FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903

K092811 · Andon Health Co, Ltd. · DXN · Jan 13, 2010 · Cardiovascular

Device Facts

• Record ID: K092811
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-7035B, KD-7921 and KD-7903 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 to 25cm.

Device Story

Non-invasive blood pressure monitor; uses oscillometric technology with silicon integrated pressure sensors; measures systolic/diastolic blood pressure and pulse rate. Input: pressure signals from inflatable wrist cuff (14-25cm). Output: digital display of BP and pulse on LCD; some models include irregular heartbeat (IHB) detection and blood pressure classification indicators. Used by medical professionals or patients at home. Device processes signals via internal MCU; provides immediate feedback to user for health monitoring. Benefits: enables convenient, non-invasive self-monitoring of cardiovascular parameters.

Clinical Evidence

Bench testing only. Device performance validated against AAMI SP10:2002 standards for manual, electronic, or automated sphygmomanometers, including amendments A1:2003 and A2:2006. Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) confirmed.

Technological Characteristics

Oscillometric measurement principle; silicon integrated pressure sensor; LCD interface. Powered by internal energy source. Cuff circumference 14-25cm. Standards: ANSI/AAMI SP10, IEC 60601-1, IEC 60601-1-2. Memory capacity varies by model (2x60, 60, or 3x40).

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via a non-invasive wrist-worn inflatable cuff (14cm-25cm 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-738 Fully Automatic Electronic Blood Pressure Monitor (K092045)

Submission Summary (Full Text)

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# Kn92811 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 1 3 2010

| Name: | Andon Health Co., Ltd. |
|----------------------|-----------------------------------------------------------------|
| Address: | No 31, Changjiang Road, Nankai District, Tianjin,<br>P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 09/04/2009 |

#### 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 Cardiovascular Panel:

#### 4.0 Predict device information

Andon Health Co., Ltd. Manufacturer: KD-738 Fully Automatic Electronic Blood Pressure Monitor Device: k092045 510(k) number:

#### 5.0 Device description

KD-7035B, KD-7921 and KD-7903 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.

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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 of KD-7035B can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-7035B, KD-7921 and KD-7903 are 2 × 60 times, 60 times and 3 × 40 times. If any irregular heartbeat is detected, it can be shown on the LCD of KD-7035B and KD-7921.

# 6.0 Intended use

KD-7035B, KD-7921 and KD-7903 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 to 25cm.

The intended use and the indication for use of KD-7035B, KD-7921 and KD-7903, as described in its labeling are the same as the predict device KD-738.

| 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 |

# 7.0 Summary comparing technological characteristics with predicate device

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# 8.0 Performance summary

KD-7035B, KD-7921 and KD-7903 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 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-7035B, KD-7921 and KD-7903 Fully Automatic Electronic J Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-738 whose 510(k) number is K092045.

KD-7035B and KD-738 are very similar in the design principle, the material, the energy source and the applicable standards. Their cuff circumference are different, their appearance are different. As regard to functions, KD-7035B has 2 × 60 times memory, the averaging of the last 3 times memory and LCD backlight. The MCU of KD-7035B is different from the predicted device KD-738.

KD-7921 and KD-738 are very similar in the design principle, the material, the energy source, the functions and the applicable standards. Their cuff circumference are different, their appearance are different. The MCU of KD-7921 is different from the predicted device KD-738.

KD-7903 and KD-738 are very similar in the design principle, the material, the energy source, the functions and the applicable standards. Their cuff circumference are different, their appearance are different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-738. KD-7903 and KD-738 also has different MCU. KD-7903 has a memory of 3 × 40 times. KD-7903 didn't have a blood pressure

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4/4

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classification function and a IHB detection function.

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/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

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

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

JAN 1 3 2010

Re: K092811

Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitors, Models KD-7035B, KD-7921 and KD-7903. 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 15 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/ucm1.15809.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,

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

SEP 1 4 2009

| <b>510(k) Number :</b> | K092811 | Received |
|------------------------|------------------------------------------------------------------------------------|----------|
| <b>Device name:</b> | KD-7035B, KD-7921 and KD-7903 Fully Automatic<br>Electronic Blood Pressure Monitor | |

## Indications for use:

KD-7035B, KD-7921 and KD-7903 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 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)

Rambler

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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number |69281|