Blood Pressure Monitor DSK-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 DSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm 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 nylon cuffs, regular size cuff for arm circumference between 8.7 and 12.6 inches (between 220 and 320 mm) and large size cuff for arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm), and is powered by four AA alkaline batteries or AC adaptor. 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 describes a 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1011. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report that establishes clinical efficacy against specific acceptance criteria.

The acceptance criteria for blood pressure monitors are typically defined by recognized standards such as the ANSI/AAMI/ISO 81060-2 standard (or its predecessors, such as ANSI/AAMI SP10). However, the document states that no clinical test report was submitted because "differences between the subject device and the predicate devices do not affect clinical performance." Instead, non-clinical tests were performed.

Therefore, this response will outline the typical acceptance criteria for blood pressure monitors (as implied by the referenced standards) and explain that the provided document does not directly present the results of a study proving the device meets these criteria through clinical testing. It relies on non-clinical testing and substantial equivalence to predicate devices.

1. A table of acceptance criteria and the reported device performance

Since no direct clinical study results with specific performance metrics are provided in the document, I will outline the typical acceptance criteria for automated sphygmomanometers (based on standards like ISO 81060-2, which is what "IEC and SP-10" likely refer to for blood pressure monitors) and note that the document claims the device meets these standards through non-clinical testing and substantial equivalence.

Acceptance Criteria (Typical for Automated Sphygmomanometers per e.g., ISO 81060-2)	Reported Device Performance (as implied by the document)
Accuracy (Mean Difference)	The device was evaluated in accordance with "IEC and SP-10" (referring to standards like ANSI/AAMI SP-10, which specifies accuracy requirements for automated sphygmomanometers). The conclusion from non-clinical tests states "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." This implies that the device meets the accuracy requirements specified in these standards for both systolic and diastolic blood pressure.
Accuracy (Standard Deviation)	(See above) Implied to meet the standard deviation requirements as per "IEC and SP-10".
Cuff Pressure Accuracy	Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.)
Pressure Indication Range	3 to 300 mmHg. (This is a specification, not a performance criterion, but tested against the device's stated capabilities.) The document indicates this range was tested and found acceptable during non-clinical tests.
Pulse Rate Accuracy	Implied to meet accuracy requirements as per "IEC and SP-10" since it determines pulse rate.
Electromagnetic Compatibility (EMC)	Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.)
Electrical Safety	Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.)
Mechanical Safety	Passed. (Typically evaluated as part of non-clinical device performance and safety testing against relevant standards.)
Biocompatibility of Patient Contacting Materials	Passed. The patient contacting materials had been used with predicate devices and do not go through any different process, implying their biocompatibility has been previously established.
Software Verification and Validation	Passed. (Though not explicitly detailed, implicitly covered under "non-clinical tests" to ensure device functionality, including features like irregular pulse rhythm detection, body movement detection, and memory functions, perform as intended.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable (N/A) – No clinical test set data is provided in this document. The submission states, "No clinical test report is submitted."
Data provenance: N/A

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A – No clinical test data is provided. For blood pressure monitor clinical studies (which were not submitted here), ground truth is typically established by trained technicians or clinicians using a reference standard device (e.g., a mercury sphygmomanometer) following a rigorous protocol (like the auscultatory method).

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

N/A – No clinical test data is provided.

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

N/A – This document is for a standalone blood pressure monitor, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not relevant in this context.

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

Yes, in effect, a standalone evaluation was performed, albeit via non-clinical testing and substantial equivalence arguments. The device itself is an automated, standalone blood pressure monitor. The submission concludes, based on non-clinical tests against recognized standards ("IEC and SP-10") and comparison to predicate devices, that the device is "as safe and as effective" as its predicates. This implies the device's algorithm and hardware were validated in a standalone capacity to meet the performance standards.

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

For the non-clinical tests, the "ground truth" refers to the established reference values and performance metrics defined by the "IEC and SP-10" standards (e.g., accuracy requirements against a precisely calibrated pressure source or a clinical reference standard). The device was tested to conform to these predefined standard requirements.

8. The sample size for the training set

N/A – This document does not describe a machine learning algorithm that requires a separate training set. The device uses an oscillometric method, which is a well-established principle for blood pressure measurement, not typically "trained" in the manner of deep learning models.

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

N/A – Not applicable as there is no mention of a training set for a machine learning model.

Summary

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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 DSK-1011 Common name: Blood pressure monitor Classification: Noninvasive blood pressure measurement system, DXN, 870.1130, Class II
(3) Predicate devices: Model DS-1901 Digital Blood Pressure Monitor, K071384, Nihon Seimitsu Sokki Co., Ltd. and Wrist blood Pressure Monitor, Model WS-1100/WS-1100PV, K080177, Nihon Seimitsu Sokki, Co., Ltd.
(4) Description of the device:

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the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.

(5) Intended use of the device:
DSK-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 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.

The indication for use of DSK-1011 system is not exactly same with but similar to the predicate devices. 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; some 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, Model DS-1901 Digital Blood Pressure Monitor. Both devices consist of the main unit and the cuff for upper arm and powered with four AA alkaline batteries or designated AC adaptor. The patient contacting materials used for the subject device had been used with either one of the predicate devices, Model DS-1901 or WS-1100/WS-1100PV 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.

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

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Device comparison table

DSK-1011, the subject device	DS-1901 (K071384)	WS-1100/WS-1100PV(K080177)	SNote
Intended use	DSK-1011 system is intended fornoninvasive measurement ofsystolic and diastolic bloodpressure, determination of pulserate and calculation of pulsepressure in adults in a homecareenvironment.The device features includedisplay of irregular pulse rhythmdetection, classification display ofmeasured blood pressure valuesagainst WHO (World HealthOrganization) guidelines, displayof body movement detection andtwo memory account to savemeasurement results.	The DS-1901 system isintended for the noninvasivemeasurement of systolic anddiastolic blood pressure anddetermination of pulse rate inadult patients, i.e., age 12and above. The product isrecommended for use bypatients with labile bloodpressure or knownhypertension in a home careenvironment as an adjunct tomedical management.The device displays irregularpulse rhythm indication whenit is detected duringmeasurement.	WS-1100/WS-1100PVsystem is intended fornoninvasive measurement ofsystolic and diastolic bloodpressure and determinationof pulse rate in adults in ahomecare environment.The device features includethe display of irregular pulserhythm detection, theclassification display ofmeasured blood pressurevalues against the guidelineby World HealthOrganization or equivalentguideline, the personalsetting for individual bloodpressure target values, thetwo memory banks to savethe measurement resultswith date and time ofmeasurement and thetransferring the saved results	Refer to "12.SubstantialEquivalenceDiscussion".
Operationprinciple	Oscillometric method	Oscillometric method	to personal computers.Oscillometric method	Same
Pressureindicationrange	3 to 300 mmHg	0 to 300 mmHg	0 to 300 mmHg	Refer to "12.SubstantialEquivalenceDiscussion".
Measurementsite and cuffsize	Upper armStandard-Large size(Approximately 8.7 to 16.5inches; 220 to 420 mm)	Upper armLarge size (Approximately9.1 to 16.9 inches; 230 to460 mm)	WristRegular size(Approximately 4.9 to 8.0;125 to 205 mm)	Same asDS-1901
Power source	4 AA alkaline batteries or100-240V 50/60Hz AC adaptor	4 AA batteries or 6VDC ACadaptor	2AAA alkaline batteries	Same asDS-1901
Inflation	Automatic air pump	Automatic with air pump	Automatic air pump	Same
Exhaust	Automatic quick exhaust valve	Automatic with EV	Automatic with quick exhaustvalve	Same ASDS-1901
Display	15 digits liquid crystal display	12 digits liquid crystal display	15 digits liquid crystal display	Same asWS-1100/WS-1100PV
Device settingby the user	Date and time	Date and time	Date and timePersonal target limits ofblood pressure values	Refer to "12.SubstantialEquivalenceDiscussion".
Memoryfeatures	2 memory banks to save 60measurement results with dateand time, when the clock isactivated; the saved readingscan be intentionally deleted bythe user.	A single memory bank tosave 30 most recent systolicand diastolic readings	2 memory banks to save 60blood pressure and pulserate readings each with dateand time; saved reading(s)can be intentionally deletedby the user.Mode to view AM and PMreadings separatelyExporting saved readings topersonal computers usingthe designated USB cable	Refer to "12.SubstantialEquivalenceDiscussion".
Main unit	Size: approximately W;4.5,D;2.6, H;4.5 inchesWeight: approximately 8.8 oz.Material: ABS and PMMA	Size: approximately W;5.8 xD;4.5 x H2.1 inchesWeight: approximately 11.6oz.Material: ABS and acrylicresin	Approximate size: W; 2.79,D; 2.56, H; 1.18 inchesApproximate weight: 4.09 oz.Material: ABS and PMMA
Cuff type	Nylon flat cuff	Nylon flat cuff	Preformed nylon cuff	Same asDS-1901

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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

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

K112691 Re:

Trade/Device Name: Blood Pressure Monitor, Model DSK-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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

Image /page/4/Picture/9 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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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 or any I edital 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 Or F Pat 007); woonling (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 Four may 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.

Sincerely yours,

Sincerely,

D. Zukerman, 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: K112691

Blood Pressure Monitor DSK-1011 Device Name:

Indications for Use:

Prescription Use_ (Per 21 CFR 801.109 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)

Sign Off

(Division Sign-Off)
Division of Cardiovascular Device:

510(k) Number

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).