The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper.

The product is not a conventional diagnostic tool.

Device Description

This product is single channel, standard 12 leads electrocardiograph ,can be widely applied in ECG check-up under different circumstances such as in family ,hospital consultation, doctor's diagnosis, physical check-up, social medical organizations etc. it can implement real time continuous records of clear and exact single-channel ECG waveform using thermo sensitive printer at the same time. waveforms also can be freezed at any time. it has manual and automatic modes to be chosen and Chinese/English operation interface, it is easy to be used.

AI/ML Overview

The provided text is a 510(k) summary for the Contec Medical Systems Co., Ltd. ECG80A Single-Channel Handheld Electrocardiograph. This document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and technical specifications. Unfortunately, it does not contain the detailed information necessary to answer the questions about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert involvement as requested.

The document states: "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications." However, it does not provide the details of these design specifications as acceptance criteria or the performance results against them.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, expert involvement, and ground truth in detail based solely on the provided text.

The information that can be extracted and inferred is limited:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. The document broadly mentions "met all design specifications, including electrical safety, EMC, specifications."
Reported Device Performance: Not explicitly stated in terms of specific metrics against criteria. The conclusion is that the device "is substantially equivalent (SE) to the predicate device Cardiette microtel (K082124) and CARDIOLINE AR1200 (K051534)."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not mentioned.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of experts: Not mentioned.
Qualifications of experts: Not mentioned.
Role of Experts: Not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not mentioned.

5. 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 MRMC study is mentioned. This device is an electrocardiograph, not an AI-assisted diagnostic tool as described. It "records and displays ECG waveform." It does not appear to involve AI assistance for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this is a device for recording and displaying ECG waveforms, not an algorithm for interpretation. The text states it "provides to the treating physician with relevant data on the cardiac rhythm" but does not indicate automated diagnostic interpretation. Furthermore, it explicitly states "The product is not a conventional diagnostic tool."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not mentioned.

8. The sample size for the training set

Not applicable/mentioned, as no algorithm training is indicated for this device.

9. How the ground truth for the training set was established

Not applicable/mentioned, as no algorithm training is indicated for this device.

Summary

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Section 3 510(k) Summary

As required by 807.97 The assigned 510(k) Number is

Sponsor

Submission Correspondent Contec Medical Systems Co., Ltd No. 24, West Huanghe Road Qinhuangdao, Hebei, 066000, China

Mr. Li Xueyong, Quality Manager Tel:+86-335-8015490 Fax: +86-335-8015505 Email: lxyong1011@163.com

Ms. Diana Hong / Mr. Tarzan Wang Shanghai Mid-Link Business Consulting Co., Ltd Sute 8D, No. 19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: 240-238-7587 Email: diana.hong@mid-link.net

Proposed Product

Trade Name Model Product Code: Regulation Number: Device Class:

Submission Purpose:

Predicate Device:

ECG80A DPS 21 CFR 870.2340 Class II

ECG MONITOR

New Device

Cardiette microtel K082124 Manufactured by: Et medical devices spa Via De Zinis 6, 38011 Cavareno (Trento) ITALY

CARDIOLINE AR1200 K051534

AUG
25 2009

(090936

オリス

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Manufactured by:

Et medical devices spa Via De Zinis 6, 38011 Cavareno (Trento) ITALY

Device Description

Test Conclusion

SE Determination

Intended Use/Indication for Use Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications.

The proposed device, ECG80A Single-Channel Handheld Electrocardiograph, is substantially equivalent (SE) to the predicate device Cardiette microtel (K082124) and CARDIOLINE AR1200 (K051534).

The product is not a conventional diagnostic tool.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized wings and tail feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 2 5 2009

Contec Medical System Co., Ltd. c/o Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Co., Ltd. Suite 8D, No. 19, Zhongxin Zhongshan Mansion, Lane 999 Zhongshan No. 2 Road (S) Shanghai CHINA 200030

Re: K090936

Trade/Device Name: Single-Channel Handheld Electrocardiograph, Model ECG80A Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: July 21, 2009 Received: July 23, 2009

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 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.

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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); 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Bram D. Zuckerman, M.D.

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

Enclosure

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Indication For Use

510(k) Number (if known): Pending

Device Name: ___ECG80A Single-Channel Handheld Electrocardiograph

Indications for Use:

The product is not a conventional diagnostic tool.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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)

signature

(Dvision Sign-Off)
Division of Cardlovascular Devices
510(k) Number K090 936

Page _I_of

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).