KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR

K052450 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · DXN · Feb 28, 2006 · Cardiovascular

Device Facts

• Record ID: K052450
• Device Name: KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-788 Wrist Measurement 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 writt according to the instruction in the user's guide manual.

Device Story

Wrist-worn non-invasive blood pressure monitor; utilizes oscillometric measurement method with silicon integrated pressure sensor; internal pump automatically inflates/deflates wrist cuff. Device processes pressure signals to calculate systolic/diastolic blood pressure and pulse rate. Results displayed on LCD interface; includes memory storage for 4 groups of 30 records with timestamp. Used by medical professionals or patients at home. Output informs clinical decision-making regarding hypertension management and cardiovascular monitoring.

Clinical Evidence

Clinical testing performed to verify accuracy against ANSI/AAMI SP10-1992 requirements. Results met or exceeded specified accuracy standards.

Technological Characteristics

Oscillometric measurement; silicon integrated pressure sensor; internal pump; LCD interface; wrist cuff (6.1023-9.8425 inch circumference). Standards: IEC 60601-1 (1988) safety, IEC 60601-2-30 (1995) automatic cycling safety, GB9706.1-1995, ISO 1833-1977. Electromagnetic compatibility testing performed.

Indications for Use

Indicated for use by medical professionals or at home to measure diastolic, systolic blood pressure, and pulse rate in adults. Contraindicated for infants and unconscious individuals. Cuff circumference range: 6.1023 to 9.8425 inches.

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-726 (K030359)

Submission Summary (Full Text)

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K052450
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#### 510(k) Summary FEB 2 8 2006

## Identification 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: | 86-22-6052 6082 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 08/08/2005 |

#### Identification of the product:

| Device proprietary Name: | KD-788 Wrist Measurement 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 |
|--------|--------------------------------------------------------|---------------|
| KD-726 | Kodon (Tianjin) Electronic and<br>Electrical Co., Ltd. | K030359 |

## Device description:

KD-788 Wrist Measurement 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 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 infernal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can divide into 4 groups and record 30 memory each group with the month, day and time of measuring.

#### Intended use:

KD-788 Wrist Measurement Automatic Electronic Blood Pressure Monitor is

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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 writt according to the instruction in the user's guide manual.

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

The design of KD-788 Wrist Measurement 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 ANSIIAAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.

#### Non-clinical Tests:

non-clinical tests All coincide the following standards, including 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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping lines or stripes, creating an abstract design. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2006

Kodon (Tianjin) Electronic & Apparatus Co., LTD c/o Mr. Liu Yi No 31, Chiangjiang Road Nankai District, Tianjin P.R. CHINA, 300193

Re: K052450

Trade Name: KD-788 Wrist Measurement Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR § 870.1130 Regulation Name: Noninvasive Blood Measurement System Monitor Regulatory Class: II (two) Product Code: DXN Dated: January 30, 2006 Received: January 30, 2006

Dear Mr. Yi :

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assession 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). and obsinctive fore, 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 adultcration.

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 r least of advised that i Drives and over device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must or any ireded statutes and regulations assimments, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements) nierally, sood manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (events (everiled in your Section 510(k) This letter will anow you to begin hantening of substantial equivalence of your device to a legally premits tourneation. The PDF Intellig of cation 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 If you desire specific acries for Jour as 1) 276-0120. Also, please note the regulation entitled, Colliable of Compuner and the the the time to the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Rimmmer 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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K052450

# Indications for Use

510(k) number:

Device name: KD-788 Wrist Measurement Automatic Electronic Blood Pressure Monitor

#### Indications for use:

The KD-788 Wrist Measurement 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 _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-counter Use YES

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Blumenthal