FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR

{0}------------------------------------------------ # PREMARKET NOTIFICATION # 510(k) SUMMARY (As Required By 21 CFR 807.92) SEP 3 0 2011 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is: K112320 Date:2011/8/9 #### 1. Submitter: Health & Life Co., Ltd. 9F, No.186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan, R.O.C. TEL : +886-2-8227-1300 FAX : +886-2-8227-1301 Contact person: Sarah Su/ Regulatory Affairs Dept. E-mail: sarah.su@hlmt.com.tw Tel: 886-2-8227-1300 ext.1201 Fax: 886-2-8227-1301 #### 2. Name of the Device: Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL168JD Common Name: Blood Pressure Monitor Classification Name: Noninvasive Blood Pressure Measurement System Classification: Class II, 21CFR 870.1130 Product Code: DXN Panel: Cardiovascular - 3. Information for the 510(k) Cleared Device (Predicate Device): Full Automatic (NIBP) Blood Pressure Monitor, Model HL168GA, K050714 #### 4. Device Description: HL168JD automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for over the age of 18 with wrist circumference ranging from approx. 5.3~ 7.7 inch (135~ 195 mm) and for home use. Page 1 of 3 {1}------------------------------------------------ #### 5. Intended Use HL168JD uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's wrist. All values can be read out in one LCD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3 ~ 7.7 inch (135 ~ 195 mm). ## 6. Comparison of device to predicate device: # Product Specification Comparison Table of HL168JD and HL168GA (K050714) | Item | Predicate<br>HL168GA (K050714) | HL168JD | |-------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | Method of<br>measurement | Oscillometric | Same as left | | Measurement<br>range of | Pressure 0- 280mmHg<br>Pulse 40-199 beats/minute | Rated range of cuff pressure: 0- 300mmHg<br>Rated range of determination: 40- 280mmHg<br>Pulse 40-199 beats/minute | | Accuracy | Pressure +/- 3mmHg<br>Pulse +/- 5% | Same as left | | Inflation | Automatic inflation (Air pump) | Same as left | | Deflation of<br>pressure | Automatic air release<br>control valve | Same as left | | Display | Liquid Crystal Display | Same as left | | Memory | 40 memory * 3 users<br>(120 memory total) | 30 memory * 3 users<br>(90 memory total) | | Cuff size | Wrist circumference<br>approx. 135 ~ 195 mm | Same as left | | Operation<br>environment | 10°C~40°C,30%~85%R.H. | 50°F~104°F (10°C ~ 40°C ),<br>15%~90% R.H. | | Storage/<br>Transportation<br>environment | - 20°C~+60°C,<br>10%~95%R.H. | - 4°F~ +158°F (- 20°C ~ + 70°C ),<br>≤90%R.H. | | Power Supply | 2 × "AAA" (1.5V )<br>Alkaline battery | Same as left | | Material | ABS housing and<br>rubber keys | Same as left | | Number of<br>Push Bottom | 5 | Same as left | | Storage case | Yes | Same as left | | Unit Weight | Approx. 133g<br>(Including batteries) | Approx. 166±5g<br>(Excluding batteries) | Page 2 of 3 5-2 {2}------------------------------------------------ ## Changes from the predicate devices HL168GA (K050714): - * 5 push buttons' positions, changing of exterior casing design - * The modification of the dimension of the inflatable bladder and cuff cloth #### 7. Discussion of Clinical Tests Performed: HL168JD is compliant to standards of ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 and AAMI / ANSI / ISO 81060-2:2009. All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met. Besides, HL168JD successfully passed the European Society of Hypertension validation according to International Protocol revision 2002 for the validation of blood pressure measuring devices in adults and has been published on dabl website as well. ## 8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: The subject device was tested to evaluate its safety and effectiveness, including the followings: - a. Safety Test: - IEC 60601-1:1988+A1:1991+A2:1995, Medical electrical equipment Part 1: General requirements for basic safety and essential performance. - IEC 80601-2-30:2009, Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers. - b. EMC Test: IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. - c. Biocompatibility Test: - ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. - ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. - ISO 10993-10:2002/Amd. 1:2006(E), Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity amendment 1. - d. Reliability Test: ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008, Manual, electronic or automated sphygmomanometers. - e. Risk Assessment: ISO 14971:2007 Medical devices Application of usability engineering to medical device. #### 9. Conclusions: The subject device was tested and fulfilled the requirements from those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate devices. Page 3 of 3 {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows a circular logo with a symbol in the center. The symbol consists of three stylized lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the perimeter of the circle. Food and Drug Adminstration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Health & Life Co.. Lid. c/o Mrs. Sarah Su Manager 9F., No. 186, Jian Yi Road Zhonghe District. New Taipei City Taiwan. 235 SEP 3 0 2011 Re: K112320 Trade/Device Name: Full automatic (NIBP) blood pressure monitor (model HL 168JD) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: August 19, 2011 Received: August 19, 2011 Dear Mrs. Su: 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. 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. {4}------------------------------------------------ Page 2 - Mrs. Sarah Su 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.hym. 18 Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indication for Use # 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL 168JD ## Indications for Use: HL168JD uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's wrist. All values can be read out in one LCD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3~7.7 inch (135~ 195 mm). Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use V (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Devices Evaluation (ODE) Page 1 of _1_ Signature inn Slan-l sion of Cardiovascular Devices 510(k) Number K112320