HL168KB 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 wrist. The intended use of this over-the-counter device is for over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3~7.7 inches) 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 storage data be transferred to the connected personal computer (PC) via USB cable.

Device Description

HL168KB 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 wrist. The intended use of this over-the-counter device is for over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3~7.7 inches) and for home use.

The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Also, 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.

Additionally, the device will display a symbol of wordlis, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat during the measurement.

AI/ML Overview

This document describes the premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL168KB.

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	Reported Device Performance
Accuracy (Pressure)	± 3 mmHg
Accuracy (Pulse)	± 5%

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the device is compliant with the ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers and that "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The ANSI/AAMI SP-10 standard itself outlines the methodology for clinical validation, which typically involves a comparison against a reference standard measured by trained observers (experts). However, the specific details of the experts for this study are not included in this summary.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The ANSI/AAMI SP-10 standard outlines statistical methods for comparing the device measurements to reference measurements, but it doesn't describe an adjudication process for disagreeing expert measurements in the way it might for image-based diagnostic studies. It focuses on the agreement between the device and the reference measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging or screening devices where human readers interpret results, and the AI's role is to assist or replace human interpretation. For a blood pressure monitor, the device provides a direct measurement, and the "human reader" aspect is not applicable in the same way. The study focuses on the accuracy of the device's measurements against a reference standard.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The study assesses the accuracy of the HL168KB device itself, without human intervention in the measurement process after initial cuff placement and operation. The device "automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method," indicating a standalone algorithm-only performance.

7. The Type of Ground Truth Used

The ground truth used for blood pressure monitors compliant with ANSI/AAMI SP-10 standards is typically simultaneous auscultatory measurements performed by trained observers (experts) using a mercury sphygmomanometer or another validated reference device. This is the gold standard for non-invasive blood pressure measurement in clinical validation studies. The document implicitly refers to this by stating compliance with the ANSI/AAMI SP-10 standard.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This type of device relies on established oscillometric principles and algorithms for blood pressure measurement, which are typically developed and refined over time, rather than being "trained" on a specific dataset in the way a modern AI/machine learning model might be. Compliance with ANSI/AAMI SP-10 primarily focuses on clinical validation of the final product, not the developmental "training" phase.

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

As above, the document does not discuss a "training set" in the context of recent AI/ML development. The fundamental principles of oscillometric blood pressure measurement are based on physiological understanding and engineering design. The "ground truth" during the development and calibration of such devices would have been established through extensive physiological studies and comparisons with invasive arterial pressure measurements or validated non-invasive methods to refine the algorithms for converting cuff oscillations into blood pressure values. This is part of the engineering development process rather than a specific "training set" as understood in current AI contexts.

Summary

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K092163
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PREMARKET NOTIFICATION

510(k) SUMMARY

NOV 1 6 2009

(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: 2008.08.27

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 HL168KB Common Name: Blood Pressure Monitor Classification Name: Noninvasive Blood Pressure Measurement System Classification: Class II, 21CFR 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 HL168FV, K060729

· B. Digital Wrist Blood Pressure Monitor, Model HEM-609N, K042505

C. Wrist Blood Pressure monitor, Model WS-1100, K080177

4. Device Description:

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over-the-counter device is for over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3~7.7 inches) and for home use.

5. Intended Use

6. Comparison of device to predicate device:

Item	HL168KB	PredicateHL168FV (K060729)
Method ofmeasurement	Oscillimetric	Oscillimetric
Range ofmeasurement	Pressure 0- 300mmHg,Pulse 40-199 Beats/minute	Pressure 0- 280mmHg,Pulse 40-200 Beats/minute
Accuracy	Pressure +/- 3mmHgPulse +/- 5%	Pressure +/- 3mmHgPulse +/- 5%
Inflation	Automatic inflation(Air pump)	Automatic inflation(Air pump)
Deflation ofPressure	Automatic air releasecontrol valve	Automatic air releasecontrol valve
Exhaust	Automatic exhaust valve	Automatic exhaust valve
Display	Liquid Crystal DigitalDisplay	Liquid Crystal DigitalDisplay

Product Specification Comparison Table of HL168KB and HL168FV (K060729)

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Sets ofmemory	3*40, total 120	3*40, total 120
Cuff size	Wrist circumference approx.135 ~ 195 mm(Approx. 5.3~7.7 inches)	Wrist circumference approx.135 ~ 195 mm
OperatingTemperature	10℃~~40℃,(50°F~~104°F),15%~90%R.H.	10℃~40℃,30%~85%R.H.
StorageTemperature	- 20℃~~+70℃,(- 4°F~~+158°F),≤90%R.H.	- 20℃~+50℃,10%~95%R.H.
Power Supply	2 × "AAA" (1.5V)Alkaline battery	2 × "AAA" (1.5V)Alkaline battery
Material	ABS housing andrubber keys	ABS housing andrubber keys
Number ofPush Bottom	5	5
Storage pouch	Yes	Yes
Unit Weight	Approx. 148gincluding batteries	Approx. 104gincluding batteries
Screen Cover	None	Yes

Changes from the predicate devices HL168FV (K060729):

5 push buttons' positions, shapes, removing the cover of the screen
Additional product features of Irregular Heartbeat Detector, Personal Target Limits, and PC Link functions

For the product features of irregular heartbeat detector, was compared with the other predicate device Omron HEM 609N (K042505).

For the product features of Personal Target Limits, was compared with the other predicate device Nissei WS-1100 (K080177).

7. Discussion of Clinical Tests Performed:

HL168KB is compliant to the ANSVAAMI 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.

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1. 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. Biocompațibility Test: ISO 10993-1:2003 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
d. Biocompatibility Test: ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
e. Biocompatibility Test: ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

f. Reliability Test: ANSI/AAMI SP-10:2002+A1:2003+A2:2006

1. Conclusions:
  The subject device was tested and fulfilled the requirements from those standards mentioned above, and it's concluded that the subject device is substantially equivalent to the predicate devices. -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is a simplified, abstract design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV 1 6 2009

Health & Life Co., Ltd. c/o Mr. Tzu-Wei Li Manager, Senior Administrator Center for Measurement Standards Industrial Technology Research Institute Rm. 30A, Bldg. 16, 321, Sec. 2 Kuang Fu Rd. Hsinchu, Taiwan 30011 R.O.C.

Re: K092163 Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL168KB Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: October 29, 2009 Received: November 2, 2009

Dear Mr. Li

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 – Mr. Tzu-Wei Li

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,

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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Indication for Use

510(k) Number (if known):

Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL168KB

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use V (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Devices Evaluation (ODE)

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W.M.S

n of Cardiovascular Devices

510(k) Number K092163

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).