KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K070395 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · DXN · Jun 7, 2007 · Cardiovascular

Device Facts

• Record ID: K070395
• Device Name: KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-525E 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

Device is a non-invasive, fully automatic electronic blood pressure monitor. Input: pressure signals from an inflatable cuff wrapped around the left upper arm. Operation: internal pump automatically inflates/deflates cuff; silicon integrated pressure sensor captures oscillometric signals; electronic interface module analyzes signals to calculate systolic/diastolic blood pressure and pulse rate. Output: results displayed on an LCD screen. Used by medical professionals or patients at home. Provides objective blood pressure and pulse rate data to assist in clinical monitoring and health management.

Clinical Evidence

Clinical testing performed to verify accuracy against ANSI/AAMI SP10-2002 standards. Results met or exceeded accuracy requirements. Non-clinical testing included electromagnetic compatibility (IEC 60601-1-2:2001), basic safety/performance (IEC 60601-1:1998+A1:1991+A2:1995), and biocompatibility (ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation/hypersensitivity).

Technological Characteristics

Oscillometric measurement principle using silicon integrated pressure sensor. Features automatic inflation pump. Form factor: upper arm cuff (22-30cm). Connectivity: none (standalone). Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10. Software: embedded electronic interface module for signal analysis.

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 (22cm-30cm circumference). 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)

{0}------------------------------------------------

K070395

# 510(k) Summary

JUN - 7 2007

### ldentification of the submitter:

Kodon (Tianjin) Electronic & Electrical Apparatus Submitter: Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 Telephone number: 86-22-6052 8012 86-22-6052 6162 Fax number: Liu Yi Contact: Date of Application: 29/01/07

## Identification of the product:

| Device proprietary Name: | KD-525E Fully Automatic Electronic Blood |
|--------------------------|-------------------------------------------------------------------------------|
| | 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-622 | Kodon (Tianjin) Electronic and Electrical<br>Apparatus Co., Ltd. | K030358 |

## Device description:

KD-525E 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 device 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.

Page 1 of 2

{1}------------------------------------------------

#### Intended use:

KD-525E 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.

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

KD-525E Fully Automatic Electronic Blood Pressure Monitor is the basic of KD-622 Memory Automatic blood pressure monitor. KD-525E has a bump to inflate automatically. Comparing with KD-622 memory automatic blood pressure monitor, KD-525E has no memory function.

#### 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.

#### Non-clinical Tests:

non-clinical tests coincide the following standards, including All Electromagnetic Compatibility test, Product Safety test and Biocompatibility test.

#### IEC601-1-2: 2001

Medical electrical equipment-----Part 1-2:General requirements for safety; Collateral standards: Electromagnetic compatibility; Requirements and test.

#### IEC60601-1: 1998+A1:1991+A2:1995

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

#### ISO 10993-5

Biological evaluation of medical device --- part 5: Test for in vitro cytotoxicity.

#### ISO 10993-10

Biological evaluation of medical device --- part 10: Tests for irritation and delayed type hypersensitivity.

Page 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of three stylized human figures. The figures are interconnected, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2007

Kondon (Tianiin) Electonic & Electrical Apparatus Co., LTD c/o Mr. Liu Yi President of the Board of Directors, No. 31 Changjiang Road, Tianjin, PR CHINA 3000193

Re: K070395

KD-525E Fully 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: May 21, 2007 Received: May 21, 2007

#### 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.

{3}------------------------------------------------

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/industry/support/index.html.

Sincerely yours,

Bhimimor for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Statement of Indications for Use

510(k) Number ( if known): _

KD702395

Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD Applicant:

KD-525E Fully Automatic Electronic Blood Pressure Device name: Monitor

#### Indications for use:

KD-525E 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-30cm.

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)

Bhummer

ular Devices 101k) Number

Page 1 of