(21 days)
Skintact radiolucent and MRI-compatible ECG electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording.
Skintact radiolucent and MRI-compatible ECG electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames) will now also be offered radiolucent and MRI-compatible. Just like the predicate electrodes, radiolucent and MRI-compatible ECG electrodes are self-adhesive, nonsterile, single-use disposable snap electrodes. The radiolucent and MRI-compatible ECG electrodes are identical in size, shape and configuration to the Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH.
The Skintact radiolucent and MRI-compatible ECG Electrodes are composed of the same materials as the predicate devices except the snap, which is made of carbon snap guarantees an unimpaired performance during the shelf-life of the product. All electrodes include an carbon ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer.
The provided documents detail the 510(k) submission for the Skintact® radiolucent and MRI-compatible ECG Electrodes. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI-powered diagnostic device. Therefore, many of the typical AI-specific criteria (like AI vs. human reader improvement, multi-reader multi-case studies, expert consensus for ground truth on training/test sets, or specific AI model performance metrics like AUC, sensitivity, specificity, F1-score) are not applicable to this submission.
The acceptance criteria and performance are primarily based on established industry standards for ECG electrodes, material biocompatibility, and specific testing for radiolucency and MRI compatibility.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials confirmed as biocompatible and introducing no risks (based on previous 510(k) clearances). | * Cytotoxicity: No adverse results shown. |
| * Skin Irritation: No adverse results shown. | ||
| * Sensitization: No adverse results shown. | ||
| Electrical Performance (ANSI/AAMI EC 12:2000) | Conformance to ANSI/AAMI EC 12:2000 for Disposable ECG electrodes. | All electrical tests (AC impedance, DC offset voltage, Defibrillation overload recovery, Combined offset instability and internal noise, Bias current tolerance) were performed according to ANSI/AAMI EC 12:2000. A certification of conformance was provided. The results confirmed electrical performance well within the standard's limits for 24 months, with negligible difference compared to predicate devices. Carbon electrodes perform the same as predicate devices with approved gels. |
| Material Equivalence (Previous 510(k)s) | All materials used previously cleared. | All materials used in the new device cleared in K 982521, K 023503, K 024264, K 024247. |
| Shelf-Life | Meet requirements for a 24-month shelf-life. | Real-time aging tests confirmed the electrical performance of the electrodes within the limits of ANSI/AAMI EC12-2000 for 24 months. Leonhard Lang has 20 years of experience with the packaging, meeting 24-month shelf-life requirements. |
| Adhesive Performance | Not affected by the change in snap material. | Repeating EC12:2000 testing confirmed equivalent data, indicating the change in snap does not affect adhesive performance. |
| Radiolucency (ASTM F640-79) | Demonstrated radiolucency according to ASTM F640-79. | Tested according to ASTM F640-79 "Standard Test Methods for Radiopacity of Plastics for Medical Use." Reference: "Radiopacity of ECG-Electrodes by Leonhard Lang GmbH - A study by Dr.Recheis Wolfgang, Dr.Verius Michael, Dr.Huttary Ralf, Mag.Torbica Pavle'." (Specific quantifiable result not provided in summary, but implied compliance with standard.) |
| MRI-Compatibility (ASTM F 2052-00, F 2182-02a, F 2119-01) | Demonstrated MRI compatibility regarding displacement force, RF heating, and image artifacts. | Tested according to: |
| * ASTM F 2052-00 "Standard Test Method for Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment." | ||
| * ASTM F 2182-02a "Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging." | ||
| * ASTM F 2119-01 "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants." | ||
| Reference: "MR-compatibility of ECG-Electrodes by Leonhard Lang GmbIl - A study by Dr.Recheis Wolfgang, Dr.Verius Michael, Dr.Huttary Ralf, Mag.Torbica Pavle." (Specific quantifiable results not provided in summary, but implied compliance with standards.) |
2. Sample Size for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated for each specific test. The testing involved, for example, "real-time aging" and a comparison of "ECG traces between carbon electrodes... and predicate device ECG electrodes." For biocompatibility, it's inferred that sufficient samples were tested to demonstrate no adverse results based on cleared materials. For electrical performance, tests were conducted according to ANSI/AAMI EC 12:2000, which would specify sample sizes for those tests. The radiolucency and MRI compatibility studies (referenced by authors) would have used defined sample sizes per those specific ASTM standards.
- Data Provenance: The company is Leonhard Lang GmbH, located in Innsbruck, Austria. The studies are referenced as being conducted by personnel from this company ("Radiopacity of ECG-Electrodes by Leonhard Lang GmbH - A study by Dr.Recheis Wolfgang, Dr.Verius Michael, Dr.Huttary Ralf, Mag.Torbica Pavle"). All testing described appears to be prospective laboratory and engineering testing, rather than retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable for this type of device. This submission did not involve diagnostic interpretation or AI model training requiring expert-established ground truth on a test set in the traditional sense of medical imaging or diagnostic algorithms. The "truth" for this device is based on objective measurements against established engineering and material standards (e.g., electrical performance, material safety, radiolucency, MRI compatibility). The referenced studies for radiolucency and MRI compatibility were authored by: Dr.Recheis Wolfgang, Dr.Verius Michael, Dr.Huttary Ralf, Mag.Torbica Pavle. Their specific qualifications (e.g., radiologist, engineer) are not given, but they are implied to be experts in their respective fields based on the nature of the studies.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" requiring adjudication by multiple experts in the context of diagnostic performance. Adjudication is typically used to resolve discrepancies in human interpretations or AI outputs against a ground truth. Here, the testing involves quantifiable physical and electrical properties benchmarked against standards.
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 was not an AI-powered diagnostic device, and therefore, no MRMC comparative effectiveness study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (ECG electrode), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is established by objective measurements against recognized industry standards and regulatory requirements. For example:
- Biocompatibility: Established by testing against known safety profiles for cleared materials.
- Electrical Performance: Defined by the specified limits within the ANSI/AAMI EC 12:2000 standard.
- Radiolucency: Defined by the parameters and methods of ASTM F640-79.
- MRI Compatibility: Defined by the parameters and methods of ASTM F 2052-00, ASTM F 2182-02a, and ASTM F 2119-01.
- Equivalence: Demonstrated by showing that the new device performs within the acceptable levels of variance compared to legally marketed predicate devices, as per the 510(k) pathway.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm that requires a "training set." The development process relies on engineering design, material selection, and testing against established performance standards.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI algorithm "training set" for this device, a ground truth for a training set was not established.
§ 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.