FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961

K090769 · Andon Health Co, Ltd. · DXN · Jun 4, 2009 · Cardiovascular

Device Facts

• Record ID: K090769
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-7961 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 6.1023 inches to 9.8425 inches.

Device Story

Non-invasive blood pressure monitor; uses inflatable wrist cuff (6.1023-9.8425 inches). Operates via oscillometric principle with silicon integrated pressure sensor. Measures systolic/diastolic blood pressure and pulse rate (40-180 bpm). Features include irregular heartbeat detection, 60-reading memory, LCD display with backlight, touch buttons, and voice function. Used by medical professionals or patients at home. Output displayed on LCD; assists clinicians and 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 provided.

Technological Characteristics

Oscillometric measurement; silicon integrated pressure sensor. Wrist-worn form factor. Powered by internal energy source. Complies with ANSI/AAMI SP10, IEC 60601-1, and IEC 60601-1-2. Features LCD interface, voice function, and irregular heartbeat detection.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via non-invasive wrist-cuff oscillometric technique. 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-795 Fully Automatic Electronic Blood Pressure Monitor (K070826)

Submission Summary (Full Text)

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K090769

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMBA @DRAID MER 807.92.

JUN - 4 2009

#### 1.0 submitter's information

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: 03/16/2009

#### 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: = Panel: Cardiovascular

#### 4.0 Predict device information

Manufacturer: Andon Health Co., Ltd. KD-795 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K070826

#### 5.0 Device description

KD-7961 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 6.1023 inches to 9.8425 inches.

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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 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. The LCD backlight, the touch key button and the voice function make it more convenient to use.

#### 6.0 Intended use

KD-7961 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 6.1023 inches to 9.8425 inches.

The intended use and the indication for use of KD-7961, as described in its labeling are the same as the predict device KD-795.

### 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-7961 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.
- 0 IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requiremants for Safety - Collateral standard: Electromagnetic Compalibirity - 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-7961 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-795 whose 510(k) number is K070826.

The two devices are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance and some functions such as touch button and LCD backlight are different. The Environmental parameters are changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min.

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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2009

Andon Health Co., Ltd. c/o Mr. Liu Yi No 31 Changjiang Road Nankai District, Tianjin China 300193

Re: K090769

Trade/Device Name: KD-7961 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: undated Received: May 7. 2009

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours.

Thathster

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 : | k090769 |
|-----------------|-----------------------------------------------------------|
| Device name: | KD-7961 Fully Automatic Electronic Blood Pressure Monitor |

#### Indications for use:

KD-7961 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 6.1023 inches to 9.8425 inches.

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 øf Device Evaluation (ODE)

Hthlsk /s BZuckeru

(Division Sign-Off) 6/4/09
Division of Cardiovascular Devices

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