HL858CP automatically measures human's Systolic 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 22 inches (approx.23 cm to 56 cm) and for home use.

The device can accurately measure in pregnant patients including those with known or suspected in preeclampsia condition.

HL858CP 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.

Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.

Device Description

HL858CP 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 22 inches (approx.23 cm to 56 cm) and for home use. The device can accurately measure blood pressure in pregnant patients including those with known or suspected in pre-eclampsia condition.

The device will display a symbol O-W- 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, when Triple Check mode is turned on by user, the symbol ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements.

HL858CP is equipped with Bluetooth Data Transmission function, which can electronic transfer the measured data of HL858CP to the paired Bluetooth-enabled device. The transferable measured data includes Systolic, Diastolic, and Pulse. The Bluetooth Data Transmission is without controlling or altering the functions or parameters of HL858CP and Paired Bluetooth-enabled device. In addition, the Bluetooth Data Transmission function could transfer the battery status of HL858CP to the Paired Bluetooth-enabled device without any controlling or altering on both devices.

Besides, Bluetooth Data Transmission function could provide Date/Time synchronization for HL858CP, which simply help users set Time/ Date information. It will help users prevent from entering incorrect time information.

AI/ML Overview

The provided text describes the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP, and its clinical validation, particularly regarding its ability to accurately measure blood pressure in pregnant patients, including those with pre-eclampsia. This information is gleaned from various sections of the 510(k) Summary.

Here's a breakdown of the requested information:

Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP

1. Table of Acceptance Criteria and Reported Device Performance

The core clinical validation for non-invasive sphygmomanometers, including this device, is typically against the ISO 81060-2 standard. This standard sets specific criteria for accuracy.

Acceptance Criteria (ISO 81060-2:2013)	Reported Device Performance (HL858CP)
For all subjects (general population):
Mean difference between device and reference standard in mmHg (Systolic and Diastolic) ≤ ±5 mmHg	The results of this clinical investigation show that the required limits for mean difference... are fulfilled by the subject device HL858CP in the group of 90 subjects. (Specific numerical mean differences are not provided in the summary but stated to meet the criteria).
Standard deviation of differences in mmHg (Systolic and Diastolic) ≤ 8 mmHg	The results of this clinical investigation show that the required limits for ... standard deviation are fulfilled by the subject device HL858CP in the group of 90 subjects. (Specific numerical standard deviations are not provided in the summary but stated to meet the criteria).
For pregnant patients (including pre-eclampsia):	The same ISO 81060-2:2013 criteria are applied specifically to this sub-population. The device aimed to show equivalence to a predicate device (Microlife BP3MW1-4B, K153077) cleared for this indication.
Mean difference between device and reference standard in mmHg (Systolic and Diastolic) ≤ ±5 mmHg	The clinical test result of HL858CP meets criteria of ISO 81060-2:2013 and proves the safety and effectiveness of pregnancy accuracy performed as well as the predicate device Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077). (Specific numerical values for pregnant patients are not provided, but compliance is asserted).
Standard deviation of differences in mmHg (Systolic and Diastolic) ≤ 8 mmHg	The clinical test result of HL858CP meets criteria of ISO 81060-2:2013 and proves the safety and effectiveness of pregnancy accuracy performed as well as the predicate device Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077). (Specific numerical values for pregnant patients are not provided, but compliance is asserted).

Note: While the summary states that the criteria were fulfilled, the exact numerical performance values (mean difference and standard deviation) are not explicitly given in the provided text for either the general or pregnant populations. The summary focuses on meeting the standard.

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

Sample Size for Test Set: "90 subjects with qualified distribution."
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, for a clinical validation study for a medical device approval, especially an accuracy study like this, it is almost exclusively prospective and generally conducted in a controlled clinical environment (e.g., a hospital or clinic). The lack of country specification likely means it was conducted where the manufacturer is based or in a region with established clinical trial infrastructure that is recognized by the FDA (e.g., often US, Taiwan, Europe).

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

The document does not specify the number or qualifications of experts used to establish the ground truth. For blood pressure measurement validation according to ISO 81060-2, the ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a validated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a rigorous protocol (e.g., auscultatory method with trained independent observers). The standard prescribes specific requirements for these observers.

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

The document does not explicitly describe an adjudication method for the test set. For ISO 81060-2 validation, the ground truth is typically captured by two independent observers (auscultatory method), and if there's a significant discrepancy, a third observer might be involved. The standard has specific requirements for the agreement between observers (e.g., differences within certain mmHg). While not explicitly stated as "adjudication," this method ensures robust 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

This device is a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The study described is a clinical validation of the device's measurement accuracy against a reference standard.

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

Yes, a standalone performance study was done. The entire clinical investigation described ("compliant to the standard of ISO 81060-2: Second Edition 2013-05-01") is a standalone algorithm (device) performance study. The device's measurements are directly compared to the clinically established ground truth, demonstrating the device's accuracy without requiring human interpretation or intervention in the measurement process beyond device operation.

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

The ground truth used is based on clinically established reference measurements of blood pressure, typically using the auscultatory method with a mercury sphygmomanometer (or an equivalent validated reference device) performed by trained medical professionals, as per the ISO 81060-2 standard. This is most akin to an expert consensus method from trained individuals applying a gold standard technique.

8. The sample size for the training set

The document does not specify a training set sample size. This is common for traditional medical devices like blood pressure monitors, which are validated against standards like ISO 81060-2 based on their mechanical and algorithmic adherence to established measurement principles, rather than being "trained" like machine learning models. The 90 subjects mentioned are for the clinical validation/test set.

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

As there is no "training set" in the context of machine learning for this device, a specific method for establishing ground truth for a training set is not applicable/not detailed. The device's internal algorithms for oscillometric blood pressure measurement are developed based on established physiological principles and engineering, not typically via a data-driven training process in the way AI models are.

Summary

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June 12, 2020

Health & Life Co., Ltd Simon Lee RA/QA Div. Deputy Manager 9F, No. 186 Jian Yi Road, Zhonghe District, New Taipei City, 23553 Taiwan

Re: K200521

Trade/Device Name: Full Automatic(NIBP) Blood Pressure Monitor, Model HL858CP Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 14, 2020 Received: May 15, 2020

Dear Simon Lee:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200521

Device Name

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP

Indications for Use (Describe)

The device can accurately measure in pregnant patients including those with known or suspected in preeclampsia condition.

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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K200521

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: Simon Lee/ RA & QA Deputy Manager. E-mail: simon.l@hlmt.com.tw Tel: 886-2-8227-1300 ext.1205 Fax: 886-2-8227-1301

2. Name of the Device:

Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP 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: HL858CL (K190507) B. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model: BP3MW1-4B (K153077)

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4. Device Description:

5. Intended Use

5-2

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intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.

The device can accurately measure blood pressure in pregnant patients including those with known or suspected in pre-eclampsia condition.

Item	Predicate DeviceHL858CL (K190507)	Subject DeviceHL858CP
Method ofmeasurement	Oscillimetric	Same as left
MeasurementType	During inflation	Same as left
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	6V 1A, 4 × AA/1.5V (LR6) Alkalinebatteries, orAC Adapter (Model: SINPRO,HPU15-102 Input: 100-240V AC47-63Hz / Output: 5.99V, DC, 2A)	Same as left
Storage/TransportationEnvironment	- 25°C ~ +60°C (- 13°F~+140°F),≤ 93% R.H.	- 25°C ~ +50°C (- 13°F~+122°F),≤ 93% R.H.
OperatingEnvironment	5°C ~ 40°C (41°F~~104°F),15% ~ 93% R.H.700~~1060hPa	Same as left
Material	ABS housing andABS keys	Same as left
Sets of memory	2*120, total 240	Same as left
Number ofPush Button	6+1 switch control(Start/Stop, Memory (M), UserSelect, Bluetooth ( ), Date/Time( ), AM/PM button; Triple Checkslider)	Same as left
Storage pouch	No	Same as left
Cuff size	Arm circumference approx.23-43 cm / approx.9~17inches(Universal Cuff)43 ~ 56 cm / approx.17 ~ 22inch(Extra Large Cuff)	Same as left
Unit Weight	Approx. 330 ± 5g(Excluding cuff andBatteries )	Same as left
UnitDimensions	118×163.8×48mm (L×W×H)	Same as left
Risk CategoryIndicator	Yes(Risk Category Indicator, FiveLevels)	Same as left
IrregularHeartbeatDetector	Yes(Irregular HeartbeatDetection)	Same as left
Triple-Check(Multi-Read)Function	Yes	Same as left
Bluetooth DataTransmission	1. Measurement DataTransmission2. Date/TimeSynchronization3. Battery Status Check	Same as left
Battery Life	$\geq$ 250 times	Same as left
Intendedpatientspopulation(PregnantAccuracy)	No	Yes
Error symbol	EE / E1 / E2 / E3 / E4 /Excessive Body MotionDetector	Same as left
Accessories	Arm cuff with tube: 23 ~ 43 cm / approx.9 ~ 17 inches(Universal cuff), 43 ~ 56 cm / approx.17 ~ 22 inches (ExtraLarge cuff), 4AA/1.5V (LR6)alkaline batteries, 5.99V DCAC Adaptor, instructionmanual, gift box.	Same as left

6. Comparison of device to predicate device:

Product Specification Comparison Table of Subject Device HL858CP, and Predicate Device HL858CL (K190507)

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Changes from the predicate devices HL858CL (K190507):

Add intended population for pregnant accuracy.
Revise the upper temperature limit of Storage/ Transportation Environment.

These features have been verified and validated and do not affect the safety and effectiveness of subject device HL858CP. As for the newly added pregnant patient population (including those with known or suspected in pre-eclampsia condition) to the subject device HL858CP, was compared with the other predicate device Microlife BP3MW1-4B (K153077). Please refer to Section 12. Substantial Equivalence Discussion for detail information. In addition, the clinical investigation record please refer to Section 20. Performance Testing- Clinical.

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7. Discussion of Clinical Tests Performed:

HL858CP, which includes the Universal cuff and Extra Large cuff, 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 HL858CP in the group of 90 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.

The subject device HL858CP featured the pregnancy accuracy which intended population is the same as the predicate device Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077). In addition, the clinical test result of HL858CP meets criteria of ISO 81060-2:2013 and proves the safety and effectiveness of pregnancy accuracy performed as well as the predicate device Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077).

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, C
d. Biocompatibility Test:
-ISO 10993-1:2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process

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-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 Edition 2 2018-03 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.1.1:2006+A1:2015, 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 62366-1:2015 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 has 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).