FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930

K101950 · Andon Health Co, Ltd. · DXN · Aug 31, 2010 · Cardiovascular

Device Facts

• Record ID: K101950
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-930 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 inflatable upper arm cuff (22-48cm). Operates via oscillometric method and silicon integration pressure sensor technology. Calculates systolic/diastolic blood pressure and pulse rate; includes blood pressure classification indicator, irregular heartbeat detection, and average of last three measurements. Used by medical professionals or patients at home. Output displayed to user; assists in monitoring cardiovascular health. Differences from predicate include lack of LCD, different MCU, and memory capacity.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1, IEC 60601-1-1, EN 60601-1-2, and AAMI/ANSI SP10:2002/A1:2003/A2:2006 standards for safety, electromagnetic compatibility, and performance of automated sphygmomanometers.

Technological Characteristics

Oscillometric measurement; silicon integration pressure sensor. Upper arm cuff (22-48cm). Standards: ANSI/AAMI SP10, IEC 60601-1, EN 60601-1-2. Electrical safety and EMC compliant. 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-556 Fully Automatic Electronic Blood Pressure Monitor (K090963)

Submission Summary (Full Text)

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101950

# 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

AUG 3 1 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: | 06/25/2010 |

#### 2.0 Device information

| Trade name: | KD-930 Fully Automatic Electronic Blood Pressure<br>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

Manufacturer: Andon Health Co., Ltd. Device: KD-556 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K090963

#### 5.0 Device description

KD-930 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.

ર- I

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

The operational principle is based on oscillometric method and silicon integration pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified and displayed by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown on to the user. More over, it can also calculate the average of the last three measurements.

### 6.0 Intended use

KD-930 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-930, as described in its labeling are the same as the predicate device KD-556.

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Similar |
| 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-930 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.
- 60601-1, Medical Electrical Equipment Part 1: General . UL Requirements for Safety, 2003.
- · IEC 60601-1-1, Medical Electrical Equipment Part 1: General Requirements for Safety - 1. Collateral standard: Safety Requirements for Medical Electrical Systems, 2000.
- · 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-930 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.

The two devices are very similar in the intended use, the design principle, the material, the performance and the applicable standards. Their appearance, memory times, energy source and MCU are different. KD-930 does not contain a LCD, which is different from the predicate device. Their temperature of operational parameter is also changed.

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/0 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

i

AUG 31 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: K101950

Trade/Device Name: KD-930 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: August 12, 2010 Received: August 13, 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 Fedral 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, isting 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 devil (1 in be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, EDA 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/CDRHQffices/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.

M. A. William

for 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 :

AUG 3 1 2010

Device name: KD-930 Fully Automatic Electronic Blood Pressure Monitor

### Indications for use:

KD-930 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 armative cuff circumference is limited to 22cm-48cm.

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR 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)

M. A. Willelmen

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number_K101950