FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031

K091737 · Andon Health Co, Ltd. · DXN · Aug 18, 2009 · Cardiovascular

Device Facts

• Record ID: K091737
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Device Story

Non-invasive blood pressure monitor; uses oscillometric principle with silicon integrated pressure sensor; measures systolic/diastolic pressure and pulse rate. Input: pneumatic pressure signals from inflatable upper arm cuff (22-48cm). Output: digital display of blood pressure and pulse rate on LCD; includes blood pressure classification indicator and irregular heartbeat detection. KD-5915/KD-5031 feature memory storage and 3-measurement averaging; KD-5915 includes voice function. Operated by medical professionals or patients at home. Healthcare providers use output for clinical assessment of hypertension and cardiovascular status. Benefits include convenient, automated, non-invasive monitoring of blood pressure trends.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and AAMI/ANSI SP10:2002 (sphygmomanometers) standards demonstrated.

Technological Characteristics

Oscillometric measurement; silicon integrated pressure sensor; LCD interface. Powered by internal energy source. Cuff circumference 22-48cm. Standards: ANSI/AAMI SP10, IEC 60601-1, IEC 60601-1-2. MCU-based processing.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via non-invasive upper arm cuff (22cm-48cm circumference). For use by medical professionals or home users.

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

• KD-5902 Fully Automatic Electronic Blood Pressure Monitor (K083317)

Submission Summary (Full Text)

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KD-5917. KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor FDA 310(k) Files

# 510(k) Summary

K091737
P 1/4

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

### 1.0 submitter's information

Andon Health Co., Ltd. Name: No 31, Changjiang Road, Nankai District, Tianjin, Address: P.R. China 86-22-6052 6161 Phone number: 86-22-6052 6162 Fax number: Liu Yi Contact: 05/27/2009 Date of Application:

### 2.0 Device information

Fully Automatic Electronic Blood Pressure Monitor Trade name: Noninvasive blood pressure measurement system Common name: Noninvasive blood pressure measurement system Classification name:

### 3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Cardiovascular Panel:

### 4.0 Predict device information

Andon Health Co., Ltd. Manufacturer: KD-5902 Fully Automatic Electronic Blood Pressure Monitor Device: Device: K083317 510(k) number:

### 5.0 Device description

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is ,a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

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It is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5917 is 60 times, the memory capability of KD-5915 is 2 X 60 times, the memory capability of KD-5031 is 3×30 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-5915 and KD-5031 also have the function of averaging the last three measurements, KD-5915 also has the voice function.

### 6.0 Intended use

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

The intended use and the indication for use of KD-5917, KD-5915 and KD-5031, as described in its labeling are the same as the predict device KD-5902.

### 7.0 Summary comparing technological characteristics with predicate device

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Similar |
| Performance | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |

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K091737
p 3/4

### 8.0 Performance summary

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor conform to the following standards:

- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- · IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- · AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.
- · AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
- · AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.

### 9.0 Comparison to the predict device and the conclusion

Our device KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5902 whose 510(k) number is K083317.

KD-5917 and KD-5902 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance are different, KD-5917 does not have the voice function. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-5902. The Environmental parameters is changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min.

KD-5915 and KD-5902 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Only their appearance and some functions such as 2×60 times memory and averaging the last three measurements are different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-5902. The Environmental parameters is changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min.

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KD-5031 and KD-5902 is very similar in the intended use, the design principle, م 4/4 the material, the energy source and the applicable standards. Only their appearance and some functions such as 3×30 times memory and averaging the last three measurements are different. KD-5031 does not have a voice function. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-5902. The Environmental parameters is changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min. The MCU is also changed.

KO91737

KD-5917, KD-5915 and KD-5031 all add a new cuff compared with the predicted device.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 1 8 2009

Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianjin China 300190

Re: K091737

Trade/Device Name: KD-5917, KD-5915, and KD-5031 Fully Automatic Electronic Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System -Regulatory-Class: Class-II-(two). Product Code: DXN Dated: undated Received: July 21, 2009

Dear Mr. Yi:

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. Liu Yi

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 (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 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/ReportalProblem/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,

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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## Statement of Indications for Use

#### Kog1737 510(k) Number :

KD-5917, KD-5915 and KD-5031 Fully Automatic Device name: Electronic Blood Pressure Monitor

#### Indications for use:

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

AND/OR Over-The-Counter Use YES Prescription use (21 CFR 807 Subpart C) Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

H.H. Stier for B. Zuckerman

vision Sign-Off) /
Division of Cardiovascular Devices
510(k) Number K091737

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