(32 days)
The IHS TM-Wick Electrode is intended for non-invasive use in acquiring electrocochleography (ECochG) data on patients of all ages, for the purpose of monitoring and recording in the diagnosis of cochlear and auditory disorders. The electrodes are biocompatible, non-sterile, single patient use, disposable devices.
IHS TM-Wick Electrodes are non-invasive, cutaneous devices used in the acquisition of electrocochleography (ECochG) signals from the tympanic membrane for the purpose of monitoring and recording. These extra-tympanic electrodes are inserted into the ear canal to make contact with the tympanic membrane for acquiring the ECochG data. The electrodes are biocompatible, non-sterile, single patient use, disposable devices.
The IHS TM-Wick Electrode is a non-invasive, TM ECochG electrode which is biocompatible, prewired, non-sterile, for single patient use, and disposable. The electrode features a fine Silver/Silver Chloride (Ag/AgCl) wire attached to a soft cotton tip (i.e., wick) pre-soaked in a highly conductive, low impedance electrode gel/saline solution, which is hypoallergenic, non-irritating, bacteriostatic, water soluble, non-staining, and non-gritty. The conductive gel reduces the impedance of the contact between the electrode surface and the skin. The Ag/AgCl wire is encased inside of a thin, soft, flexible silicone tubing which is resilient, stretchable, non-corrosive, and inert. This tubing's small size and characteristics provide for ease of insertion and removal, as well as patient comfort and safety.
The other end of the Ag/AgCl wire is permanently adhered to an electrode cable lead wire. The solder joint is then covered by a heat shrink tubing so as not to allow exposure of the lead wire, as well as to provide strain relief. The electrode cable lead is terminated on the opposite end using two industry standard 1.5mm (0.06in) molded DIN safety socket connectors, which are subsequently used to interface to the monitoring device. For electrical safety, these connectors do not allow accidental connection to an A/C wall electrical outlet.
The provided 510(k) summary for the IHS TM-Wick Electrode does not describe a clinical study in the traditional sense, with specific acceptance criteria related to accuracy, sensitivity, or specificity of diagnostic performance for the device itself. Instead, it relies on demonstrating substantial equivalence to a predicate device (Bio-Logic TM-ECochGtrode, K944314) by comparing technological characteristics and ensuring compliance with established safety standards.
Therefore, the "acceptance criteria" and "device performance" in this context refer to the device meeting the requirements established for substantial equivalence through a comparison of its specifications and materials with those of the predicate device, and demonstrating compliance with relevant biocompatibility and electrical safety standards.
Here's an breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence submission for an electrode, the "acceptance criteria" are predominantly about meeting safety and functional equivalence to the predicate device, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Implied from comparison and standards) | Reported Device Performance (IHS TM-Wick Electrode) |
|---|---|
| Intended Use (Same as predicate) | Non-invasive acquisition of ECochG data on patients of all ages, for monitoring & recording in the diagnosis of cochlear and auditory disorders. (Same as predicate) |
| Indications for Use (Same as predicate) | Monitoring & recording in the diagnosis of cochlear and auditory disorders. (Same as predicate) |
| Target Population (Same as predicate) | All Ages (Same as predicate) |
| Design Equivalence/Functionality | Construction: Thin, bare, conducting Ag/AgCl wire insulated inside flexible silicone tubing, with end attached to a soft cotton tip pre-soaked in conductive gel/saline solution. Pre-wired/Assembled: Fully assembled and pre-wired in individual packaging. Connectivity: Electrode cable lead terminated with two industry standard 1.5mm molded DIN safety socket connectors for interface to monitoring device. Size: Silicone tubing is approximately 1/3 smaller in size diameter than the predicate's tubing (implying enhanced ease of insertion/removal and patient comfort). |
| Materials Equivalence/Biocompatibility | Silicone tubing, cotton wick tip, conductive gel/saline, Silver/Silver-Chloride wire, electrode cable lead, molded DIN safety socket connectors. Biocompatibility: All patient-contacting components meet ISO 10993-1, -5 (Cytotoxicity), -10 (Skin irritation & sensitization) standards. |
| Sterility (Same as predicate) | None Required (Non-sterile). (Same as predicate) |
| Safety - Electrical | Electrode lead wire assembly is in compliance with FDA 21 CFR 898 (Performance Standard for Electrode Lead Wires and Patient Cables). DIN safety connectors prevent accidental connection to A/C electrical outlets. |
| Safety - Patient Comfort | Silicone tubing's small size and characteristics provide for ease of insertion and removal, as well as patient comfort and safety. Conductive gel is hypoallergenic, non-irritating, bacteriostatic, water soluble, non-staining, and non-gritty. |
| Disposable/Single Use (Same as predicate) | Single patient use, disposable devices. (Same as predicate) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a test set or data provenance in the way one would for a clinical performance study involving patient data. The basis for safety and effectiveness is a comparison to a predicate device and compliance with established standards (ISO 10993, 21 CFR 898). No human subject data (prospective or retrospective) is mentioned in relation to proving the performance of the device for ECochG signal acquisition in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No clinical test set with a ground truth established by experts is described in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication method is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe a MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. This is a physical electrode, not a software algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic accuracy. The "ground truth" here is the established safety and performance profile of the predicate device and the biocompatibility and electrical safety standards. The new device is shown to be equivalent or compliant with these.
8. The Sample Size for the Training Set
Not applicable. No training set is described as this is not an AI/ML device related to diagnostic accuracy based on a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is described.
In summary, this 510(k) submission for the TM-Wick Electrode focuses on demonstrating substantial equivalence to a legally marketed predicate device (Bio-Logic TM-ECochGtrode) by comparing their intended use, indications, target population, design, materials, and safety characteristics. The "study" involves a detailed comparison of specifications and confirmation of compliance with relevant engineering and biocompatibility standards, rather than a clinical trial with performance metrics like sensitivity and specificity.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).