Full Automatic (NIBP) Blood Pressure Monitor

• K Number: K161156
• Device Name: Full Automatic (NIBP) Blood Pressure Monitor
• Manufacturer: HEALTH & LIFE CO., LTD.
• Date Cleared: 2016-06-14 ( 50 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

HL858TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. 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. HL858TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

Device Description

HL858TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. 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 device will display a symbol ( heartbeat rhythm as defined as a rhythm 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.

Predicate Devices

K153214

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard oscillometric blood pressure measurement and basic rhythm detection based on interval variation, without mentioning any AI/ML algorithms or training/test data.

Therapeutic

No
The device is described as a blood pressure monitor intended for measurement and tracking, not for treatment or therapy.

Diagnostic

Yes

The device measures blood pressure and heart rate, detects irregular heartbeats, and provides a risk category indicator, all of which are used to assess a health condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it measures blood pressure using the oscillometric method during inflation and has an LCD panel for readout, indicating it is a physical hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The HL858TA measures blood pressure and heart rate using the oscillometric method on the upper arm. This is a non-invasive measurement taken directly from the body, not from a sample in vitro (in glass/outside the body).
• Intended Use: The intended use is for measuring blood pressure and heart rate in adults at home. This aligns with a general medical device for physiological monitoring, not an IVD for analyzing biological samples.

Therefore, the HL858TA is a non-invasive blood pressure monitor, which is a type of medical device, but not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HL858TA automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. 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.

HL858TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

Product codes

DXN

Device Description

HL858TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. 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 device will display a symbol (heartbeat rhythm as defined as a rhythm 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human being's upper arm

Indicated Patient Age Range

adults aged 18 years and older

Intended User / Care Setting

home use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Clinical Investigation
Sample Size: 105 subjects
Key Results: The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858TA in the group of 105 subjects with qualified distribution. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K153214

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2016

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

Re: K161156

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858TA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 21, 2016 Received: April 25, 2016

Dear Ms. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

for 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) K161156

Device Name

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858TA

Indications for Use (Describe)

HL858TA automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. 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.

HL858TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K161156

Page 1 of 6

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: _ K161156 __ Date: ____________________________________________________________________________________________________________________________

1. Submitter:

Health & Life Co., Ltd. 9F. No.186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan, R.O.C TEL: [phone] FAX: [phone]

Contact person: Sarah Su/ QA & RA Dept. E-mail: [e-mail] Tel: [phone] ext.1201 Fax: [phone]

2. Name of the Device:

Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858TA Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21 CFR 870.1130 Classification Panel: 74 Cardiovascular Product Code: DXN

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

Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858DI (K153214)

4. Device Description:

HL858TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. 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 device will display a symbol ( heartbeat rhythm as defined as a rhythm 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.

5. Intended Use

HL858TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. 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.

HL858TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

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6. Comparison of device to predicate device:

Product Specification Comparison Table of Subject Device HL858TA, and Predicate Device HL858DI (K153214)

| Item | Predicate Device
HL858DI (K153214) | Subject Device
HL858TA |
|-------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Method of
measurement | Oscillimetric | Same as left |
| Measurement
Type | During inflation | Same as left |
| Range of
measurement | Pressure 0- 300mmHg,
Pulse 40-199 Beats/minute | Same as left |
| Accuracy | Pressure ± 3mmHg
Pulse ± 5% | Same as left |
| Pressure
Changed Rate | 25mmHg/sec. | Same as left |
| Exhaust | Automatic exhaust valve | Same as left |
| Display | Liquid Crystal Digital | Same as left |
| Power Supply | 6V 1A, 4 × AA/1.5V (LR6)
Alkaline batteries, or
AC adapter (optional) | 6V 1A, 4 × AAA/1.5V (LR03)
Alkaline batteries |
| Storage/
Transportation
Environment | - 25°C ~ + 70°C (- 13°F ~
+158°F),
≤ 93% R.H. | Same as left |
| Operating
Environment | 5℃40℃ (41°F104°F),
15%93% R.H. | Same as left |
| Material | ABS housing and
ABS keys | Same as left |
| Sets of
memory | 260,total 120 | 160 |
| Number of | 5 keys | 2 keys |
| Push Button | | |
| Storage pouch | Yes | No |
| Cuff size | Arm circumference approx.
2343cm / 917 inch
(Universal cuff) | 1. Arm circumference approx. 2333cm / 913 inch (Standard cuff)
2. Arm circumference approx. 2343cm / 917 inch (Universal cuff; optional) |
| Unit Weight | Approx. 310 ± 10g
(Excluding cuff and Batteries ) | Approx. 221 ± 5g
(Excluding cuff and Batteries ) |
| Risk Category
Indicator | Yes | Same as left |
| Irregular
Heartbeat
Detector | Yes | Same as left |

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Changes from the predicate devices HL858DI (K153214):

*Changing the battery type form four AA (LR6) alkaline batteries and AC adapter to four AAA (LR03) alkaline batteries only.

• • Changing the memory of 120 (260, total 120) to 60 (160).

• Changing the 5 keys to the 2 keys.

• • Adding the Standard cuff (2333cm / 913 inch).
    These features have been verified and validated and do not affect the safety and effectiveness of subject device HL858TA.Please refer to Section 12. Substantial Equivalence Discussion for detail information.

7. Discussion of Clinical Tests Performed:

HL858TA is compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858TA in the group of 105 subjects with qualified distribution. Thus, all the

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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 is as follows:

The subject device was tested to evaluate its safety and effectiveness, including the followings:

• a. EMC Test: IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment -Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests
• b. 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 Requirement for basic safety and essential performance- Collateral Standard: Requirements for medical electrical systems used in the home healthcare environment

• 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 cvtotoxicity

-ISO 10993-10:2010, Third Edition Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization

• e. Reliability Test:
  IEC 80601-2-30 Edition1.1 2013-07 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

• f. Risk Assessment: ISO 14971:2007 Second Edition, Medical devices -

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Application of risk management to medical devices

g. Software Verification and Validation:

-IEC 62304 Ed.1.0 (2006), Medical device software - Software life cycle processes,

-IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems, edition 1.1

h. Usability Validation:

-IEC 62366-1:2015 Medical devices - Application of usability engineering to medical devices

-IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

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.