ELECTRO-LUBE

K033880 · Mectra Labs, Inc. · GEI · Mar 10, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033880
• Device Name: ELECTRO-LUBE
• Applicant: Mectra Labs, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking. CAUTION: Federal law restricts this device to use by or at the direction of a physician.

Device Story

Electro-Lube is a single-patient-use topical agent applied to electrosurgical electrodes. Its primary function is to reduce tissue sticking to the electrode during electrosurgical cutting and coagulation procedures. Used in clinical settings by physicians or under their direction. The device acts as a lubricant to improve electrode performance and minimize tissue trauma during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical accessory (Product Code GEI) intended for application to electrodes to reduce sticking. Single-patient-use form factor.

Indications for Use

Indicated for use on electrosurgical electrodes to reduce sticking during surgical procedures. Restricted to use by or at the direction of a physician.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

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MAR 1 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles E. Allgood, Jr. Director, Admin. Support Division Mectra Labs, Inc. Highway 231 South 2 Quality Way Bloomfield, Indiana 47424

Re: K033880

Trade/Device Name: Electro-Lube Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 2, 2004 Received: March 2, 2004

Dear Mr. Allgood:

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Charles E. Allgood, Jr.

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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for 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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## Indications for Use

510(k) Number (if known): K033880

Device Name: Electro-Lube

Indications For Use:

Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.

The following is on our label:

CAUTION: Federal law restricts this device to use by or at the direction of a physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart ID) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C-Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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K033880 510(k) Number_