(309 days)
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.
ECG electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring.
Bio Protech electrodes are self-adhesive, non-sterile, single use disposable ECG electrodes. All include an Ag/Agc 1 sensing element and the solid adhesive hydro gel has very low impedance level. Most importantly, the adhesive gel sticks on both skin of patient and the sensing element so that the movement artifact can be significantly lowered. The adhesive qualities of the foam is strong enough to use for stress test and holter.
The provided text describes the 510(k) summary for the BIO PROTECH ECG Electrode (K020003). This document aims to demonstrate the substantial equivalence of the new device to a predicate device, not to prove that the device meets specific performance criteria through a detailed study in the way an AI/ML device would. Therefore, many of the requested elements for AI/ML device studies are not applicable or cannot be extracted from this type of regulatory submission.
However, I can provide the available information relevant to acceptance criteria and performance as presented in the Performance Summary section.
Here's a breakdown based on the provided text, emphasizing what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| Medical Devices Directive: EU Council Directive 93/42/EEC | Meets requirements |
| ANSI/AAMI ec12-2000 | Meets requirements |
| Biocompatibility (based on ISO 10993-1) | Materials demonstrate appropriate levels of biocompatibility |
| Shelf Life (24 months) | Data obtained in real-time shelf life studies substantiates the claim |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The summary refers to compliance with standards, implying internal testing was conducted, but details of the test sets (size, origin, retrospective/prospective nature) are not included.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the evaluation focuses on electrical performance, biocompatibility, and shelf life, not on interpretations requiring expert consensus for images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation does not involve subjective interpretations requiring 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 relevant for AI/ML devices where the AI assists human readers. The device in question is a physical ECG electrode.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical electrode, not a software algorithm. The "performance" refers to its electrical and material properties.
7. The Type of Ground Truth Used
- Electrical Performance: Ground truth would be defined by the specifications of the standards (EU Council Directive 93/42/EEC and ANSI/AAMI ec12-2000), which outline acceptable electrical characteristics for ECG electrodes (e.g., impedance, offset voltage).
- Biocompatibility: Ground truth is established by the materials' compliance with ISO 10993-1, typically through laboratory testing for cytotoxicity, sensitization, irritation, etc., against established thresholds.
- Shelf Life: Ground truth is established by demonstrating that the device maintains its specified performance characteristics over the claimed 24-month period through real-time stability testing.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
Summary of the Study Proving Device Meets Acceptance Criteria (based on the provided text):
The provided text states that the "Performance Summary" indicates the electrical performance of BIO PROTECH ECG electrodes "meets the requirements of the Medical Devices Directive: EU Council Directive 93/42/EEC, ANSI/AAMI ec12-2000, and has been issued a Certificate of Conformity (01-KOR-MDD-0003)."
For biocompatibility, it states: "The biological safety of the PRO TECH ECG electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The tests were selected on the basis of ISO 10993-1, Biological Evaluation of Medical Devices - Part 1 - Guidance on selection of tests."
For shelf life, it states: "Data obtained in real time shelf life studies was reviewed and found to substantiate the 24 month shelf life claim."
While these statements confirm that studies were conducted to demonstrate compliance with these standards and claims, the specific methodologies, sample sizes, and detailed results of these internal studies are not provided in this 510(k) summary document. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, often by showing compliance with applicable recognized standards rather than detailing the full study reports.
§ 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.