(84 days)
LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin.
LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin. It is supplied in 250 grams dispensers with a 3-year shelf life.
The provided text is a 510(k) Summary for a medical device called LEKTROGEL™ (Model LK3001), an electroconductive gel media. This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting full performance study data with specific acceptance criteria and detailed study designs.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims identical performance to the predicate device. Therefore, the "acceptance criteria" appear to be defined by the performance characteristics of the predicate device. However, no specific quantitative acceptance criteria or numerical performance metrics are provided for either device.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (LEKTROGEL™) |
|---|---|---|
| Indications for use | Identical to predicate device (Contact Conductive Adhesive Gel) | Identical |
| Target population | Identical to predicate device | Identical |
| Design | Identical to predicate device | Identical |
| Materials | Identical to predicate device | Identical |
| Performance | Identical to predicate device | Identical |
| Sterility | Identical to predicate device | Identical |
| Biocompatibility | Identical to predicate device | Identical |
| Mechanical safety | Identical to predicate device | Identical |
| Chemical safety | Identical to predicate device | Identical |
| Anatomical sites | Identical to predicate device | Identical |
| Human factors | Identical to predicate device | Identical |
| Energy used and/or delivered | Identical to predicate device | Identical |
| Compatibility with environment | Identical to predicate device | Identical |
| Standards met | Identical to predicate device | Identical |
| Electrical safety | Identical to predicate device | Identical |
| Thermal safety | Identical to predicate device | Identical |
| Radiation safety | Identical to predicate device | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set or a study with a sample size in the traditional sense of clinical or performance testing. The basis for the substantial equivalence claim is the asserted "identical" nature of the device to its predicate. There's no mention of country of origin for test data, or whether it was retrospective or prospective, as no such study is detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no independent test set with performance evaluation is described, there's no mention of experts establishing ground truth for such a set. The "ground truth" for the submission is the established characteristics and performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring expert adjudication is described.
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 device is an electroconductive gel, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant and not discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (gel), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is the established characteristics, safety, and performance of the legally marketed predicate device (Contact Conductive Adhesive Gel from Parker Laboratories, Inc., 510k # K852956). The entire submission argues that LEKTROGEL™ is "IDENTICAL" to this predicate.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or evidence provided to prove the device meets acceptance criteria is based on a comparative analysis of technological characteristics between LEKTROGEL™ and a predicate device (Contact Conductive Adhesive Gel from Parker Laboratories, Inc., 510k # K852956). The submission asserts that the new device is "IDENTICAL" to the predicate device across all critical technological characteristics, including indications for use, design, materials, performance, sterility, biocompatibility, safety, and other factors.
The acceptance criteria are implicitly defined as matching all characteristics of the predicate device. By demonstrating identity, the manufacturer aims to prove substantial equivalence, thereby meeting the regulatory requirements without needing to conduct extensive independent performance studies that would be required for a novel device. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates the FDA accepted the claim of identical characteristics as sufficient evidence for substantial equivalence in this context.
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510(k) Summary As Required by 21 section 807.92 ( c )
| 1-Submitter Name: | Mansour Consulting LLC | |
|---|---|---|
| 2-Address: | 1308 Morningside Park DrAlpharetta, GA 30022 USA | JUN 13 2003 |
| 3-Phone: | (678) 908-8180 | |
| 4-Fax: | (425) 795-9341 | |
| 5-Contact Person: | Jay Mansour | |
| 6-Date summary prepared: | March 18th, 2003 | |
| 7-Device Trade or Proprietary Name: | LEKTROGEL™ | |
| 8-Device Common or usual name: | EKG diagnosis gel (LK3001) | |
| 9-Device Classification Name: | Media, electroconductive | |
| 10-Substantial Equivalency is claimed against the following device: | • Contact Conductive Adhesive Gel from Parker Laboratories, Inc. |
- 510k # K852956
11-Description of the Device:
LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin. It is supplied in 250 grams dispensers with a 3-year shelf life.
12-Intended use of the device: (refer to FDA form attached)
LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is IDENTICAL to the predicate device. Refer to the explanations within the main submission.
| FDA file reference number | 510k # K852956 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
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KO30887
| Sterility | Identical |
|---|---|
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with its wings forming a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2003
Mr. Jay Mansour Inmed LTDA C/O: Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022
Re: K030887
Trade/Device Name: LEKTROGEL ™ Model LK3001 Regulation Numbers: 21 CFR 882.1275 Regulation Names: Electroconductive Media Regulatory Class: Class II Product Codes: GYB Dated: March 18, 2003 Received: March 21, 2003
Dear Mr. Mansour:
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
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Page 2 - Mr. Jay Mansour
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. 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark A. Milliken
Celia 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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Page / of /
KO30887 510(k) Number (if known):
Device Name: LEKTROGEL TM
Indications for Use:
LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
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(Optional Format 3-10-98)
Mark N Milburn
(Division S Division of General, Restorative and Neurological Devices
510(k) Number_
§ 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).