HL158TB 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.

HL158TB 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 user tracking their blood pressure level.

Device Description

The device will display a symbol ♥*~, to indicate the detection of irregular 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 text describes the submission for a medical device called the "Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TB." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (HL158TA, K160336).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document states that the subject device (HL158TB) and the predicate device (HL158TA, K160336) have the "same method of measurement, measure type, critical components (ex. air pump, sensor...) and algorithm." Therefore, the acceptance criteria and performance are implicitly aligned with the predicate device. The performance specifications are given in comparison to the predicate device.

Item	Acceptance Criteria (based on Predicate Device HL158TA)	Reported Device Performance
Accuracy	Pressure $\pm$ 3mmHg	Same as predicate
	Pulse $\pm$ 5%	Same as predicate
Range of measurement	Cuff Pressure: 0~300mmHg	Same as predicate
	Determination: 40~280mmHg (Blood Pressure)	Same as predicate
	Pulse: 40~199 Beats/minute	Same as predicate
Inflation	Automatic Inflation (Air Pump)	Same as predicate
Deflation	Automatic Air Release Control Valve	Same as predicate
Pressure Changed Rate	2~5mmHg/sec.	Same as predicate
Display	Liquid Crystal Digital	Same as predicate
Power Supply	2 "AAA(LR03)(1.5V)" Alkaline Batteries	Same as predicate
Storage/Transport	-25°C~70°C, ≤93% R.H.	Same as predicate
Operating environment	5°C ~ 40°C, 15% ~ 93% R.H., 700~1060 hPa	Same as predicate
Material	ABS housing and ABS keys	Same as predicate
Memory	1*60, total 60 sets	Same as predicate
Cuff size	Wrist circumference approx. 135 ~ 195 mm	Same as predicate
Irregular Heartbeat	Yes (detection)	Same as predicate

Note: While the "Risk Category Indicator" and "Error icon" have been updated, the core accuracy and measurement parameters remain the same, implying the HL158TB meets the same performance acceptance criteria for blood pressure and pulse accuracy as the predicate.

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

The document states: "In ISO 81060-2 Second Edition 2013-05-01 Non-invasive sphygmomanometers-Part 2: Clinical validation of automated measurement type, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."

However, this statement refers to the predicate device (K160336). The document explicitly says, "clinical study results can be transferred from the K160336 predicate to the subject device." Therefore, the clinical validation for the subject device relies on the predicate's study.

Sample size: Not specified for the predicate device's clinical validation study, only that it followed ISO 81060-2 which has specific patient number requirements (e.g., typically at least 85 subjects with specific age and blood pressure distributions).
Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

This information is not detailed in the provided text for the clinical study of the predicate device. The ISO 81060-2 standard typically involves trained observers for ground truth measurements (using auscultation), but their specific number and detailed qualifications are not provided here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not detailed in the provided text. ISO 81060-2 outlines a specific methodology for collecting reference blood pressure measurements (often including multiple observers), but the specific adjudication method (e.g., 2+1) is not explicitly mentioned here.

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

This is not applicable. The device is a "Full Automatic Blood Pressure Monitor" which automatically measures blood pressure. It does not involve "human readers" or "AI assistance" in the context of interpreting medical images or complex diagnostic data. Its primary function is a direct measurement.

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

Yes, the device is standalone. It is a "Full Automatic (NIBP) Blood Pressure Monitor." The clinical validation, transferred from the predicate device that followed ISO 81060-2, assessed the device's accuracy against reference measurements, which is an assessment of its standalone performance. The ISO 81060-2 standard is for the validation of automated sphygmomanometers.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For blood pressure monitors validated according to ISO 81060-2, the ground truth is typically established by cuff auscultation (e.g., by trained observers using a mercury sphygmomanometer), considered the gold standard for non-invasive blood pressure measurement in clinical validation studies.

8. The sample size for the training set:

This information is not provided. The document discusses clinical validation, which is an evaluation of the device's performance, not the training of an algorithm in the machine learning sense. While the device utilizes an oscillometric algorithm, details about its development or any training data used are not disclosed. The primary claim for HL158TB's performance relies on the transfer of clinical study results from its predicate, which shares the "same... algorithm."

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

This information is not provided. As mentioned above, details about algorithm development or training data are not available in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 20, 2019

Health & Life Co., Ltd. Js Hsu Manager 9F, No. 186, Jian Yi Road Zhonghe District, New Taipei City, 23553 TAIWAN

Re: K190134

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, HL158TB Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 3, 2019 Received: April 22, 2019

Dear Js Hsu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Matthew Hillebrenner Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190134

Device Name

Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TB

Indications for Use (Describe)

HL158TB 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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:

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FORM FDA 3881 (7/17)

Page 1 of 1

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PREMARKET NOTIFICATION 510(K) SUMMARY (As Requirement 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: Date: _

Submitter: 1. 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: JS Hsu E-mail: js.hsu@hlmt.com.tw TEL: +886-2-8227-1300 ext.1201 FAX: +886-2-8227-1301
1. Name of the Device:
  Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TB 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
Information for the 510(k) Cleared Device (Predicate Device): 3. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL158TA (K160336)
1. Device Description:

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ട. Intended Use
HL158TB 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.

6. Comparison of device to predicate device Table 6.1 Product Specification Comparison Table of Subject Device HL158TB, and Predicate Device HL158TA (K160336)

Item	Predicate DeviceHL158TA (K160336)	Subject DeviceHL158TB
Method ofmeasurement	Oscillometric	Same as left
Measurement Type	During inflation	Same as left
Range ofmeasurement	Rated Range of Cuff Pressure:0~ 300mmHg,Rated Range of Determination:40~~280mmHg,Pulse 40~~199 Beats/minute	Same as left
Accuracy	Pressure $\pm$ 3mmHgPulse $\pm$ 5%	Same as left
Inflation	Automatic Inflation (Air Pump)	Same as left
Deflation	Automatic Air Release ControlValve	Same as left
Pressure Changed Rate	2~5mmHg/sec.	Same as left

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Display	Liquid Crystal Digital	Same as left
Power Supply	2 "AAA(LR03)(1.5V)"Alkaline Batteries	Same as left
Storage/Transportation environment	-25°C~~70°C(-13°F~~158°F)≤93% R.H.	Same as left
Operating environment	5°C ~ 40°C (41°F ~~104°F),15% ~ 93% R.H.700~~1060 hPa	Same as left
Material	ABS housing and ABS keys	Same as left
Sets of memory	1*60, total 60	Same as left
Number of push Button	2 keys(Start/Stop, M(Memory))	3keys(Start/Stop,M(Memory),Date/Time(©))
Cuff size	Wrist circumference approx.135 ~ 195 mm(Approx. 5.3~7.7 inches)	Same as left
Unit weight(excluding batteries)	Approx. 91.7 ± 10 g	Approx. 120 ± 10 g
Risk Category Indicator	AHA 2003	AHA 2017
Irregular Heartbeat Detector	Yes	Same as left
Error icon	EE & E1 & E2 & E3	("("&)") & EE & E1 & E2 & E3

Changes from the predicate devices HL158TA (K160336):

Changing the 2 keys to the 3 keys.

- Update the Risk Category Indicator.
- Modifying error icon.

These additional features have been verified and validated and do not affect the safety and effectiveness of subject device HL158TB.

7. Discussion of Clinical Tests Performed

The subject device HL158TB and the predicated device HL158TA (K160336) have the same method of measurement, measure type, critical components (ex. air pump, sensor...) and algorithm, so clinical study results can be transferred from the K160336 predicate to the subject device. In ISO 81060-2 Second Edition 2013-05-01 Non-invasive sphygmomanometers-Part 2: Clinical validation of automated measurement type, all the relevant

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activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.

1. 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:
EMC Test: a.
- . 19-8, IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment -Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests
b. Safety Test
- . 19-4, IEC 60601-1:2005+A1:2012/ AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . 19-14, IEC 60601-1-11 Edition 2.0 2015, Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
FCC Test C.
- . FCC 47 CFR Part 15, Subpart B
ರ. Biocompatibility Test
- . 2-220, ISO 10993-1 Edition 4:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 2-245, ISO 10993-5 Edition 3:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . 2-174, ISO 10993-10 Edition 3:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Reliability Test e.
- . 3-123, IEC 80601-2-30 Edition 1.1:2013, Medical electrical equipment

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Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
f. Risk Assessment
- . 5-40, ISO 14971 Edition 2:2007, Medical devices - Application of risk management to medical devices
Software Verification and Validation 8.
- . 13-79, IEC 62304 Edition 1.1:2015, Medical device software - Software life cycle processes
- . IEC 60601-1-4 Edith1.1:2000 , Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
h. Usability Validation ()
- . 5-114, IEC 62366-1 Edition 1.0:2015, Medical devices - Part 1: Application of usability engineering to medical devices
- . 5-89, IEC 60601-1-6 Edition 3.1:2013, Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
1. 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).