(24 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 non-sterile 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 be offered with KL 02 liguid gel. Just like the QR liquid gel electrodes, KL 02 liquid gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The KL 02 liquid gel electrodes are identical in size, shape and configuration to the QR liquid gel Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH. All electrode configurations include a stainless steel stud to guarantee an unimpaired performance during the shelf-life of the product. All electrodes include an 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. This is the same construction as the current Skintact® ECG electrode using QR liquid gel conducting media.
Here's an analysis of the provided 510(k) summary regarding the Skintact® ECG Electrodes with KL 02 liquid gel, focusing on acceptance criteria and supporting studies:
Overview:
This 510(k) submission seeks to demonstrate substantial equivalence of the Skintact® ECG Electrodes with KL 02 liquid gel to a predicate device (Skintact® ECG Electrodes with QR liquid gel) that was previously cleared (K982521). The primary change is the type of liquid gel used. The testing focuses on proving that this change does not negatively impact the device's performance regarding biocompatibility, electrical properties, and clinical utility.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the ANSI/AAMI EC 12:2000 standard for "Disposable ECG electrodes" and equivalence comparisons to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (from ANSI/AAMI EC 12:2000 & Equivalence) | Reported Device Performance (Skintact® ECG Electrodes with KL 02 liquid gel) | Pass/Fail |
|---|---|---|---|
| I. Biocompatibility | Cytotoxicity | No adverse results | Pass |
| Skin Irritation | No adverse results | Pass | |
| Sensitization | No adverse results | Pass | |
| II. Electrical Performance | AC Impedance (limits defined by ANSI/AAMI EC 12:2000) | Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate | Pass |
| DC Offset Voltage (limits defined by ANSI/AAMI EC 12:2000) | Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate | Pass | |
| Defibrillation Overload Recovery (limits defined by ANSI/AAMI EC 12:2000) | Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate | Pass | |
| Combined Offset Instability and Internal Noise (limits defined by ANSI/AAMI EC 12:2000) | Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate | Pass | |
| Bias Current Tolerance (limits defined by ANSI/AAMI EC 12:2000) | Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate | Pass | |
| III. Shelf-Life | Electrical performance within ANSI/AAMI EC 12:2000 limits for 24 months | Electrical performance stayed within limits for 24 months (real-time aging) | Pass |
| IV. Clinical Equivalence | Equivalent ECG traces compared to predicate device | "KL 02 liquid gel performs the same" and "ECG traces... demonstrate that KL 02 liquid gel electrodes are equivalent to the QR liquid gel electrodes." | Pass |
| No skin problems during 48-hour wear | "Did not cause any skin problems for the volunteers." | Pass | |
| No deterioration of electrical performance during 48-hour wear | "No deterioration of electrical performance" | Pass | |
| Gel did not dry out during 48-hour wear | "Gel did not dry out" | Pass | |
| No displacement during 48-hour wear | "Did not show any displacement" | Pass |
Study Details:
Based on the provided text, the studies are primarily intended to demonstrate equivalence to a predicate device and adherence to industry standards, rather than proving novel clinical effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Biocompatibility Testing: The specific sample sizes for cytotoxicity, skin irritation, and sensitization tests are not provided in the summary.
- Electrical Performance Testing: The specific sample sizes for AC impedance, DC offset voltage, etc., are not provided. The testing "was used to define the requirements for Skintact ECG Electrodes with KL 02 liquid gel" and involved a "certification to conformance EC12:2000."
- Shelf-Life Testing: "Real-time aging" was performed, and "retain samples" were tested. Specific sample sizes are not provided.
- Clinical Data (Trace Testing & Wear Tests):
- Trace Testing: No specific sample size is mentioned for the "clinical trace testing per the FDA guidance." It states the gel was evaluated, implying direct comparison.
- Wear Tests: "Three wear test reports for Holter monitoring electrodes used for 48 hours were provided." This implies a small sample size, likely involving a few participants per report, but the exact number of individuals is not specified.
- Data Provenance: The manufacturer is Leonhard Lang GmbH, located in Austria. It is highly probable the data originated from Austria or a European location, given the company's geographical information. The studies appear to be prospective as they were specifically conducted for this submission (e.g., repeating clinical trace testing, real-time aging, wear tests).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Biocompatibility/Electrical Performance/Shelf-Life: These tests typically use validated laboratory methods and standards (ANSI/AAMI EC 12:2000) for determining "ground truth." Expert review would be part of the lab's quality assurance, but no specific external experts are mentioned for establishing the objective pass/fail criteria.
- Clinical Data (Wear Tests): "A physician reviewed the performance of the wear tests and examined for skin irritation."
- Number of Experts: One physician is explicitly mentioned.
- Qualifications: "Physician." No further specific qualifications (e.g., years of experience, specialty) are provided in the summary.
4. Adjudication Method for the Test Set:
- Biocompatibility/Electrical Performance/Shelf-Life: Not applicable in the context of standard human-read adjudication. These are objective measurements against defined technical standards.
- Clinical Data (Wear Tests): A single "physician reviewed the performance." There is no explicit multi-reader adjudication method (like 2+1, 3+1) described for the clinical wear tests or the trace comparisons. The "clinical trace testing" simply states the KL 02 gel "performs the same" as the QR gel, implying a direct comparison without detailing an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was NOT done. The studies focused on demonstrating equivalence of the device (specifically the new gel) to a predicate device and adherence to technical standards. There is no mention of human readers and their improvement with or without AI assistance. This device is an electrode, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone algorithm performance study was NOT done. This device is an ECG electrode, which is a hardware component for collecting physiological signals, not a software algorithm.
7. Type of Ground Truth Used:
- Biocompatibility: Ground truth is established by standardized, validated laboratory protocols for cytotoxicity, irritation, and sensitization (e.g., ISO 10993 series, though not explicitly cited here, implied by "biocompatibility testing").
- Electrical Performance: Ground truth is defined by the objective limits and testing methodologies specified in the ANSI/AAMI EC 12:2000 "Disposable ECG electrodes" standard.
- Shelf-Life: Ground truth is the adherence to the electrical performance limits defined by ANSI/AAMI EC 12:2000 over time, as measured through real-time aging.
- Clinical Data (Trace Testing & Wear Tests):
- Trace Equivalence: The "ground truth" for trace equivalence is likely a visual or quantitative comparison by experts of the generated ECG waveforms from the new gel electrodes versus the predicate gel electrodes, judged to be "the same" or "equivalent."
- Skin Irritation/Performance: The "ground truth" for skin irritation and overall electrode performance (adhesion, gel drying, electrical performance during wear) is the physician's review and observation for the wear tests.
8. Sample Size for the Training Set:
- Not applicable. This submission describes a medical device (ECG electrode), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, there is no training set for an AI model.
§ 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.