(512 days)
Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to twelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.
Dynamic ECG System, TLC5000, mainly consists of two parts: a recorder, analysis software and accessories. The recorder is designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms, as well as the patient information will be displayed and stored in the memory of the recorder. The information stored can be downloaded to PC; the ECG signal then can be analyzed by the analysis software. The analysis results are only used as advisory basis. The accessories contain disposable electrodes, cables, USB connecting line.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list acceptance criteria as quantitative thresholds for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "Automatic analysis function verification per AAMI EC 57" was performed, and that "The test results complied with FDA recognized standards and be evaluated to determine it was acceptable." This implies that the device's performance was judged against the requirements of the AAMI EC 57 standard for automated ECG analysis.
Acceptance Criteria (Implied from text):
- Compliance with IEC 60601-1:1988+A1:1991+A2:1995 (Electrical Safety Test)
- Compliance with IEC 60601-1-2:2001+A1:2004 (EMC Test)
- Compliance with IEC 60601-2-47:2001 (Performance Test)
- Compliance with ISO 10993 series standards (Biocompatibility Test)
- Compliance with AAMI EC 57 (Automatic analysis function verification)
Reported Device Performance:
The document states: "The test results complied with FDA recognized standards and be evaluated to determine it was acceptable, therefore, safety and effectiveness were demonstrated substantially equivalent (SE) to the predicate device."
Table format (best effort given limited data):
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Electrical Safety) | Complied |
| IEC 60601-1-2 (EMC) | Complied |
| IEC 60601-2-47 (Performance) | Complied |
| ISO 10993 (Biocompatibility) | Complied |
| AAMI EC 57 (Auto Analysis) | Complied |
It is important to note that the specific quantitative performance metrics (e.g., beat detection accuracy, arrhythmia classification accuracy) required by AAMI EC 57 and the device's actual performance against those metrics are not provided in this summary. The summary only states that the device "complied."
Study Information
The document describes several tests conducted to establish the safety and effectiveness of the device, ultimately concluding substantial equivalence to a predicate device. However, it does not describe a specific clinical study or an algorithm-specific performance study with detailed methodology, sample sizes, and ground truth establishment in the way typically expected for AI/ML device submissions today.
The "Automatic analysis function verification per AAMI EC 57" is the closest mention of a performance evaluation relevant to the analytical components of the ECG system.
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
-
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not specified. The document only mentions that the analysis results are for review by a "trained physician in health facilities." It does not detail who established the ground truth for the verification testing.
-
Adjudication Method for the Test Set:
- Not specified.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC study is not mentioned. The document describes tests primarily related to electrical safety, EMC, performance against a standard (IEC 60601-2-47), biocompatibility, and automatic analysis verification per AAMI EC 57. There is no information about human reader performance or the effect of AI assistance on human readers.
-
Standalone Performance Study (Algorithm Only):
- Yes, implicitly. The "Automatic analysis function verification per AAMI EC 57" suggests a standalone evaluation of the algorithm's performance against a recognized standard. However, the details of this evaluation (e.g., specific metrics, dataset) are not provided beyond the statement of compliance.
-
Type of Ground Truth Used:
- For "Automatic analysis function verification per AAMI EC 57," the ground truth would typically be established by expert review (e.g., cardiologists, electrophysiologists) of the ECG recordings, but this is not explicitly stated or detailed in the document. It is implied by the standard itself.
-
Sample Size for the Training Set:
- Not specified. The document does not describe the development or training of an AI/ML algorithm, or any associated training data. It refers to an "analysis software" with "automatic analysis function."
-
How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified, as information about a training set or algorithm development is not provided.
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Exhibit #1 510(k) Summary
SEP 3 0 2011
11
ﺗ
1
| This 510(k) Summary is prepared per the request of 21 CFR 807.92. | |
|---|---|
| Date of Preparation | 25 AUG 2011 |
| Assigned 510(k) #. | K101273 |
| Sponsor | Contec Medical Systems Co., Ltd Establishment Registration Number: 3006979678 |
| No. 24, Huanghe West Road, Economic & Technical Development Zone | |
| Qinhuangdao, Hebei, 066004, China | |
| Correspondent | Ms. Diana Hong / Mr. Lee Fu |
| Shanghai Mid-Link Business Consulting Co., Ltd | |
| Suite 5D, No. 19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China | |
| Proposed Device | Dynamic ECG Systems, TLC5000 |
| Classification | Electrocardiograph, ambulatory, with analysis algorithm; MLO; 870.2800; Class II |
| Intended Use | Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up totwelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will bestored in the recorder first and then download to PC for analysis, reviewing and printing by a trainedphysician in health facilities. |
| Device Description | Dynamic ECG System, TLC5000, mainly consists of two parts: a recorder, analysis software andaccessories. The recorder is designed to acquire, display and record ECG signals from patient bodysurface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms, aswell as the patient information will be displayed and stored in the memory of the recorder. Theinformation stored can be downloaded to PC; the ECG signal then can be analyzed by the analysissoftware. The analysis results are only used as advisory basis. The accessories contain disposableelectrodes, cables, USB connecting line. |
| Testing | The following tests were performed to evaluate the safety and effectiveness of the proposed devices:> Electrical Safety Test per IEC 60601-1:1988+A1:1991+A2:1995;> EMC Test per IEC 60601-1-2:2001+A1:2004;> Performance Test Report per IEC 60601-2-47:2001;> Biocompatibility Test per ISO 10993 series standards:> Automatic analysis function verification per AAMI EC 57.The test results complied with FDA recognized standards and be evaluated to determine it wasacceptable, therefore, safety and effectiveness were demonstrated substantially equivalent (SE) to thepredicate device. |
| Predicate Device | Matrix Holter System, K051730 |
| SE Conclusion | The proposed device, Dynamic ECG System, TLC5000 is substantially equivalent (SE) to the predicatedevice, Matrix Holter System, K051730. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Contec Medical System Co., Ltd. c/o Diana Hong Shanghai Midlink Business Consulting Co., Ltd. Suite 5D No 19, Lane 999 Zhongshan No.2 Roads Shanghai. China 200030
SEP 3 0 2011
Re: K101273
Trade/Device Name: Dynamic ECG Systems, TLC5000 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MLQ Dated: September 15, 2011 Received: September 16, 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.
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
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Page 2 - Ms. Diana Hong
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 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.
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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K101273 1/1
Premarket Notification Section 510(k) Submission Report SN: SHA0202009091IFDA Indication for Use Statement
Exhibit #1 Idication for Use Statement
510(k) Number: K101273
Device Name: Dynamic ECG System, TLC5000
Indication for Use:
Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to twelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.
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)
.
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K10/273
ll-1
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).