(190 days)
Not Found
No
The device description and performance studies focus solely on the physical and electrical properties of a conductive gel, with no mention of data processing, algorithms, or any form of intelligent analysis.
No
Explanation: The device is intended to reduce impedance between the scalp and electrodes for EEG/EP recordings, which is a diagnostic function, not a therapeutic one.
No
The device description indicates that "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." Their function is to facilitate the recording of signals, not to interpret or diagnose. They are components that enable a diagnostic device (EEG/EP system) to function, but are not diagnostic themselves.
No
The device description clearly states that Tech Dots are conductive gel dots made of physical materials (Potassium Chloride, thickening agents, humectants, water) and have physical characteristics (diameter, height, weight, color, pH, impedance, conductivity). It is a physical component used in conjunction with electrodes, not a software program.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "clinical and research EEG/EP recordings from humans." This involves facilitating the electrical connection between the scalp and electrodes for measuring electrical activity in the brain. This is a direct interaction with the body for physiological measurement, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the physical properties and function of the conductive gel as a conductor and impedance reducer. It does not mention any analysis of biological samples or substances.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens such as blood, urine, tissue, etc., to provide information about a person's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis.
The device described is a medical device used in conjunction with other medical devices (electrodes and EEG/EP equipment) for physiological monitoring.
N/A
Intended Use / Indications for 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
Product codes
GYB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Adult and children
Intended User / Care Setting
Neurologists; Clinical and research EEG/EP recordings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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: Gel, Type of contact: Skin (Y), Blood (N), Tissue (N), Material: Water, Glycerol (vegetable origin), Polyacrylate co-polymer (proprietary), Potassium chloride. Contact duration: >24h,
§ 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).
0
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
1
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
2
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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3
| Image: Globe logo | Tech Dots – Conductive gel | REV. | 5 | Date
REV. | 19.07.2019 |
|--------------------|------------------------------------------------------------------------------|-------------|---|--------------|------------|
| 510(k) Summary | | | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091
Battipaglia (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 Facco
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
510(k) number: K111717 |
| Device Description: | 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.
4
| Image: Globe Logo | Tech Dots – Conductive gel | REV. | 5 | Date
REV. | 19.07.2019 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---|--------------|------------|
| Traditional 510(k) | Spes Medica S.r.I. Via Europa , Zona Industriale – 84091
Battipaglia (SA) | 510(k) Summary | | | |
| Page 2 of 6 | | | | | |
| Intended Use: | 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
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 | | | | |
| Technological Comparison: | The Tech Dots consist in conductive gel dots laid on a siliconized PET support. The
characteristics of Tech Dots are substantially equivalent to the predicate device. No
new questions of safety or effectiveness are raised.
Tech Dots employ the same technological characteristics as the predicate device
with just different design of packaging: the predicate device is provided in jar (dot). | | | | |
| | To support the technological comparison the ingredients, pH, impedance, weight
and conductivity of the TechDots were evaluated internally and compared to the
predicate device.
Both devices are water based with salt as conductive material and with thickening
agents (Glycerin is used for both the products). TechDots do not contain any
preservatives. | | | | |
| | The pH of the TechDot is comparable to the Predicate: the pH evaluated by Spes
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
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.
5
| 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 | ||||
| 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 | ||
| EEG/EP recordings from humans. It is used with | |||
| external electrodes as the conductor between the scalp | |||
| and the (recessed) electrodes. It also reduces | |||
| impedance (resistance to alternating current) between | |||
| the electrode surface and the skin. | 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 | 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 |
6
| Image: Globe Logo | Tech Dots – Conductive gel | REV. | 5 | Date
REV. | 19.07.2019 |
|--------------------|------------------------------------------------------------------------------|------|---|--------------|------------|
| 510(k) Summary | | | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091
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 |
| materials are validated. |
7
| Image: Globe logo | Tech Dots – Conductive gel | REV. | 5 | Date
REV. | 19.07.2019 |
|--------------------|------------------------------------------------------------------------------|----------------|---|--------------|------------|
| | | 510(k) Summary | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091
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,