HL868BF Measures automatically 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 over the age of 18 with arm circumference ranging from 9 inches to 17 inches (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

HL868BF 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 over the age of 18 with arm circumference ranging from 9 inches to 17 inches (23 cm to 43 cm) 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 ****ordes, 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

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

Acceptance Criteria and Device Performance Study

The primary study cited for the device's performance is compliance with the ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers. This standard dictates the acceptance criteria for accuracy of blood pressure and pulse rate measurements.

1. Table of Acceptance Criteria and Reported Device Performance

The direct acceptance criteria and reported device performance from the provided text are as follows:

Acceptance Criteria (from ANSI/AAMI SP-10 Standard)	Reported Device Performance (HL868BF)
Blood Pressure Accuracy: Not explicitly stated, but implied by compliance to standard. The ANSI/AAMI SP-10 standard typically requires: - Mean difference between device and reference standard: ≤ ±5 mmHg - Standard deviation of the differences: ≤ 8 mmHg	Pressure: +/- 3mmHg
Pulse Accuracy: Not explicitly stated, but implied by compliance to standard. The ANSI/AAMI SP-10 standard typically requires: - No specific numeric criteria provided in the document for pulse, but compliance to the standard implicitly means the device meets its pulse accuracy requirements.	Pulse: +/- 5%

Note: The reported device performance values (+/- 3mmHg and +/- 5% pulse) are explicitly stated in the "Product Specification Comparison Table" as the "Accuracy" for both the HL868BF and its predicate device. This implies these are the performance metrics tested against the standard.

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 compliance testing was performed in accordance with the ANSI/AAMI SP-10 standard. The ANSI/AAMI SP-10 standard itself specifies requirements for subject recruitment (demographics, blood pressure ranges, etc.) and sample size (typically at least 85 subjects for accuracy validation). However, the specific details for this device are not provided in the 510(k) summary.

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

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. In compliance with the ANSI/AAMI SP-10 standard, ground truth for blood pressure measurements is typically established by comparing the automated device readings with simultaneous readings taken by trained observers using a mercury sphygmomanometer or another validated reference method. The standard outlines requirements for multiple trained observers.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used. For ANSI/AAMI SP-10 compliance, it is common to have at least two trained observers taking simultaneous readings, and if their readings differ beyond a certain threshold, a third observer or a predefined adjudication process is typically involved.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of how human readers improve with AI vs without AI assistance. This device is a standalone blood pressure monitor and does not involve AI assistance for human readers in the context of diagnostic interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The device, HL868BF, itself is a standalone device that automatically measures blood pressure and heart rate. The entire compliance study to ANSI/AAMI SP-10 assesses the performance of the device without human intervention beyond proper cuff placement and initiation of the measurement. The "Accuracy" metrics provided (Pressure +/- 3mmHg, Pulse +/- 5%) are directly from the device's standalone operation.

7. Type of Ground Truth Used

The type of ground truth used is implied by the compliance to the ANSI/AAMI SP-10 standard. This standard typically relies on reference measurements obtained simultaneously by trained human observers using a validated reference method (e.g., mercury sphygmomanometer or equivalent). This is a form of expert consensus or highly standardized measurement.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This type of device (traditional oscillometric blood pressure monitor) is typically developed and validated using engineering and clinical studies. While there are algorithms involved, it's not a machine learning or AI device that would have a distinct "training set" in the modern sense. The "training" or development process would involve iterative design and testing against a set of physiological data to optimize the oscillometric algorithm.

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

As noted above, a distinct "training set" with established ground truth in the context of modern machine learning is not applicable here. The development of the oscillometric algorithm would involve calibrating and refining it against a range of actual blood pressure recordings, likely using simultaneous reference measurements from established methods (e.g., intra-arterial catheter readings or auscultatory measurements by trained clinicians) to ensure accuracy across different patient populations and blood pressure ranges.

Summary

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09216

REMARKET NOTIFICATION

510(k) SUMMARY

SEP 30 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 HL868BF 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 HL888SF, K060835

B. Automatic Blood Pressure Monitor, Model HEM 780N3, K061822

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 arm circumference ranging from 9 inches to 17 inches (23 cm to 43 cm) and for home use.

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5. Intended 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.

6. Comparison of device to predicate device:

Product Specification Comparison Table of HL868BF and HL888SF (K060835)

Item	HL868BF	PredicateHL888SF (K060835)
Method ofmeasurement	Oscillimetric	Oscillimetric
Range ofmeasurement	Pressure 0- 300mmHg,Pulse 40-199 Beats/minute	Pressure 0- 280mmHg,Pulse 40-199 Beats/minute
Accuracy	Pressure +/- 3mmHgPulse +/- 5%	Pressure +/- 3mmHgPulse +/- 5%
Inflation	Automatic inflation(Air pump)	Automatic inflation(Air pump)
Deflation of	Automatic air release	Automatic air release
Pressure	control valve	control valve
Exhaust	Automatic exhaust valve	Automatic exhaust valve
Display	Liquid Crystal DigitalDisplay	Liquid Crystal DigitalDisplay

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Power Supply	6V DC, 4 x "AA" (1.5V)Alkaline batteriesor AC adapter (optional)	6V DC, 4 x "AA" (1.5V)Alkaline batteriesor AC adapter (optional)
StorageTemperature	-20℃ ~ +70℃(-4°F ~ +158°F),$\leq$ 90%RH	-20℃ ~ +50℃,30 ~ 85%RH
OperatingTemperature	10℃ ~ 40℃(50°F ~ 104°F),15% ~ 90%RH	10℃ ~ 40℃,15% ~ 95%RH
Material	ABS housing andrubber keys	ABS housing andrubber keys
Temperature value	Yes	Yes
Sets of memory	3*80, total 240	3*30, total 90
Number ofPush Button	5	5
Storage pouch	Yes	Yes
Cuff size	Arm circumference approx.23-43 mm(9-17 inches)	Arm circumference approx.23-43 mm(9-17 inches)
Unit Weight	Approx. 400gincluding batteries	Approx. 265gexcluding batteries

Changes from the predicate devices HL888SF (K060835):

5 push buttons' positions, shapes, changing of exterior casing design
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 780N3 (K061822).

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:

HL868BF 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. Biocompatibility 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 Standard for Manual, electronic, or automated sphygmomanometers

9. 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

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

Health & Life Co., Ltd. c/o Mr. Tzu-Wei Li 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: K092161

Trade/Device Name: Fully Automatic (NIBP) Blood Pressure Monitor, Model HL868BF Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 28, 2009 Received: August 31, 2009

SEP 3 0 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/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,

Barry D. Zuckerman, M.

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

9216 510(k) Number (if known):

Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL868BF

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)

Page 1 of 1

(Division Sign-On)
Division of Cardiovascular Devices

510(k) Number_

4-1

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).