Blood Pressure Monitor DSK-1031 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) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.

Device Description

Blood Pressure Monitor DSK-1031 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 cuff that is applicable to 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 appropriateness of cuff application. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO (World Health Organization) guideline also on the display. User can choose to activate clock function of the device to review measured readings with measurement date and time.

AI/ML Overview

The provided 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1031 (K112620) focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It explicitly states that no clinical tests were submitted because "differences between the subject device and the predicate devices do not affect clinical performance" (Section 6, (2) Clinical tests).

Therefore, the document does not contain the acceptance criteria or a study proving the device meets performance criteria through clinical data. The information below is extracted from the provided text, primarily relating to its equivalence claims which are based on established standards rather than a de novo clinical performance study.

Here's an attempt to answer your request based on the available information:

Acceptance Criteria and Device Performance Study for Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1031 (K112620)

Based on the provided 510(k) summary, the device's "acceptance criteria" for performance are not explicitly stated in terms of specific clinical accuracy thresholds (e.g., mean difference and standard deviation against a reference standard in a clinical study). Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical tests and adherence to recognized standards.

The document states that the device was evaluated "in accordance with IEC and SP-10" to demonstrate substantial equivalence and establish better safety. ANSI/AAMI SP-10 is a key standard for blood pressure monitors. While the specific numerical acceptance criteria (e.g., AAMI accuracy standards for mean difference and standard deviation) are not explicitly listed in the summary, adherence to ANSI/AAMI SP-10 implies meeting those criteria for accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria derived from clinical studies are not presented in this 510(k) summary, and no clinical performance data is reported, this table cannot be fully completed as requested.

However, based on the implicit criteria of substantial equivalence and adherence to ANSI/AAMI SP-10, the "reported performance" is that the device is expected to meet the accuracy requirements of this standard through its design and non-clinical testing.

Acceptance Criterion (Implied by adherence to ANSI/AAMI SP-10)	Reported Device Performance (Implied from non-clinical tests and substantial equivalence)
Blood Pressure Accuracy (Systolic)	Expected to meet ANSI/AAMI SP-10 requirements
Blood Pressure Accuracy (Diastolic)	Expected to meet ANSI/AAMI SP-10 requirements
Pulse Rate Accuracy	Expected to meet relevant standards
Electrical Safety	Conforms to IEC 60601-1:1998 + A1:1991 + A2:1995
Electromagnetic Compatibility (EMC)	Conforms to IEC 60601-1-2 (various revisions) and CISPR 11

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not applicable for a clinical test set, as no clinical tests were submitted.
Data Provenance: Not applicable for a clinical test set. The submission focuses on non-clinical engineering and performance testing against standards.

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

Not applicable as no clinical test set with expert-established ground truth was submitted.

4. Adjudication Method for the Test Set

Not applicable as no clinical test set was submitted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study was done or reported. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool involving human readers.

6. If a Standalone Performance Study (algorithm only without human-in-the-loop performance) was done

Yes, a form of standalone performance assessment was implicitly done through the non-clinical tests demonstrating compliance with recognized standards such as ANSI/AAMI SP-10. This standard sets forth requirements for the accuracy of automated sphygmomanometers, which constitutes a standalone performance assessment for the device's core function. However, the details of the specific tests and resulting numerical accuracy are not provided in this summary.

7. The Type of Ground Truth Used

For the non-clinical performance (accuracy) relative to standards like ANSI/AAMI SP-10, the "ground truth" would typically be established by a reference method (e.g., auscultation by trained observers with a mercury sphygmomanometer) as specified in these standards. The specific ground truth used in the underlying tests is not detailed in the summary.

8. The Sample Size for the Training Set

Not applicable as this is a traditional medical device submission, not an AI/ML-based device that typically involves training sets. The device uses an oscillometric method, which is a well-established algorithm.

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

Not applicable as this is not an AI/ML-based device using a "training set." The oscillometric algorithm's principles are based on established physiological measurements and engineering.

Summary

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2 2012

AUG

5. 510(K) Summarv

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: July 23,2012

(2) Trade name of the device: Blood Pressure Monitor DSK-1031 Common name: Blood pressure monitor Classification: Noninvasive blood pressure measurement system, DXN, 870.1130, Class 11

(3) Predicate devices: Model DS-181 Digital Blood Pressure Monitor, K993890/Model DSK-1011 Blood Pressure Monitor, K112691/Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV, K080177 manufactured by Nohon -Seimitsu Sokki Co., Ltd. and Model HEM-789N3/BP785/BP760 Blood Pressure Monitor, K061822 manufactured by OMRON HEALTHCARE Co., Ltd.
(4) Description of the device:

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(5) Intended use of the device:
DSK-1031 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 guideline' display of cuff condition, display of body movement detection and two memory accounts to save measurement results.

The indication for use of DSK-1031 system is not exactly same with but similar to the predicate device. Model DSK-1011 Blood Pressure Monitor and Wrist blood Pressure Monitor, Model WS-1100/WS-1100PV. However, 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. Model DS-181 Digital Blood Pressure Monitor and Model DSK-1011 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-181 and DSK-1011 or WS-1100/WS-1100PV and these materials do not go through anv different process from the predicate devices. The list of patient contacting materials and components is included in the relevant section of this application.

The following devices comparison table shouws the derails of differences between the subject device and the claimed predicats.

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	DSK-1031, the subject device	WS-1100/WS-1100PV	DS-181	HEM-780N3/BP785/BP760	DSK-1011	Note	Site and applicable circumference	Power source	Inflation	Deflation	Exhaust	Illustrational image of the device	Display	Device setting by the user	Supplemental product features	MemoryFeatures	H.D.M.S ModeExporting The SavedReadings to Your PC	Auxiliaryfeature	Main unit	Cuff	Referencestandard(s)	Irregular Heartbeat SymbolMorning HypertensionSymbolMoring Average SymbolEvening Average SymbolCalibration Check SystemBlood Pressure LevelIndicator	SubstantialEquivalenceDiscussion".
510(K)No.	K112620	K080177	K993890	K061822	K112691		Approximately 8.7 to 16.5 inches (220 to 420 mm)	4 AA alkaline batteries or 100-240V 50/60Hz AC adaptor	Automatic air pump	Automatic electric control valve	Automatic quick exhaust valve	Image: Blood pressure monitor	15 digits liquid crystal display	Date and time	Irregular Pulse Rhythm SymbolBody Motion SymbolCuff SymbolWHO Classification SymbolPulse Pressure Display Symbol	2 memory banks to save60 measurement resultswith date and time, whenthe clock is activated; thesaved readings can beintentionally deleted by theuser.	2 memory banks to save 60blood pressure and pulserate readings each withdate and time; savedreading(s) can beintentionally deleted by theuser.Mode to view AM and PMreadings separatelyExporting saved readingsto personal computersusing the designated USBcable	None	Size: approximately W;4.5,D;2.6, H;4.5 inchesWeight: approximately 8.8oz.	Material: ABS and PMMAPreformed nylon cuff	IEC 60601-1:1998 +A1:1991 + A2:1995IEC 60601-1-2, 2001 +A1:2004/IEC60601-1-2CISPR 11:2003 + A1:2004+ A2:2006IEC 61000-4-2,-3,-8ANSI/AAMI SP-10-2002	A single memory bank tosave 30 blood pressurereadings; readings aredeleted at batteryreplacement.	Same asDSK-1011.
Intended use	DSK-1031 system isintended for noninvasivemeasurement of systolicand diastolic bloodpressure, determination ofpulse rate and calculationof pulse pressure in adultsin a homecareenvironment.The device featuresinclude display of irregularpulse rhythm detection,classification display ofmeasured blood pressurevalues against WHO(World HealthOrganization) guidelinesdisplay of cuff condition,display of body movementdetection and two memoryaccount to savemeasurement results.	WS-1100/WS-1100PVsystem is intended fornoninvasive measurementof systolic and diastolicblood pressure anddetermination of pulse ratein adults in a homecareenvironment.The device features includethe display of irregularpulse rhythm detection, theclassification display ofmeasured blood pressurevalues against theguideline by 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 savedresults to personalcomputers.	Noninvasive measurementof systolic and diastolicblood pressure anddetermination of pulse ratein adult patients, age 18and above	The device is a digitalmonitor intended for use inmeasuring blood pressureand pulse rate in adultpatient population with armcircumference ranging from9 inches to 17 inches(22cm - 42cm).The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal withreadings.The blood pressure monitorcompares average bloodpressure results topre-established AHA(American HeartAssociation) hypertensionguideline of 135/85 mmHg.The Omron 780N3 modelis not intended to be adiagnostic device. Contactyour physician ifhypertensive values areindicated.	Blood Pressure MonitorDSK-1011 is intended fornoninvasive measurementof systolic and diastolicblood pressure,determination of pulse rateand calculation of pulsepressure in adults in ahomecare environment.The device features includedisplay of irregular pulserhythm detection,classification display ofmeasured blood pressurevalues against WHO(World HealthOrganization) guidelinesdisplay of body movementdetection and two memoryaccounts to savemeasurement results.	Refer to "12.SubstantialEquivalenceDiscussion".	Approximately 4.9 to 8.0 inches (125 to 205 mm)	2AAA alkaline batteries	Automatic air pump	Automatic electric control valve	Automatic quick exhaust valve	Image: Blood pressure monitor	15 digits liquid crystal displayDate and time display	Personal target limits of blood pressure values	Irregular Pulse Rhythm SymbolNoneNoneJNC-7 Classification SymbolNone			Position guideLock Key	Approximate size: W; 2.79,D; 2.56, H; 1.18 inchesApproximate weight: 4.09oz.	Material: ABS and PMMAPreformed nylon cuff	36.202 ofEN60601-1-2:1993(EMS)EN55011:3.1991(EMI)	2 memory banks to save100 measurement resultswith date and time, whenthe clock is activated; thesaved readings can beintentionally deleted by theuser.
Operationprinciple	Oscillometric method	Oscillometric method	Oscillometric method	Oscillometric method	Oscillometric method	Same	Standard Approximately 9.1 to 12.6 inches (230 to 320 mm)Large Approximately 12.6 to 16.5 inches (320 to 420mm)	4 AA alkaline batteries or 6VDC AC adaptor	Automatic air pump	Automatic electric control valve	Automatic quick exhaust valve	Image: Blood pressure monitor	7 digits liquid crystal display	None	NoneNoneNoneNoneNone			None.	Approximate size: W; 6,23,D; 3.94, H; 2.05 inchesApproximate weight: 9.35oz.	Material: ABS and PCNylon flat arm cuff	ANSI/AAMI SP-10-2002	2 memory banks to save 60measurement results withdate and time, when theclock is activated; thesaved readings can beintentionally deleted by theuser.	Same asWS-1100/WS-1100PV
Pressureindicationrange	3 to 300 mmHg	0 to 300 mmHg	0 to 300 mmHg	0 to 299 mmHg	3 to 300 mmHg	Same asDSK-1011.	Approximately 9 to 17 inches (220 to 420 mm)	4 AA batteries or 120V 60Hz AC adaptor	Automatic by electric pump	Automatic pressure release valve	Automatic quick exhaust	Image: Blood pressure monitor	13 digits liquid crystal displayDate and time display	Date and time TRURED™ MODE	NoneMovement Error SymbolCuff Wrap Guide SymbolNoneNone			None	Approximate size: W; 4 7/8,D; 6 1/4, H; 3 5/16 inchesApproximate weight: 15 1/8oz.	Material: ABS and PCPreformed nylon cuff		None
Measurement	Upper arm	Wrist	Upper arm	Upper arm	Upper arm	Same as DS-181and DSK-1011	Standard-Large size (Approximately 8.7 to 16.5 inches; 220 to 420 mm)	4 AA alkaline batteries or 100-240V 50/60Hz AC adaptor	Automatic air pump	None	Automatic quick exhaust valve	Image: Blood pressure monitor	15 digits liquid crystal displayDate and time display	Date and time	Same as WS-1100/ WS-1100PV and DSK-1011SameBody movement and Cuff winding are the same as HEM-780N3/BP785/BP760 and DSK-1011.NoneRefer to "12.			None	Size: approximately W:4.5,D;2.6, H;4.5 inchesWeight: approximately 8.8 oz.	Material: ABS and PMMANylon flat arm cuff	IEC 60601-1:1998 +A1:1991+A2:1995IEC 60601-1-2, 2001 +A1:2004/IEC60601-1-2CISPR 11:2009+ A1:2010IEC61000-3-2:2005+A1+A2:2009IEC 61000-3-3:2008	None
Same as DS-181 and DSK-1011	Same	Same	Same

Device comparison tabl

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IEC61000-4-2:2008IEC61000-4-3:2006+A1:2007+A2:2010IEC61000-4-4:2004+A1:2010IEC61000-4-5:2005IEC61000-4-6:2008IEC61000-4-8:2009IEC61000-4-11:2004ANSI/AAMI SP10:2002		IEC61000-4-2:2008IEC61000-4-3:2006+A1:2007+A2:2010IEC61000-4-4:2004+A1:2010IEC61000-4-5:2005IEC61000-4-6:2008IEC61000-4-8:2009IEC61000-4-11:2004ANSI/AAMI SP10:2002


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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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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the right.

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

2 2012 AUG

Nihon Seimitsu Sokki Co., Ltd. c/o Mr. Koji Kubo Manager Cosmos Corporation 2F, 6-5-3 Komagome Bunkyo-ku Tokyo 113-0021 JAPAN

Re: K112620

Trade/Device Name: Digital Blood Pressure Monitor, Model DSK-1031 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 9, 2012 Received: July 10, 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.

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.

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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); 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.

Sincerely yours.

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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K112620

510(K) Number: K112620

Blood Pressure Monitor DSK-1031 Device Name:

Indications for Use:

Prescription Use (Per 21 CFR 801.109 Subpart D)

(21 CFR 807 Subpart C)

AND / OR Over-The Counter Use

(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 Cardiovascular Devices

510(k) Number K112620

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).