KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K030359 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · DXN · Nov 6, 2003 · Cardiovascular

Device Facts

• Record ID: K030359
• Device Name: KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-726 Memory Wrist 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 anyone each time, except infants and unconscious people, with an air cuff buckled around one's wrist according to the instruction in the user's guide manual.

Device Story

Non-invasive blood pressure monitor; uses oscillometric method with silicon integrated pressure sensor. Input: pressure signals from wrist-worn inflatable cuff. Processing: internal electronic interface module analyzes signals to calculate systolic/diastolic blood pressure and pulse rate. Output: results displayed on LCD; device stores data in memory. Used by medical professionals or patients at home. Provides objective blood pressure/pulse data to assist in health monitoring.

Clinical Evidence

Clinical testing performed in compliance with ANSI/AAMI SP10-1992 accuracy requirements. Results met or exceeded specified accuracy standards.

Technological Characteristics

Oscillometric measurement; silicon integrated pressure sensor; internal pump for automatic cuff inflation/deflation; LCD interface; wrist-worn form factor. Standards: IEC601-1 (1988), IEC 60602-2-30: 1995, GB9706.1-1995, ISO 1833-1977. Electromagnetic compatibility testing performed.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via non-invasive wrist cuff (circumference 6.1023-9.8425 inches). Contraindicated for infants and unconscious individuals.

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

• HEM-630 (K001671)

Submission Summary (Full Text)

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K030359

510k document for KD-726 Memory Wrist Automatic Electronic Blood Pressure Mor

# NOV - 6 2003

# 510(k) Summary

## ldentification of the submitter:

| Submitter: | Kodon (Tianjin) Electronic & Electrical Apparatus<br>Co., LTD<br>No 31, Changjiang Road, Nankai District, Tianjin,<br>P.R. China, 300193 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone number: | 86-22-27470070 |
| Fax number: | 86-22-27371293 |
| Contact: | Liu Yi |
| Date of Application: | 01/28/2003 |

### ldentification of the product:

| Device proprietary Name: | KD-726 Memory Wrist Automatic Electronic Blood<br>Pressure Monitor | | | | |
|--------------------------|-------------------------------------------------------------------------------|--|--|--|--|
| Common name: | Noninvasive blood pressure measurement<br>systems | | | | |
| Classification name: | Noninvasive blood pressure measurement system<br>Class II per 21 CFR 870.1130 | | | | |

### Marketed Devices to which equivalence is claimed:

| Device | manufacture | 510(k) number |
|---------|------------------------|---------------|
| HEM-630 | OMRON HEALTHCARE, INC. | K001671 |

### Device description:

KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist 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.

### Intended use:

KD-726 Memory Wrist 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 anyone each time, except

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infants and unconscious people, with an air cuff buckled around one's wrist according to the instruction in the user's guide manual.

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

The design of KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor utilizes Oscilliometric measurement method, with an electronic interface module and a silicon integrate pressure sensor and a air cuff automatically inflated and released by an internal pump over the wrist to obtain blood pressure signals in the same manner as the predicate device.

### Clinical Tests:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.

### Non-clinical Tests:

non-clinical tests coincide the following standards, including All Electromagnetic Compatibility test.

IEC601-1 (1988)

Medical electrical equipment-----Part 1:General requirements for safety IEC601-1 (1988)

Amendment 2

IEC 60602-2-30: 1995

Medical electrical equipment-part2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. GB9706.1-1995 ISO 1833-1977

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2003

Kondon (Tianjin) Electronic & Electrical Apparatus Co., Ltd. c/o Mr. Liu Yi Presdient, Board of Directors No. 31. Changjiang Road Nankai District Tianjin CHINA 300193

## Re: K030359

Trade Name: KD-726 Memory Wrist 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: September 22, 2003 Received: September 22, 2003

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 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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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); 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

cmeyar moye

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

| Applicant: | Kondon (Tianjin) Electronic & Electrical Apparatus Co., LTD |
|----------------|-----------------------------------------------------------------|
| 510(k) number: | K030359 |
| Device name: | KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor |

## Indications for use:

The KD-726 Memory Wrist 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.

## Marta Mayer for BDZ

**Author Sign on**

510(k) Number K030354