HL858DK 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 the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use.

HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

Device Description

HL858DK 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.

Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

AI/ML Overview

The device referenced is the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DK.

Here's an analysis of its acceptance criteria and the study proving compliance:

1. Table of Acceptance Criteria and Reported Device Performance

The primary performance criterion for non-invasive blood pressure monitors, as per ISO 81060-2, relates to the accuracy of blood pressure and pulse measurements.

Performance Criterion (Acceptance Criteria per ISO 81060-2)	Reported Device Performance
Mean difference and standard deviation within required limits for blood pressure measurements.	Blood Pressure Measurement: The clinical investigation report states, "The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858DK in the group of 85 subjects with qualified distribution." (Specific numerical values for mean difference and standard deviation are not provided in the document.)
Accuracy for pressure (within ± 3mmHg)	This is listed as the device's accuracy specification, consistent with common standards, but the clinical validation report only broadly states "required limits ... are fulfilled" without specifying that this exact ±3mmHg was the direct acceptance criterion of the study.
Accuracy for pulse (within ± 5%)	This is listed as the device's accuracy specification. The clinical validation report directly addresses blood pressure accuracy, and the document later mentions a separate study for IHB detection affecting pulse, implying overall pulse accuracy is also assessed.
Clinical validation of Advanced Irregular Heartbeat (IHB) Detection.	Advanced Irregular Heartbeat Detection: Achieved 97.8% sensitivity and 100% specificity in a clinical test with 189 subjects.

2. Sample Sizes and Data Provenance

Test Set (Blood Pressure Accuracy):
- Sample Size: 85 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of a "clinical investigation" strongly suggests a prospective study specifically designed to validate the device's accuracy.
Test Set (Advanced Irregular Heartbeat Detection):
- Sample Size: 189 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Similar to the BP accuracy study, this sounds like a prospective clinical test.

3. Number of Experts and Qualifications (for Ground Truth)

The document does not provide details about the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For blood pressure monitors, ground truth for clinical validation (e.g., according to ISO 81060-2) typically involves simultaneous auscultatory measurements performed by trained clinicians (often two or more) using a mercury sphygmomanometer or validated reference device. For IHB detection, the ground truth would typically be established by a reference ECG/EKG or similar cardiological assessment.

4. Adjudication Method for Test Set

The document does not explicitly describe the adjudication method used for establishing the ground truth (e.g., 2+1, 3+1). For ISO 81060-2 studies, simultaneous measurements by two independent observers are standard, with a third if discrepancies occur, but this specific detail is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor is there any mention of an effect size for human readers improving with AI vs. without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance

Yes, a standalone performance study was clearly done. The clinical investigation directly assessed the performance of the device itself (HL858DK) against established standards for blood pressure accuracy (ISO 81060-2) and the performance of its Advanced Irregular Heartbeat Detection feature. There is no human-in-the-loop component described for these performance evaluations.

7. Type of Ground Truth Used

Blood Pressure Accuracy: The explicit reference to "ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type" implies that the ground truth was established through simultaneous reference measurements (e.g., auscultatory measurements from trained observers using a calibrated reference device) on the same subjects. This is the standard method for validating automated blood pressure devices.
Irregular Heartbeat Detection: While not explicitly stated, the ground truth for "Advanced IHB detection" performance (sensitivity and specificity) would typically be established by a reference electrocardiogram (ECG) or similar cardiological gold standard to confirm the presence or absence of irregular heartbeats.

8. Sample Size for Training Set

The document does not provide any information about a "training set" or its sample size. This suggests that the device's algorithms (e.g., for oscillometric measurement or IHB detection) were likely developed and validated internally by the manufacturer, and the described studies are the clinical validation/test sets for regulatory submission, not part of an AI model's training phase. Devices like this typically use established, non-AI algorithms.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for an AI model, this question is not applicable based on the provided document. The device uses an oscillometric method (a well-established principle) and likely rule-based or signal processing algorithms for IHB detection, rather than a machine learning model requiring a distinct training pipeline and associated ground truth establishment.

Summary

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October 17, 2018

Health & Life Co. Ltd. J. Hsu RA / OA Div. Manager 9F, No. 186 Jian Yi Road Zhonghe District, New Taipei City, 23553 TAIWAN

Re: K180240

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DK Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 28, 2018 Received: September 6, 2018

Dear J. Hsu:

We have reviewed vour 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.html; 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 mediation-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, Shawn W.

Forrest -A

Digitally signed by Shawn W. Forrest -A
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=1300403341
cn=Shawn W. Forrest -A
Date: 2018.10.17 15:29:01 -04'00'

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) K180240

Device Name

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DK

Indications for Use (Describe)

HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.

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)

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K180240

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.

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: JS Hsu/ RA & QA Manager. E-mail: js.hsu@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 HL858DK 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):

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

B. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858GA (K130563)

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4. Device Description:

Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

5. Intended Use

HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

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1. Comparison of device to predicate device:
  Product Specification Comparison Table of Subject Device HL858DK, and Predicate Device HL858DI (K153214)

Item	Predicate DeviceHL858DI (K153214)	Subject DeviceHL858DK
Method ofmeasurement	Oscillimetric	Same as left
MeasurementType	During inflation	During inflation
Range ofmeasurement	Pressure 0- 300mmHg,Rated Range of Determination:40~280mmHg,Pulse 40-199 Beats/minute	Same as left
Accuracy	Pressure ± 3mmHgPulse ± 5%	Same as left
PressureChanged Rate	2~5mmHg/sec.(from 90mmHg to 150mmHg)	Same as left
Display	Liquid Crystal Digital	Same as left
Power Supply	4 × AA/1.5V (LR6) Alkalinebatteries, orAC Adapter(Model: Fuhua,UE08WCP-060100SPA Input: 100-240V AC 50-60Hz / Output: 6V, DC,1A)	4 × AAA/1.5V (LR03) Alkalinebatteries, orAC Adapter (Model: SINPRO,HPU15-102 Input: 100-240V AC 47-63Hz/ Output: 5.99V, DC, 2A)
	Storage/TransportationEnvironment	- 25℃ ~ + 70℃ (- 13°F ~+158°F),≤ 93% R.H.	Same as left
	OperatingEnvironment	5℃ ~ 40℃ (41°F~~104°F),15% ~ 93% R.H.700~~1060hPa	Same as left
Material		ABS housing andABS keys	Same as left
	Sets ofmemory	2*60, total 120
Number ofPush Button	5 keys control(Start/Stop, Memory, User 1/2, Set(+), Mode (clock button)	5 keys control(Start/Stop, Memory, Up, Down,Time (clock button)
Storage pouch	Yes	Same as left
Cuff size	Arm circumference approx.23~~43cm / 9~~17 inch(Universal cuff)	Same as left
Unit Weight	Approx. 310 ± 10g(Excluding cuff and Batteries )	Approx. 320 ± 5g(Excluding cuff and Batteries )
Risk/BPCategoryIndicator	Yes(Risk Category Indicator, FourLevels)	Yes(BP Category Indicator, Six Levels)
IrregularHeartbeatDetector	Yes(Irregular Heartbeat Detection)	Yes(Advanced Irregular HeartbeatDetection)

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Changes from the predicate devices HL858DI (K153214):

- Modifying the power supply form AA (LR6) Alkaline batteries to AAA (LR03) Alkaline batteries and changing the supplier of AC Adapter.
- Modifying the memory of 260 (total 120) to 340 (total 120).
- The predicate device HL858DI (K153214) and subject device HL858DK have the same numbers of push button, but that have differences function and name of push button.
- Changing the Unit Weight from Approx. 310 ± 10g to Approx. 320 ± 5g.
- Modifying the feature of Risk/BP Category Indicator from Risk Category Indicator (Four Levels) to BP Category Indicator (Six Levels).
- Modifying the Irregular Heartbeat Detector to Advanced Irregular Heartbeat Detection.

These features have been verified and validated and do not affect the safety and effectiveness of subject device HL858DK. As for the BP Category Indicator, implemented on the subject device HL858DK, was compared with the other predicate

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device HL858GA (K130563). Please refer to Section 12. Substantial Equivalence Discussion for detail information.

7. Discussion of Clinical Tests Performed:

HL858DK 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 HL858DK 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.

In additional, the subject device HL858DK had equipped with Advanced Irregular Heartbeat Detection implemented by a photoplethysmogram (PPG) module. The clinical test included 189 subjects, which the test report showed a 97.8% sensitivity value and 100% specificity vale. All the evaluation activities were performed by designate individual(s) and 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, 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

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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:

IEC 80601-2-30 Edition1.1 2013-07 Medical electricalequipment-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 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 62366:2014 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).