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

Device Description

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.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CONTEC08A Electronic Sphygmomanometer are based on the ANSI/AAMI SP10:2002 & A1:2003 & A2:2006 standard for manual, electronic, or automated sphygmomanometers. While the specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text, the document confirms that "The test results demonstrated that the proposed device comply with the standard requirements and the accuracy the manufacture declared."

Acceptance Criteria (Based on ANSI/AAMI SP10 Standard)	Reported Device Performance
Specific numerical accuracy criteria not provided in the text	Complies with the standard requirements and the accuracy declared by the manufacturer.

2. Sample Size and Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided text.
Data Provenance: The clinical test was conducted in Qinhuangdao Maternal and Child Health Hospital, China. This indicates a prospective clinical study conducted in China.

3. Number of Experts and Qualifications

Not explicitly stated in the provided text. The document mentions "clinical test following ANSI/AAMI SP10," but does not detail the involvement or qualifications of experts in establishing ground truth.

4. Adjudication Method

Not explicitly stated in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The provided text describes a clinical test for an automatic non-invasive blood pressure monitor, not a study evaluating human readers' performance with or without AI assistance.

6. Standalone Performance

Yes, a standalone performance evaluation was conducted. The clinical test evaluated the device's accuracy against the ANSI/AAMI SP10 standard. The device "can automatically complete the inflation, deflation and BP measurement," indicating its standalone capability.

7. Type of Ground Truth Used

The type of ground truth used is implied to be a reference standard for blood pressure measurement, as mandated by the ANSI/AAMI SP10 standard. This standard typically involves comparisons to auscultatory reference measurements performed by trained observers.

8. Sample Size for Training Set

Not applicable. This device is an automatic sphygmomanometer, and the description of its testing focuses on clinical validation rather than a machine learning model that would require a distinct training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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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.
1. 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: +86-335-8015490 Fax: +86-335-8015489 Email: Ixy1011@163.com

1. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
-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.

1. 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.

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.

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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).