(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 19, 2019
Spes Medica S.r.l. Giorgio Facco Regulatory Affairs & Quality Assurance Via Europa - zona industriale Battipaglia (SA), 84091 It
Re: K190050
Trade/Device Name: Tech Dots - Conductive gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: May 23, 2019 Received: June 19, 2019
Dear Giorgio Facco:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190050
Device Name Tech Dots - Conductive gel
Indications for Use (Describe)
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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Image: Globe logo | Tech Dots – Conductive gel | REV. | 5 | DateREV. | 19.07.2019 |
|---|---|---|---|---|---|
| 510(k) Summary | |||||
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (SA) | ||||
| Page 1 of 6 |
510(k) Summary
| Manufacturer's Name: | Spes Medica S.r.l.via Europa (Zona Ind.le), 84091 Battipaglia (SA) - Italy |
|---|---|
| Official Correspondent: | Giorgio FaccoQuality Assurance and Regulatory Affairs |
| Telephone Number: | 0039 0828 614191 |
| Fax Number: | 0039 0828 341788 |
| Trade Names: | Tech Dots - Conductive gel |
| Common or Usual Name: | Conductive gel |
| Classification Name: | Media, Electroconductive |
| Device Class: | Class II |
| Product Code: | GYB |
| Classification Regulation: | 882.1275 |
| Predicate Device: | Electro-Gel510(k) number: K111717 |
| Device Description: | Tech Dots are conductive gel dots to be used with external electrodes as theconductor between skin and electrode and to reduce impedance between theelectrode 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 skinand of getting the impedance lower for a better recording of the signal. Tech Dotsare for use with external electrodes only.Tech Dot is made of Potassium Chloride as conductor, combined with thickeningagents and humectants, all in an aqueous solvent.The composition is the following:Water, Glycerol (vegetable origin), Polyacrylate co-polymer (proprietary), Potassiumchloride |
The pH range is 4.1 ± 0.1, and Impedance at 10Hz is 80 ± 10 Ohm.
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| Image: Globe Logo | Tech Dots – Conductive gel | REV. | 5 | DateREV. | 19.07.2019 |
|---|---|---|---|---|---|
| Traditional 510(k) | Spes Medica S.r.I. Via Europa , Zona Industriale – 84091Battipaglia (SA) | 510(k) Summary | |||
| Page 2 of 6 | |||||
| Intended Use: | The Conductivity is 2 mS/cmShelf life of TechDots is 3 years if stored properly in sealed aluminum pouch and atthe limits of temperature indicated on the labelingTech Dots are intended for use in clinical and research EEG/EP recordings fromhumans. They are used with external electrodes as the conductor between the scalpand recessed electrodes to reduce impedance between the electrode surface andthe skin | ||||
| Technological Comparison: | The Tech Dots consist in conductive gel dots laid on a siliconized PET support. Thecharacteristics of Tech Dots are substantially equivalent to the predicate device. Nonew questions of safety or effectiveness are raised.Tech Dots employ the same technological characteristics as the predicate devicewith just different design of packaging: the predicate device is provided in jar (dot). | ||||
| To support the technological comparison the ingredients, pH, impedance, weightand conductivity of the TechDots were evaluated internally and compared to thepredicate device.Both devices are water based with salt as conductive material and with thickeningagents (Glycerin is used for both the products). TechDots do not contain anypreservatives. | |||||
| The pH of the TechDot is comparable to the Predicate: the pH evaluated by SpesMedica is 4÷5. The impedance is 80 ± 10 Ohm, lower than the Predicate Device | |||||
| Substantial Equivalence: | Tech Dots are equivalent to the device cleared under K111717 as is presented belowin Table. |
It has been shown in this 510(k) submission that the differences between Tech Dots and the predicate device Electro-Gel do not raise any questions regarding its safety and effectiveness. The Tech Dots device is substantially equivalent to the predicate device as it has the same intended use and similar technological characteristics as the previously cleared predicate devices.
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| Image: Globe logo | Tech Dots – Conductive gel | REV. | 5 | Date REV. | 19.07.2019 |
|---|---|---|---|---|---|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (SA) | 510(k) Summary | |||
| Page 3 of 6 |
| Manufacturer | Electro-Cap international, Inc | Spes Medica S.r.l. | |
|---|---|---|---|
| Trade Name | Electro-Gel | Tech Dots | |
| 510(k) number | K111717 | K190050 | Discussion Differences |
| Product Code | GYB | GYB | |
| Indications for use | Electro-Gel is intended for use in clinical and researchEEG/EP recordings from humans. It is used withexternal electrodes as the conductor between the scalpand the (recessed) electrodes. It also reducesimpedance (resistance to alternating current) betweenthe electrode surface and the skin. | Tech Dots are intended for use in clinical and researchEEG/EP recordings from humans. They are used withexternal electrodes as the conductor between thescalp and recessed electrodes to reduce impedancebetween 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 (NaCl) | Salt (NaCl) | Same as predicate device |
| Thickening agent | Aragum, Glycerin | Sodium Acrylates Copolymers, Glycerin | Equivalent to predicate device |
| Sterilization method | Provide non sterile | Provide non sterile | Same as predicate device |
| Shelf-life | 1 year | 3 years | More than predicate device |
| Chemical Safety | No OSHA PEL | No OSHA PEL | Same as predicate device |
| Preservative | Methylparaben and Propylparaben | No preservative | Equivalent to predicate |
| Biocompatibility | Test in accordance with ISO 10993 | Test in accordance with ISO 10993 | Same as predicate device |
| Cytotoxicity | Yes | Yes | Same as predicate device |
| Irritation | Yes | Yes | Same as predicate device |
| Sensitization | Yes | Yes | Same as predicate device |
| Single Use | Yes | Yes | Same as predicate device |
| pH | $4.5÷6.0$ | $4÷5$ | Comparable to predicate device |
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| Image: Globe Logo | Tech Dots – Conductive gel | REV. | 5 | DateREV. | 19.07.2019 |
|---|---|---|---|---|---|
| 510(k) Summary | |||||
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (SA) | ||||
| Page 4 of 6 |
| Manufacturer | Electro-Cap international, Inc | Spes Medica S.r.l. | Discussion Differences |
|---|---|---|---|
| Trade Name | Electro-Gel | Tech Dots | |
| 510(k) number | K111717 | K190050 | |
| Product Code | GYB | GYB | |
| Impedance | 0.5K Ohm | $80 \pm 10$ Ohm | Less than predicate device |
| Weight | 16, 32 or 128 ounces | $0.14 \pm 0.01$ g per Dot | Different packaging and shape |
| Characteristics | Salt Base | Salt Base | Equivalent to predicate device |
| Non-irritating | Non-irritating | ||
| Non toxic | Non toxic | ||
| Packaging | PE | Aluminum/PET/PE | Different ways of packaging. Bothmaterials are validated. |
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| Image: Globe logo | Tech Dots – Conductive gel | REV. | 5 | DateREV. | 19.07.2019 |
|---|---|---|---|---|---|
| 510(k) Summary | |||||
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (SA) | Page 5 of 6 |
Summary of Performance Testing-Biocompatibility
Spes Medica Tech Dots are no invasive product, the Biocompatibility Evaluation testing summarized below was conducted on Tech Dots to demonstrate compliance of this product to the following standards:
- . ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
| Component Name | Type of contact | Material | ||
|---|---|---|---|---|
| Skin | Blood | Tissue | ||
| Gel | Y | N | N | Water, Glycerol (vegetable origin), Polyacrylate co-polymer (proprietary), Potassium chloride |
Contact duration: >24h, <30days
Performance Testing-Bench Testing
Performance Testing was performed on device characteristics of Spes Medica Tech Dots. This performance mechanical testing consisted of
- Aging test
The aim of this test was to validate the shelf life of 3 years through an accelerated aging procedure according to the ASTM F1980-16 "Standard guide for accelerated aging of sterile barrier system for medical devices").
Pass/fail criteria was fixed at the beginning of the test and all the result of the parameters evaluated (colour, odour, crystallization, flocculation, brightness, pH) comply according to the pass/fail criteria: TechDots should be characterized by clear colour, no crystallization, no flocculation, no adverse smell, brightness.
Also the impedance was evaluated and was found out to comply according to the ANSI/AAMIEC12:2000/(R)2015.
. Long term conductivity
The aim of this test was to evaluate the electrical performances (in terms of AC Impedance and DC Offset Voltage) of the product TechDots over time.
Pass/fail criteria were set at the beginning of the test according to ANSI/AAMIEC12:2000/(R)2015 : the DC Offset voltage should not exceed 100mV and AC Impedance should not exceed 2000 Ohm. The parameters of AC Impedance and DC Offset Voltage comply according to the ANSI/AAMIEC12:2000/(R)2015 limits even after 7 days testing.
Spes Medica Tech Dots are tested internally for pH, impedance on a regular basis
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| Image: Globe logo | Tech Dots – Conductive gel | REV. | 5 | DateREV. | 19.07.2019 |
|---|---|---|---|---|---|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (SA) | 510(k) Summary | |||
| Page 6 of 6 |
Conclusion
All performance testing conducted as outlined above demonstrate that the device meets the performance and design specifications.
§ 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).