ELECTRONIC SPHYGMOMANOMETER

K110774 · Contec Medical System Co., Ltd. · DXN · May 13, 2011 · Cardiovascular

Device Facts

• Record ID: K110774
• Device Name: ELECTRONIC SPHYGMOMANOMETER
• Applicant: Contec Medical System Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

CONTECO8A Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

Device Story

CONTEC08A is a battery-powered, automatic non-invasive blood pressure monitor; utilizes oscillometric technique via upper-arm cuff to measure systolic, diastolic, mean blood pressure, and pulse rate. Device performs automated inflation and deflation. Features include data storage for measurement history (time, BP, pulse) and user-configurable physiological alarms for out-of-limit readings; technical alarm triggers for low battery (<3.9V). Data can be uploaded to a PC via USB for review using proprietary software. Used in clinical or home settings; operated by clinicians or patients. Provides objective BP and pulse metrics to assist healthcare providers in monitoring patient cardiovascular status.

Clinical Evidence

Clinical testing conducted at Qinhuangdao Maternal and Child Health Hospital following ANSI/AAMI SP10:2002+A1:2003+A2:2006 standards. Results demonstrated that the device complies with standard requirements and the manufacturer-declared accuracy specifications.

Technological Characteristics

Battery-powered, automatic oscillometric blood pressure monitor. Features USB connectivity for PC data transfer. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ANSI/AAMI SP10 (performance). Supports measurement units in mmHg or kPa. Includes physiological and technical alarm systems.

Indications for Use

Indicated for adult, pediatric, and neonatal patients for non-invasive measurement of systolic, diastolic, and mean blood pressure and pulse rate using an upper-arm cuff.

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

• Blood Pressure Monitor, MD200A (K093013)

Submission Summary (Full Text)

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Premarket Notification 510(k) Submission Section III 510(k) Summary Project #: MIDLINK0032011Aa

### 1 3 2011 MAY

#### Section III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

- Date of Submission: February, 15, 2011 l.
- 2. Sponsor

CONTEC MEDICAL SYSTEMS CO., LTD NO.24 Huanghe West Road, Economic &Technical Development Zone, Qinhuangdao, Hebei Province, 066004,China Establishment Registration Number: 3006979678 Contact Person: Xueyong Li Position: Quality Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
- -Proposed-Device-Identification-

Proposed Device Name: Electronic Sphygmomanometer Proposed Device Model: CONTEC08A Classification: Class II Product Code: DXN Regulation Number: 21 CFR 870.1130 Review Panel: Cardiovascular Intended Use Statement:

CONTEC08A Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an

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inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

- 5. Predicate Device Identification
510(k) Number: K093013 Product Name: Blood Pressure Monitor, MD200A Manufacturer: Beijing Choice Electronic Technology Co., Ltd

- Device Description 6.
The proposed device, CONTEC08A Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation, deflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can be used on adult, pediatric, and neonatal individuals.

The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.

CONTEC08A has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, the device has technical alarm function which will be triggered when the battery voltage is lower than 3.9V, and this alarm can not be cancelled unless being closed or the power replaced.

- Test Conclusion 7.
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1: 1988 +A1: 1991 +A2: 1995, Medical Electrical Equipment - Part 1: General requirements for safety.

IEC 60601-1-2: 2007, Medical Electrical Equipment – Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.

ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006 , Manual, electronic, or automated sphygmomanometers

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The clinical test following ANSI/AAMI SP10:2002+A1:2003+A2:2006 is conducted on proposed device in Qinhuangdao Maternal and Child Health Hospital. The test results demonstrated that the proposed device comply with the standard requirements and the accuracy the manufacture declared.

8. Substantially Equivalent Conclusion

The proposed device, CONTEC08A Electronic Sphygmomanometer, is determined to be Substantially Equivalent (SE) to the predicate device, Blood Pressure Monitor MD200A (K093013), in respect of safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Contec Medical Systems Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 CHINA

MAY 1 3 2011

K110774 Re:

> Trade/Device Name: Electronic Sphygmomanometer, CONTEC08A Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: March 18, 2011 Received: March 21, 2011

Dear Ms. Hong:

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 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 - Ms. Diana Hong

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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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# Section II Indications for Use

K110774 510(k) Number: Device Name: Electronic Sphygmomanometer, CONTEC08A

Indications for Use:

CONTECO8A Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

�PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

**Division of Cardiovascular Devices**

510(k) Number K110774