Full Automatic (NIBP) Blood Pressure Monitor

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that create the impression of feathers. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 29, 2016 Health & Life Co., Ltd. Ms. Sarah Su Director 9f, No. 186, Jian Yi Road Zhonghe District, New Taipei City, 23553 CN Re: K160336 Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 5, 2016 Received: February 8, 2016 Dear Ms. Sarah 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. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.htm. Sincerely yours. Mitchell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K160336 Device Name Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TA #### Indications for Use (Describe) HL158TA automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. 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 adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use. HL158TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level. Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K160336 # Page 1 of 6 # 510(k) SUMMARY (As Required By 21 CFR 807.92) 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: __ K160336 Date: ________________________________________________________________________________________________________________________________________________________________________ #### 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 HL158TA Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21 CFR 870.1130 Classification Panel: 74 Cardiovascular Product Code: DXN {4}------------------------------------------------ #### 3. Information for the 510(k) Cleared Device (Predicate Device): Full Automatic (NIBP) Blood Pressure Monitor, Model: HL158BT (K093824) ### 4. Device Description: HL158TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. 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 adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.135 mm to 195 mm) and for home use. The device will display a symbol ( heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level. #### 5. Intended Use HL158TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. 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 adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.135 mm to 195 mm) and for home use. HL158TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level. #### 6. Comparison of device to predicate device: {5}------------------------------------------------ Product Specification Comparison Table of Subject Device HL158TA, and Predicate Device HL158BT (K093824) | Item | Predicate Device<br>HL158BT (K093824) | Subject Device<br>HL158TA | |-------------------------------------------|-----------------------------------------------------------|-------------------------------------------------| | Method of<br>measurement | Oscillimetric | Same as left | | Measurement<br>Type | During deflation | During inflation | | Range of<br>measurement | Pressure 0- 300mmHg,<br>Pulse 40-199 Beats/minute | Same as left | | Accuracy | Pressure ± 3mmHg<br>Pulse ± 5% | Same as left | | Pressure<br>Changed Rate | 2~5mmHg/sec. | Same as left | | Exhaust | Automatic<br>(Rapid exhaust valve) | Automatic<br>(Passive exhaust valve) | | Display | Liquid Crystal Digital | Same as left | | Power Supply | 2 × AAA/1.5V (LR03)<br>Alkaline batteries | Same as left | | Storage/<br>Transportation<br>Environment | - 4°F~ +158°F<br>(-20℃ ~ + 70℃),<br>≤ 90% R.H. | - 13°F~ +158°F<br>(-25℃ ~ + 70℃),<br>≤ 93% R.H. | | Operating<br>Environment | 10℃ ~ 40℃ (50°F~104°F),<br>15% ~ 90% R.H. | 5℃ ~ 40℃ (41°F~104°F),<br>15% ~ 93% R.H. | | Material | ABS housing and<br>ABS keys | Same as left | | Sets of<br>memory | 2*60, total 120 | 1*60,total 60 | | Number of<br>Push Button | 7 keys control | 2 keys control | | Cuff size | Wrist circumference approx.<br>135mm~195mm / 5.3~7.7 inch | Same as left | | Unit Weight | Approx. 136 ± 5g<br>(Excluding batteries ) | Approx. 91.7 ± 10g<br>(Excluding batteries ) | | Risk Category<br>Indicator | Yes | Same as left | | Irregular<br>Heartbeat<br>Detector | Yes | Same as left | | Talking<br>Function | Yes | No | | Data Link<br>function | Yes (USB) | No | {6}------------------------------------------------ #### Changes from the predicate devices HL158BT (K093824): * Modifying the measurement type from "during deflation" into "during inflation". * Changing the memory of 120 (2*60, total 120) to 60 (1*60, total 60). * Changing the 7 keys to the 2 keys control. * Removing the Talking Function and Data Link Function. These features have been verified and validated and do not affect the safety and effectiveness of subject device HL158TA. Please refer to Section 12. Substantial Equivalence Discussion for detail information. #### 7. Discussion of Clinical Tests Performed: HL158TA is compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL158TA in the group of 85 subjects with qualified distribution. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met. ## 8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows: {7}------------------------------------------------ ### K160336 #### Page 5 of 6 The subject device was tested to evaluate its safety and effectiveness, including the followings: - a. EMC Test: IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment -Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests - b. Safety Test: -IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance -IEC 60601-1-11:2010, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance- Collateral Standard: Requirements for medical electrical systems used in the home healthcare environment - c. FCC Test: FCC 47 CFR Part 15, Subpart B ### d. 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 cvtotoxicity -ISO 10993-10:2010, Third Edition Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization - e. Reliability Test: IEC 80601-2-30 Edition1.1 2013-07 Medical electricalequipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. - f. Risk Assessment: ISO 14971:2007 Second Edition, Medical devices -Application of risk management to medical devices - g. Software Verification and Validation: -IEC 62304 Ed.1.0 (2006), Medical device software - Software life cycle processes. -IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems, edition 1.1 {8}------------------------------------------------ ### h. Usability Validation: -IEC 62366-1:2015 Medical devices - Application of usability engineering to medical devices -IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability ### 9. Conclusions: The subject device was tested and fulfilled the requirements of those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate device.