FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557

K100014 · Andon Health Co, Ltd. · DXN · Jan 29, 2010 · Cardiovascular

Device Facts

• Record ID: K100014
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 29, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-557 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

KD-557 is a non-invasive, fully automatic electronic blood pressure monitor for adult use in clinical or home settings. Device utilizes an inflatable upper arm cuff (22-48cm) to capture oscillometric signals via a silicon integrated pressure sensor. Internal electronics process these signals to calculate systolic/diastolic blood pressure and pulse rate. Features include irregular heartbeat detection, blood pressure classification indicator, memory for 2x60 measurements, and an averaging function for the last three readings. Results are displayed on an integrated LCD interface. Device provides objective physiological data to assist healthcare providers or patients in monitoring cardiovascular status.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and AAMI/ANSI SP10:2002/A1:2003/A2:2006 (sphygmomanometer performance). No clinical trial data presented.

Technological Characteristics

Oscillometric measurement principle using silicon integrated pressure sensor. Powered by electronic interface module. Features LCD display, 2x60 memory, irregular heartbeat detection, and 3-measurement averaging. Complies with ANSI/AAMI SP10, IEC 60601-1, and IEC 60601-1-2 standards. Cuff circumference 22-48cm.

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 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-556 Fully Automatic Electronic Blood Pressure Monitor (K091500)

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

JAN 2 9 2010

(100014

\$1/3

| Name: | Andon Health Co., Ltd. |
|----------------------|----------------------------------------------------------------------------|
| Address: | No. 3 Jin Ping Street, Ya An Road, Nankai District,<br>Tianjin, P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 12/28/2009 |

#### 2.0 Device information

| Trade name: | Fully Automatic Electronic Blood Pressure Monitor |
|----------------------|---------------------------------------------------|
| 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: II Panel: Cardiovascular

#### 4.0 Predict device information

Manufacturer: Andon Health Co., Ltd. KD-556 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K091500

#### 5.0 Device description

KD-557 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 is 2×60 times. If any irregular heartbeat is detected, it can be shown on the LCD. It also has the function of averaging the last three measurements.

## 6.0 Intended use

KD-557 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-557, as described in its labeling are the same as the predict device KD-556.

| 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 | Identical |

# 7.0 Summary comparing technological characteristics with predicate device

5- 2

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### 8.0 Performance summary

KD-557 Fully Automatic Electronic Blood Pressure Monitor conforms 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 Safety - Collateral standard: Electromagnetic Requirements for 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-557 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K091500.

The two devices are very similar in the intended use, the design principle, the material, the performance, the safety, the energy source and the applicable standards. Only their appearances are different.

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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, resembling a bird in flight.

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

JAN 2 9 2010

Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin China 300190

Re: K100014

> Trade/Device Name: KD-557 Fully Automated Electronic Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: December 30, 2009 Received: January 4, 2010

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 (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 vours.

W.M.

s/ 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

K100014 510(k) Number :

Device name:

KD-557 Fully Automatic Electronic Blood Pressure Monitor

# Indications for use:

KD-557 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 systems of 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.

Prescription use Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use YES (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.W.W.

ision of Cardiovascular Devices

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510(k) Number