KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K042418 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · DXN · Mar 21, 2005 · Cardiovascular

Device Facts

• Record ID: K042418
• Device Name: KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

use by medical professionals or at home to monitor and display d 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

Oscillometric blood pressure monitor; uses silicon integrated pressure sensor; internal pump automatically inflates/deflates cuff wrapped around left upper arm. Analyzes pressure signals to determine systolic/diastolic blood pressure and pulse rate. Used by medical professionals or patients at home. Results displayed on LCD; device stores 120 measurements with date/time stamps. Enables patient tracking of physical condition over time.

Clinical Evidence

Bench testing only. Device complied with ANSI/AAMI SP10-1992 accuracy requirements for non-invasive blood pressure monitoring.

Technological Characteristics

Oscillometric measurement; silicon integrated pressure sensor; internal pump; LCD interface; 120-measurement memory. Standards: IEC601-1 (safety), IEC 60602-2-30 (automatic cycling safety), GB9706.1-1995, ISO 1833-1977.

Indications for Use

Indicated for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in adults. 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

• KD-622 (K030358)

Submission Summary (Full Text)

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K042418

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# 510(k) Summary

## 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: | 86-22-60526082 |
| Fax number: | 86-22-60526162 |
| Contact: | Liu Yi |
| Date of Application: | 08/25/04 |

### Identification of the product:

| Device proprietary Name: | KD-575 Memory Automatic Electronic Blood<br>Pressure Monitor |
|--------------------------|-------------------------------------------------------------------------------|
| Common name: | Noninvasive blood pressure measurement 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-622 | Kodon (Tianjin) Electronic and Electrical<br>Apparatus Co., Ltd. | K030358 |

## Device description:

KD-575 Fuily 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. It can storage and show 120 times measuring result with the month, day, time of measuring.

### Intended use:

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use by medical professionals or at home to monitor and display d 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.

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

KD-575 Memory Automatic Electronic Blood Pressure Monitor can storage and show 120 times measuring results with the month, day, time of measuring. It can help patients to memorize the measuring data of their measuring results. Therefore the patients can analyze the measuring data and inspect their physical conditions. The time and the date are the advantages of KD-575 compare with 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:

tests the following standards, including non-clinical coincide 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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Public Health Service

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MAR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042418

Trade/Device Name: KD-575 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 18, 2005 Received: January 21, 2005

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.

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 - Mr. Liu Yi

or any Federal statutes and regulations administered by other Federal agencies. You must or ally Federal statutes and regulations and admited to: registration and listing (21 comply with an the Act 3 requirements, morealing, were and 800 manufacturing as set 80 miles of as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radianon control provisions (Declons of I device as described in your Section 5 10(k) I his letter will anow you to obgin maneting your antial equivalence of your device to a legally premits notification. THC PDA miding of castomination 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 acrive ior your as [phone]. Also, please note the regulation entitled, Contact the Online of Comphane at (210) 21 Top Part 807.97). You may obtain Misoranding by reference to premanteering in the Act from the Division of Small other general informational 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,

Bhimmarfor

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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## Indications for Use

510(k) Number (if known): K042418

Device Name: KD-575 Fully Automatic Electronic Blood Pressure Monitor

Indications For Use:

The KD-575 Memory 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 8.6614 inches to 13.78 inches

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhummer

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042418

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Yes