DISITAL BLOOD PRESSURE MONITOR

K112620 · Nihon Seimitsu Sokki Co., Ltd. · DXN · Aug 2, 2012 · Cardiovascular

Device Facts

• Record ID: K112620
• Device Name: DISITAL BLOOD PRESSURE MONITOR
• Applicant: Nihon Seimitsu Sokki Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

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 Story

Automatic sphygmomanometer for home use; measures systolic/diastolic blood pressure and pulse rate via oscillometric method. Input: oscillations against upper arm cuff. Processing: analyzes pulse wave; detects irregular pulse rhythm and body movement; calculates pulse pressure; classifies blood pressure per WHO guidelines. Output: digital display of readings, pulse pressure, and status indicators (cuff condition, irregular rhythm, body motion). Operated by patient; powered by AA batteries or AC adapter. Benefits: enables self-monitoring of blood pressure and pulse in home environment; provides visual feedback on measurement quality and hypertension status.

Clinical Evidence

No clinical data submitted. Substantial equivalence established via non-clinical bench testing against recognized standards (IEC 60601-1, IEC 60601-1-2, ANSI/AAMI SP-10).

Technological Characteristics

Oscillometric measurement; upper arm cuff (8.7-16.5 inches). Materials: ABS, PMMA, nylon. Power: 4 AA batteries or AC adapter. Features: 15-digit LCD, irregular pulse/body motion detection, WHO classification, 2 memory banks. Standards: IEC 60601-1, IEC 60601-1-2, CISPR 11, IEC 61000 series, ANSI/AAMI SP-10.

Indications for Use

Indicated for noninvasive measurement of systolic and diastolic blood pressure, pulse rate, and pulse pressure in adults in a homecare environment.

Regulatory Classification

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.

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)
• Model HEM-789N3/BP785/BP760 Blood Pressure Monitor (K061822)

Submission Summary (Full Text)

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K112620
P'1/7

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:

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.

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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.

7) 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 | Memory<br>Features | H.D.M.S Mode<br>Exporting The Saved<br>Readings to Your PC | Auxiliary<br>feature | Main unit | Cuff | Reference<br>standard(s) | Irregular Heartbeat Symbol<br>Morning Hypertension<br>Symbol<br>Moring Average Symbol<br>Evening Average Symbol<br>Calibration Check System<br>Blood Pressure Level<br>Indicator | Substantial<br>Equivalence<br>Discussion". |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------|----------------------------------|-------------------------------|------------------------------------|-----------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| 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 Symbol<br>Body Motion Symbol<br>Cuff Symbol<br>WHO Classification Symbol<br>Pulse Pressure Display Symbol | 2 memory banks to save<br>60 measurement results<br>with date and time, when<br>the clock is activated; the<br>saved readings can be<br>intentionally deleted by the<br>user. | 2 memory banks to save 60<br>blood pressure and pulse<br>rate readings each with<br>date and time; saved<br>reading(s) can be<br>intentionally deleted by the<br>user.<br>Mode to view AM and PM<br>readings separately<br>Exporting saved readings<br>to personal computers<br>using the designated USB<br>cable | None | Size: approximately W;4.5,<br>D;2.6, H;4.5 inches<br>Weight: approximately 8.8<br>oz. | Material: ABS and PMMA<br>Preformed nylon cuff | IEC 60601-1:1998 +<br>A1:1991 + A2:1995<br>IEC 60601-1-2, 2001 +<br>A1:2004/IEC60601-1-2<br>CISPR 11:2003 + A1:2004<br>+ A2:2006<br>IEC 61000-4-2,-3,-8<br>ANSI/AAMI SP-10-2002 | A single memory bank to<br>save 30 blood pressure<br>readings; readings are<br>deleted at battery<br>replacement. | Same as<br>DSK-1011. |
| Intended use | DSK-1031 system is<br>intended for noninvasive<br>measurement of systolic<br>and diastolic blood<br>pressure, determination of<br>pulse rate and calculation<br>of pulse pressure in adults<br>in a homecare<br>environment.<br>The device features<br>include display of irregular<br>pulse rhythm detection,<br>classification display of<br>measured blood pressure<br>values against WHO<br>(World Health<br>Organization) guidelines<br>display of cuff condition,<br>display of body movement<br>detection and two memory<br>account to save<br>measurement results. | WS-1100/WS-1100PV<br>system is intended for<br>noninvasive measurement<br>of systolic and diastolic<br>blood pressure and<br>determination of pulse rate<br>in adults in a homecare<br>environment.<br>The device features include<br>the display of irregular<br>pulse rhythm detection, the<br>classification display of<br>measured blood pressure<br>values against the<br>guideline by World Health<br>Organization or equivalent<br>guideline, the personal<br>setting for individual blood<br>pressure target values, the<br>two memory banks to save<br>the measurement results<br>with date and time of<br>measurement and the<br>transferring the saved<br>results to personal<br>computers. | Noninvasive measurement<br>of systolic and diastolic<br>blood pressure and<br>determination of pulse rate<br>in adult patients, age 18<br>and above | The device is a digital<br>monitor intended for use in<br>measuring blood pressure<br>and pulse rate in adult<br>patient population with arm<br>circumference ranging from<br>9 inches to 17 inches<br>(22cm - 42cm).<br>The device detects the<br>appearance of irregular<br>heartbeats during<br>measurement and gives a<br>warning signal with<br>readings.<br>The blood pressure monitor<br>compares average blood<br>pressure results to<br>pre-established AHA<br>(American Heart<br>Association) hypertension<br>guideline of 135/85 mmHg.<br>The Omron 780N3 model<br>is not intended to be a<br>diagnostic device. Contact<br>your physician if<br>hypertensive values are<br>indicated. | Blood Pressure Monitor<br>DSK-1011 is intended for<br>noninvasive measurement<br>of systolic and diastolic<br>blood pressure,<br>determination of pulse rate<br>and calculation of pulse<br>pressure in adults in a<br>homecare environment.<br>The device features include<br>display of irregular pulse<br>rhythm detection,<br>classification display of<br>measured blood pressure<br>values against WHO<br>(World Health<br>Organization) guidelines<br>display of body movement<br>detection and two memory<br>accounts to save<br>measurement results. | Refer to "12.<br>Substantial<br>Equivalence<br>Discussion". | 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 display<br>Date and time display | Personal target limits of blood pressure values | Irregular Pulse Rhythm Symbol<br>None<br>None<br>JNC-7 Classification Symbol<br>None | | | Position guide<br>Lock Key | Approximate size: W; 2.79,<br>D; 2.56, H; 1.18 inches<br>Approximate weight: 4.09<br>oz. | Material: ABS and PMMA<br>Preformed nylon cuff | 36.202 of<br>EN60601-1-2:1993(EMS)<br>EN55011:3.1991(EMI) | 2 memory banks to save<br>100 measurement results<br>with date and time, when<br>the clock is activated; the<br>saved readings can be<br>intentionally deleted by the<br>user. | |
| Operation<br>principle | Oscillometric method | Oscillometric method | Oscillometric method | Oscillometric method | Oscillometric method | Same | Standard Approximately 9.1 to 12.6 inches (230 to 320 mm)<br>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 | None<br>None<br>None<br>None<br>None | | | None. | Approximate size: W; 6,23,<br>D; 3.94, H; 2.05 inches<br>Approximate weight: 9.35<br>oz. | Material: ABS and PC<br>Nylon flat arm cuff | ANSI/AAMI SP-10-2002 | 2 memory banks to save 60<br>measurement results with<br>date and time, when the<br>clock is activated; the<br>saved readings can be<br>intentionally deleted by the<br>user. | Same as<br>WS-1100/<br>WS-1100PV |
| Pressure<br>indication<br>range | 3 to 300 mmHg | 0 to 300 mmHg | 0 to 300 mmHg | 0 to 299 mmHg | 3 to 300 mmHg | Same as<br>DSK-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 display<br>Date and time display | Date and time TRURED™ MODE | None<br>Movement Error Symbol<br>Cuff Wrap Guide Symbol<br>None<br>None | | | None | Approximate size: W; 4 7/8,<br>D; 6 1/4, H; 3 5/16 inches<br>Approximate weight: 15 1/8<br>oz. | Material: ABS and PC<br>Preformed nylon cuff | | None | |
| Measurement | Upper arm | Wrist | Upper arm | Upper arm | Upper arm | Same as DS-181<br>and 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 display<br>Date and time display | Date and time | Same as WS-1100/ WS-1100PV and DSK-1011<br>Same<br>Body movement and Cuff winding are the same as HEM-780N3/BP785/BP760 and DSK-1011.<br>None<br>Refer to "12. | | | None | Size: approximately W:4.5,<br>D;2.6, H;4.5 inches<br>Weight: approximately 8.8 oz. | Material: ABS and PMMA<br>Nylon flat arm cuff | IEC 60601-1:1998 +<br>A1:1991+A2:1995<br>IEC 60601-1-2, 2001 +<br>A1:2004/IEC60601-1-2<br>CISPR 11:2009+ A1:2010<br>IEC<br>61000-3-2:2005+A1+A2:20<br>09<br>IEC 61000-3-3:2008 | None | |
| Same as DS-181 and DSK-1011 | Same | Same | Same | | | | | | | | | | | | | | | | | | | | |

Device comparison tabl

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K112620
P47

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K112620
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| IEC61000-4-2:2008<br>IEC61000-4-3:2006+A1:20<br>07+A2:2010<br>IEC61000-4-4:2004+A1:20<br>10<br>IEC61000-4-5:2005<br>IEC61000-4-6:2008<br>IEC61000-4-8:2009<br>IEC61000-4-11:2004<br>ANSI/AAMI SP10:2002 | | IEC61000-4-2:2008<br>IEC61000-4-3:2006+A1:20<br>07+A2:2010<br>IEC61000-4-4:2004+A1:20<br>10<br>IEC61000-4-5:2005<br>IEC61000-4-6:2008<br>IEC61000-4-8:2009<br>IEC61000-4-11:2004<br>ANSI/AAMI SP10:2002 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
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| 5.6 | | |
| | | K112620<br>P6/7 |

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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 [phone] or [phone] 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:

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.

Prescription Use (Per 21 CFR 801.109 Subpart D)

(21 CFR 807 Subpart C)

X

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