HL858TA 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 upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.

HL858TA 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

The provided document describes the K161156 premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858TA. This device is a non-invasive blood pressure measurement system.

Here's the breakdown of the acceptance criteria and study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The key performance acceptance criteria for non-invasive blood pressure monitors are typically defined by recognized standards like ISO 81060-2. The document explicitly states compliance with ISO 81060-2. This standard specifies limits for the mean difference and standard deviation between the device's measurements and reference measurements.

While the exact numerical thresholds specified by ISO 81060-2 are not explicitly listed in this FDA summary document, the summary states:

Acceptance Criteria (Based on ISO 81060-2)	Reported Device Performance (HL858TA)
Required limits for mean difference and standard deviation (between device & reference measurement) for blood pressure and pulse rate (as per ISO 81060-2)	Fulfilled by the subject device HL858TA

In addition to the clinical validation, the device also meets the following technical performance criteria, which are often derived from predicate device performance and relevant standards:

Acceptance Criteria	Reported Device Performance
Pressure Measurement Range: 0-300mmHg	Same (0-300mmHg) as predicate device
Pulse Measurement Range: 40-199 Beats/minute	Same (40-199 Beats/minute) as predicate device
Pressure Accuracy: ± 3mmHg	Same (± 3mmHg) as predicate device
Pulse Accuracy: ± 5%	Same (± 5%) as predicate device

2. Sample size used for the test set and the data provenance

Test Set Sample Size: 105 subjects (used for the clinical investigation compliant with 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. Clinical validation studies for these types of devices are typically prospective in nature, as they involve actively taking measurements on subjects under controlled conditions to compare against a reference method.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. However, for a clinical validation compliant with ISO 81060-2, the ground truth is established by simultaneous measurements using a reference standard, usually by trained operators (e.g., medical professionals using a mercury sphygmomanometer or an equivalent calibrated method). The standard specifies the requirements for these reference measurements and the personnel performing them.

4. Adjudication method for the test set

The document does not mention an adjudication method in the context of human readers or image interpretation, as this device measures physiological parameters directly. For blood pressure measurements, the "adjudication" is inherent in the direct comparison against a reference standard measurement, often performed simultaneously by a trained human operator.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic imaging devices where human interpretation is involved. The HL858TA is a direct measurement device and does not involve human interpretation of complex images aided by AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the algorithm without human interaction. For this device, the "algorithm" is the oscillometric method and its processing of the pressure signals to determine BP and heart rate. The clinical validation described in the document (ISO 81060-2) directly assesses the performance of this algorithm in a standalone manner (albeit with a human applying the cuff and initiating the measurement), comparing its output to a reference standard. Therefore, a standalone performance assessment was done.

7. The type of ground truth used

The ground truth used was simultaneous measurements by a validated reference method (e.g., mercury sphygmomanometer) as per the requirements of ISO 81060-2. This is a form of direct physiological measurement ground truth, not pathology, outcomes data, or expert consensus (in the sense of interpreting subjective data).

8. The sample size for the training set

The document does not specify the sample size for a training set. This is because the device is not based on machine learning in the conventional sense (where a model is "trained" on a large dataset). It uses an established oscillometric method. Its calibration and internal algorithms are based on fundamental principles of blood pressure measurement, rather than a data-driven training process that requires a distinct "training set."

9. How the ground truth for the training set was established

As there is no "training set" in the machine learning sense, there is no ground truth established for it. The device's underlying principles are based on established biophysics and engineering, validated through rigorous clinical testing on a test set (as described in point 2).

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2016

Health & Life Co., Ltd. Ms. Sarah Su Director 9f, No. 186, Jian Yi Road Zhonghe District, New Taipei City, 23553 CN

Re: K161156

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858TA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 21, 2016 Received: April 25, 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

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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

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Indications for Use

510(k) Number (if known) K161156

Device Name

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858TA

Indications for Use (Describe)

HL858TA 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 upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K161156

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: _ K161156 __ 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/ QA & RA 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 HL858TA 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

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3. Information for the 510(k) Cleared Device (Predicate Device):

Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858DI (K153214)

4. Device Description:

5. Intended Use

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6. Comparison of device to predicate device:

Product Specification Comparison Table of Subject Device HL858TA, and Predicate Device HL858DI (K153214)

Item	Predicate DeviceHL858DI (K153214)	Subject DeviceHL858TA
Method ofmeasurement	Oscillimetric	Same as left
MeasurementType	During inflation	Same as left
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 exhaust valve	Same as left
Display	Liquid Crystal Digital	Same as left
Power Supply	6V 1A, 4 × AA/1.5V (LR6)Alkaline batteries, orAC adapter (optional)	6V 1A, 4 × AAA/1.5V (LR03)Alkaline batteries
Storage/TransportationEnvironment	- 25°C ~ + 70°C (- 13°F ~+158°F),≤ 93% R.H.	Same as left
OperatingEnvironment	5℃~~40℃ (41°F~~104°F),15%~93% R.H.	Same as left
Material	ABS housing andABS keys	Same as left
Sets ofmemory	2*60,total 120	1*60
Number of	5 keys	2 keys
Push Button
Storage pouch	Yes	No
Cuff size	Arm circumference approx.23~~43cm / 9~~17 inch(Universal cuff)	1. Arm circumference approx. 23~~33cm / 9~~13 inch (Standard cuff)2. Arm circumference approx. 23~~43cm / 9~~17 inch (Universal cuff; optional)
Unit Weight	Approx. 310 ± 10g(Excluding cuff and Batteries )	Approx. 221 ± 5g(Excluding cuff and Batteries )
Risk CategoryIndicator	Yes	Same as left
IrregularHeartbeatDetector	Yes	Same as left

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Changes from the predicate devices HL858DI (K153214):

*Changing the battery type form four AA (LR6) alkaline batteries and AC adapter to four AAA (LR03) alkaline batteries only.

- Changing the memory of 120 (260, total 120) to 60 (160).

Changing the 5 keys to the 2 keys.

- Adding the Standard cuff (23~~33cm / 9~~13 inch).
  These features have been verified and validated and do not affect the safety and effectiveness of subject device HL858TA.Please refer to Section 12. Substantial Equivalence Discussion for detail information.

7. Discussion of Clinical Tests Performed:

HL858TA 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 HL858TA in the group of 105 subjects with qualified distribution. Thus, all the

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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:

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 electrical equipment-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 -

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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

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).