(79 days)
Not Found
No
The device description and intended use clearly describe a conductive gel, which is a passive material and does not involve AI or ML technology. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device, Quik gel, is described as a conductive gel intended to enhance electrical conductivity and facilitate electrode adherence. It's used in conjunction with electrodes, likely for diagnostic or monitoring purposes, rather than directly providing a therapeutic effect itself. The predicate devices are also conductive gels.
No
Explanation: The device, "Quik gel," is described as enhancing electrical conductivity and helping electrodes adhere to the patient. Its intended use is to facilitate the transmission of signals between electrodes and the skin, which is a supportive function for various procedures, but not a diagnostic one itself. Diagnostic devices actively generate information about a patient's condition, whereas this gel is an accessory to such processes.
No
The device description clearly states it is a "jellylike mass" consisting of physical components, indicating it is a physical substance, 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 to enhance electrical conductivity and electrode adhesion to the skin. This is a physical function related to the application of electrodes for various medical procedures (like ECG, EEG, etc.), not for examining specimens in vitro (outside the body).
- Device Description: The description lists components that facilitate conductivity and adhesion, not reagents or materials used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on specimen analysis.
The device is clearly intended for external application to the skin to improve the performance of electrodes, which is a function of a medical device, but not an IVD. The predicate devices listed (Conductive Gel, TEN20 Conductive) also support this conclusion, as they are also conductive gels used with electrodes, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
GYB
Device Description
A jellylike mass consisting of salts combined with carbohydrate thickening agent, hypo-allergenic organic emollient, anti-fungal agents all in a aqueous solvent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K033052 (pg 1 of 1)
510(k) SUMMARY V.
| Submitted by: | Compumedics USA, Ltd.
7850 Paseo Del Norte
El 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 Gel
K022006
TEN20 Conductive
K883149 |
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
1
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.
2
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
3
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