Wrist Blood Pressure Monitor WSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.

The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.

Device Description

Blood Pressure Monitor WSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at wrist non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the cuff that is applicable to wrist circumference between 4.9 and 8.9 inches (between 125 and 225 mm), singly mounted. The device is powered by two AAA alkaline batteries. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.

AI/ML Overview

The provided text is a 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor WSK-1011. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, a standalone study for the device's performance against those criteria, or an MRMC comparative effectiveness study.

The summary states:

"No clinical test report is submitted because differences between the subject device and the predicate devices do not affect clinical performance."
"The subject device was evaluated in accordance with IEC and SP-10 not only to demonstrate the substantial equivalence but also to establish the better safety."

Therefore, based solely on the provided text, I cannot directly answer most of your detailed questions regarding acceptance criteria, study specifics, ground truth, and sample sizes for a clinical performance study. The document explicitly states no clinical test report was submitted due to assumed equivalence in clinical performance.

However, I can extract information related to the non-clinical tests that were performed.

Here's what can be inferred or directly stated from the provided text, with limitations:

1. Table of acceptance criteria and the reported device performance:

Since no clinical study report is provided, specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure accuracy cannot be extracted from this document, nor can the device's performance against such criteria. The document states the device was evaluated according to IEC and SP-10 standards. These standards (such as ISO 81060-2 for non-invasive sphygmomanometers) would define the acceptance criteria for accuracy.

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

Test Set Sample Size: Not applicable/Not provided. No clinical test set details are given.
Data Provenance: Not applicable/Not provided for clinical data. The non-clinical tests follow IEC and SP-10 standards.

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

Not applicable/Not provided. No clinical test set details are given.

4. Adjudication method for the test set:

Not applicable/Not provided. No clinical test set details are given.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a blood pressure monitor, not an AI-powered diagnostic imaging device involving human readers.

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

The document implies that the device's performance was evaluated through non-clinical bench testing against established standards (IEC and SP-10) for substantial equivalence in safety and effectiveness. A standalone clinical performance study was explicitly stated as not submitted.

7. The type of ground truth used:

For non-clinical tests, the "ground truth" would be measurements obtained using reference standards and calibrated equipment as specified by IEC and SP-10 standards for blood pressure monitor testing.
For clinical performance, if a study were done, the ground truth for blood pressure measurement would typically be established by validated invasive or non-invasive reference methods (e.g., auscultatory method by trained observers using a mercury sphygmomanometer). However, as stated, no clinical tests were submitted.

8. The sample size for the training set:

Not applicable/Not provided. This device is a hardware blood pressure monitor, not an AI/machine learning model that typically requires a training set.

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

Not applicable/Not provided, for the same reason as above.

Summary

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K112690

5. 510(K) Summary

This document was prepared in accordance with 21 CFR 807.92.

Section (a)

(1) Name of the submitter: Nihon Seimitsu Sokki Co., Ltd. Address: 2508-13 Nakago, Shibukawa, Gunma 377-0293, Japan Telephone number: 81-279-20-2311 Contact person: Mitsuo Kanai Date of documentation: September 14, 2011
(2) Trade name of the device: Blood Pressure Monitor WSK-1011 Common name: Blood pressure monitor Classification: Noninvasive blood pressure measurement system, DXN, 870.1130, Class II
(3) Predicate devices: Wrist blood Pressure Monitor, Model WS-1100/WS-1100PV, K080177, Nihon Seimitsu Sokki, Co., Ltd.

(4) Description of the device:

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(5) Intended use of the device:
WSK-1011 system is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.

The indication for use of WSK-1011 system is not exactly same with but similar to the predicate device. The fundamental intended use, which is to measure adults' blood pressure non-invasively in home care environment, remains the same. The difference between the indications for use of the subject device and the predicate device lies in supplemental product features of the predicate device are not provided with the new device and some new features are introduced with the subject device. As demonstrated in relevant sections of this submission, these features are concluded not to affect the device safety and effectiveness.

(6) Technological characteristics of the subject device and the predicate device:
The subject device holds the same technological fundamentals with the predicate device. Both devices consist of the single-mounted main unit and cuff for wrist and powered with two AAA alkaline batteries. The patient contacting materials used for the subject device had been used with the predicate device and these materials do not go through any different process from the predicate devices. The list of patient contacting materials and components is included in the relevant section of this application.

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(7) The following Device comparison table,shows the details of differences between the subject device and the claimed predicats.

	WSK-1011, the subject device	WS-1100/WS-1100PV(K080177)	Note
Intended use	WSK-1011 system is intended fornoninvasive measurement of systolic anddiastolic blood pressure, determination ofpulse rate and calculation of pulsepressure in adults in a homecareenvironment.The device features include display ofirregular pulse rhythm detection,classification display of measured bloodpressure values against WHO (WorldHealth Organization) guidelines, displayof body movement detection and twomemory account to save measurementresults.	WS-1100/WS-1100PV system isintended for noninvasivemeasurement of systolic anddiastolic blood pressure anddetermination of pulse rate in adultsin a homecare environment.The device features include thedisplay of irregular pulse rhythmdetection, the classification display ofmeasured blood pressure valuesagainst the guideline by World HealthOrganization or equivalent guideline,the personal setting for individualblood pressure target values, the twomemory banks to save themeasurement results with date andtime of measurement and thetransferring the saved results topersonal computers.
Operationprinciple	Oscillometric method	Oscillometric method	Same
Pressureindicationrange	3 to 300 mmHg	0 to 300 mmHg
Measurementsite and cuffsize	WristRegular size (Approximately 4.9 to 8.9inches; 125 to 225 mm)	WristRegular size (Approximately 4.9 to8.0; 125 to 205 mm)	Same
Power source	2 AAA alkaline batteries	2AAA alkaline batteries	Same
Inflation	Automatic air pump	Automatic air pump	Same
Deflation	Automatic electric control valve	Automatic electric control valve	Same
Exhaust	Automatic quick exhaust valve	Automatic quick exhaust valve	Same
Display	15 digits liquid crystal displayDate and time display	15 digits liquid crystal displayDate and time display	Same
Device settingby the user	Date and time	Date and timePersonal target limits of bloodpressure values
Memoryfeatures	2 memory banks to save 60easurement results with date and time,when the clock is activated; the savedreadings can be intentionally deleted bythe user.	2 memory banks to save 60 bloodpressure and pulse rate readingseach with date and time; savedreading(s) can be intentionallydeleted by the user.Mode to view AM and PM readingsseparatelyExporting saved readings to personalcomputers using the designated USBcable
Main unit	Size: approximately W;2.76 x D;1.06 xH;2.76 inchesWeight: approximately 3.9 oz.Material: ABS and PMMA	Approximate size: W; 2.79, D; 2.56,H; 1.18 inchesApproximate weight: 4.09 oz.Material: ABS and PMMA
Cuff type	Preformed nylon cuff	Preformed nylon cuff	Same

Device comparison table

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Section (b)

(1) Non-clinical tests

The subject device was evaluated in accordance with IEC and SP-10 not only to demonstrate the substantial equivalence but also to establish the better safety. This is why some reference standards were added to test the subject device when compared to the predicated devices. The detailed information of reference standards is provided in the relevant sections of this submission.

(2) Clinical tests

No clinical test report is submitted because differences between the subject device and the predicate devices do not affect clinical performance.

(3) Conclusions drawn from non-clinical tests

It is concluded from the non-clinical tests conducted that the subject device is not only as safe and as effective as the predicate devices but is also safer and more effective than the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2 4 2012

Nihon Seimitsu Sokki Co., Ltd. c/o Mr. Koji Kubo Manager Cosmos Corporation 6-5-3 Beaunce Honkomagome 2F, Honkomagome Bunkyo-ku, Tokyo

JAPAN 113-0021

Re: K112690

Trade/Device Name: Blood Pressure Monitor, Model WSK-1011 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: February 14, 2012 Received: February 16, 2012

Dear Mr. Kubo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications ferenced above and nave determined by marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device American son to cominerce prov to May 20, 1970, the enaocance 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 You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the 110t liveling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Frease note: CDNT does not evaluate in the truthful and not misleading.

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Page 2 - Mr. Koji Kubo

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

-fs

Sincerely yours,

Brom D. Zuckerman, M.D.

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: K112690

Blood Pressure Monitor WSK-1011 Device Name:

Indications for Use:

Prescription Use (Per 21 CFR 801.109 Subpart D)

X 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)

(Division Sign-Off) Division of Čardiovascular Device

510(k) Number K112690

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).