(231 days)
Endy Gel is an Electroconductive gel media used with external electrode to reduce the impedance to alternating current) of the contact between the electrode surface and the skin.
EndyMed's EndyGel™ is an Electroconductive gel media used with external electrode to enhance electrical conductivity by reducing the impedance (resistance to alternating current) of the radiofrequency signals path from the electrode surface between the electrode surface and the skin.
This document is a 510(k) Pre-Market Notification for EndyGel™, an electroconductive gel media. The purpose is to demonstrate substantial equivalence to a predicate device, Electro-Gel (K111717).
Here's the analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (EndyGel™) |
|---|---|
| Device Class: Class II | Class II |
| Classification Panel: Neurology | Neurology |
| Product Code: GYB | GYB |
| Regulation Description: Electroconductive media | Electroconductive media |
| Regulation number: 21 CFR 882.1275 | 21 CFR 882.1275 |
| Indications for Use: Electro-Gel device is intended for use with external electrodes as the conductor between the scalp and the electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin. | EndyMed's EndyGel™ is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin. |
| Principles of Operation: Functions as a conductor between the skin and the electrodes. Intended to be used prior to Handpiece's electrodes placement to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin. The energy is then transferred via the gel to the patient's tissue. | Same as predicate. |
| Body contact: Intact Skin | Intact Skin |
| Biocompatibility: Complies with requirements of ISO 10993-1, including: Cytotoxicity (ISO 10993-5), Irritation and Sensitization (ISO 10993-10) | Complies with requirements of ISO 10993-1, including: Cytotoxicity (ISO 10993-5), Irritation and Sensitization (ISO 10993-10) |
| Sterilization: Provided non-sterile | Provided non-sterile |
| Shelf life: 3 years | 2 years |
| Impedance (at 1 MHz): 549.71 | 527.68 |
| Conductive material: Water (Aqua) with immersed Sodium chloride | Water (Aqua) with immersed Triethanolamine |
| Composition: Water (solvent), Sodium Chloride (preservative), Aragum T-1998 (thickener), Potassium Bitartrate (Stabilizer), Glycerin (lubricant), Methylparaben (preservative), Propylparaben (preservative) | Water (solvent), Carbomer (gel forming), Triethanolamine (Buffering), Methylisothiazolinone and Methylcloroisothiazolinone (preservative) |
| pH: 6.99 | 7.15-7.33 |
Study proving device meets acceptance criteria:
The safety and efficacy of the EndyGel™ were established by a series of performance tests, including biocompatibility testing, electrical performance, and stability.
- Biocompatibility testing:
- Complies with ISO 10993-1, ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Sensitization).
- Electrical Performance testing:
- The impedance of EndyGel™ (527.68 at 1 MHz) is within 4% of the predicate device (549.71).
- Stability testing:
- The EndyGel™ has a shelf life of 2 years (compared to 3 years for the predicate).
- pH:
- The pH of EndyGel™ (7.15-7.33) is within 2.2% of the predicate device (6.99).
The document states that "The difference in total impedance and in pH between the two gels is negligible and do not impact the safety and effectiveness of the EndyGel." Also, "V&V and compliance testing, including: Biocompatibility testing, Electrical Performance testing and Stability testing, were successfully conducted and did not raise any new safety questions or identify any new risks."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set or the data provenance for the performance tests (biocompatibility, electrical performance, stability). It broadly refers to "performance tests" that were successfully conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an electroconductive gel, and the "ground truth" for its performance is based on quantifiable physical and chemical properties and standard biological safety tests, not human expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication.
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
Not applicable. This is not an AI/software device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device. Performance is based on intrinsic physical, chemical, and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the acceptance criteria for this device are established by:
- Industry standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 13485, ISO 14971-1).
- Quantifiable physical properties (impedance, pH, shelf life).
- Chemical composition analysis.
- Comparison to an existing legally marketed predicate device with a history of safe and effective use.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).