V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER by TaiDoc Technology Corporation

The V-TRUST TD-2202 portable ECG recorder is intended for recording and displaying ECG data of adult patients who are concerned about their heart rhythm. A patient can either equip a five lead-wires ECG cable to take a long term monitoring; or choose to use event reading option when feeling any heart condition occur. This recorder allows the patient to record their ECG data in SD memory card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.

The V-TRUST TD-2202 portable ECG recorder can also wirelessly transmit recorded ECG to a Bluetooth-enabled computer.

Device Description

The V-TRUST TD-2202 Portable ECG Recorder provides a long-period recording with multiple channels and transient recording with single channel for individual use. This portable electrocardiograph has a touch screen interface, TFT (Thin Film Transistor)-LCD waveform display, one SD (Secure Digital) memory card insertion port, data transmission via Bluetooth, and 24 hours of continuous recording (in non-compressed format).

AI/ML Overview

The provided text describes a 510(k) summary for the V-TRUST TD-2202 Portable ECG Recorder, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and specific performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Bench Tests:	IEC 60601-1, IEC 60601-1-2 Medical, and AAMI EC 38 standards met. These standards likely cover:
- Electrical safety	- Conforms to standards
- Electromagnetic compatibility (EMC)	- Conforms to standards
- Accuracy of ECG recording signals	- Conforms to standards
- Frequency response	- Conforms to standards
- Patient isolation	- Conforms to standards
- Other performance requirements for ECG devices	- Conforms to standards
Clinical Performance:	Not explicitly stated in terms of specific metrics (e.g., sensitivity, specificity for arrhythmia detection). The document implies clinical performance through substantial equivalence to predicate devices for recording and display of ECG data for analysis by a physician.

Explanation: The document states that "The bench tests were performed according to IEC 60601-1, IEC 60601-1-2 Medical and AAMI EC 38, and the results demonstrate that the V-TRUST TD-2202 Portable ECG Recorder conform to the standards and is safe and effective." This means the device met the requirements outlined in these consensus standards, which serve as the "acceptance criteria" for basic device performance, safety, and effectiveness. However, the exact numerical performance metrics against these standards are not provided in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. Bench testing typically involves testing multiple units of the device; no patient data is mentioned for performance evaluation beyond the device's ability to record.
Data Provenance: Not applicable for the described bench tests. The tests are performed on the device itself, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for bench tests is defined by the technical specifications and requirements within the IEC and AAMI standards. No human experts are mentioned for establishing ground truth in this context.

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

Not applicable. Bench tests don't typically involve adjudication in the way clinical studies do. Compliance with standards is usually a pass/fail outcome based on measurement against defined thresholds.

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. This device is a portable ECG recorder, not an AI-powered diagnostic tool. The document does not describe any MRMC study or AI assistance. Its purpose is to record and display ECG data for analysis by a physician, not to interpret it automatically.

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

No. This device's primary function is data acquisition and display. There is no mention of an algorithm performing standalone interpretation.

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

For the bench tests, the "ground truth" is adherence to the technical specifications and performance limits defined by the referenced international standards (IEC 60601-1, IEC 60601-1-2, and AAMI EC 38). These standards establish benchmarks for electrical safety, EMC, and fundamental ECG signal characteristics.

8. The sample size for the training set:

Not applicable. This device does not appear to use machine learning or AI that would require a "training set."

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

Not applicable, as there is no training set mentioned.

Summary

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MAR - 1 2011

A. 510(k) Summary

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510(K) SUMMARY

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

The Assigned 510(k) number is: K101569

1. Submitter's Identification:
  TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan

Correspondence: Teling Hsu Regulatory Affairs Specialist

Tel: +886-2-6625-8188 Fax: +886-2-6625-0288
Prepared date: Jun 2, 2010

Device name:

Proprietary name: V-TRUST TD-2202 Portable ECG Recorder, MODEL TD-2202 Regulatory information:

A. Regulation section: 21 CFR 870.2340
B. Classification: Class II
C. Product Code: DPS, electrocardiograph
D. Panel: Cardiovascular
1. Intended Use:

A- 1 of 2

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K10/569

a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.

The V-TRUST TD-2202 portable ECG recorder can also wirelessly transmit recorded ECG to a Bluetooth-enabled computer.

1. Device Description:
  The V-TRUST TD-2202 Portable ECG Recorder provides a long-period recording with multiple channels and transient recording with single channel for individual use. This portable electrocardiograph has a touch screen interface, TFT (Thin Film Transistor)-LCD waveform display, one SD (Secure Digital) memory card insertion port, data transmission via Bluetooth, and 24 hours of continuous recording (in non-compressed format).
1. Substantial Equivalence Information:
- A. Predicate device name and k number:
  - . E3-80 Portable ECG Recorder & Analyzer (K071085)
  - HCG-801 portable EGG Monitor (K060766) .
- B. Comparison with predicate:

The V-TRUST TD-2202 Portable ECG Recorder has equivalent technological characteristics and the similar intended use as the predicate devices.

1. Test Principle:
  The V-TRUST TD-2202 Portable ECG Recorder uses the same test principle as the predicate devices.
1. Performance Characteristics:
  The bench tests were performed according to IEC 60601-1, IEC 60601-1-2 Medical
and AAMI EC 38, and the results demonstrate that the V-TRUST TD-2202 Portable ECG Recorder conform to the standards and is safe and effective.
1. Conclusion:

Based on the information provided in this submission, the V-TRUST TD-2202 Portable ECG Recorder is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

Public Health Service

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

TaiDoc Technology Corporation c/o Ms. Teling Hsu Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd Rd., Wugu Township Taipei County 24888 Taiwan

MAR = 1 2011

Re: K101569

Trade/Device Name: V-TRUST TD-2202 Portable ECG Recorder Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: December 31, 2010 Received: January 3, 2011

Dear Ms. Hsu:

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. Teling Hsu

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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W. Wood.

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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Indications for Use

1210.1569

510(k) Number:K101569

Device Name: V-TRUST TD-2202 Portable ECG Recorder, MODEL TD-2202

Indications for Use:

The V-TRUST TD-2202 portable ECG recorder can also wirelessly transmit recorded ECG to a Bluetooth-enabled computer.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (QDE)

(Division Sign-Off)

on of Cardiovascular Devices

510(k) Number K061567

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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).