HL858GB 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 arm. All values can be read out in one LCD panel. The device is designed and recommended for use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 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 the Near Field Communication (NFC) function allows user to transmit measuring result from the blood pressure monitor into NFC-enabled device simply and safely.

Besides, BP Category Indicator 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

The device will display a symbol - worth , 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 BP Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level. Furthermore, the Near Field Communication (NFC) function allows user to transmit measuring results from the blood pressure monitor into NFC-enabled device simply and safely.

AI/ML Overview

The provided text describes the regulatory clearance for the "Full Automatic (NIBP) Blood Pressure Monitor, Model HL858GB" and includes information about its performance validation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ISO 81060-2:2013)	Reported Device Performance (HL858GB)
Pressure Accuracy: Mean difference (device vs. reference) and standard deviation within specified limits. (Specific numeric limits not explicitly stated here but implied by compliance to ISO 81060-2).	The clinical investigation results show that the "required limits for mean difference and standard deviation are fulfilled by the subject device HL858GB."
Pulse Accuracy: (Specific criteria not explicitly stated here, but typically evaluated in NIBP devices)
Safety: Compliance with IEC 60601-1:2005 for basic safety and essential performance.	Device successfully tested against IEC 60601-1:2005.
EMC: Compliance with IEC 60601-1-2 Edition 3:2007-03.	Device successfully tested against IEC 60601-1-2 Edition 3:2007-03.
Biocompatibility: Compliance with ISO 10993-1, -5, -10 related to patient contact materials.	Device successfully tested against ISO 10993-1, -5, -10.
Software Verification & Validation: Compliance with IEC 62304 and IEC 60601-1-4.	Software verified and validated against IEC 62304 and IEC 60601-1-4.
Usability Validation: Compliance with IEC 62366.	Usability validated against IEC 62366.
Reliability: Compliance with IEC 80601-2-30.	Reliability tested against IEC 80601-2-30.

Study Proving Acceptance Criteria:

The primary study proving the device's accuracy in measuring blood pressure is a clinical investigation conducted according to ISO 81060-2: Second Edition 2013-05-01 "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type."

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

Sample size: 85 subjects.
Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin. However, clinical validation according to ISO 81060-2 typically involves prospective data collection.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth in the clinical validation. However, ISO 81060-2 (the standard cited) mandates specific procedures for reference measurements, usually involving multiple trained operators taking auscultatory measurements simultaneously or sequentially, with their measurements serving as the reference. These operators would be considered the "experts" for ground truth in this context, but their number and specific qualifications (e.g., years of experience as clinicians or trained technicians) are not detailed in this summary.

4. Adjudication Method for the Test Set:

The document does not explicitly describe an adjudication method for the test set. In the context of ISO 81060-2, the "ground truth" (reference measurements) are typically established by averaging or reconciling readings from two or three trained observers, which acts as a form of adjudication. The standard itself outlines how discrepancies between observers should be handled.

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 document pertains to a blood pressure monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that human readers would interpret. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable here.

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

Yes, a standalone performance study was done. The clinical investigation performed according to ISO 81060-2 evaluates the automated blood pressure monitor's accuracy by comparing its readings directly against a validated reference method (typically auscultatory measurements by trained observers). This assesses the algorithm's performance in determining blood pressure values automatically without human intervention in the measurement process itself, beyond initiation and cuff placement.

7. The Type of Ground Truth Used:

The ground truth for the clinical investigation (ISO 81060-2) is established by expert reference measurements, typically simultaneous or sequential auscultatory measurements performed by trained observers using a mercury sphygmomanometer or another validated reference device. This is a form of expert consensus if multiple observers are used and their readings reconciled.

8. The Sample Size for the Training Set:

The document does not provide information on a training set size. Blood pressure monitors using the oscillometric method are typically based on established algorithms and hardware components. While there might be internal algorithm development and calibration, the provided regulatory submission focuses on the clinical validation of the final product as per ISO standards rather than detailing a machine learning training process.

9. How the Ground Truth for the Training Set was Established:

As no specific training set is mentioned in the context of an AI/ML model, the establishment of ground truth for a training set is not applicable here. The device's "training" in a broad sense would be the development and calibration of the oscillometric algorithm against various blood pressure profiles, which is a standard engineering process for such devices rather than a machine learning training paradigm described for AI.

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 features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines connecting them, representing health and human services.

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

August 18, 2015

Health & Life Co., Ltd. Ms. Sarah Su. Manager. Regulatory Affairs Department 9F, No. 186, Jian Yi Road Zhonghe District, New Taipei City Taiwan 23553 ROC

Re: K150311

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858GB Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: July 15, 2015 Received: July 17, 2015

Dear Ms. 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): K150311

Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858GB

Indications for Use:

Besides, BP Category Indicator 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.

Prescription Use ___________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Page 1 of

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K150311

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.

Date: FEB 06 2015 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 HL858GB Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21CFR 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 HL858GA, K130563

4. Device Description:

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5. Intended Use

Besides, BP Category Indicator 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.

6. Comparison of device to predicate device:

Product Specification Comparison Table of Subject device HL858GB and predicate device HL858GA (K130563)

Item	Predicate deviceHL858GA (K130563)	Subject deviceHL858GB
Method ofmeasurement	Oscillometric	Same as left
Range ofMeasurement	Rated Range of cuff pressure0 ~ 300 mmHgRated Range of Determination40 ~ 280 mmHgPulse 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 releasecontrol valve	Same as left

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Exhaust	Automatic exhaust valve	Same as left
Display	Liquid Crystal Digital Display	Same as left
Power Supply	AA/LR6 (1.5V)Alkaline Battery × 4	Same as left
Storage/TransportationEnvironment	- 25°C ~ + 70°C(- 13°F~ +158°F),≤ 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	3×40,total 120	1×99,total 99
Number ofPush Button	4	Same as left
Storage pouch	Yes	Same as left
Cuff size	Arm circumference9~~17 inches (approx.23~~43cm)	Same as left
Unit Weight	8.73 ± 0.35 oz (247.5 ± 10 g)(Cuff and Batteries Excluded)	Same as left
BP CategoryIndicator	Yes	Same as left
IrregularHeartbeat Detector	Yes	Same as left
Data Link function	Yes(Via Usb cable)	Yes(Via NFC)

Changes from the predicate device HL858GA (K130563):

*Changing the sets of memory.

*Modifying the data-link feature from USB cable into Near Field Communication (NFC).

These modifications have been verified and validated to demonstrate that it does not affect the safety and effectiveness of subject device HL858GB.

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7. Discussion of Clinical Tests Performed:

HL858GB 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 HL858GB 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 are as follows:

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

EMC Test: IEC 60601-1-2 Edition 3:2007-03. Medical Electrical Equipment a. Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests
b. Radio Frequency Wireless Test:

-ETSI EN 301 489-1, Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements

-ETSI EN 301 489-3, Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 40 GHz

-ETSI EN 302 291-1, Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Close Range Inductive Data Communication equipment operating at 13,56 MHz; Part 1: Technical characteristics and test methods

-ETSI EN 302 291-2, Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Close Range Inductive Data Communication equipment operating at 13,56 MHz; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive

c. 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

-IEC 80601-2-30 Edition1.1 2013-7 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

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K150311

d. FCC Test: FCC 47 CFR Part 15, Subpart B

e. 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

f. Reliability Test: IEC 80601-2-30 Edition1.1 2013-7 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.
g. Risk Assessment: ISO 14971:2007 Second Edition, Medical devices Application of risk management to medical devices

h. 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

i. Usability Validation: IEC 62366:2007 Medical devices Application of usability engineering to medical devices

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).