(14 days)
Skintact 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 ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Electrodes with Conductive Adhesive are composed of the same naterials as the predicate devices by Leonhard Lang except the gel, which is made by AmGel Technologies.
Here's a breakdown of the acceptance criteria and study information for the Skintact® ECG Electrodes with Conductive Adhesive, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Criteria | Acceptance Criteria (Set by ANSI/AAMI EC12:2000) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993 standards for intact skin. | "Biocompatibility testing was the same as predicate devices and passed ISO 10993 for intact skin." The new device's gel, made by AmGel Technologies, had been previously cleared in a submission by the manufacturer, implying its biocompatibility was established. |
| Electrical Performance (Initial) | Meets specifications as established in ANSI/AAMI EC12:2000. This standard covers areas like DC offset voltage, combined offset instability and internal noise, AC impedance, and defibrillation overload recovery. | "The performance data of Skintact® ECG Electrodes with Conductive Adhesive and the predicate devices (K023503, K040249) met specifications as established in ANSI/AAMU EC12:2000." This indicates the device performed within the limits defined by the standard for electrical characteristics. |
| Electrical Performance (After Shelf-Life) | Meets specifications as established in ANSI/AAMI EC12:2000 after accelerated aging. | "The shelf life of Skintact® ECG Electrodes with Conductive Adhesive was tested in accelerated aging in the same manner as the predicate devices." The implication, given the overall substantial equivalence claim, is that the device also met ANSI/AAMI EC12:2000 specifications after accelerated aging, demonstrating stability over its claimed shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size for the test set used in the performance testing. It refers to "performance data" and "biocompatibility testing."
Regarding data provenance:
- Country of Origin: Not explicitly stated, but the submitter (Leonhard Lang GmbH) is based in Austria. The testing itself could have been conducted anywhere.
- Retrospective or Prospective: Not explicitly stated. For performance standards like ANSI/AAMI EC12:2000, testing typically involves prospective laboratory measurements of electrode characteristics. Biocompatibility testing is also generally prospective lab testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. ECG electrodes are physical medical devices, and their "ground truth" for performance is established by objective measurements against recognized engineering and safety standards (like ISO 10993 for biocompatibility and ANSI/AAMI EC12:2000 for electrical performance). There are no experts establishing "ground truth" in the way one would for diagnostic image interpretation.
4. Adjudication Method for the Test Set
This is not applicable. As discussed above, the "truth" is determined by objective measurements against established standards, not by expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging systems or AI algorithms where human interpretation is a key component and the AI's effect on human performance is being evaluated. This 510(k) is for a disposable ECG electrode, a hardware component.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
No, a "standalone" study in the context of an algorithm's performance was not done. This 510(k) is for a hardware device, not an algorithm. The performance evaluation focuses on the physical and electrical characteristics of the electrode itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurements against recognized industry standards:
- Biocompatibility: Conformance to ISO 10993 standards.
- Electrical Performance: Conformance to ANSI/AAMI EC12:2000 for ECG electrodes.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device (ECG electrode), not an AI algorithm or a diagnostic system that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
§ 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.