HL158LA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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 use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(13.5 cm to 19.5 cm) and for home use.

When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. And this device can let the memory data be transferred to the connected personal computer (PC) via USB cable.

Besides, Risk Category Indicator (Six Levels) feature will judge blood pressure results into six levels based on WHO (World Health Organization) classification with corresponding bar segment on the edge of screen.

Device Description

HL158LA uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's wrist. All values can be read out in one LCD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3 ~ 7.7 inch (13.5 ~ 19.5 cm).

The device is equipped with Irregular Heartbeat Detector function. It will display a symbol of order to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat during the measurement.

Besides, user can save and manage the measurement data by transferring the measured readings of blood pressure to the connected personal computer (PC) via USB cable. Additionally, the Risk Category Indicator (Six Levels) feature will classify the blood pressure results with WHO (World Health Organization) Classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, Normal, and Optimal. The Corresponding LCD segment will be turned on along with the systolic, diastolic, and heart rate information.

AI/ML Overview

The acceptance criteria for the HL158LA Full Automatic (NIBP) Blood Pressure Monitor are primarily based on the ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Standard for Manual, electronic, or automated sphygmomanometers.

1. Table of Acceptance Criteria and Reported Device Performance:

Item	Acceptance Criteria (from Predicate Device/Standard)	Reported Device Performance
Accuracy	Pressure: +/- 3 mmHg	Meets +/- 3 mmHg
	Pulse: +/- 5%	Meets +/- 5%
Measurement Range	Pressure: 0-300 mmHg (cuff pressure)	Rated range of determination: 40-280mmHg (for blood pressure)
	Pulse: 40-199 beats/minute	Pulse: 40-199 beats/minute

Note: The document states "Same as left" for the accuracy of the subject device (HL158LA) when compared to the predicate device (HL158BT), indicating it meets the predicate's stated accuracy.

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

The document states that the device is compliant with the ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Standard. This standard outlines the requirements for clinical validation of automated sphygmomanometers. While the specific number of subjects is not explicitly stated in this summary, the ANSI/AAMI SP10 standard typically requires a specific number of subjects (e.g., at least 85 subjects for validation).
Data Provenance: Not explicitly stated in the provided document. The study is described as a "clinical test" performed in compliance with an international standard, suggesting prospective data collection. There is no information about the country of origin of the data.

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 or qualifications of experts used. However, clinical validation studies for blood pressure monitors generally involve trained professionals (e.g., physicians, nurses) to perform the reference measurements according to established protocols like ANSI/AAMI SP10. The standard dictates the methodology for obtaining reference blood pressure measurements.

4. Adjudication method for the test set:

The document does not explicitly mention the adjudication method. For AAMI SP10 compliance, reference blood pressure measurements are typically taken by multiple trained observers, and the average or a specific combination of their readings (often a consensus or averaging method) serves as the reference (ground truth).

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 performed. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool.

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

Yes, a standalone performance assessment was conducted. The clinical tests evaluate the accuracy of the device itself (HL158LA) in measuring blood pressure and pulse rate, comparing its readings against a validated reference method, as required by ANSI/AAMI SP10. The device operates automatically and provides readings without human intervention for interpretation beyond basic usage.

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

The ground truth for the clinical study would be reference blood pressure measurements obtained by trained observers using a validated method (e.g., auscultation with a mercury sphygmomanometer or another validated device) according to the ANSI/AAMI SP10 standard. This can be considered a form of "expert consensus" or "gold standard measurement" within the field.

8. The sample size for the training set:

The document does not mention a "training set" in the context of an algorithm. This device uses an oscillometric method, which is a known algorithm for blood pressure measurement, but the document does not describe its development as an AI/machine learning model that requires a separate training set. The clinical study described is for validation, not training.

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

As there is no mention of a "training set" for an AI/ML algorithm, this question is not applicable based on the provided document. The device relies on an established oscillometric principle rather than a continuously learning or adaptable algorithm requiring a training dataset.

Summary

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K130564 PREMARKET NOTIFICATION

JUN 1 9 2013

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.

Date: March 01 2013 The assigned 510(k) number is:

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 HL 158LA Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21CFR 870.1130 Product Code: DXN Panel: 74 Cardiovascular

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

A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL158BT, K093824 B. A&D Digital Blood Pressure Monitor, Model UB-512, K042967

4. Device Description:

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K130564

5. Intended Use

6. Comparison of device to predicate device:

Product Specification Comparison Table of HL158LA and HL158BT (K093824)

Item	Predicate DeviceHL158BT (K093824)	Subject DeviceHL158LA
Method ofmeasurement	Oscillometric	Same as left
Measurementrange of	Pressure 0- 300mmHgPulse 40-199 beats/minute	Rated range of cuff pressure:0-300 mmHgRated range of determination:40-280mmHgPulse: 40-199 beats/minute
Accuracy	Pressure +/- 3 mmHgPulse +/- 5%	Same as left
Inflation	Automatic inflation (Air pump)	Same as left
Deflation ofpressure	Automatic air releasecontrol valve	Same as left
Display	Liquid Crystal Display	Same as left

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Memory	60 memory * 2 users(120 memory total)	40 memory * 3 users(120 memory total)
Cuff size	Wrist circumferenceapprox. 5.3~~7.7 inch(13.5~~19.5 cm)	Same as left
Operationenvironment	50°F ~ 104°F (10°C ~ 40°C),15%~90%R.H.	41°F~104°F (5°C ~ 40°C),15%~93% R.H.
Storage/Transportationenvironment	-4°F ~ +158°F (-20°C ~ +70°C),≤ 90% R.H.	- 13°F~+158°F (-25°C ~ +70°C),≤93%R.H.
Power Supply	2 × "AAA" (1.5V)Alkaline battery	Same as left
Material	ABS housing andrubber keys	ABS housing andABS keys
Number ofPush Button	7	4
Storage case	Yes	Same as left
Unit Weight	Approx. 106 ± 5 g(Excluding batteries)	Approx. 119 ± 5 g(Excluding cuff and batteries)

Changes from the predicate devices HL158BT (K093824):

4 push buttons, changing of exterior casing design and sets of memory
Additional modified feature of Risk Category Indicator (Six Levels)

For the modified feature of Risk Category Indicator (Six Levels), was compared with the other predicate device A&D UB-512 (K042967).

7. Discussion of Clinical Tests Performed:

HL158LA is compliant to the ANSI/AAM1 SP10:2002/(R)2008 & ANSI/AAM1 SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Standard for Manual, electronic, or automated sphygmomanometers. All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.

8. Discussions of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The subject device was tested to evaluate its safety and effectiveness, including the followings:

a. Safety Test
- IEC 60601-1:2005, Medical electrical equipment Part 1: General r requirements for basic safety and essential performance.

5-3

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K130564

IEC 60601-1-11:2010, 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.
b. EMC Test: IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests.
FCC Test: FCC 47 CFR Part 15, Subpart B:2011 C.

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
e. Reliability Test: ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10: 2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers.
ೆ. Risk Assessment: ISO 14971:2007 Second Edition, Medical devices -Application of risk management to medical devices.

9. Conclusions:

The subject device was tested and fulfilled the requirements from those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate devices.

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Image /page/4/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings forming three curved lines.

June 19, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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

Re: K130564

Trade/Device Name: Full automatic (nibb) blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: May 14, 2013 Received: May 20, 2013

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); fabeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 Small Manufacturers, International and Consumer Assistance 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,

Owen P Faris -S

for

Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K130564

Indication for Use

510(k) Number (if known):

Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL 158LA

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Devices Evaluation (ODE) ven P. Faris -S Page 1 of 1 13.06.19 16:03:41 4-1

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).