FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K102930 · Andon Health Co, Ltd. · DXN · Nov 3, 2010 · Cardiovascular

Device Facts

• Record ID: K102930
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 3, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Fully Automatic Electronic Blood Pressure Monitor are for use by KD-512 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. KD-712 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 wrist. The cuff circumference is limited to 14cm-25cm.

Device Story

Non-invasive blood pressure monitors (KD-512 upper arm; KD-712 wrist) for clinical or home use. Device uses inflatable cuff and silicon integrated pressure sensor to capture oscillometric signals. Internal processing calculates systolic/diastolic blood pressure and pulse rate; detects irregular heartbeats; computes average of last three measurements. Results displayed on LCD. Healthcare providers or patients use output to monitor cardiovascular status. Benefits include convenient, automated blood pressure tracking.

Clinical Evidence

Bench testing only. Conformance to IEC 60601-1, EN 60601-1-2, and AAMI SP10:2002 standards for safety, electromagnetic compatibility, and sphygmomanometer performance.

Technological Characteristics

Oscillometric measurement principle; silicon integrated pressure sensor; LCD display; upper arm (22-48cm) or wrist (14-25cm) cuff; powered by internal energy source; compliant with AAMI SP10, IEC 60601-1, and EN 60601-1-2 standards.

Indications for Use

Indicated for adult individuals to measure diastolic/systolic blood pressure and pulse rate via non-invasive oscillometric technique using an inflatable cuff (upper arm for KD-512, wrist for KD-712).

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 (K090963)
• KD-738 Fully Automatic Electronic Blood Pressure Monitor (K092045)

Submission Summary (Full Text)

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# 510(k) Summary

K.10293e
Pg 1 of 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

NOVT == 3 = 2010 ;

| Name: | Andon Health Co., Ltd. |
|----------------------|---------------------------------------------------|
| Address: | No 3, Jinping Street Ya An 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: | 09/27/2010 |

# 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 Predicate device information

| 1 | Manufacturer: | Andon Health Co., Ltd. |
|---|----------------|-------------------------------------------------------------|
| | Device: | KD-556 Fully Automatic Electronic Blood Pressure<br>Monitor |
| | 510(k) number: | K090963 |
| 2 | Manufacturer: | Andon Health Co., Ltd. |
| | Device: | KD-738 Fully Automatic Electronic Blood Pressure<br>Monitor |
| | 510(k) number: | K092045 |

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K102930e
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#### 5.0 Device description

KD-512 Fully Automatic Electronic Blood Pressure Monitor are 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.

KD-712 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 wrist. The cuff circumference is limited to 14cm-25cm.

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. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.

#### 6.0 Intended use

KD-512 Fully Automatic Electronic Blood Pressure Monitor are 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.

KD-712 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 wrist. The cuff circumference is limited to 14cm-25cm.

The intended use and the indication for use of KD-512, as described in the

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K102930
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labeling are the same as their predicated device KD-556. While the intended use and the indication for use of KD-712 is the same as its predicated devices KD-738.

# 7.0 Summary comparing technological characteristics with predicate device

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| 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-512 and KD-712 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.
- · EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
- · 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 predicate device and the conclusion

Our device KD-512 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K090963. And KD-712 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-738 whose 510(k) number is K092045.

KD-512 is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time, the display information and the averaging measurement function are different.

KD-712 is very similar with the predicate device KD-738 in the intended use. the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time and the display information are different.

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

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Andon Health Co., Ltd. C/O Mr. Liu Yi, President No. 3 Jinping Street Ya'an Road Nankai District, Tianjin 300190 China

NOV - 3 2010

Re: K102930

Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor, Models: KD-512, KD-712 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: Not Dated Received: October 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, Or to 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. 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 statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Liu Yi

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.

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

NOV - 3 2010

| 510(k) Number : | |
|-----------------|--|
|-----------------|--|

(102930

Device name:

KD-512 and KD-712 Fully Automatic Electronic Blood Pressure Monitor

### Indications for use:

Fully Automatic Electronic Blood Pressure Monitor are for use by KD-512 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.

KD-712 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 wrist. The cuff circumference is limited to 14cm-25cm.

| Prescription use<br>Part 21 CFR 801 Subpart D) | AND/OR Over-The-Counter Use YES<br>(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.A.M.A.T.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K102938

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