LEKTROGEL, MODEL LK3001

K030887 · Inmed Ltda. · GYB · Jun 13, 2003 · Neurology

Device Facts

• Record ID: K030887
• Device Name: LEKTROGEL, MODEL LK3001
• Applicant: Inmed Ltda.
• Product Code: GYB · Neurology
• Decision Date: Jun 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2

Intended 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.

Device Story

LEKTROGEL™ is an electroconductive gel applied to skin at electrode sites; functions to reduce electrical impedance between electrode surface and patient skin; facilitates signal transmission for diagnostic procedures; supplied in 250g dispensers; used by clinicians in diagnostic settings; benefits patient by ensuring reliable electrical contact for EKG or similar monitoring.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological and performance comparisons to the predicate device.

Technological Characteristics

Electroconductive gel media; 250g dispenser form factor; 3-year shelf life. No specific materials or standards cited beyond functional equivalence to predicate.

Indications for Use

Indicated for use as an electroconductive medium to reduce impedance between external electrodes and skin during diagnostic procedures.

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

• Contact Conductive Adhesive Gel from Parker Laboratories, Inc. (K852956)

Submission Summary (Full Text)

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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 Dr<br>Alpharetta, GA 30022 USA | JUN 13 2003 |
| 3-Phone: | [phone] | |
| 4-Fax: | [phone] | |
| 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 |

6

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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 |

1

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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 [phone] . 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 [phone] or [phone] 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_