AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,

K110156 · Contec Medical System Co., Ltd. · DXN · Jul 27, 2011 · Cardiovascular

Device Facts

• Record ID: K110156
• Device Name: AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
• Applicant: Contec Medical System Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ABPM50 Automatic Blood Pressure Monitor is intended to monitor 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

ABPM50 is a battery-powered, non-invasive automatic blood pressure monitor. It uses an inflatable cuff wrapped around the patient's upper arm to measure systolic, diastolic, and mean blood pressure, plus pulse rate, via the oscillometric technique. The device features internal data storage for measurement time and vital signs, which can be uploaded to a PC via USB for processing. It includes user-configurable physiological alarms for measurement limits and a mandatory technical alarm for low battery voltage (<2.3V). The device is intended for use on adult, pediatric, and neonatal populations. Healthcare providers use the stored data and real-time measurements to assess patient cardiovascular status. The device aids in clinical decision-making by providing automated, repeatable blood pressure monitoring.

Clinical Evidence

Clinical testing was 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 meets the manufacturer-declared accuracy specifications.

Technological Characteristics

Battery-powered, non-invasive oscillometric blood pressure monitor. Features include USB connectivity for PC data transfer, physiological and technical alarm systems, and selectable measurement units (mmHg or kPa). Complies with IEC 60601-1, IEC 60601-1-2, and ANSI/AAMI SP10 standards.

Indications for Use

Indicated for monitoring systolic, diastolic, mean blood pressure, and pulse rate in adult, pediatric, and neonatal patients using non-invasive oscillometric technique with 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

• Accutorr V Monitor (K091068)

Submission Summary (Full Text)

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## JUL 2 7 2011

## Attachment II 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: __________________________________________________________________________________________________________________________________________________

1. Date of Submission: December 27, 2010

- 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 4.

> Proposed Device Name: Automatic Blood Pressure Monitor Proposed Device Model: ABPM50 Classification: Class II Product Code: DXN Regulation Number: 21 CFR 870.1130 Review Panel: Cardiovascular Intended Use Statement:

ABPM50 Automatic Blood Pressure Monitor is intended to monitor the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable

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

- Predicate Device Identification 5.
510(k) Number: K091068 Product Name: Accutorr V Monitor Manufacturer: Datascope Patient Monitoring, Mindray DS USA, Inc.

- Device Description 6.
The proposed device, ABPM50 Automatic Blood Pressure Monitor, is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation 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. ABPM50 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.

ABPM50 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, it has technical alarm function which will be triggered when the battery voltage is lower than 2.3V , 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

The clinical tests following ANSI/AAMI SP10:2002+A1:2003+A2:2006 are conducted on proposed II-2

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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, ABPM50 Automatic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Accutorr V Monitor (K091068), in respect of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.

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 Diana Hong Midlink Consulting Co., Ltd. PO Box 237-023 Shanghai, China 200237

JUL 2 7 2011

Re: K110156

Trade/Device Name: ABPM50 Automatic Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement systems Regulatory Class: Class II (two) Product Code: DXN Dated: July 18, 2011 Received: July 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 (OS) 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.

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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## Attachment III Indications for Use

510(k) Number: K110156

Device Name: Automatic Blood Pressure Monitor, ABPM50

Indications for Use:

ABPM50 Automatic Blood Pressure Monitor is intended to monitor 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) [ ]OVER-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 K//0/56