HL888V is a manual inflate type blood pressure monitor for measurement of 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 upper arm. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

HL868JM is a manual inflate type blood pressure monitor for measurement of 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 upper arm. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

Device Description

Both HL888V and HL868JM are manual inflate type blood pressure monitors for measurement of 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 upper arm. The intended use of the over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 ~13 inches (approx.23cm-33cm) and for home use.

HL868JM features a Risk Category Indicator 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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Full Automatic (NIBP) Blood Pressure Monitor, Models HL888V and HL868JM, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The devices (HL888V and HL868JM) were found to be compliant with the ANSI/AAMI SP-10:2002+ A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers. This standard likely sets the specific acceptance criteria for blood pressure monitor accuracy. The 510(k) summary references the predicate device's accuracy which is assumed to be the target for the new devices.

Acceptance Criteria (from Predicate Device)	Reported Device Performance (HL888V & HL868JM)
Pressure: $\pm$ 3mmHg	Fully met (compliant with ANSI/AAMI SP-10)
Pulse: $\pm$ 5%	Fully met (compliant with ANSI/AAMI SP-10)

Study Details

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

Sample Size: Not explicitly stated in the provided document. The statement "All the relevant activities were performed by designate individual(s)" suggests a clinical study was conducted. However, the exact number of participants is not disclosed.
Data Provenance: Not explicitly stated. Given that the manufacturer is Health & Life Co., Ltd. from Taiwan, R.O.C., the study might have been conducted in Taiwan, but this is not confirmed. The document does not specify whether the data was retrospective or prospective.

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

Not explicitly stated. The ANSI/AAMI SP-10 standard typically involves comparison against a reference standard, often conducted by trained technicians or clinicians, but details on the number and qualifications of experts are not provided in this summary.

4. Adjudication method for the test set:

Not explicitly stated. The ANSI/AAMI SP-10 standard outlines specific protocols for measurement and comparison, which would inherently include methods for handling discrepancies, but the specific adjudication method is not mentioned.

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:

A MRMC comparative effectiveness study was not performed. This device is a standalone blood pressure monitor and does not involve AI assistance or human readers for diagnostic interpretation.

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

Yes, a standalone performance evaluation was done. The study was conducted to demonstrate the accuracy of the blood pressure monitor itself in accordance with the ANSI/AAMI SP-10 standard. The device's oscillometric method is an algorithm that processes pressure oscillations to determine blood pressure values without human intervention in the measurement process.

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

The ground truth would have been established by comparing the device's measurements against a recognized reference standard for blood pressure measurement, typically auscultatory measurement by trained observers using a mercury sphygmomanometer or an equivalent validated non-invasive method, as prescribed by the ANSI/AAMI SP-10 standard.

8. The sample size for the training set:

Not applicable. As a medical device that does not employ machine learning or AI models with a "training set" in the computational sense, there is no training set sample size to report. The device's underlying oscillometric algorithm is a classic engineering principle, not a trained AI model.

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

Not applicable, as there is no training set in the context of this device's technology.

Summary

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PREMARKET NOTIFICATION

510(k) SUMMARY

JAN 22 2010

(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.

DEC 0 9 2009 The assigned 510(k) number is: K093823 Date:

Submitter:

Name: Health & Life Co., Ltd. Address: 9F, No.186, Jian Yi Road. Chung Ho City, Taipei County, Taiwan, R.O.C.

Contact person: Sarah Su/ Regulatory Affairs Dept. E-mail: sarah.su@hlmt.com.tw

Tel: +886-2-8227-1300 ext.1201 Fax: +886-2-3234-9601

1. Name of the Device:
  Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888V, HL868JM

Common Name: Blood Pressure Monitor

Classification Name: Non-Invasive Blood Pressure Measurement System

Classification: Class II

Regulation Number: 21 CFR 870.1130

Product Code: DXN

Panel: Cardiovascular

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

H&L Full Automatic (NIBP) Blood Pressure Monitor, Model HL888BM, K032837

4. Device Description:

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K093823

position is at human being's upper arm. The intended use of the over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 ~13 inches (approx.23cm-33cm) and for home use.

5. Intended Use

6. Comparison of device to predicate device:

Item	PredicateHL888BM (K032837)	HL888V
Method ofmeasurement	Oscillimetric	Same as left
Range ofmeasurement	Pressure 0- 300mmHg,Pulse 40-199 Beats/minute	Same as left
Accuracy	Pressure $\pm$ 3mmHgPulse $\pm$ 5%	Same as left
Inflation	Manual inflation	Same as left
Exhaust	Manual deflation	Same as left
Deflation ofPressure	Automatic air releasecontrol valve	Same as left

Product Specification Comparison Table of HL888V and HL888BM (K032837)

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K093823

Display	Liquid Crystal Digital Display	Same as left
Cuff size	Arm circumference approx.24~~32 cm(9.5~~13 inches)	Arm circumference approx.23~~33 cm(9~~13 inches)
Sets of memory	48 sets	99 sets
OperatingTemperature	10℃~40℃ ,30 ~ 85% RH	10℃~~40℃(50°F~~104°F),15% ~90% RH
StorageTemperature	-20℃ ~ + 50℃ ,10~95% RH	- 20℃ ~ + 70℃(- 4°F~ +158°F),≤ 90%RH
Power Supply	4 × "AA" ( 1.5V )Alkaline batteries	One 3V CR2032 battery
Battery life	Approx.300 timesmeasurement	Approx. 180 timesmeasurement
Unit Weight	Approx. 265gincluding batteries	Approx. 100gincluding batteries

Changes from the predicate device HL888BM (K032837):

Both of HL888V and HL888BM have 4 push buttons and remain the same features such as with date, time, memory, measuring blood pressure and heart rate.

HL888V obtains its energy source from one 3V CR2032 battery, and the inflation bulb was connected with the unit directly. Besides, HL888V is changing the exterior casing design, and the appearance of the symbol "Inflation/Deflation".

Therefore, HL888V does not involve any changes or modifications which could significantly affect or effectiveness of the predicate device, as compared to the HL888BM.

page 3 of 6

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Product Specification Comparison Table of HL868JM and HL888BM (K032837)

Item	PredicateHL888BM (K032837)	HL868JM
Method ofmeasurement	Oscillimetric	Same as left
Range ofmeasurement	Pressure 0- 300mmHg,Pulse 40-199 Beats/minute	Same as left
Accuracy	Pressure +/- 3mmHgPulse +/- 5%	Same as left
Inflation	Manual inflation	Same as left
Exhaust	Manual deflation	Same as left
Deflation ofPressure	Automatic air releasecontrol valve	Same as left
Display	Liquid Crystal DigitalDisplay	Same as left
Cuff size	Arm circumference approx.24~~32 cm(9.5~~13 inches)	Arm circumference approx.23~~33 cm(9~~13 inches)
Sets of memory	48 sets	99 sets
OperatingTemperature	10℃~40℃,30 ~ 85% RH	10℃~~40℃(50°F~~104°F),15%~90% RH
StorageTemperature	-20℃~~+50℃,10~~95% RH	-20℃~~+70℃(-4°F~~+158°F),≤ 90%RH
Power Supply	4 × "AA" (1.5V)Alkaline batteries	2 × "AA" (1.5V)Alkaline batteries
Unit Weight	Approx. 265gincluding batteries	Approx. 159gwithout batteries
Battery life	Approx.300 timesmeasurement	Same as left
Risk CategoryIndicator	None	Yes

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K093823

Changes from the predicate devices HL888BM (K032837):

Both of HL868JM and HL888BM have 4 push buttons and remain the same features such as with date, time, memory, measuring blood pressure and heart rate.

HL868JM obtains its energy source from 2 "AA" (1.5V) Alkaline batteries. Additional product feature is Risk Category Indicator function. HL868JM is changing the exterior casing design, and the appearance of the symbol "Inflation/Deflation".

Therefore, HL868JM does not involve any changes or modifications which could significantly affect or effectiveness of the predicate device, as compared to the HL888BM.

7. Discussion of Clinical Tests Performed:

Both HL888V and HL868JM are compliant to the ANSI/AAMI SP-10:2002+

A 1:2003+A2:2006 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. 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:

a. Safety Test: IEC 60601-1:1988+A1:1991+A2:1995 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
b. EMC Test: IEC 60601-1-2:2001+A1:2004 Medical Electrical Equipment Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test
c. Reliability Test: ANSI/AAMI SP-10:2002+A1:2003+A2:2006
d. Risk Assessment: ISO 14971:2007 Medical devices Application of risk management to medical devices
e. Software Verification and Validation: IEC 62304 Ed. 1.0, Medical device software - Software life cycle processes. (Software/Informatics) and IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems
f. Usability Validation: IEC 62366 Medical devices Application of usability engineering to medical devices

દ્વાર

page 5 of 6

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093823

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.

and the comments of the comments of

pg 6 of 6

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is black and has a simple, modern design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 22 2010

Health & Life Co., Ltd. c/o Ms. Sarah Su 9F, No. 186, Jian Yi Road Chung Ho City, Taipei County 23553 TAIWAN R.O.C.

Re: K093823

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888V and Model HL868JM Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: January 12, 2010 Received: January 19, 2009

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.

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.

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Page 2 - Ms. Sara Su

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 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.

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.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 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,

[signature]

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): K093823

Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888V, HL868JM

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use 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((

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Evaluation (ODE)

ision of Cardiovascular Devices

2-1

510(k) Number 409382

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).