(253 days)
CONTECTM Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
The proposed device, CONTECTM Electrocardiograph, has three models: ECG100G, ECG300G and ECG1200G. The three models all have three design modules, which are power module, signal acquisition and processing module and control module. The proposed devices acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via single channel/ three channel/ twelve channel. The proposed device, model ECG100G, has two recording modes, including automatic mode and manual mode; the other two models, ECG300G and ECG1200G have three recording modes, including automatic mode, manual mode and rhythm mode. The proposed devices are designed to acquire, process, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed on the LCD screen and recorded on the paper through thermal printer. ECG data, waveform and patient information could be stored in the memory of the device;
The provided document K131900 is a 510(k) summary for the CONTECTM Electrocardiograph. It outlines the device's technical specifications and compares it to predicate devices to establish substantial equivalence. However, it does not describe a clinical study with acceptance criteria and reported device performance in the way a traditional clinical efficacy study would.
Instead, this document focuses on non-clinical tests to verify that the proposed device meets design specifications and complies with relevant international and national standards. The acceptance criteria are implicit in these standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed with corresponding "reported device performance" in terms of clinical outcomes or diagnostic accuracy. Instead, the document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The "reported device performance" is the statement that it complies with the listed standards and its technical specifications match or are similar to the predicate devices.
| Feature/Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1:1988+A1:1991+A2:1995 | Complies with IEC 60601-1:1988+A1:1991+A2:1995 |
| EMC | Compliance with IEC 60601-1-2: 2007 | Complies with IEC 60601-1-2: 2007 |
| ECG Safety | Compliance with IEC 60601-2-25:1993+A1:1999 | Complies with IEC 60601-2-25:1993+A1:1999 |
| Diagnostic ECG | Compliance with ANSI/AAMI EC11:1991/(R) 2007 | Complies with ANSI/AAMI EC11:1991/(R) 2007 |
| Patient Leak Current | 60 dB (general), >100 dB (with AC filter) | >60 dB, >100 dB (with AC filter) (Similar to predicate) |
| Input CIR current | 50M Ω | >50M Ω (Same as predicate) |
| Intended Use | Acquire ECG signals from adult patients, help users analyze and diagnose heart disease in healthcare facilities by doctors/professionals. | (Stated as intended use, presumed to be met by device function) |
| Technical Features | 1/3/12 channel, Simultaneous 12-lead acquisition, specific recording modes (auto/manual/rhythm for ECG300G/ECG1200G, auto/manual for ECG100G) | Matches predicate devices or is clearly described. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of diagnostic accuracy. The tests performed are non-clinical, related to electrical safety, electromagnetic compatibility, and performance according to engineering standards. There is no mention of patient data or its provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication is described.
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
Not applicable. This device is an electrocardiograph, which acquires and displays ECG signals. It does not appear to incorporate AI for interpretation or assistance with human readers. The document does not mention any "Measurement/Analysis Function" for the proposed device, as shown in the comparison table where it explicitly states "No" for this function, contrasting with one of the predicate devices that has "Yes".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device itself is an acquisition device, not an algorithm for interpretation. It explicitly states "No" for "Measurement/Analysis Function."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As described, the "ground truth" for this submission are the engineering and medical device standards (e.g., IEC 60601 series, ANSI/AAMI EC11) which define acceptable electrical and physical performance, rather than diagnostic accuracy against a clinical gold standard.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device with an interpretation algorithm.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or its ground truth establishment is mentioned.
Summary of the Study:
The "study" described in K131900 is a series of non-clinical bench tests designed to demonstrate that the CONTECTM Electrocardiograph adheres to established electrical safety, electromagnetic compatibility (EMC), and specific performance standards for electrocardiographs. The "acceptance criteria" are the requirements set forth in these international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ANSI/AAMI EC11) and the technical specifications listed in the comparison table, which are either identical or similar to legally marketed predicate devices. The "proof" is the statement that "The test results demonstrated that the proposed device complies with the following standards" and the detailed comparison table that shows its technical specifications meet or are equivalent to the predicate devices. This type of submission is common for medical devices that aim to show substantial equivalence based on technical and performance characteristics, without requiring new clinical efficacy data if the intended use and technology are sufficiently similar to approved predicate devices.
§ 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).