FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902

K083317 · Andon Health Co, Ltd. · DXN · Jan 29, 2009 · Cardiovascular

Device Facts

• Record ID: K083317
• Device Name: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-5902 Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the left upper arm according to the instruction in the user's quide manual, which is same as predicated device.

Device Story

Non-invasive blood pressure monitor; uses oscillometric method and silicon integrated pressure sensor. Input: pressure signals from inflatable cuff (22cm-48cm) wrapped around left upper arm. Processing: electronic interface module analyzes signals to calculate systolic/diastolic blood pressure and pulse rate. Output: results displayed on LCD; includes blood pressure classification indicator; voice output feature; stores 60 measurements with time/date. Used by medical professionals or patients at home. Provides objective data for clinical decision-making; assists in monitoring cardiovascular health.

Clinical Evidence

Bench testing only. Device demonstrated compliance with ANSI/AAMI SP-10, EN60601-1 (General safety), and EN60601-1-2 (Electromagnetic Compatibility). No clinical study data provided.

Technological Characteristics

Oscillometric measurement method; silicon integrated pressure sensor; LCD interface; voice output; cuff circumference 22cm-48cm. Powered by electrical energy. Standards met: ANSI/AAMI SP-10, EN60601-1, EN60601-1-2.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate using a non-invasive inflatable cuff (22cm-48cm circumference) on the upper arm. 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-595 Andon Health Co., Ltd (K070828)

Submission Summary (Full Text)

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# 510(k) Summary

#### ldentification of the submitter:

JAN 2 9 2009

083317

Submitter: Andon Health Co., Ltd. No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-6052 6161 Telephone number: Fax number: 86-22-6052 6162 Contact: Liu Yi Date of Application: 10/29/08

### Identification of the product:

Device proprietary Name: Fully Automatic Electronic Blood Pressure Monitor Common name: Noninvasive blood pressure measurement systems Classification name: Noninvasive blood pressure measurement system Class II per 21 CFR 870.1130

### Marketed Devices to which equivalence is claimed:

Device manufacture 510(k) number KD-595 Andon Health Co., Ltd K070828

#### Device description:

KD-5902 Fully Automatic Electronic Blood Pressure Monitor is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm, the device can analyze the signals promptly and display the test results. It can storage and show 60 times measuring result with the day and time. Specially, it can speak them out. Besides, KD-5902 has the function of blood pressure classification indicator.

#### Intended use:

KD-5902 Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the left upper arm according to the instruction in the user's quide manual, which is

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same as predicated device.

## Summary comparing technological characteristics with predicate device:

KD-5902 Fully Automatic Electronic Blood Pressure Monitor has the same principle with predicated device, which utilizes Oscilliometric measurement method to monitor the blood pressure and the result can be shown on the LCD.

The modifications that were made are:

JAN 2 9 2009

- 1. Appearance
- 2. Cuff size change into 22cm-48cm from 22cm-30cm.

Please find the following tabulated comparison supporting that the proposed device is substantially equivalent to the predicated device.

| FDA file reference number | 510K# K070828 |
|-------------------------------|-------------------|
| Technological Characteristics | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Identical |
| Sterility | Not Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Energy used and/or delivered | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |

#### Device testing:

KD-5902 Fully Automatic Electronic Blood Pressure Monitor meets the following standards:

- ANSI/AAMI SP-10 standard
- EN60601-1 Medical electrical equipment Part 1: General requirements for safety
- EN60601-1-2 Electromagnetic Compatibility

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a simple, vectorized design.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2009

Andon Health Co., Ltd. c/o Ms. Liu Yi No 31, Changjiang Road, Nankai District, Tianiin, P.R. China, 300193

Re: K083317

Trade/Device Name: KD-5902 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: December 19, 2008 Received: December 29, 2008

Dear Ms. 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 such 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

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#### Page 2 - Ms. Liu Yi

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

h

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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SIOK submission for KD-5902 Fully Automatic Electronic Blood Pressure Monitor

# Statement of Indications for Use

| 510(k) Number : | K083317 |
|-----------------|---------|
|-----------------|---------|

Applicant: Andon Health Co., Ltd

Device name:

## KD-5902 Fully Automatic Electronic Blood Pressure Monitor

#### Indications for use:

KD-5902 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.

Prescription use Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

YES

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(Please DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of GDRH, Office of Device Evaluation (ODE)

(Division (Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko833377

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