(68 days)
Not Found
No
The device is a conductive and abrasive gel for EEG/EP recordings, and the description focuses on its physical properties and composition, with no mention of AI or ML.
No
The device is a conductive and abrasive gel used to reduce impedance during EEG/EP recordings for diagnostic purposes, not for treating a disease or condition.
No
Justification: This device is a conductive and abrasive gel used to prepare the skin and facilitate electrical conductivity for EEG/EP recordings. It is an accessory to diagnostic devices (EEG instruments) by improving signal quality, but it does not independently perform diagnosis or provide diagnostic information.
No
The device is a conductive and abrasive gel, which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for facilitating electrical signal transmission during EEG/EP recordings by preparing the skin and acting as a conductor. This is a physical function related to the recording process, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the physical properties and composition of the gel, emphasizing its role in reducing impedance and conducting electrical signals. It doesn't mention any analysis of biological samples or diagnostic interpretation.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is a medical device used in conjunction with other equipment (EEG instruments) for a diagnostic procedure (EEG/EP recording), but it is not an IVD itself.
N/A
Intended Use / Indications 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 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.
Product codes
GYB
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.
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, Electrophysiological
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the GT5 conductive & abrasive gel were established and the substantial equivalence determination was supported by a series of performance testing, including biocompatibility testing, shelf life testing, and physical property testing.
Biocompatibility: The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards. This biocompatibility evaluation establishes the biological safety for the GT5 conductive & abrasive gel.
Shelf life testing: 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 results of the parameters evaluated (appearance, color, odor, pH, impedance and conductivity) comply with the pass/fail criteria.
Physical property testing: GT5 conductive & abrasive gel is tested internally for appearance, color, odor, pH, impedance and conductivity on a regular basis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
pH range: 6.5-7.5
Impedance: 0.2K Ohm or less
Conductivity: 18.0+/-0.5 mS/cm
Predicate Device(s)
K111717, K190050, K970694, K885306
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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
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,
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
| Enterprise Center, Special No.1, Guanggu Avenue, East Lake | |
| High-tech Development Zone, Wuhan, CHINA 430074 | |
| Contact person: | Yarong Liu |
| Title: | Manager |
| E-mail: | lyr@gtsensor.com |
| Tel: | +86-27-88185488 |
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
4
| 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.
5
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
(this submission) | Electro-Gel | Tech Dots – Adhesive and
Conductive Gel | Comparison |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K111717 | K190050 | - |
| Product Code | GYB | GYB | GYB | Same |
| Indications 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. | Electro-Gel is intended for use in
clinical and research EEG/EP
recordings from humans. The
Electro-Gel 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 | The core of the "indications
for use" of the subject
device is the same to
predicate devices, which is
to reduce the impedance to
the skin without affecting
the use of EEG
equipments. The slight
differences in description
will not raise any safety or
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,
Sodium chloride,
Water,
Methylparaben,
Propylparaben,
Sodium Carboxymethyl cellulose,
Alkyl indican,
Aluminum Oxide | Glycerin,
Sodium Chloride,
Water,
Methylparaben,
Propylparaben,
Aragun T-1998,
Potassium Bitartrate | Water,
Glycerol,
Polyacrylate copolymer,
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
10993 | Test in accordance with ISO
10993 | Test in accordance with ISO
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
subject device is a little
different from predicate
device, but the difference is
slight, and it is close to the
pH value of human skin
surface, the pH is closed to
7 (neutral). So the slight
differences in description
will not raise any safety or
effectiveness issue. |
| Impedance | 0.2K Ohm or less | 0.5K Ohm or less | 80±10 Ohm | The value of impedance of
the subject device is a little
bigger than the predicate
device (K192606), but
much less than the |
| | | | | predicate device
(K111717). No new
questions of safety or
effectiveness are raised. |
| Conductivity | $18.0\pm0.5$ mS/cm | - | 2 mS/cm | The subject device has a
higher value of conductivity
comparing to the predicate
device (K190050), this is
an advantage, as the gel
results to be more
conductive than the
predicate device.
Considering that, no new
questions of safety or
effectiveness are raised. |
| Characteristics | Salt Base
Non-irritating
Non toxic | Salt Base
Non-irritating
Non toxic | Salt Base
Non-irritating
Non toxic | Same |
6
7
8
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
(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
of use | Electrophysiological | Not publicly available | Not publicly available | - |
| Intended user | Neurologists | Not publicly available | Not publicly available | - |
| Target patient | Adult and children | Not publicly available | Not publicly available | - |
| Where used | Topically on intact skin | Not publicly available | Topically on healthy, intact skin | Same |
| Thickening agent | Sodium Carboxymethyl cellulose,
Glycerin | Not publicly available | Sodium Polyacrylate,
1,2-Propanediol | Equivalent to predicates |
| Composition | Glycerin,
Sodium chloride,
Water,
Methylparaben,
Propylparaben,
Sodium Carboxymethyl cellulose,
Alkyl indican,
Aluminum Oxide | Not publicly available | Water,
Aluminum Oxide,
1,2-Propanediol,
Sodium Polyacrylate,
Methylparaben,
Propylparaben,
FD&C Blue 1,
FD&C Red 40,
FD&C Yellow 5 | Although the specific
materials of subject device
are not the same as
predicate devices, but both
the materials for the subject
device and for the
predicate device have
substantially equivalent
function (for solvent, gel
forming, moisturizing,
preservative, abrasive
particles) in the process of
producing the gel, so these
differences do not raise
different issue of safety or
effectiveness. |
| Abrasive particle | Aluminum Oxide | Not publicly available | Aluminum Oxide | Same |
| Sterilization
method | Provide non sterile | Not publicly available | Not publicly available | - |
| Shelf-life | 3 years | Not publicly available | 3 years | Same |
| Chemical Safety | No OSHA PEL | Not publicly available | No OSHA PEL | Same |
| Preservative | Methylparaben, Propylparaben | Not publicly available | Methylparaben, Propylparaben | Same |
| Biocompatibility | Test in accordance with ISO | Not publicly available | Not publicly available | - |
| | 10993 | | | |
| Single Use | Yes | Yes | Yes | Same |
| pH range | 6.5-7.5 | Not publicly available | Not publicly available | - |
| Impedance | 0.2 K Ohm or less | Not publicly available | Not publicly available | - |
| Conductivity | 18.0±0.5 mS/cm | Not publicly available | Not publicly available | - |
| Characteristics | Salt Base
Non-irritating
Non toxic | Not publicly available | Non toxic | Same |
9
10
11
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 device.
12
7. Performance Testing
The safety and effectiveness of the GT5 conductive & abrasive gel were established and the substantial equivalence determination was supported by a series of performance testing, including biocompatibility testing, shelf life testing, and physical property testing.
Biocompatibility
The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards. This biocompatibility evaluation establishes the biological safety for the GT5 conductive & abrasive gel.
Shelf life testing
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 results of the parameters evaluated (appearance, color, odor, pH, impedance and conductivity) comply with the pass/fail criteria.
Physical property testing
GT5 conductive & abrasive gel is tested internally for appearance, color, odor, pH, impedance and conductivity on a regular basis.
8. CONCLUSION
The device comparison and the results of the above listed performance testing indicate that the GT5 conductive & abrasive gel is substantially equivalent to the predicate devices, and the minor differences does not raise any different issues of safety or effectiveness.