(196 days)
INTCO Tab Electrodes are designed for use with general electrocardiographic procedures when ECG monitoring is deemed necessary by a physician. Such procedures include ECG surveillance and diagnosis recording. INTCO Tab Electrodes are non-sterile and are to only be used on intact (uninjured) skin.
INTCO Tab electrodes are composed of PET tape, Ag/AgCl or carbon conductive layer, and a conductive gel. These are configured as ten electrodes applied to a siliconized card, with 10 cards per pouch
The provided 510(k) summary describes the Intco Tab Electrode, a disposable ECG electrode. This device does not involve AI or algorithms, so the majority of the requested information about AI model performance, training sets, and expert adjudication is not applicable.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ANSI/AAMI EC12:2000/(R)2005 | Conforms to the standard |
| Biocompatibility (ISO 10993-1) | Non-irritating |
| Non-cytotoxic | |
| Non-sensitizing | |
| Shelf life | 24 months (accelerated aging tests performed) |
Study Details
The submission focuses on demonstrating substantial equivalence to a predicate device (Leonard Lang GmbH Skintact ECG Tab Electrode K030509) by showing compliance with recognized consensus standards and comparable physical/technical characteristics.
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Sample size used for the test set and the data provenance: Not explicitly stated as a clinical study with a "test set" in the context of an AI model. The performance evaluation is based on conformance to industry standards and biocompatibility testing. For the standards testing, specific sample sizes for tests within ANSI/AAMI EC12:2000/(R)2005 are not detailed, but standard conformance implies appropriate sampling for those tests. The data provenance is generally from laboratory testing performed by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert-established ground truth for an AI model. Biocompatibility testing results are laboratory-derived, and standard conformance is assessed against defined technical parameters.
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Adjudication method for the test set: Not applicable. There is no expert adjudication process described.
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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 electrode, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an algorithm.
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The type of ground truth used:
- Standard Conformance: The "ground truth" is defined by the technical specifications and test methods outlined in the ANSI/AAMI EC12:2000/(R)2005 standard for disposable ECG electrodes. The device performance is measured against these established parameters.
- Biocompatibility: The "ground truth" is established by the accepted scientific methodologies for assessing irritation, cytotoxicity, and sensitization as defined in ISO 10993-1.
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The sample size for the training set: Not applicable. This device does not utilize a training set as it is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
Summary of Device Evaluation:
The INTCO Tab Electrode's acceptance criteria and proven performance are primarily based on:
- Conformance to the ANSI/AAMI EC12:2000/(R)2005 consensus standard, which specifies requirements for characteristics such as impedance, DC offset, combined offset and offset instability, and input noise performance for disposable ECG electrodes. The submission states the device "have been tested and conform to recognized consensus standard."
- Biocompatibility testing according to ISO 10993-1, which demonstrated the conductive gel to be non-irritating, non-cytotoxic, and non-sensitizing.
- Accelerated aging tests to substantiate a 24-month shelf life.
The submission aims to demonstrate substantial equivalence to a legally marketed predicate device by showing that the INTCO Tab Electrode meets these established performance and safety benchmarks.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.