HL858GA uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's arm. All values can be read out in one LCD panel. The device is designed and recommended for use by people over the age of 18 with arm circumference ranging from approx.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.

Besides, Risk Category Indicator (Six Levels) feature will judge blood pressure results into six levels based on WHO (World Health Organization) classification with corresponding bar segment on the edge of screen.

Device Description

The device is equipped with Irregular Heartbeat Detector function which display a symbol of or or ma, 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. Besides, 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 Risk Category Indicator (Six Levels) feature will classify the blood pressure results with WHO (World Health Organization) Classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, Normal, and Optimal. The Corresponding LCD segment will be turned on along with the systolic, diastolic, and heart rate information.

AI/ML Overview

The provided text describes the 510(k) summary for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858GA. Here's an analysis of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (from predicate device HL868RT (K093831))	Reported Device Performance (HL858GA)
Pressure Accuracy	+/- 3mmHg	Same as left (implies +/- 3mmHg)
Pulse Accuracy	+/- 5%	Same as left (implies +/- 5%)
Method of Measurement	Oscillometric	Same as left (implies Oscillometric)
Range of Measurement (Pressure)	0~300mmHg	Same as left (implies 0~300mmHg)
Range of Measurement (Pulse)	40-199 beats/minute	Same as left (implies 40-199 beats/minute)

Note: The document explicitly states "Same as left" in the "Subject device HL858GA" column for these performance criteria, indicating that the new device aims to meet the same specifications as its predicate device. The clinical study confirmed that these criteria were met.

Study Details

Sample size used for the test set and the data provenance:
- The document states that the device is "compliant to the ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002 / / A 1:2003/(R )2008 & ANSI/AAMI SP10:2002/ A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers."
- These standards typically specify the number of subjects required for validation (e.g., 85 subjects with specific age and blood pressure distributions as per AAMI SP10). However, the specific sample size used in this particular study is not explicitly stated in the provided text.
- Data provenance: Not explicitly stated. These standards generally involve prospective clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. For blood pressure monitors, ground truth is typically established by trained human observers using a mercury sphygmomanometer or a validated auscultatory reference device, following the AAMI SP10 protocol. The standard would define the qualifications for these observers, generally requiring specific training and certification in auscultatory blood pressure measurement.
Adjudication method for the test set:
- Not explicitly stated. AAMI SP10, which the device complies with, typically involves multiple observers (often two) taking simultaneous measurements, with their readings compared against each other and against the automated device's readings. Discrepancies may be resolved by a third observer or specific statistical methods.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The entire premise of automated blood pressure monitors is to provide readings without human-in-the-loop interpretation beyond operating the device. The clinical study assessed the device's accuracy against reference measurements, which is a standalone performance evaluation for such a device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For blood pressure monitors, the ground truth is established through simultaneous measurements by trained human observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer). This aligns with the methodologies prescribed in the ANSI/AAMI SP10 standard.
The sample size for the training set:
- Not applicable / Not stated. Automated blood pressure monitors like this one are based on oscillometric algorithms, which are typically developed using engineering principles and physiological models, rather than machine learning "training sets" in the modern sense of deep learning. While initial algorithm development involves data, it's not typically referred to as a "training set" in the context of these devices. The approval process focuses on validation of the final algorithm's performance.
How the ground truth for the training set was established:
- Not applicable / Not stated. As mentioned above, the concept of a "training set" with established ground truth, as used in AI/ML, doesn't directly apply here in the same way. The oscillometric method's principles are established, and the manufacturer fine-tunes the algorithm to accurately transform cuff pressure oscillations into blood pressure values. Ground truth for validation (testing) would be established by trained observers as per AAMI SP10.

Summary

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K130563

PREMARKET NOTIFICATION

JUN 1 8 2013

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: www.varance.com Date: MAR 01 2013 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: Sarah Su/ Regulatory Affairs Dept. E-mail: sarah.su@hlmt.com.tw Tel: 886-2-8227-1300 ext.1201 Fax: 886-2-8227-1301

2. Name of the Device:

Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858GA Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21CFR 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 HL868RT, K093831 B. A&D Digital Blood Pressure Monitor, Model UB-512, K042967

4. Device Description:

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K130563

5. Intended Use

6. Comparison of device to predicate device:

Product Specification Comparison Table of Subject device HL858GA and predicate device HL868RT (K093831)

Item	Predicate deviceHL868RT (K093831)	Subject deviceHL858GA
Method ofmeasurement	Oscillimetric	Same as left
Range ofMeasurement	Pressure 0~300mmHgPulse 40-199 beats/minute	Same as left
Accuracy	Pressure +/- 3mmHgPulse +/- 5%	Same as left
Inflation	Automatic inflation(Air pump)	Same as left
Deflation	Automatic air releasecontrol valve	Same as left
Exhaust	Automatic exhaust valve	Same as left
Display	Liquid Crystal Display	Same as left
Power Supply	AA(1.5V)alkaline battery × 4or 6V AC adapter (optional)	AA(1.5V)alkaline battery × 4
Storage/Transportation	- 20°C ~ + 70°C(- 4°F~ +158°F),	- 25°C ~ + 70°C(- 13°F~ +158°F),

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K130563

Environment	≤ 90% R.H.	≤ 93% R.H.
OperatingEnvironment	10℃~~40℃(50°F~~104°F),15%~90% R.H.	5℃~~40℃(41°F~~104°F),15%~93% R.H.
	Material	ABS housing andrubber keys	ABS housing andABS keys
	Sets of memory	2×60, total 120	3×40,total 120
Number ofPush Button	7	4
Storage pouch	Yes	Same as left
Cuff size	Arm circumference approx.23~~43cm (9~~17 inches)	Same as left
Unit Weight	10.33 ± 0.35oz (293±10g)(Batteries Excluded)	8.73 ± 0.35 oz (247.5 ± 10 g)(Cuff and Batteries Excluded)

Changes from the predicate device HL868RT (K093831):

*Changing of numbers of push buttons, push buttons' material and positions.

Additional modified feature of Risk Category Indicator (Six Levels)

For the modified feature of Risk Category Indicator (six levels) was compared with the other predicate device A&D UB-512 (K043217).

7. Discussion of Clinical Tests Performed:

Subject device HL858GA is compliant to the ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002 / / A 1:2003/(R )2008 & ANSI/AAMI SP10:2002/ A2:2006/(R)2008 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 60601-1:2005, Medical electrical equipment - Part 1: General Requirements for basic safety, and essential performance

-IEC 60601-1-11:2010, Medical electrical equipment-Part 1-11 :General safety and essential performance-Requirement for basic Collateral Standard :Requirements for medical electrical systems used in the home healthcare environment.

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b. EMC Test: IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
c.FCC Test: FCC 47 CFR Part 15, Subpart B

d. Biocompatibility Test:

ISO 10993-1:2009, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process.
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: ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008, Manual, electronic or automated sphygmomanometers.
f. Risk Assessment: ISO 14971:2007 Second Edition. Medical devices -Application of risk management to medical devices
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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Image /page/4/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 three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-002

June 18, 2013

Health & Life Co., Ltd. Sarah Su 9f, No.186, Jian Yi Road Zhonghe District, New Taipei City, 23553 TW

Re: K130563

Trade/Device Name: Full automatic (nibp) blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: May 14, 2013 Received: May 20, 2013

Dear Sarah 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. 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 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.

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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.him 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.htmfor 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,

Owen P. Faris -S

for

Bram D. Zuckerman, Ph.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): _K130563 1

Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858GA

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use V AND/OR (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

Owen P. Faris -S
2013.06.18
09:39:19 -04'00'

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).