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.

Device Description

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TA
Predicate Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158BT (K093824)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy (Pressure)	± 3mmHg
Accuracy (Pulse)	± 5%
Clinical Validation	Met required limits for mean difference and standard deviation in accordance with ISO 81060-2:2013
EMC Compliance	Compliant with IEC 60601-1-2 Edition 3:2007-03
Safety Compliance	Compliant with IEC 60601-1:2005, IEC 60601-1-11:2010
FCC Compliance	Compliant with FCC 47 CFR Part 15, Subpart B
Biocompatibility	Compliant with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010
Reliability	Compliant with IEC 80601-2-30 Edition 1.1 2013-07
Risk Assessment	Compliant with ISO 14971:2007
Software V&V	Compliant with IEC 62304 Ed.1.0 (2006), IEC 60601-1-4
Usability Validation	Compliant with IEC 62366-1:2015, IEC 60601-1-6

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 85 subjects for the clinical investigation (ISO 81060-2).
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the clinical investigation was performed.

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

The document does not provide information about the number of experts or their qualifications for establishing the ground truth in the clinical study. However, the ISO 81060-2 standard for non-invasive sphygmomanometers typically requires measurements by trained observers or reference devices to establish ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the test set in the clinical study. ISO 81060-2 standards involve comparison against auscultatory blood pressure measurements, often performed by multiple trained observers to mitigate error.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a clinical validation study against a recognized standard (ISO 81060-2) for objective performance, not a study comparing human reader performance with and without AI assistance. The device is an automated blood pressure monitor, not an AI diagnostic tool that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary clinical study described for the HL158TA is a standalone performance study of the device's accuracy in measuring blood pressure, as required by ISO 81060-2. This standard evaluates the algorithm and hardware's ability to accurately measure blood pressure independently of human interpretation of readings, although human subjects are part of the measurement process. The device provides "Full Automatic" measurements.

7. The Type of Ground Truth Used

For the clinical study (ISO 81060-2), the ground truth for blood pressure measurements is typically established through auscultatory measurements performed by trained observers using a reference sphygmomanometer. This is the standard reference method against which automated devices are validated.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It focuses on the clinical validation (test set) for regulatory submission.

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

The document does not provide information on how the ground truth for the training set was established, as a training set is not explicitly mentioned or detailed in the regulatory submission information provided. This information is typically proprietary to the device manufacturer and not always included in 510(k) summaries, which focus on safety and effectiveness demonstration rather than development details.

Summary

{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.

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:

5. Intended Use

6. Comparison of device to predicate device:

{5}------------------------------------------------

Product Specification Comparison Table of Subject Device HL158TA, and Predicate Device HL158BT (K093824)

Item	Predicate DeviceHL158BT (K093824)	Subject DeviceHL158TA
Method ofmeasurement	Oscillimetric	Same as left
MeasurementType	During deflation	During inflation
Range ofmeasurement	Pressure 0- 300mmHg,Pulse 40-199 Beats/minute	Same as left
Accuracy	Pressure ± 3mmHgPulse ± 5%	Same as left
PressureChanged Rate	2~5mmHg/sec.	Same as left
Exhaust	Automatic(Rapid exhaust valve)	Automatic(Passive exhaust valve)
Display	Liquid Crystal Digital	Same as left
Power Supply	2 × AAA/1.5V (LR03)Alkaline batteries	Same as left
Storage/TransportationEnvironment	- 4°F~ +158°F(-20℃ ~ + 70℃),≤ 90% R.H.	- 13°F~ +158°F(-25℃ ~ + 70℃),≤ 93% R.H.
OperatingEnvironment	10℃ ~ 40℃ (50°F~104°F),15% ~ 90% R.H.	5℃ ~ 40℃ (41°F~104°F),15% ~ 93% R.H.
Material	ABS housing andABS keys	Same as left
Sets ofmemory	2*60, total 120	1*60,total 60
Number ofPush Button	7 keys control	2 keys control
Cuff size	Wrist circumference approx.135mm~~195mm / 5.3~~7.7 inch	Same as left
Unit Weight	Approx. 136 ± 5g(Excluding batteries )	Approx. 91.7 ± 10g(Excluding batteries )
Risk CategoryIndicator	Yes	Same as left
IrregularHeartbeatDetector	Yes	Same as left
TalkingFunction	Yes	No
Data Linkfunction	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 (260, total 120) to 60 (160, 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.

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).