CONTEC08C 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 individuals.

Device Description

The proposed device, CONTEC08C Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. The device 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. It can be only used on adult 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.

The device has technical alarm function which will be triggered when the battery voltage is lower than 3.7V, and this alarm can not be cancelled unless being closed or the power replaced.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTEC08C Electronic Sphygmomanometer:

The provided document describes the clearance of a non-invasive blood pressure monitor (sphygmomanometer) through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally relies on performance testing against recognized standards rather than extensive clinical efficacy studies typically seen for novel devices.

Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed against the recognized standard ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006. This standard outlines requirements for automatic sphygmomanometers, including accuracy specifications.

Acceptance Criteria (from ANSI/AAMI SP10)	Reported Device Performance
Blood Pressure Accuracy
- Mean difference: ≤ ±5 mmHg	Met standard requirements
- Standard deviation: ≤ 8 mmHg	Met standard requirements
Pulse Rate Accuracy
(Not explicitly stated in provided text, but implied to be met per the standard.)	Met standard requirements
Other safety and performance standards
- IEC 60601-1: 1988 +A1: 1991 +A2: 1995 (General safety)	Complies with standard
- IEC 60601-1-2: 2007 (EMC)	Complies with standard

Note: The provided text states that "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: ... ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006." While it confirms compliance, specific numerical performance results (e.g., the exact mean difference and standard deviation achieved) are not detailed in this summary. However, meeting ANSI/AAMI SP10 implicitly means meeting its accuracy requirements for blood pressure (mean difference ≤ ±5 mmHg and standard deviation ≤ 8 mmHg).

Study Details

Given the nature of a 510(k) for a sphygmomanometer tested against ANSI/AAMI SP10, the "study" referred to is a specific blood pressure accuracy validation protocol as defined by that standard.

Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of subjects (the sample size) used for the blood pressure accuracy testing according to ANSI/AAMI SP10. The standard itself specifies minimum subject requirements for various test phases (e.g., 85 subjects for the clinical validation of accuracy).
- Data Provenance: The document states that "Bench tests were conducted." The sponsor and submission correspondent are based in China (CONTEC MEDICAL SYSTEMS CO., LTD and Mid-Link Consulting Co., Ltd.), which suggests the testing was likely conducted in China. The data is prospective, meaning it was collected specifically for the purpose of validating the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For blood pressure validation, the "ground truth" is typically established by trained observers (auscultators) using a mercury sphygmomanometer or validated reference device according to a standardized protocol. ANSI/AAMI SP10 requires at least two trained observers to simultaneously obtain reference blood pressure measurements.
- Qualifications of experts: These observers must be specifically trained and certified as competent in auscultatory blood pressure measurement. While the document doesn't detail their specific qualifications, compliance with ANSI/AAMI SP10 implies that appropriately qualified personnel were used.
Adjudication method for the test set:
- ANSI/AAMI SP10 specifies an adjudication method for observer differences. Typically, if the two observers' readings differ by more than a predefined amount (e.g., 4 mmHg), a third observer or a re-measurement may be required, or the data point may be discarded. The exact protocol would follow the standard.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an automatic electronic sphygmomanometer and does not involve "human readers" interpreting images or data with or without AI assistance in the way an MRMC study would apply. Its function is to provide direct measurements. Therefore, an MRMC comparative effectiveness study was not performed and is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the primary testing described is a standalone performance test of the device. The device's algorithm (oscillometric technique) measures blood pressure automatically without human input during the measurement phase. The "bench tests" and compliance with ANSI/AAMI SP10 are evaluations of this standalone performance.
The type of ground truth used:
- For blood pressure devices, the ground truth is expert auscultatory measurements (or another validated reference method) conducted concurrently with the device measurements on human subjects, as dictated by the ANSI/AAMI SP10 standard.
The sample size for the training set:
- The document does not refer to a distinct "training set" for an algorithm to be learned or optimized in the sense of machine learning. The device utilizes an oscillometric algorithm which is a well-established technique for blood pressure measurement. Any internal calibration or algorithm refinement by the manufacturer would have been part of the device's design and development, not typically described as a "training set" in a 510(k) summary for such a device. The testing described is validation of the final device.
How the ground truth for the training set was established:
- As there is no "training set" explicitly mentioned or applicable in the context of an AI/machine learning model as typically discussed, this question is not relevant to the provided information. The device's underlying algorithm is based on established oscillometric principles rather than a data-driven "training" process from a ground truth dataset in the AI sense.

Summary

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Section III 510(k) Summarv

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

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: lxy1011@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 4.

Proposed Device Name: Electronic Sphygmomanometer Proposed Device Model: CONTEC08C Classification: Class II Product Code: DXN Regulation Number: 21 CFR 870.1130 Review Panel: Cardiovascular Intended Use Statement:

CONTEC08C 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

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Project #: MIDLINK0032011Aa

cuff is wrapped around the upper arm. It can be used on adult individuals.

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

6. Device Description

The device has technical alarm function which will be triggered when the battery voltage is lower than 3.7V, and this alarm can not be cancelled unless being closed or the power replaced.

7. Test Conclusion

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

Substantially Equivalent Conclusion 8.

The proposed device, CONTEC08C Electronic Sphygmomanometer, is determined to be III-2

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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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

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

Re: K110775

Trade/Device Name: Electronic Sphygmomanometer, CONTEC08C 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/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,

Bryan 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

K110775 510(k) Number: Device Name: Electronic Sphygmomanometer, CONTEC08C

Indications for Use:

�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)

Signature

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

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).