissei) 2508-13 Nakago, Shibukawa, Gunma 377-0293 Japan Tel: +81-279-20-2311 Fax: +81-279-20-2411

2. Official Correspondent

Hideki Tomaru (Mr.) Assistant Manager of International Sales Div.

3. Date of Submission May 16, 2007

Device Trade name Model DS-1901 Digital Blood Pressure Monitor

5. Common/Usual Name

Blood Pressure Monitor

6. Classification Number

Class II, 74 DXN, 21 CFR 870. 1130 - Cardiovascular Devices Panel

7. Predicate Device

Manufacturer Trade Name .. Model 1901 Digital Blood Pressure Monitor : K050697 510(k) No. . .

8. Description of Device

9. Indication for use

The device displays irregular pulse rhythm indication when it is detected during measurement.

10. Technical Characteristics

There is not a difference of intended use and technology characteristic between the subject device and any predicate device (K050697). The reason for 510(K) submission is to include detection and display of irregular pulse rhythm in the Indication for use Statement. This feature is already included in the predicate device. Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are equivalent in the areas of technical characteristics, general functions.

OCT - 9 2007

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Appendix 1: Comparison Table with Predicate Device

SUBJECT DEVICE	PREDICATE DEVICE: K050697
Indications for use:	Indications for use:
Measurement of blood pressure and pulse rate	Measurement of blood pressure and pulse rate
adult patients	adult patients
Function to detect and display irregular pulse
wave
Method of measurement:	Method of measurement:
It is the same as the right	Oscillometric
Display of indications:	Display of indications:
It is the same as the right	12-digit LCD: systolic, diastolic, pulse rate,
	memory data number, 4 status
	clock - hour and minute
Error Indications:	Error Indications:
It is the same as the right	Four, plus weak battery charge on status
	indicator
Range of pressure:	Range of pressure:
It is the same as the right	0 to 300 mmHg
Range of measuring:	Range of measuring:
It is the same as the right	Systolic: 50 to 250 mmHg
	Diastolic: 40 to 160 mmHg
	Pulse rate: 40 to 160 bpm
Accuracy of measurement:	Accuracy of measurement:
It is the same as the right	Pressure: + /- 3 mmHgPulse rate: +/- 5% or reading
Memory:	Memory:
It is the same as the right	30 most recent systolic and diastolic
	Reading plus average measured time
Inflation:	Inflation:
It is the same as the right	Automatic by air pump
Deflation:	Deflation:
It is the same as the right	None
Exhaust:	Exhaust:
It is the same as the right	Automatic by EV
Operating Temperature and Humidity:	Operating Temperature and Humidity:
It is the same as the right	+10℃ to 40℃; 15 to 90% RH
Storage Temperature:	Storage Temperature:
It is the same as the right	-20℃ to +50℃; 15 to 90% RH
Cuff Size:	Cuff Size:
It is the same as the right	142mm×580mm
	(arm circumference range 230 to 460mm)
Power:	Power:
It is the same as the right	4×1.5-volt "AA" batteries, or 6VDC AC adaptor,consumption 4.0 W (max.)
Weight. Main unit:	Weight. Main unit:
It is the same as the right	Approx. 330 grams

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2007

Nihon Seimitsu Sokki Co. Ltd. c/o Mr. Koji Kubo Cosmos Corporation 3F, 2-17-6 Akebono-cho Tachikawa-shi, Tokyo 190-0012 JAPAN

K071384 Re: Trade/Device Name: Digital Blood Pressure Monitor, Model DS-1901 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 11, 2007 Received: September 13, 2007

Dear Mr. Kubo:

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 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) 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.

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Page 2 -- Mr. Koji Kubo

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blyminmorfor

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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510(K) Number: K071384

Device Name: Model DS-1901 Digital Blood Pressure Monitor

Indications for Use:

The device displays irregular pulse rhythm indication when it is detected during measurement.

× AND / OR Over-The-Counter Use Prescription Use_ ____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Per 21 CFR 801.109 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blymmmer

ાજકરી

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).