(79 days)
The Quik gel is intended to enhance electrical conductivity by facilitating transmission of the electrode-to-skin interface. It also helps the electrodes adhere to the patient.
A jellylike mass consisting of salts combined with carbohydrate thickening agent, hypo-allergenic organic emollient, anti-fungal agents all in a aqueous solvent.
This is a 510(k) premarket notification for an electroconductive gel, not an AI-powered medical device. Therefore, most of the requested information regarding acceptance criteria for device performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test sets is not applicable.
Here's an explanation of why and what information can be extracted:
- Device Type: The device, "Quik Gel, EEG Electrodeconductive Gel," is a physical substance (a gel) intended to improve electrical conductivity and electrode adherence. It's not a software algorithm or an AI-powered diagnostic tool.
- 510(k) Pathway: A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate, often through comparisons of technological characteristics, intended use, and performance where applicable. For a simple gel, this typically involves material compatibility, electrical impedance measurements, and safety (e.g., biocompatibility, non-irritancy).
Here's a breakdown of the relevant (and irrelevant) sections:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the provided text: The document explicitly states, "The Quik-Gel® has the same technological characteristics as the predicate device." For this type of device and 510(k), explicit performance acceptance criteria and reported numerical performance in the submission document are usually not detailed for simple physical characteristics when substantial equivalence is claimed based on identical characteristics to a predicate. The focus is on the equivalence rather than novel performance metrics.
- Likely underlying criteria (not in text): For electroconductive gels, typical performance criteria would involve:
- Electrical Impedance/Conductivity: The gel should reduce skin impedance sufficiently for its intended use (e.g., EEG). This would be measured in ohms.
- Adherence Properties: The gel should facilitate electrode adhesion.
- Biocompatibility/Safety: Non-irritating, non-cytotoxic, non-sensitizing.
- Stability: Shelf life, consistency over time.
- pH: Within a range suitable for skin contact.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable: No clinical or performance test sets in the context of diagnostic accuracy, which would require AI-specific data. The comparison is based on the inherent characteristics of the gel being "the same" as predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable: No ground truth establishment for diagnostic performance as this is an electroconductive gel, not a diagnostic AI.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: No test set involving human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth for diagnostic performance. The "ground truth" for this device would be its physical and chemical properties matching or performing equivalently to predicate devices for its intended function (e.g., impedance reduction, adherence).
8. The sample size for the training set
- Not Applicable: No training set for an AI model.
9. How the ground truth for the training set was established
- Not Applicable: No training set for an AI model.
Summary based on the provided text:
The provided documents describe a 510(k) clearance for an electroconductive gel based on substantial equivalence to predicate devices (K022006 Conductive Gel and TEN20 Conductive K883149). The core argument for acceptance is that the "Quik-Gel® has the same technological characteristics as the predicate device." This means the product is fundamentally similar in composition and function to existing, legally marketed gels, and therefore is presumed to be as safe and effective. No specific performance metrics or studies beyond this declaration of equivalence are detailed in the provided text.
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K033052 (pg 1 of 1)
510(k) SUMMARY V.
| Submitted by: | Compumedics USA, Ltd.7850 Paseo Del NorteEl Paso, TX 79912 |
|---|---|
| Contact Person: | Elvira Garcia |
| Date Prepared: | September 24, 2003 |
| Proprietary Name: | Quik Gel, EEG Electrodeconductive Gel |
| Common Name: | QuikGel® |
| Classification Name: | Electroconductive Media |
| Predicate Devices: | Conductive GelK022006TEN20 ConductiveK883149 |
A jellylike mass consisting of salts combined with Description of the Device: carbohydrate thickening agent, hypo-allergenic organic emollient, anti-fungal agents all in a aqueous solvent.
Intended Use of the Device: The Quik Gel® is intended for use when a reduction of skin impedance would enhance a test result. It also helps the Quik Cap electrodes adhere to the patient.
Technological Characteristics: The Quik-Gel® has the same technological characteristics as the predicate device.
K022006 Conductive Gel TEN20 Conductive K883149
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2003
Ms. Elvira Garcia Quality Assurance Manager Compumedics USA, Ltd. 7850 Paseo Del Norte El Paso, Texas 79912
Re: K033052 Trade/Device Name: Quik Gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: II Product Code: GYB Dated: September 24, 2003 Received: September 29, 2003
Dear Ms. Garcia:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Elvira Garcia
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Cclia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K033052 510(k) Number (if known):
Quik Gel _____________________________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: The Quik gel is intended to enhance electrical conductivity by
the for the first the first the fact and waisance from the natient to the Indications For Use." The Quik get is intention to onlines enom the patient to the facilitating transmission of the electrode-to-skin interface. It also helps the equipmont tectrodes adhere to the patient.
Prescription Use X (Part 21 CFR 801 Subpart D)
:
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
iriam C. Provost
(Division Sign-Off) (Division of General, Restorative DIVISIOn of Neurological Devices
510(k) Number K033052
§ 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).