This device automatically measures human's Systolic 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 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.

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.

Device Description

HL868RT 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 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.

The additional optional talking function equipped of this device can help the user to know how to use the device to measure the blood pressure and the pulse step by step, and let the user know the measurement results by hearing. Besides, the device will display a symbol if the difference between the longest and shortest heartbeat intervals 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. Furthermore, the 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pressure Accuracy: +/- 3mmHg	Compliant to ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard
Pulse Accuracy: +/- 5%	Compliant to ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard
Safety Testing	Compliant to IEC 60601-1:1988+A1:1991+A2:1995
EMC Testing	Compliant to IEC 60601-1-2:2001+A1:2004
Reliability Testing	Compliant to ANSI/AAMI SP-10:2002+A1:2003+A2:2006
Risk Assessment	Compliant to ISO 14971:2007
Software V&V	Compliant to IEC 62304 Ed. 1.0; IEC 60601-1-4:2000
Usability Validation	Compliant to IEC 62366

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

The document does not explicitly state the specific sample size used for the clinical test set, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions that the device is compliant with ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers, which would dictate the required number of subjects for clinical validation. This standard generally requires a minimum of 85 subjects for blood pressure device validation.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any specific clinical test set. The compliance to the ANSI/AAMI SP-10 standard usually implies the use of reference measurements taken by trained observers using auscultation, which serves as the "ground truth."

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. For blood pressure device validation against the ANSI/AAMI SP-10 standard, the "ground truth" is typically established by trained observers taking mercury sphygmomanometer readings, not through a consensus of multiple reviewers of the device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This section is not applicable to the provided device. The HL868RT is a standalone blood pressure monitor and does not involve AI assistance for human readers or interpretation of medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The device itself, the Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT, is designed to provide blood pressure and heart rate measurements automatically using the oscillometric method. Its performance was tested and found compliant with relevant standards like ANSI/AAMI SP-10. This indicates a standalone assessment of its accuracy against a reference measurement.

7. The Type of Ground Truth Used

Based on the compliance to the ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard, the ground truth for blood pressure measurements would be established using reference measurements from trained observers using auscultation with a mercury sphygmomanometer.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This type of non-invasive blood pressure monitor typically relies on established algorithms and calibration methods rather than a "training set" in the machine learning sense. The underlying algorithms are developed and refined based on extensive physiological and engineering principles, then validated for accuracy with clinical testing.

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

Since a "training set" in the machine learning context is not explicitly mentioned or implied for this device, the concept of establishing ground truth for a training set is not applicable in this submission. The accuracy of the device's measurements is validated against established clinical standards (ANSI/AAMI SP-10) where the gold standard for blood pressure is determined by trained human observers using a reference method.

Summary

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PREMARKET NOTIFICATION

MAR 2 5 2010

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: K093831

DEC 0 9 2009 Date:

1. Submitter:

Health & Life Co., Ltd. 9F, No.186, Jian Yi Road, Chung Ho City, Taipei County, Taiwan, R.O.C. TEL: +886-2-8227-1300 FAX: +886-2-3234-9601

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

2. Name of the Device:

Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT Common Name: Blood Pressure Monitor Classification Name: Noninvasive 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):

A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL868BF, K092161 B. H&L Full Automatic Blood Pressure Monitor, Model 168ET, K043437

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4. Device Description:

The additional optional talking function equipped of this device can help the user to know how to use the device to measure the blood pressure and the pulse step by step, and let the user know the measurement results by hearing. Besides, the device will display a symbol ****************************************************************************************************************************************************************************** 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. Furthermore, the 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.

5. Intended Use

This device automatically measures human's Systolic 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 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.

6. Comparison of device to predicate device:

Item	PredicateHL868BF (K092161)	HL868RT
Method ofmeasurement	Oscillimetric	Same as left

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Range ofmeasurement	Pressure 0- 300mmHg,Pulse 40-199 Beats/minute	Same as left
Accuracy	Pressure +/- 3mmHgPulse +/- 5%	Same as left
Inflation	Automatic inflation(Air pump)	Same as left
Deflation ofPressure	Automatic air releasecontrol valve	Same as left
Exhaust	Automatic exhaust valve	Same as left
Display	Liquid Crystal DigitalDisplay	Same as left
Power Supply	6V DC, 4 × "AA" ( 1.5V )Alkaline batteriesor AC adapter (optional)	Same as left
StorageTemperature	- 20℃ ~ + 70℃(-4°F~ +158°F),≤ 90%RH	Same as left
OperatingTemperature	10℃~~40℃(50°F~~104°F),15% ~ 90%RH	Same as left
Sets of memory	3*80, total 240	2*60, total 120
Number ofPush Bottom	5	7
Storage pouch	Yes	Same as left
Cuff size	Arm circumference approx.23-43 cm (9~17 inches)	Same as left
Unit Weight	Approx. 312gexcluding batteries	Approx. 293 ± 5gexcluding batteries

Changes from the predicate devices HL868BF (K092161):

7 push buttons, changing of exterior casing design
Additional product features of Risk Category Indicator, and Talking Function For the product feature of Talking Function, was compared with the other predicate device H&L Full Automatic Blood Pressure Monitor, Model 168ET(K043437)

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K093831
p4/4

7. Discussion of Clinical Tests Performed:

HL868RT is compliant to the ANSI/AAMI SP-10:2002+A1:2003+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

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 devices.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

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

MAR 2 5 2010

Health and Life Co., Ltd. c/o Ms. Sara Su Deputy Manager 9F., No. 186, Jian Yi Road Chung Ho City, Taipei County TAIWAN 235 R.O.C.

Re: K093831

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: January 7, 2010 Received: January 25, 2010

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,

Lara Bram D. Zuckerman, M.D.

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

Enclosure

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Indication for Use

510(k) Number (if known): K093831

Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT

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 (ODE)
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(Division Sign-Off)

of Cardiovascular Devices

510(k) Number K093283

2-1

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).