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510(k) Data Aggregation
(301 days)
The Disposable Pre-gelled Surface Electrodes are intended for recording/stimulation and monitoring of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potential (EP) signals.
The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single use only.
A conductive solid gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated eyelet, an adhesive cloth substrate, label, lead wire with a 0.60" diameter touch-proof female socket per DIN 42802 and polystyrene release liner. These are available in various lead lengths, lead configurations, electrode styles/sizes, and wire colors.
This document is a 510(k) Summary for the Rochester Electro-Medical Disposable Pre-gelled Surface Electrode, demonstrating its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly enumerated with numerical targets in this summary. Instead, the document states that the physical and electrical characteristics of the subject device (Rochester Disposable Adhesive Surface Electrodes) were evaluated against those of the predicate device (Xian Friendship Medical K110289). The overarching acceptance criterion is "substantially equivalent" to the predicate device, meaning there are no new concerns regarding safety or effectiveness.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Physical and electrical characteristics comparable to predicate device. | "Physical and electrical characteristics evaluated during bench testing and in the comparison chart of this submission demonstrate that the design, materials, chemical composition, packaging, intended use, electrical performance and other characteristics of the subject device are comparable to those of the predicate device." |
| Electrode Impedance measurements (comparable to predicate and method similar to K010431). | "Bench testing included electrode impedance measurements of the subject device and the predicate using a 1kHz source and a Digital Multimeter, a method similar to that used in K010431. Details of this testing and performance criteria are included in section 18 of this submission, Performance Testing - Bench." (Specific numerical results are not provided in this summary, but are referenced as being in Section 18). |
| Gel uniformity inspection. | "Additionally gel uniformity was inspected." (Details and specific results not provided in this summary). |
| Biocompatibility (Cytotoxicity, Skin irritation, Skin sensitization). | "The contact material is Tyco hydrogel RG-63 with slight proprietary variations and has been previously tested for material safety and biocompatibility to: Cytotoxicity study – ISO 10993-5, Skin irritation study - ISO 10993-10, Skin sensitization study - ISO 10993-10. There were no changes to the formulation for the new intended use." (Implied successful completion based on original testing of material). |
| Shelf life | "18 Months in unopened pouch." (This is a stated characteristic rather than a performance measure against a predicate in this summary document, but implies it meets expected criteria for stability). |
| No new concerns regarding safety or effectiveness compared to predicate device. | "The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes are substantially equivalent to the predicate device... There are no new concerns regarding safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "bench testing" that included electrode impedance measurements and gel uniformity inspection. However, the specific sample size used for these tests is not provided in this 510(k) summary. The data provenance is implied to be from internal laboratory testing conducted by Rochester Electro-Medical, Inc. or an affiliated testing facility. It is prospective testing, performed specifically for this submission.
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 submission. The device is a physical electrode, and its performance is evaluated against engineering specifications and comparison to a predicate device, not through expert-labeled data for a diagnostic algorithm.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation is based on bench testing of physical and electrical properties, not on expert review of ambiguous cases.
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
This information is not applicable. The device is a physical electrode, not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by engineering measurements (e.g., electrode impedance, physical dimensions, material composition) and biocompatibility testing standards (ISO 10993 series). The ultimate "ground truth" for regulatory approval relies on demonstrating substantial equivalence to a predicate device that has already been deemed safe and effective based on similar scientific and engineering principles.
8. The sample size for the training set
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as in point 8.
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