Tech Dots - Adhesive and conductive gel

K190050 · Spes Medica Srl · GYB · Jul 19, 2019 · Neurology

Device Facts

• Record ID: K190050
• Device Name: Tech Dots - Adhesive and conductive gel
• Applicant: Spes Medica Srl
• Product Code: GYB · Neurology
• Decision Date: Jul 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Tech Dots are pre-formed conductive gel dots used as an interface between human skin and external electrodes during EEG/EP recordings. The gel, composed of water, glycerol, polyacrylate co-polymer, and potassium chloride, acts as a conductor to lower electrical impedance, facilitating improved signal acquisition. Used by neurologists in clinical and research settings, the device is applied topically to intact skin. The output is an electrical connection that enables the recording of electrophysiological signals. The device benefits patients by ensuring high-quality signal transmission for diagnostic or research purposes.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed non-cytotoxicity, non-irritation, and non-sensitization. Mechanical/electrical testing validated shelf-life (ASTM F1980-16) and electrical performance (ANSI/AAMI EC12:2000/(R)2015), with AC impedance (80 ± 10 Ohm) and DC offset voltage meeting safety limits.

Technological Characteristics

Conductive gel dots (11mm diameter, 2.5mm height, 0.14g). Composition: Water, Glycerol, Polyacrylate co-polymer, Potassium chloride. Non-sterile. Shelf-life: 3 years. Electrical: 2 mS/cm conductivity, 80 ± 10 Ohm impedance at 10Hz. Packaging: Aluminum/PET/PE. Complies with ANSI/AAMI EC12:2000/(R)2015 for electrical performance and ISO 10993 for biocompatibility.

Indications for Use

Indicated for use in clinical and research EEG/EP recordings in adults and children to reduce impedance between the scalp and recessed electrodes.

Regulatory Classification

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.

Predicate Devices

• Electro-Gel (K111717)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;"></span> </span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <span style="text-decoration: underline;"></span> </span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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| Image: Globe logo | Tech Dots – Conductive gel | REV. | 5 | Date<br>REV. | 19.07.2019 |
|--------------------|------------------------------------------------------------------------------|-------------|---|--------------|------------|
| 510(k) Summary | | | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091<br>Battipaglia (SA) | | | | |
| | | Page 1 of 6 | | | |

# 510(k) Summary

| Manufacturer's Name: | Spes Medica S.r.l.<br>via Europa (Zona Ind.le), 84091 Battipaglia (SA) - Italy |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Giorgio Facco<br>Quality 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-Gel<br>510(k) number: K111717 |
| Device Description: | Tech Dots are conductive gel dots to be used with external electrodes as the<br>conductor between skin and electrode and to reduce impedance between the<br>electrode surface and the skin.<br>A single Tech Dot has a 11 ± 1 mm diameter, 2.5 ± 0.5 mm high, and weights 0.14 ±<br>0.01 g.<br>It's characterized by clear colour, no crystallization, no flocculation, no adverse smell,<br>brightness.<br>Tech Dots function is of conductor between the electrode used and the patient's skin<br>and of getting the impedance lower for a better recording of the signal. Tech Dots<br>are for use with external electrodes only.<br>Tech Dot is made of Potassium Chloride as conductor, combined with thickening<br>agents and humectants, all in an aqueous solvent.<br>The composition is the following:<br>Water, Glycerol (vegetable origin), Polyacrylate co-polymer (proprietary), Potassium<br>chloride |

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 | Date<br>REV. | 19.07.2019 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---|--------------|------------|
| Traditional 510(k) | Spes Medica S.r.I. Via Europa , Zona Industriale – 84091<br>Battipaglia (SA) | 510(k) Summary | | | |
| Page 2 of 6 | | | | | |
| Intended Use: | The Conductivity is 2 mS/cm<br>Shelf life of TechDots is 3 years if stored properly in sealed aluminum pouch and at<br>the limits of temperature indicated on the labeling<br>Tech Dots are intended for use in clinical and research EEG/EP recordings from<br>humans. They are used with external electrodes as the conductor between the scalp<br>and recessed electrodes to reduce impedance between the electrode surface and<br>the skin | | | | |
| Technological Comparison: | The Tech Dots consist in conductive gel dots laid on a siliconized PET support. The<br>characteristics of Tech Dots are substantially equivalent to the predicate device. No<br>new questions of safety or effectiveness are raised.<br>Tech Dots employ the same technological characteristics as the predicate device<br>with just different design of packaging: the predicate device is provided in jar (dot). | | | | |
| | To support the technological comparison the ingredients, pH, impedance, weight<br>and conductivity of the TechDots were evaluated internally and compared to the<br>predicate device.<br>Both devices are water based with salt as conductive material and with thickening<br>agents (Glycerin is used for both the products). TechDots do not contain any<br>preservatives. | | | | |
| | The pH of the TechDot is comparable to the Predicate: the pH evaluated by Spes<br>Medica 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 below<br>in 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 – 84091<br>Battipaglia (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 research<br>EEG/EP recordings from humans. It is used with<br>external electrodes as the conductor between the scalp<br>and the (recessed) electrodes. It also reduces<br>impedance (resistance to alternating current) between<br>the electrode surface and the skin. | Tech Dots are intended for use in clinical and research<br>EEG/EP recordings from humans. They are used with<br>external electrodes as the conductor between the<br>scalp and recessed electrodes to reduce impedance<br>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 (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 | Date<br>REV. | 19.07.2019 |
|--------------------|------------------------------------------------------------------------------|------|---|--------------|------------|
| 510(k) Summary | | | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091<br>Battipaglia (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. Both<br>materials are validated. |

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| Image: Globe logo | Tech Dots – Conductive gel | REV. | 5 | Date<br>REV. | 19.07.2019 |
|--------------------|------------------------------------------------------------------------------|----------------|---|--------------|------------|
| | | 510(k) Summary | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091<br>Battipaglia (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 | Date<br>REV. | 19.07.2019 |
|--------------------|------------------------------------------------------------------------------|----------------|---|--------------|------------|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091<br>Battipaglia (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.