KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K080319 · Andon Health Co, Ltd. · DXN · Jul 2, 2008 · Cardiovascular

Device Facts

• Record ID: K080319
• Device Name: KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-591 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 on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.

Device Story

Device is a fully automatic electronic blood pressure monitor for adult use. Input: oscillometric pressure signals from an inflatable cuff wrapped around the left upper arm. Operation: internal pump inflates/deflates cuff; silicon integrated pressure sensor captures signals; electronic module analyzes signals to determine systolic/diastolic blood pressure and pulse rate. Output: results displayed on LCD; device stores 60 measurements with date/time; includes blood pressure level classification. Used in clinical or home settings by professionals or patients. Healthcare providers use output to monitor patient blood pressure trends and inform clinical decisions.

Clinical Evidence

Clinical tests performed in compliance with ANSI/AAMI SP-10-2002 standards. Results met or exceeded accuracy requirements for non-invasive blood pressure measurement.

Technological Characteristics

Oscillometric measurement method; silicon integrated pressure sensor; LCD interface; internal pump for automatic cuff inflation/deflation; cuff size 22-48cm; storage for 60 measurements; blood pressure level classification function.

Indications for Use

Indicated for non-invasive measurement of systolic and diastolic blood pressure and pulse rate in adults. Cuff circumference limited to 22cm-48cm. 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-595 (K070828)

Submission Summary (Full Text)

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510(k) Summary

Submitter:

# K080319

# JUL - 2 2008

### Identification of the submitter:

Telephone number: Fax number: Contact: Date of Application:

Andon Health Co., Ltd. No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-6052 6161 86-22-6052 6162 Liu Yi 30/05/08

## Identification of the product:

Device proprietary Name: KD-591 Fully Automatic Electronic Blood Pressure Monitor Common name: Noninvasive blood pressure measurement systems Noninvasive blood pressure measurement system Classification name: 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-591 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 devices are 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 automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Besides, the devices have the function of blood pressure level classification. And the cuff size is limited to 22-48cm.

#### Intended use:

KD-591 Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic

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blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.

## Comparison of technological characteristics of new device to predicate devices:

KD-591 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 main functions of proposed device is same with the predicated device except for the appearance, lacking voice function and cuff size range, which from 22cm-48cm.

The accuracy and effectiveness of the extra large cuffs used in KD-391 Blood Pressure Monitor has been validated through the ANSI/AAMI SP-10 standard.

### Clinical Tests:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol to the right, resembling a person embracing or supporting another. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL - 2 2008

Andon Health Co., Ltd. c/o Ms. Mona Technology Department No. 31, Changjiang Road, Nankia District, Tianjin P.R. China 300193

Re: K080319

Trade Name: Fully Automatic 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: June 3, 2008 Received: June 11, 2008

Dear Ms. Mona:

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.

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## Pagc 2 - Ms. Mona

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 Fedcral 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 Biometric's (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,

Ashley B. Boan

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 (if known): | K080319 |
|---------------------------|---------|
|---------------------------|---------|

Andon Health Co., Ltd Applicant:

Device name: KD-591 Fully Automatic Electronic Blood Pressure Monitor

### Indications for use:

KD-591 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 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)

Ashlee Boaine fa BDZ

(Division Sign-off)
Division of Cardiovascular Devices
510(k) Number K080319

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