Full Automatic(NIBP) Blood Pressure Monitor

K180240 · Health & Life Co., Ltd. · DXN · Oct 17, 2018 · Cardiovascular

Device Facts

• Record ID: K180240
• Device Name: Full Automatic(NIBP) Blood Pressure Monitor
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

HL858DK 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 the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use. HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level. HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

Device Story

The HL858DK is an automated, oscillometric non-invasive blood pressure (NIBP) monitor for home use. It measures systolic/diastolic blood pressure and heart rate at the upper arm during cuff inflation. The device features a BP Category Indicator for tracking and an Advanced Irregular Heartbeat (IHB) detection feature. The IHB feature uses a photoplethysmogram (PPG) module to collect and analyze pulses; if specific irregular heartbeats are detected that may affect measurement accuracy, the device provides a warning signal to the user. Results are displayed on an integrated LCD panel. The device is operated by the patient (adults 18+). It aids users in monitoring their blood pressure levels and alerts them to potentially inaccurate readings caused by irregular heartbeats, facilitating informed self-management of cardiovascular health.

Clinical Evidence

Clinical validation performed per ISO 81060-2:2013 on 85 subjects, meeting acceptance criteria for mean difference and standard deviation. Advanced IHB detection validated in a separate clinical study of 189 subjects, reporting 97.8% sensitivity and 100% specificity.

Technological Characteristics

Oscillometric measurement during inflation; ABS housing/keys; LCD display; powered by 4x AAA batteries or AC adapter. Includes PPG module for IHB detection. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, ISO 10993, and ISO 14971. Software developed per IEC 62304.

Indications for Use

Indicated for adults aged 18+ with arm circumference 9-17 inches (23-43 cm) for home use to measure systolic/diastolic blood pressure and heart rate. Includes BP category indicator and irregular heartbeat (IHB) detection warning.

Regulatory Classification

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.

Predicate Devices

• Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858DI (K153214)
• Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858GA (K130563)

Submission Summary (Full Text)

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October 17, 2018

Health & Life Co. Ltd. J. Hsu RA / OA Div. Manager 9F, No. 186 Jian Yi Road Zhonghe District, New Taipei City, 23553 TAIWAN

Re: K180240

Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DK Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 28, 2018 Received: September 6, 2018

Dear J. Hsu:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Shawn W.

> Forrest -A

Digitally signed by Shawn W. Forrest -A
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=1300403341
cn=Shawn W. Forrest -A
Date: 2018.10.17 15:29:01 -04'00'

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) K180240

Device Name

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DK

#### Indications for Use (Describe)

HL858DK 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 the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use.

HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

Type of Use (*Select one or both, as applicable*)

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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K180240

# PREMARKET NOTIFICATION

# 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: ________________________ 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: JS Hsu/ RA & QA Manager. E-mail: [e-mail] Tel: [phone] ext.1201 Fax: [phone]

#### 2. Name of the Device:

Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DK 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

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

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

B. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858GA (K130563)

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#### 4. Device Description:

HL858DK 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.

Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

#### 5. Intended Use

HL858DK 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 the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use.

HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

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- 6. Comparison of device to predicate device:
Product Specification Comparison Table of Subject Device HL858DK, and Predicate Device HL858DI (K153214)

| Item | Predicate Device<br>HL858DI (K153214) | Subject Device<br>HL858DK | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Method of<br>measurement | Oscillimetric | Same as left | |
| Measurement<br>Type | During inflation | During inflation | |
| Range of<br>measurement | Pressure 0- 300mmHg,<br>Rated Range of Determination:<br>40~280mmHg,<br>Pulse 40-199 Beats/minute | Same as left | |
| Accuracy | Pressure ± 3mmHg<br>Pulse ± 5% | Same as left | |
| Pressure<br>Changed Rate | 2~5mmHg/sec.<br>(from 90mmHg to 150mmHg) | Same as left | |
| Display | Liquid Crystal Digital | Same as left | |
| Power Supply | 4 × AA/1.5V (LR6) Alkaline<br>batteries, or<br>AC Adapter(Model: Fuhua,<br>UE08WCP-060100SPA Input: 100-<br>240V AC 50-60Hz / Output: 6V, DC,<br>1A) | 4 × AAA/1.5V (LR03) Alkaline<br>batteries, or<br>AC Adapter (Model: SINPRO,<br>HPU15-102 Input: 100-240V AC 47-<br>63Hz/ Output: 5.99V, DC, 2A) | |
| | Storage/<br>Transportation<br>Environment | - 25℃ ~ + 70℃ (- 13°F ~<br>+158°F),<br>≤ 93% R.H. | Same as left |
| | Operating<br>Environment | 5℃ ~ 40℃ (41°F~104°F),<br>15% ~ 93% R.H.<br>700~1060hPa | Same as left |
| Material | | ABS housing and<br>ABS keys | Same as left |
| | Sets of<br>memory | 2*60, total 120 | |
| Number of<br>Push Button | 5 keys control<br>(Start/Stop, Memory, User 1/2, Set<br>(+), Mode (clock button) | 5 keys control<br>(Start/Stop, Memory, Up, Down,<br>Time (clock button) | |
| Storage pouch | Yes | Same as left | |
| Cuff size | Arm circumference approx.<br>23~43cm / 9~17 inch<br>(Universal cuff) | Same as left | |
| Unit Weight | Approx. 310 ± 10g<br>(Excluding cuff and Batteries ) | Approx. 320 ± 5g<br>(Excluding cuff and Batteries ) | |
| Risk/BP<br>Category<br>Indicator | Yes<br>(Risk Category Indicator, Four<br>Levels) | Yes<br>(BP Category Indicator, Six Levels) | |
| Irregular<br>Heartbeat<br>Detector | Yes<br>(Irregular Heartbeat Detection) | Yes<br>(Advanced Irregular Heartbeat<br>Detection) | |

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#### Changes from the predicate devices HL858DI (K153214):

- * Modifying the power supply form AA (LR6) Alkaline batteries to AAA (LR03) Alkaline batteries and changing the supplier of AC Adapter.
- * Modifying the memory of 2*60 (total 120) to 3*40 (total 120).
- * The predicate device HL858DI (K153214) and subject device HL858DK have the same numbers of push button, but that have differences function and name of push button.
- * Changing the Unit Weight from Approx. 310 ± 10g to Approx. 320 ± 5g.
- * Modifying the feature of Risk/BP Category Indicator from Risk Category Indicator (Four Levels) to BP Category Indicator (Six Levels).
- * Modifying the Irregular Heartbeat Detector to Advanced Irregular Heartbeat Detection.

These features have been verified and validated and do not affect the safety and effectiveness of subject device HL858DK. As for the BP Category Indicator, implemented on the subject device HL858DK, was compared with the other predicate

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device HL858GA (K130563). Please refer to Section 12. Substantial Equivalence Discussion for detail information.

#### 7. Discussion of Clinical Tests Performed:

HL858DK 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 HL858DK in the group of 85 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.

In additional, the subject device HL858DK had equipped with Advanced Irregular Heartbeat Detection implemented by a photoplethysmogram (PPG) module. The clinical test included 189 subjects, which the test report showed a 97.8% sensitivity value and 100% specificity vale. All the evaluation activities were performed by designate individual(s) and 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 4:2014, 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 60601-1-11:2015, 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

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### 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:

IEC 80601-2-30 Edition1.1 2013-07 Medical electricalequipment-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 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 62366:2014 Medical devices - Application of usability engineering to medical devices

-IEC 60601-1-6:2013 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.