(270 days)
Not Found
No
The summary describes a device for recording and displaying ECG data, with no mention of AI or ML for analysis or interpretation. The analysis is intended to be performed by a physician or knowledgeable individual.
No.
The device is intended for recording and displaying ECG data for diagnostic purposes, not for therapeutic intervention or treatment.
Yes
The device is used to record and display ECG data for analysis by a physician for the purpose of diagnosing heart rhythm conditions.
No
The device description explicitly mentions hardware components such as a touch screen interface, TFT-LCD waveform display, SD memory card insertion port, and the ability to use a five lead-wires ECG cable. It is a portable ECG recorder, which is a physical device.
Based on the provided text, the V-TRUST TD-2202 portable ECG recorder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The V-TRUST TD-2202 records electrical signals from the body's surface (ECG data), not from a specimen.
- The intended use clearly states it records and displays ECG data of adult patients. This is a direct measurement from the patient, not an analysis of a biological sample.
- The device description focuses on the hardware and functionality for recording and transmitting ECG signals. There is no mention of analyzing biological samples.
Therefore, the V-TRUST TD-2202 falls under the category of a medical device that directly interacts with the patient to collect physiological data, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
MAR - 1 2011
A. 510(k) Summary
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
ﺘﮯ
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
-
- Submitter's Identification:
TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
- Submitter's Identification:
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
-
- Intended Use:
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- 1 of 2
1
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.
-
- 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).
- Device Description:
-
- Substantial Equivalence Information:
The V-TRUST TD-2202 Portable ECG Recorder has equivalent technological characteristics and the similar intended use as the predicate devices.
-
- Test Principle:
The V-TRUST TD-2202 Portable ECG Recorder uses the same test principle as the predicate devices.
- Test Principle:
-
- Performance Characteristics:
The bench tests were performed according to IEC 60601-1, IEC 60601-1-2 Medical
- Performance Characteristics:
-
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.
-
- Conclusion:
Based on the information provided in this submission, the V-TRUST TD-2202 Portable ECG Recorder is substantially equivalent to the predicate devices.
2
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.
3
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
4
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 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.
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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