FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918

K092588 · Andon Health Co, Ltd. · DXN · Dec 29, 2009 · Cardiovascular

Device Facts

• Record ID: K092588
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-5910 and KD-5918 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

Device is a non-invasive, fully automatic electronic blood pressure monitor for adult use in clinical or home settings. Input is obtained via an inflatable upper arm cuff (22-48cm). Operation utilizes oscillometric sensing and silicon integrated pressure sensor technology. Device processes pressure signals to calculate systolic/diastolic blood pressure and pulse rate; detects irregular heartbeats. Output is displayed on an LCD interface; includes blood pressure classification indicator. KD-5910 stores 60 measurements; KD-5918 stores 2x60 measurements and includes voice output. Healthcare providers or patients use displayed data to monitor cardiovascular status. Differences from predicate include MCU, cuff range, memory capacity, and voice functionality.

Clinical Evidence

Bench testing only. Device performance validated against AAMI SP10:2002 and its amendments (A1:2003, A2:2006) for manual, electronic, or automated sphygmomanometers. No clinical trial data provided.

Technological Characteristics

Oscillometric measurement principle using silicon integrated pressure sensors. Powered by electronic interface module with LCD. Cuff circumference 22-48cm. Standards met: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), AAMI SP10 (sphygmomanometers).

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). Suitable for use by medical professionals or at home.

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-5901 Fully Automatic Electronic Blood Pressure Monitor (K090768)

Submission Summary (Full Text)

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# 510(k) Summary

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

DEC 2 9 2009

Name: Andon Health Co., Ltd. Address: No 31, Changjiang Road, Nankai District, Tianjin, P.R. China Phone number: 86-22-6052 6161 Fax number: 86-22-6052 6162 Contact: Liu Yi Date of Application: 08/07/2009

#### 2.0 Device information

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

#### 3.0 Classification _

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

#### 4.0 Predict device information

Manufacturer: Andon Health Co., Ltd. Device: Device: KD-5901 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K090768

### 5.0 Device description

KD-5910 and KD-5918 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.

It is designed and manufactured according to ANSI/AAMI SP10--manual,

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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-5910 is 60 times, the memory capability of KD-5918 is 2×60 times. If any irregular heartbeat is detected, it can be shown on the LCD, KD-5918 also has the voice function.

### 6.0 Intended use

KD-5910 and KD-5918 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-5910 and KD-5918, as described in its labeling are the same as the predict device KD-5901.

# 7.0 Summary comparing technological characteristics with predicate device

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

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## 8.0 Performance summary

KD-5910 and KD-5918 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-5910 and KD-5918 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5901 whose 510(k) number is K090768.

KD-5910 and KD-5901 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance are different. KD-5910 does not have the voice function. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-5901. KD-5910 also has a different MCU.

KD-5918 and KD-5901 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 are different.

KD-5910 and KD-5918 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/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a staff with two snakes entwined around it, often used as a symbol of medicine and healthcare. The seal is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

DEC 2 9 2009

Re: K092588

KD-5910 and KD-5918 Fully Automatic Electronic Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: December 1, 2009

Dear Mr. Liu:

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 (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W.M.

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

510(k) Number :

Device name: KD-5910 and KD-5918 Fully Automatic Electronic Blood Pressure Monitor

#### Indications for use:

KD-5910 and KD-5918 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.

Part 21 CFR 801 Subpart D)

Prescription use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.P.

Division of Cardiovascular Devices

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510(k) Number K092588