Medline Cautery Electrode (PTFE)

K173889 · Medline Industries, Inc. · GEI · Apr 9, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173889
• Device Name: Medline Cautery Electrode (PTFE)
• Applicant: Medline Industries, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medline PTFE Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures.

Device Story

Medline Cautery Electrode (PTFE) is an electrosurgical accessory used to cut and coagulate soft tissue. Device functions by delivering high-frequency electrical current to target tissue. Used in clinical settings by physicians during surgical procedures. PTFE coating reduces tissue adhesion to electrode tip. Device connects to standard electrosurgical generators. Output is thermal effect on tissue for cutting or hemostasis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical electrode with PTFE (polytetrafluoroethylene) coating. Designed for use with high-frequency electrosurgical generators. Class II device, product code GEI.

Indications for Use

Indicated for cutting and/or coagulating soft tissues during electrosurgical procedures. Prescription use only.

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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 9, 2018

Medline Industries, Inc. Mr. Matt Clausen Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K173889

Trade/Device Name: Medline Cautery Electrode (PTFE) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 27, 2018 Received: March 28, 2018

Dear Mr. Clausen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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## Page 2 - Mr. Matt Clausen

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K173889

Device Name Medline Cautery Electrode (PTFE)

Indications for Use (Describe)

The Medline PTFE Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
| <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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