HL158UA 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.

HL158UA 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 wor ma, 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.

Besides, HL158UA has a built-in Wrist Position Guide. By holding START/STOP button, the display will illuminate with different icons that are designed to guide you move your wrist.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor model HL158UA. While it mentions clinical and non-clinical tests were performed and met acceptance criteria, it does not provide a detailed breakdown of the acceptance criteria nor the specific results of a study to prove the device meets these criteria in the format requested.

The text focuses on demonstrating substantial equivalence to a predicate device (HL158VA K160557) by comparing specifications and listing standards the device complies with.

Here's a breakdown of what can be extracted and what information is missing from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device is compliant with ISO 81060-2: Second Edition 2013-05-01 "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type." This standard defines the acceptance criteria for clinical accuracy of automated sphygmomanometers. However, the document does not explicitly list the acceptance criteria from this standard in a table, nor does it present the specific performance results from the clinical validation study against those criteria.

It only states: "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."

Based on the ISO 81060-2 standard, typical acceptance criteria for blood pressure monitors involve:

Mean difference: The average difference between the device's readings and reference measurements (e.g., from a mercury sphygmomanometer).
Standard deviation: The variability of these differences.

The typical acceptance criteria from ISO 81060-2 are:

Mean difference ± Standard Deviation: ≤ ±5 mmHg for both systolic and diastolic blood pressure.
Individual differences: Not more than 5 mmHg for a high percentage of measurements (e.g., 60% or 80%), and not more than 15 mmHg for nearly all measurements (e.g., 95%).

Since the document does not provide the specific reported device performance, I cannot fill in the "Reported Device Performance" column with actual numbers.

Metric (based on ISO 81060-2)	Acceptance Criteria (from ISO 81060-2)	Reported Device Performance (Not provided in text)
Mean Difference (Systolic)	≤ ±5 mmHg	Not provided
Standard Deviation (Systolic)	≤ 8 mmHg	Not provided
Mean Difference (Diastolic)	≤ ±5 mmHg	Not provided
Standard Deviation (Diastolic)	≤ 8 mmHg	Not provided
Pulse Accuracy	± 5%	Same as left (from comparison table)

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

The document states compliance with ISO 81060-2 for clinical validation. This standard typically requires a minimum of 85 participants for clinical testing, covering a range of blood pressures and demographic characteristics.

Sample size for the test set: Not explicitly stated, but inferred to be compliant with the minimum requirements of ISO 81060-2 (typically 85 subjects).
Data provenance: Not specified (e.g., country of origin, retrospective or prospective). Clinical studies conforming to ISO standards are generally prospective.

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

The ISO 81060-2 standard requires that reference blood pressure measurements, which serve as the ground truth, be taken by two trained observers (experts) using auscultation with a mercury sphygmomanometer or an equivalent validated device. These observers must be trained and blinded to each other's readings and the results of the automated device.

Number of experts: Not explicitly stated, but inferred to be at least two (as per ISO 81060-2).
Qualifications of experts: Not specified (e.g., "radiologist with 10 years of experience"), but implied to be trained observers in blood pressure measurement as required by the ISO standard.

4. Adjudication method for the test set

The ISO 81060-2 standard specifies a method for comparing the automated device's readings with reference measurements taken by two trained observers. It typically involves averaging the two observers' readings or comparing discrepancies. If there's a significant difference between the two observers, a third observer might be involved, or the measurement discarded.

Adjudication method: Not explicitly stated, but inferred to follow the methodology outlined in ISO 81060-2 for comparison against two independent observers' readings.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret images with or without AI assistance. The device in question is a non-invasive blood pressure monitor, and its validation revolves around direct measurement accuracy, not interpretation by human readers.

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

Yes, the clinical validation described as compliant with ISO 81060-2 is inherently a standalone performance test for the device's algorithm. The standard assesses the device's ability to accurately measure blood pressure readings independently against a reference standard. While a human initiates the measurement, the accuracy evaluation focuses on the automated device's output.

7. The type of ground truth used

The ground truth for blood pressure monitors validated to ISO 81060-2 is established by expert auscultation measurements using a reference standard like a mercury sphygmomanometer. This involves trained observers listening to Korotkoff sounds.

Type of ground truth: Expert auscultation measurements (reference standard blood pressure readings).

8. The sample size for the training set

The document does not provide information on a training set sample size. This is typical for a medical device cleared via substantial equivalence, especially for a blood pressure monitor. While the device's development likely involved internal data for calibrating the oscillometric algorithm, the 510(k) summary only focuses on the validation against established standards. The ISO 81060-2 standard is for clinical validation, not algorithm training.

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

As no training set information is provided in the document, this cannot be answered. If a training set were used for algorithm development, its ground truth would typically be established similarly to the validation set—i.e., through expert auscultation or other highly accurate reference methods.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing right, with flowing lines representing hair or clothing.

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

September 21, 2016

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

Re: K162338

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor model HL158UA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 19, 2016 Received: August 22, 2016

Dear 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K162338

Device Name

Full Automatic (NIBP) Blood Pressure Monitor, Model HL158UA

Indications for Use (Describe)

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:

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."

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PREMARKET NOTIFICATION

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.

AUG 19 2016 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ 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/ RA & QA Division. 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 HL158UA 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

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

Full Automatic (NIBP) Blood Pressure Monitor, Model: HL158VA (K160557)

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4. Device Description:

Besides, HL158UA has a built-in Wrist Position Guide. By holding START/STOP button, the display will illuminate with different icons that are designed to guide you move your wrist.

5. Intended Use

HL158UA 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 arm circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 cm) and for home use.

6. Comparison of device to predicate device:

A. Product Specification Comparison Table of Subject Device HL158UA, and Predicate Device HL158VA (K160557)

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Item	Predicate DeviceHL158VA (K160557)	Subject DeviceHL158UA
Method ofmeasurement	Oscillimetric	Same as left
Measurement Type	During inflation	Same as left
Range ofmeasurement	Rated Range of CuffPressure: 0~ 300mmHg,Rated Range ofDetermination:40~~280mmHg,Pulse 40~~199Beats/minute	Same as left
	Accuracy		Pressure ± 3mmHgPulse ± 5%	Same as left
			Inflation
	Deflation		Automatic(Passive Exhaust Valve)	Same as left
	PressureChanged Rate		2-5 mmHg/sec.(from 90mmHg to 150mmHg)	Same as left
	Display		Liquid Crystal Digital	Same as left
	Power Supply		2 "AAA(LR03)(1.5V)"Alkaline Batteries	Same as left
Storage/TransportationEnvironment	- 25°C ~ + 70°C(- 13°F~ +158°F),$\leq$ 93% R.H.	Same as left
OperatingEnvironment	5°C ~ 40°C(41°F~~104°F),15% ~ 93% R.H.700~~1060 hPa	Same as left
	Material		ABS housing andABS keys	Same as left
			Sets of memory
	Number ofPush Button		6 keys(Start/Stop,M(Memory) ,Date/Time (🕰),Set ( + ), User(👤/👥) ,Bluetoothbutton ( 🛜 ))	5 keys(Start/Stop,M(Memory) ,Date/Time (🕰), Set(+), User(👤/👥))
Storage pouch	Yes(Storage Pouch)	Yes(Storage Case)
Cuff size	Wrist circumferenceapprox.135 ~ 195 mm(Approx. 5.3~7.7 inches)	Same as left
Unit Weight(excluding batteries)	Approx. 128 ± 10 g	Approx. 120 ± 5 g
Risk CategoryIndicator	Yes	Same as left
Irregular HeartbeatDetector	Yes	Same as left
Bluetooth DataTransmissionFunction	Yes	No
Wrist Position Guide	Yes	Yes

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Changes from the predicate devices HL158VA (K160557):

Changing the memory of 240 (2120, total 240) to 200 (2100, total 200).
Changing the 6 keys to the 5 keys.
Removing the Bluetooth Data Transmission Function.

These additional features have been verified and validated and do not affect the safety and effectiveness of subject device HL158UA. Please refer to Section 12. Substantial Equivalence Discussion for detail information.

7. Discussion of Clinical Tests Performed:

HL158UA is compliant to the standard of ISO 81060-2: Second Edition 2013-05-01

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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.

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 4: 2014, Medical Electrical Equipment Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests
b. Safety Test:

-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 -IEC 60601-1-11:2015, 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 cytotoxicity

-ISO 10993-10:2010, Third Edition Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization

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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

Risk Assessment: ISO 14971:2007 Second Edition, Medical devices f. Application of risk management to medical devices

g. Software Verification and Validation:

-IEC 62304 Ed.1.1 (2015), 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 62366:2014 Medical Devices - Application of Usability Engineering to Medical Devices

-IEC 60601-1-6:2013 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).