GT5 conductive & abrasive gel

K212787 · Wuhan Greentek Pty , Ltd. · GYB · Nov 8, 2021 · Neurology

Device Facts

• Record ID: K212787
• Device Name: GT5 conductive & abrasive gel
• Applicant: Wuhan Greentek Pty , Ltd.
• Product Code: GYB · Neurology
• Decision Date: Nov 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.

Device Story

GT5 conductive & abrasive gel is an electroconductive medium used in clinical and research EEG/EP recordings. It functions as both a skin-prep agent and a conductive interface between the scalp and external electrodes. The gel contains abrasive particles (aluminum oxide) to lightly abrade the skin, reducing impedance to alternating current and improving signal quality. It is applied topically to intact skin by neurologists or technicians. The gel facilitates the transfer of brain electrical activity to EEG instruments. It is a non-sterile, single-use product available in various container sizes (syringe, tube, bottle). Benefits include improved signal quality through reduced skin-electrode impedance. It is not for use with stimulating electrodes.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility testing per ISO 10993, shelf-life validation per ASTM F1980-16, and physical property testing (appearance, color, odor, pH, impedance, and conductivity). All results met pre-defined pass/fail criteria.

Technological Characteristics

Salt-based (NaCl) conductive gel containing glycerin, water, methylparaben, sodium carboxymethyl cellulose, alkyl indican, and aluminum oxide (abrasive). pH 6.5-7.5; impedance ≤0.2K Ohm at 10Hz; conductivity 18±0.5 mS/cm. Non-sterile, single-use, topical application. Shelf life 3 years.

Indications for Use

Indicated for use in clinical and research EEG/EP recordings in adults and children. Used as a skin-prep gel to abrade skin surface to reduce impedance and as a conductor between scalp and external electrodes. Contraindicated for use with stimulating 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

• Eletro-Gel (K111717)
• Tech Dots – Adhesive and Conductive Gel (K190050)
• Model 1700, HydroPrep (K970694)
• NuPrep (K885306)

Submission Summary (Full Text)

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November 8, 2021

Wuhan Greentek Pty Ltd. Yarong Liu Manager Room 03-2, Floor 3, Dingye Building, Phase III, International Enterprise Center, Special No. 1, Guanggu Ave Wuhan, 430074 China

Re: K212787

Trade/Device Name: GT5 conductive & abrasive gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: Class II Product Code: GYB Dated: August 13, 2021 Received: September 1, 2021

Dear Yarong Liu:

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,

For Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine 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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## Indications for Use

510(k) Number (if known) K212787

Device Name GT5 conductive & abrasive gel

#### Indications for Use (Describe)

GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92 Prepared Date: 13 August 2021

## 1. Submitter's Information

The submitter of this pre-market notification is:

| Name: | Wuhan Greentek Pty Ltd. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Room 03-2, Floor 3, Dingye Building, Phase III, International<br>Enterprise Center, Special No.1, Guanggu Avenue, East Lake<br>High-tech Development Zone, Wuhan, CHINA 430074 |
| Contact person: | Yarong Liu |
| Title: | Manager |
| E-mail: | [e-mail] |
| Tel: | [phone] |

#### 2. Device Identification

| Trade/Device Name: | GT5 conductive & abrasive gel |
|----------------------|-------------------------------|
| Common Name: | Electroconductive Media |
| Requlations: | 21 CFR 882.1275 |
| Classification Name: | Media, Electroconductive |
| Regulation Class: | Class II |
| Product Code: | GYB |

## 3. Predicate Device

| 510(K) number: | K111717 |
|----------------------|-----------------------------------------|
| Device Name: | Eletro-Gel |
| Manufacturer: | Electro-Cap International, Inc. |
| Regulations: | 21 CFR 882.1275 |
| Classification Name: | Media, Electroconductive |
| Regulation Class: | Class II |
| Product Code: | GYB |
| | |
| 510(K) number: | K190050 |
| Device Name: | Tech Dots – Adhesive and Conductive Gel |
| Manufacturer: | Spes Medica S.r.l. |
| Regulations: | 21 CFR 882.1275 |
| Classification Name: | Media, Electroconductive |
| Regulation Class: | Class II |
| Product Code: | GYB |

510(K) number: K970694 Device Name: Model 1700, HydroPrep

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| Manufacturer: | Physiometrix, Inc. |
|----------------------|--------------------------|
| Regulations: | 21 CFR 882.1275 |
| Classification Name: | Media, Electroconductive |
| Regulation Class: | Class II |
| Product Code: | GYB |
| 510(K) number: | K885306 |
| Device Name: | NuPrep |
| Manufacturer: | WEAVER & COMPANY |
| Regulations: | 21 CFR 870.2360 |
| Classification Name: | Media, Electroconductive |
| Regulation Class: | Class II |
| Product Code: | DRX |

## 4. Device Description

GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. The electrical activity of the brain is transferred to the electrode and then to EEG instruments and computer equipment. GT5 conductive & abrasive gel is for use with external electrodes only.

GT5 conductive & abrasive gel is an off-white color, opaque, no adverse smell gel with sodium chloride as the conductive material combined with thickening agents, emulsifiers, humectants, preservatives and abrasive particles. With the abrasive particles in the gel, the gel can be also used as skin preparation by being applied to the skin surface to rub the skin lightly in order to reduce skin impedance efficiently and increase signal quality recorded with EEG electrodes.

The composition of GT5 conductive & abrasive gel is as follows:

Glycerin, Sodium chloride, Water, Methylparaben, Sodium Carboxymethyl cellulose, Alkyl indican, Aluminum Oxide.

The pH range is 6.5-7.5, and the impedance at 10Hz is 0.2K Ohm or less. The conductivity is 18±0.5 mS/cm. GT5 conductive & abrasive gel is available in the following sizes: a pre-filled syringe of 20g, a tube of 100g, a bottle container of 473g, a bottle container of 946g. Shelf life is 3 years if stored properly, i.e. kept with containers tightly closed and at room temperature.

#### 5. Indication for use

GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.

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#### 6. Comparison to Predicate Device

Table 1 Compares features and specifications of the GT5 conductive & abrasive gel under review to the predicates Electro-Gel and Tech Dots -Adhesive and Conductive Gel.

| Feature | GT5 conductive & abrasive gel<br>(this submission) | Electro-Gel | Tech Dots – Adhesive and<br>Conductive Gel | Comparison |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K111717 | K190050 | - |
| Product Code | GYB | GYB | GYB | Same |
| Indications for use | GT5 conductive & abrasive gel is<br>intended for use in clinical and<br>research EEG/EP recordings<br>from humans. It can be not only<br>used as skin-prep gel to abrade<br>the skin surface lightly in order to<br>reduce impedance (resistance to<br>alternating current) efficiently, but<br>also used as the conductor<br>between the scalp and the<br>external electrodes to reduce<br>impedance between the<br>electrode surface and the skin.<br>GT5 conductive & abrasive gel is<br>not intended for use with<br>stimulating electrodes. | Electro-Gel is intended for use in<br>clinical and research EEG/EP<br>recordings from humans. The<br>Electro-Gel is used with external<br>electrodes as the conductor<br>between the scalp and the<br>(recessed) electrodes. It also<br>reduces impedance (resistance<br>to alternating current) between<br>the electrode surface and the<br>skin. | Tech Dots are intended for use in<br>clinical and research EEG/EP<br>recordings from humans. They<br>are used with external electrodes<br>as the conductor between the<br>scalp and recessed electrodes to<br>reduce impedance between the<br>electrode surface and the skin | The core of the "indications<br>for use" of the subject<br>device is the same to<br>predicate devices, which is<br>to reduce the impedance to<br>the skin without affecting<br>the use of EEG<br>equipments. The slight<br>differences in description<br>will not raise any safety or<br>effectiveness issue. |
| Regulation Name | Media, Electroconductive | Media, Electroconductive | Media, Electroconductive | Same |
| Regulation | 882.1275 | 882.1275 | 882.1275 | Same |
| Number | | | | |
| Environment of use | Electrophysiological | Electrophysiological | Electrophysiological | Same |
| Intended user | Neurologists | Neurologists | Neurologists | Same |
| Target patient | Adult and children | Adult and children | Adult and children | Same |
| Where used | Topically on intact skin | Topically on intact skin | Topically on intact skin | Same |
| Conductive material | Salt (NaCl) | Salt (NaCl) | Salts (KCl) | Same |
| Thickening agent | Sodium Carboxymethyl cellulose, Glycerin | Aragun, Glycerin | Polyacrylate copolymer, Glycerol | Equivalent to predicates |
| Composition | Glycerin,<br>Sodium chloride,<br>Water,<br>Methylparaben,<br>Propylparaben,<br>Sodium Carboxymethyl cellulose,<br>Alkyl indican,<br>Aluminum Oxide | Glycerin,<br>Sodium Chloride,<br>Water,<br>Methylparaben,<br>Propylparaben,<br>Aragun T-1998,<br>Potassium Bitartrate | Water,<br>Glycerol,<br>Polyacrylate copolymer,<br>Potassium chloride | Although the specific materials of subject device are not exactly the same as predicate devices, but both the materials for the subject device and for the predicate devices have substantially equivalent function (for solvent, gel forming, moisturizing, preservative) in the process of producing the gel, so these differences do not raise different issue of safety or effectiveness. |
| Sterilization | Provide non sterile | Provide non sterile | Provide non sterile | Same |
| method | | | | |
| Shelf-life | 3 years | 1 year | 3 years | Same |
| Chemical Safety | No OSHA PEL | No OSHA PEL | No OSHA PEL | Same |
| Preservative | Methylparaben, Propylparaben | Methylparaben, Propylparaben | No preservative | Same |
| Biocompatibility | Test in accordance with ISO<br>10993 | Test in accordance with ISO<br>10993 | Test in accordance with ISO<br>10993 | Same |
| Cytotoxicity | Yes | Yes | Yes | Same |
| Irritation | Yes | Yes | Yes | Same |
| Sensitization | Yes | Yes | Yes | Same |
| Single Use | Yes | Yes | Yes | Same |
| pH range | 6.5-7.5 | 4.5-6 | 4-5 | Although the pH of the<br>subject device is a little<br>different from predicate<br>device, but the difference is<br>slight, and it is close to the<br>pH value of human skin<br>surface, the pH is closed to<br>7 (neutral). So the slight<br>differences in description<br>will not raise any safety or<br>effectiveness issue. |
| Impedance | 0.2K Ohm or less | 0.5K Ohm or less | 80±10 Ohm | The value of impedance of<br>the subject device is a little<br>bigger than the predicate<br>device (K192606), but<br>much less than the |
| | | | | predicate device<br>(K111717). No new<br>questions of safety or<br>effectiveness are raised. |
| Conductivity | $18.0\pm0.5$ mS/cm | - | 2 mS/cm | The subject device has a<br>higher value of conductivity<br>comparing to the predicate<br>device (K190050), this is<br>an advantage, as the gel<br>results to be more<br>conductive than the<br>predicate device.<br>Considering that, no new<br>questions of safety or<br>effectiveness are raised. |
| Characteristics | Salt Base<br>Non-irritating<br>Non toxic | Salt Base<br>Non-irritating<br>Non toxic | Salt Base<br>Non-irritating<br>Non toxic | Same |

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All the differences do not affect the safety and effectiveness of the subject device which is concluded after all the required testing, so there are no safety and effectiveness issues relating to the subject system.

Table 2 Compares features and specifications of the GT5 conductive & abrasive gel under review to the prep and NuPrep.

| Feature | GT5 conductive & abrasive gel<br>(this submission) | Model 1700 HydroPrep | NuPrep | Comparison |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K970694 | K885306 | - |
| | | | 510(K) Exempt | |
| Product Code | GYB | GYB | DRX | Same |
| Indications for use | GT5 conductive & abrasive gel is | HydroPrep and Nuprep are skin | Abrasive skin prepping gel | The core of the "indications |
| | intended for use in clinical and | preparation materials that are | intended for use when a | for use" of the subject |
| | research EEG/EP recordings | design for use by EEG | reduction of skin impedance | device is the same to |
| | from humans. It can be not only | Technicians. Both substances are | would enhance a test result | predicate devices, which is |
| | used as skin-prep gel to abrade | applied to the skin surface with a | e.g.: EEG exams, evoked | to reduce the impedance to |
| | the skin surface lightly in order to | cotton swab in order to reduce skin | potential procedures, ECG | the skin without affecting |
| | reduce impedance (resistance to | impedance and increase signal | stress tests, cardiac | the use of EEG |
| | alternating current) efficiently, but | quality recorded with EEG | rehabilitation monitoring, and | equipments. The slight |
| | also used as the conductor | electrodes. HydroPrep is not | cardiac catheter monitoring | differences in description |
| | between the scalp and the | intended for use with stimulating | exam procedures. | will not raise any safety or |
| | external electrodes to reduce | electrodes. | | effectiveness issue. |
| | impedance between the | | | |
| | electrode surface and the skin. | | | |
| | GT5 conductive & abrasive gel is | | | |
| | not intended for use with | | | |
| | stimulating electrodes. | | | |
| Regulation Name | Media, Electroconductive | Media, Electroconductive | Media, Electroconductive | Same |
| Regulation | 882.1275 | 882.1275 | 870.2360 | Same |
| Number | | | | |
| Environment<br>of use | Electrophysiolog…