FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM

K093823 · Health & Life Co., Ltd. · DXN · Jan 22, 2010 · Cardiovascular

Device Facts

• Record ID: K093823
• Device Name: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

HL888V is a manual inflate type blood pressure monitor for measurement of 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. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm). HL868JM is a manual inflate type blood pressure monitor for measurement of 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. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

Device Story

Manual inflate blood pressure monitors (HL888V, HL868JM) measure systolic/diastolic blood pressure and heart rate using oscillometric method; input via manual inflation bulb; output displayed on LCD panel. HL868JM includes Risk Category Indicator for blood pressure level tracking. Used in home setting by adult patients. Healthcare providers use readings to monitor patient blood pressure status. Benefits include convenient, self-administered blood pressure tracking.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for manual/electronic sphygmomanometers demonstrated that predetermined acceptance criteria were met. Safety and performance verified via IEC 60601-1, IEC 60601-1-2, and software validation per IEC 62304.

Technological Characteristics

Oscillometric measurement; manual inflation/deflation with automatic air release valve. LCD display. Power: 3V CR2032 (HL888V) or 2xAA batteries (HL868JM). Dimensions/weight vary from predicate. Software-based processing for oscillometric signal analysis. Standards: ANSI/AAMI SP-10, IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 62366.

Indications for Use

Indicated for adults aged 18+ with arm circumference 23-33cm for non-invasive measurement of systolic/diastolic blood pressure and heart rate via oscillometric method at the upper arm. Intended for home use.

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

• H&L Full Automatic (NIBP) Blood Pressure Monitor, Model HL888BM (K032837)

Submission Summary (Full Text)

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# PREMARKET NOTIFICATION

## 510(k) SUMMARY

JAN 22 2010

### (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.

DEC 0 9 2009 The assigned 510(k) number is: K093823 Date:

1. Submitter:

Name: Health & Life Co., Ltd. Address: 9F, No.186, Jian Yi Road. Chung Ho City, Taipei County, Taiwan, R.O.C.

Contact person: Sarah Su/ Regulatory Affairs 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 HL888V, HL868JM

Common Name: Blood Pressure Monitor

Classification Name: Non-Invasive Blood Pressure Measurement System

Classification: Class II

Regulation Number: 21 CFR 870.1130

Product Code: DXN

Panel: Cardiovascular

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

H&L Full Automatic (NIBP) Blood Pressure Monitor, Model HL888BM, K032837

### 4. Device Description:

Both HL888V and HL868JM are manual inflate type blood pressure monitors for measurement of 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

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K093823

position is at human being's upper arm. The intended use of the over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 ~13 inches (approx.23cm-33cm) and for home use.

HL868JM features a Risk Category Indicator 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

HL888V is a manual inflate type blood pressure monitor for measurement of 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. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

HL868JM is a manual inflate type blood pressure monitor for measurement of 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. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

### 6. Comparison of device to predicate device:

| Item | Predicate<br>HL888BM (K032837) | HL888V |
|--------------------------|---------------------------------------------------|--------------|
| Method of<br>measurement | Oscillimetric | Same as left |
| Range of<br>measurement | Pressure 0- 300mmHg,<br>Pulse 40-199 Beats/minute | Same as left |
| Accuracy | Pressure $\pm$ 3mmHg<br>Pulse $\pm$ 5% | Same as left |
| Inflation | Manual inflation | Same as left |
| Exhaust | Manual deflation | Same as left |
| Deflation of<br>Pressure | Automatic air release<br>control valve | Same as left |

Product Specification Comparison Table of HL888V and HL888BM (K032837)

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K093823

| Display | Liquid Crystal Digital Display | Same as left |
|--------------------------|----------------------------------------------------------|--------------------------------------------------------|
| Cuff size | Arm circumference approx.<br>24~32 cm<br>(9.5~13 inches) | Arm circumference approx.<br>23~33 cm<br>(9~13 inches) |
| Sets of memory | 48 sets | 99 sets |
| Operating<br>Temperature | 10℃~40℃ ,<br>30 ~ 85% RH | 10℃~40℃<br>(50°F~104°F),<br>15% ~90% RH |
| Storage<br>Temperature | -20℃ ~ + 50℃ ,<br>10~95% RH | - 20℃ ~ + 70℃<br>(- 4°F~ +158°F),<br>≤ 90%RH |
| Power Supply | 4 × "AA" ( 1.5V )<br>Alkaline batteries | One 3V CR2032 battery |
| Battery life | Approx.300 times<br>measurement | Approx. 180 times<br>measurement |
| Unit Weight | Approx. 265g<br>including batteries | Approx. 100g<br>including batteries |

## Changes from the predicate device HL888BM (K032837):

Both of HL888V and HL888BM have 4 push buttons and remain the same features such as with date, time, memory, measuring blood pressure and heart rate.

HL888V obtains its energy source from one 3V CR2032 battery, and the inflation bulb was connected with the unit directly. Besides, HL888V is changing the exterior casing design, and the appearance of the symbol "Inflation/Deflation".

Therefore, HL888V does not involve any changes or modifications which could significantly affect or effectiveness of the predicate device, as compared to the HL888BM.

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# Product Specification Comparison Table of HL868JM and HL888BM (K032837)

.

| Item | Predicate<br>HL888BM (K032837) | HL868JM |
|----------------------------|----------------------------------------------------------|--------------------------------------------------------|
| Method of<br>measurement | Oscillimetric | Same as left |
| Range of<br>measurement | Pressure 0- 300mmHg,<br>Pulse 40-199 Beats/minute | Same as left |
| Accuracy | Pressure +/- 3mmHg<br>Pulse +/- 5% | Same as left |
| Inflation | Manual inflation | Same as left |
| Exhaust | Manual deflation | Same as left |
| Deflation of<br>Pressure | Automatic air release<br>control valve | Same as left |
| Display | Liquid Crystal Digital<br>Display | Same as left |
| Cuff size | Arm circumference approx.<br>24~32 cm<br>(9.5~13 inches) | Arm circumference approx.<br>23~33 cm<br>(9~13 inches) |
| Sets of memory | 48 sets | 99 sets |
| Operating<br>Temperature | 10℃~40℃,<br>30 ~ 85% RH | 10℃~40℃<br>(50°F~104°F),<br>15%~90% RH |
| Storage<br>Temperature | -20℃~+50℃,<br>10~95% RH | -20℃~+70℃<br>(-4°F~+158°F),<br>≤ 90%RH |
| Power Supply | 4 × "AA" (1.5V)<br>Alkaline batteries | 2 × "AA" (1.5V)<br>Alkaline batteries |
| Unit Weight | Approx. 265g<br>including batteries | Approx. 159g<br>without batteries |
| Battery life | Approx.300 times<br>measurement | Same as left |
| Risk Category<br>Indicator | None | Yes |

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K093823

## Changes from the predicate devices HL888BM (K032837):

Both of HL868JM and HL888BM have 4 push buttons and remain the same features such as with date, time, memory, measuring blood pressure and heart rate.

HL868JM obtains its energy source from 2 "AA" (1.5V) Alkaline batteries. Additional product feature is Risk Category Indicator function. HL868JM is changing the exterior casing design, and the appearance of the symbol "Inflation/Deflation".

Therefore, HL868JM does not involve any changes or modifications which could significantly affect or effectiveness of the predicate device, as compared to the HL888BM.

### 7. Discussion of Clinical Tests Performed:

Both HL888V and HL868JM are compliant to the ANSI/AAMI SP-10:2002+

A 1:2003+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.

## 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 60601-1:1988+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. Reliability Test: ANSI/AAMI SP-10:2002+A1:2003+A2:2006
- d. Risk Assessment: ISO 14971:2007 Medical devices Application of risk management to medical devices
- e. Software Verification and Validation: IEC 62304 Ed. 1.0, Medical device software - Software life cycle processes. (Software/Informatics) and IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems
- f. Usability Validation: IEC 62366 Medical devices Application of usability engineering to medical devices

દ્વાર

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## 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.

and the comments of the comments of

:

.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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 its wings spread, facing to the right. The eagle is black and has a simple, modern design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 22 2010

Health & Life Co., Ltd. c/o Ms. Sarah Su 9F, No. 186, Jian Yi Road Chung Ho City, Taipei County 23553 TAIWAN R.O.C.

Re: K093823

> Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888V and Model HL868JM Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: January 12, 2010 Received: January 19, 2009

Dear Ms. 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.

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 - Ms. Sara Su

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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

[signature]

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): K093823

Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888V, HL868JM

Indications for Use:

HL888V is a manual inflate type blood pressure monitor for measurement of 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. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

HL868JM is a manual inflate type blood pressure monitor for measurement of 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. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).

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((

Page 1 of 1

Evaluation (ODE)

ision of Cardiovascular Devices

2-1

510(k) Number 409382