KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K030358 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · DXN · Oct 31, 2003 · Cardiovascular

Device Facts

• Record ID: K030358
• Device Name: KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-622 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 anyone each time, except infants and unconscious people, with the air cuff around the left upper arm according to the instruction in the user's guide manual.

Device Story

KD-622 is a non-invasive, fully automatic electronic blood pressure monitor. It uses an inflatable cuff wrapped around the left upper arm (1-2cm above elbow) to capture blood pressure signals via a silicon integrated pressure sensor. An internal pump automatically inflates and releases the cuff. The device employs oscillometric technology to analyze signals and calculate systolic/diastolic blood pressure and pulse rate. Results are displayed on an integrated LCD screen; the device includes memory for data storage. Intended for use by medical professionals or patients at home. It provides objective blood pressure and pulse rate data to assist in monitoring cardiovascular health.

Clinical Evidence

Clinical testing performed to verify accuracy against ANSI/AAMI SP10-1992 standards. Results met or exceeded accuracy requirements. No specific sample size or statistical metrics (e.g., mean error, SD) provided in the summary.

Technological Characteristics

Oscillometric measurement method; silicon integrated pressure sensor; internal pump for automatic cuff inflation/deflation; LCD display; electronic interface module. Complies with IEC 60601-1, IEC 60601-2-30, and GB9706.1 standards. Standalone device.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via non-invasive oscillometric technique using an upper arm cuff (circumference 8.66-13.78 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-757 (K001670)

Submission Summary (Full Text)

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K030358

page 4

# OCT 3 1 2003

## 510(k) Summarv

## 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 |

## Identification of the product:

| Device proprietary Name: KD-622 Fully Automatic Electronic Blood Pressure<br>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-757 | OMRON HEALTHCARE, INC. | K001670 |

### Device description:

KD-622 Fully 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. Swathing the air cuff around the left upper arm 1-2cm above elbow joint 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-622 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 anyone each time, except infants and

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K030358

unconscious people, with the air 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:

The design of KD-622 Fully 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 left upper arm 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:

the non-clinical tests coincide 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/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2003

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

Re: K030358

Trade Name: KD-622 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1300 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,

Dna Heuskin 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

| Applicant: | Kondon (Tianjin) Electronic & Electrical Apparatus Co., LTD |
|----------------|-------------------------------------------------------------|
| 510(k) number: | K030358 |
| Device name: | KD-622 Fully Automatic Electronic Blood Pressure Monitor |

#### Indications for use:

The KD-622 Fully 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 8.6614 inches to 13.78 inches.

Dia Heenhe

(Division Sign-Off)
Division of Cardio

**510(k) Number** K02