(15 days)
ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates.
By design and manufacturing process, the IP-SET® ECG electrodes are of multidisciplinary use, and the unit choice is performed by the Physician, in function of the desired application.
Set of disposable, single-use, pre-gelled ECG electrodes are regrouped on a flat cable sole or by pair (dual electrodes) and located to ease their positioning on the patient. Electrode number and positioning design vary according to the monitoring/diagnostics application.
Pre-gelled (hydro-gel) electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 90 mm in diameter or oblong / rectangular shape.
Lead wires are regrouped in a flat cable and are made of copper (radio-opaque) or carbon fiber (radio-translucent).
Sets are supplied non-sterile. Each set / harness is packaged in one OPP/PE laminated pouch (sealed foil); 10 to 50 pouches are supplied per box; Shipping cartons contain 12 boxes.
The provided document, K101685, is a 510(k) summary for Integral-Process's ECG Electrode "IP-SET®". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on specific performance acceptance criteria. As such, it does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding specific acceptance criteria and detailed study results from a clinical trial or performance study.
The document primarily relies on comparisons to legally marketed predicate devices and compliance with relevant standards. Here's what can be inferred from the provided text regarding device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" (e.g., in terms of sensitivity, specificity, accuracy, or electrical performance thresholds) and reported device performance (e.g., percentages, mean improvements) from a dedicated study are provided. The device performance is generally stated as being "at least as well as other disposable ECG electrodes" based on comparison to predicate devices and compliance with standards.
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated but Implied by Equivalence) | Reported Device Performance |
|---|---|---|
| Functionality | Equivalent to predicate devices (K944260, K944497) | "Identical in function" to Unomedical ECG monitoring electrodes. |
| Welding Process | Equivalent to predicate device (K003804) | "Identical welding process" to Sensi-Prema ECG monitoring electrode. Electrical and mechanical safety of connection "covered." |
| Electrical Safety | Cleared by predicate device (K011564) | "Cleared by predicate Neolead ECG electrode." |
| Biocompatibility | Cleared by predicate device (K011564) | "Cleared by predicate Neolead ECG electrode." |
| Overall Effectiveness | Safe and effective for intended use, performs as well as other disposable ECG electrodes. | "Safe and effective for their intended use and perform at least as well as other disposable ECG electrodes." |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document does not describe a performance study with a test set. Substantial equivalence is demonstrated through technological comparisons and compliance with relevant standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. There is no mention of a test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported. This device is an ECG electrode, not an AI or image-based diagnostic tool that would typically undergo an MRMC study to compare human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This device is a physical medical device (ECG electrode), not an algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used:
Not applicable. There is no mention of a primary ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for demonstrating substantial equivalence for this type of device relies on established performance characteristics of the predicate devices and compliance with recognized standards.
8. Sample Size for the Training Set:
Not applicable. This document pertains to the 510(k) clearance of a physical medical device (ECG electrode), not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this 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.