BLOOD PRESSURE MONITOR

{0}------------------------------------------------ 1/4 #### 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: 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 {1}------------------------------------------------ 14 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! {2}------------------------------------------------ 14 # Device comparison table | DSK-1011, the subject device | DS-1901 (K071384) | WS-1100/WS-1100PV<br>(K080177) | SNote | | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Intended use | DSK-1011 system is intended for<br>noninvasive measurement of<br>systolic and diastolic blood<br>pressure, determination of pulse<br>rate and calculation of pulse<br>pressure in adults in a homecare<br>environment.<br>The device features include<br>display of irregular pulse rhythm<br>detection, classification display of<br>measured blood pressure values<br>against WHO (World Health<br>Organization) guidelines, display<br>of body movement detection and<br>two memory account to save<br>measurement results. | The DS-1901 system is<br>intended for the noninvasive<br>measurement of systolic and<br>diastolic blood pressure and<br>determination of pulse rate in<br>adult patients, i.e., age 12<br>and above. The product is<br>recommended for use by<br>patients with labile blood<br>pressure or known<br>hypertension in a home care<br>environment as an adjunct to<br>medical management.<br>The device displays irregular<br>pulse rhythm indication when<br>it is detected during<br>measurement. | WS-1100/WS-1100PV<br>system is intended for<br>noninvasive measurement of<br>systolic and diastolic blood<br>pressure and determination<br>of pulse rate in adults in a<br>homecare environment.<br>The device features include<br>the display of irregular pulse<br>rhythm detection, the<br>classification display of<br>measured blood pressure<br>values against the guideline<br>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 results | Refer to "12.<br>Substantial<br>Equivalence<br>Discussion". | | Operation<br>principle | Oscillometric method | Oscillometric method | to personal computers.<br>Oscillometric method | Same | | Pressure<br>indication<br>range | 3 to 300 mmHg | 0 to 300 mmHg | 0 to 300 mmHg | Refer to "12.<br>Substantial<br>Equivalence<br>Discussion". | | Measurement<br>site and cuff<br>size | Upper arm<br>Standard-Large size<br>(Approximately 8.7 to 16.5<br>inches; 220 to 420 mm) | Upper arm<br>Large size (Approximately<br>9.1 to 16.9 inches; 230 to<br>460 mm) | Wrist<br>Regular size<br>(Approximately 4.9 to 8.0;<br>125 to 205 mm) | Same as<br>DS-1901 | | Power source | 4 AA alkaline batteries or<br>100-240V 50/60Hz AC adaptor | 4 AA batteries or 6VDC AC<br>adaptor | 2AAA alkaline batteries | Same as<br>DS-1901 | | Inflation | Automatic air pump | Automatic with air pump | Automatic air pump | Same | | Exhaust | Automatic quick exhaust valve | Automatic with EV | Automatic with quick exhaust<br>valve | Same AS<br>DS-1901 | | Display | 15 digits liquid crystal display | 12 digits liquid crystal display | 15 digits liquid crystal display | Same as<br>WS-1100/<br>WS-1100PV | | Device setting<br>by the user | Date and time | Date and time | Date and time<br>Personal target limits of<br>blood pressure values | Refer to "12.<br>Substantial<br>Equivalence<br>Discussion". | | Memory<br>features | 2 memory banks to save 60<br>measurement results with date<br>and time, when the clock is<br>activated; the saved readings<br>can be intentionally deleted by<br>the user. | A single memory bank to<br>save 30 most recent systolic<br>and diastolic readings | 2 memory banks to save 60<br>blood pressure and pulse<br>rate readings each with date<br>and time; saved reading(s)<br>can be intentionally deleted<br>by the user.<br>Mode to view AM and PM<br>readings separately<br>Exporting saved readings to<br>personal computers using<br>the designated USB cable | Refer to "12.<br>Substantial<br>Equivalence<br>Discussion". | | Main unit | Size: approximately W;4.5,<br>D;2.6, H;4.5 inches<br>Weight: approximately 8.8 oz.<br>Material: ABS and PMMA | Size: approximately W;5.8 x<br>D;4.5 x H2.1 inches<br>Weight: approximately 11.6<br>oz.<br>Material: ABS and acrylic<br>resin | Approximate size: W; 2.79,<br>D; 2.56, H; 1.18 inches<br>Approximate weight: 4.09 oz.<br>Material: ABS and PMMA | | | Cuff type | Nylon flat cuff | Nylon flat cuff | Preformed nylon cuff | Same as<br>DS-1901 | {3}------------------------------------------------ ### 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. {4}------------------------------------------------ ## 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. {5}------------------------------------------------ ### 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 {6}------------------------------------------------ 510(K) Number: K112691 Blood Pressure Monitor DSK-1011 Device Name: #### Indications for Use: 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. 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