(190 days)
Tech Dots are intended for use in clinical and research EEG/EP recordings from humans. They are used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin
Tech Dots are conductive gel dots to be used with external electrodes as the conductor between skin and electrode and to reduce impedance between the electrode surface and the skin. A single Tech Dot has a 11 ± 1 mm diameter, 2.5 ± 0.5 mm high, and weights 0.14 ± 0.01 g. It's characterized by clear colour, no crystallization, no flocculation, no adverse smell, brightness. Tech Dots function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. Tech Dots are for use with external electrodes only. Tech Dot is made of Potassium Chloride as conductor, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Glycerol (vegetable origin), Polyacrylate co-polymer (proprietary), Potassium chloride. The pH range is 4.1 ± 0.1, and Impedance at 10Hz is 80 ± 10 Ohm. The Conductivity is 2 mS/cm. Shelf life of TechDots is 3 years if stored properly in sealed aluminum pouch and at the limits of temperature indicated on the labeling.
This document is a 510(k) premarket notification for a medical device called "Tech Dots - Conductive gel," submitted by Spes Medica S.r.l. to the FDA. The submission aims to demonstrate that Tech Dots are substantially equivalent to a legally marketed predicate device (Electro-Gel, K111717).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "Tech Dots - Conductive gel" are primarily established through demonstrating substantial equivalence to the predicate device and meeting relevant performance standards for electroconductive media. The reported performance is based on internal testing.
| Characteristic / Acceptance Criteria | Reported Device Performance (Tech Dots) | Comparison to Predicate (Electro-Gel) |
|---|---|---|
| Intended Use (Clinical and research EEG/EP recordings from humans, as conductor between scalp/skin and recessed electrodes to reduce impedance) | Intended for use in clinical and research EEG/EP recordings from humans. Used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. | Same as predicate device. |
| Regulation Name (Media, Electroconductive) | Media, Electroconductive | Same as predicate device. |
| Regulation Number (882.1275) | 882.1275 | Same as predicate device. |
| Environment of Use (Electrophysiological) | Electrophysiological | Same as predicate device. |
| Intended User (Neurologists) | Neurologists | Same as predicate device. |
| Target Patient (Adult and children) | Adult and children | Same as predicate device. |
| Where Used (Topically on intact skin) | Topically on intact skin | Same as predicate device. |
| Conductive Material (Salt) | Potassium Chloride (a salt) | Predicate uses NaCl (Sodium Chloride). The document states "Salt (NaCl)" for Tech Dots here, but later specifies "Potassium Chloride." The discussion indicates "Same as predicate device" for "Conductive material: Salt (NaCl)", but this appears to be a slight inconsistency as the detailed composition lists Potassium Chloride. However, the overall characteristic of "Salt Base" is maintained and considered equivalent. |
| Thickening Agent | Sodium Acrylates Copolymers, Glycerin | Predicate uses Aragum, Glycerin. Considered "Equivalent to predicate device." |
| Sterilization Method (Provide non sterile) | Provide non sterile | Same as predicate device. |
| Shelf-life | 3 years | More than predicate device (1 year). This is a difference, but not one that raises new questions of safety or effectiveness, as demonstrated by the aging test. |
| Chemical Safety (No OSHA PEL) | No OSHA PEL | Same as predicate device. |
| Preservative | No preservative | Predicate uses Methylparaben and Propylparaben. Considered "Equivalent to predicate device." This difference (absence of preservatives) is presented as not raising new safety/effectiveness concerns. |
| Biocompatibility Testing (Test in accordance with ISO 10993) | Test in accordance with ISO 10993 (ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation and skin sensitization) | Same as predicate device. Pass/Fail criteria met for cytotoxicity, irritation, and sensitization. |
| Cytotoxicity | Yes (positive result meaning "Pass") | Same as predicate device. |
| Irritation | Yes (positive result meaning "Pass") | Same as predicate device. |
| Sensitization | Yes (positive result meaning "Pass") | Same as predicate device. |
| Single Use | Yes | Same as predicate device. |
| pH | 4 ± 0.1 (detailed description on page 3) / 4-5 (summary table) | Predicate: 4.5-6.0. Considered "Comparable to predicate device." Internal evaluation by Spes Medica shows 4-5, which overlaps with the lower end of the predicate's range. |
| Impedance | 80 ± 10 Ohm (at 10Hz) | Predicate: 0.5 K Ohm (500 Ohm). Tech Dots impedance (80 ± 10 Ohm) is "Less than predicate device," which is usually a desirable characteristic for conductive gel, indicating better conductivity. This doesn't raise new safety/effectiveness concerns. Tested according to ANSI/AAMIEC12:2000/(R)2015, not exceeding 2000 Ohm. |
| Weight (per dot where applicable) | 0.14 ± 0.01 g per Dot | Predicate: 16, 32 or 128 ounces (presumably in jars). This is a difference in "Different packaging and shape," but not related to inherent performance for substantial equivalence. |
| Characteristics (Salt Base, Non-irritating, Non toxic) | Salt Base, Non-irritating, Non toxic | Equivalent to predicate device. |
| Packaging Material | Aluminum/PET/PE | Predicate: PE. "Different ways of packaging. Both materials are validated." |
| Aging Test (Shelf Life) | Clear color, no crystallization, no flocculation, no adverse smell, brightness after accelerated aging. Impedance complies with ANSI/AAMIEC12:2000/(R)2015. | Demonstrates meeting 3-year shelf life. |
| Long Term Conductivity (Electrical performance over time) | DC Offset voltage ≤ 100mV (pass). AC Impedance ≤ 2000 Ohm (pass). Parameters comply with ANSI/AAMIEC12:2000/(R)2015 limits even after 7 days testing. | Bench testing successfully demonstrates the product's ability to maintain electrical performance within specified standards over time. |
2. Sample Size Used for the Test Set and Data Provenance
The document details performance testing (Biocompatibility and Bench Testing) for the Tech Dots device itself, rather than a clinical study involving human subjects or image data for AI.
- Sample Size for Testing: The specific sample sizes for tests like aging, pH, impedance, and long-term conductivity are not explicitly stated in the provided text (e.g., "how many units were tested"). It mentions "Spes Medica Tech Dots are tested internally for pH, impedance on a regular basis," implying ongoing quality control, but not a specific sample size for a formal study dataset. For biocompatibility, it indicates the gel "Gel" as 'Component Name' being tested.
- Data Provenance: The studies are described as "Performance Testing was performed on device characteristics of Spes Medica Tech Dots," and "Spes Medica Tech Dots are tested internally." This implies the data is prospective (generated for this submission/validation) and produced by the manufacturer (Spes Medica S.r.l.) in Italy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This document describes the validation of a conductive gel, not an AI-powered diagnostic device that requires expert-established ground truth from medical images. Therefore, the concept of "experts" establishing "ground truth" for a test set (e.g., radiologists for disease presence) is not applicable here. The "ground truth" for the device's performance is established by technical specifications and recognized industry standards (e.g., ISO 10993, ANSI/AAMIEC12). The "experts" involved would be the engineers and quality assurance personnel at Spes Medica S.r.l. who conducted the tests and verified compliance with these standards. Their specific qualifications are not detailed beyond "Quality Assurance and Regulatory Affairs" for the Official Correspondent.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI device or a clinical study requiring human interpretation of medical data, there is no need for an adjudication method. The test results are objective measurements against defined standards.
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 device, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or needed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device. Its performance is inherent to its physical and chemical properties as a conductive gel.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for validating "Tech Dots - Conductive gel" is based on:
- Performance Standards: Recognized international and national standards for medical devices and electroconductive media (e.g., ISO 10993 for biocompatibility, ANSI/AAMIEC12 for electrical performance/impedance).
- Predicate Device Characteristics: The established characteristics and cleared performance of the legally marketed predicate device (Electro-Gel, K111717) serve as a comparative ground truth for demonstrating substantial equivalence of intended use and technological characteristics.
- Defined Chemical and Physical Specifications: Internal specifications for pH, conductivity, viscosity, appearance, etc., which are then verified through laboratory testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI model, there is no ground truth established for it.
§ 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).