Medline Electrocautery Pencil

K190643 · Medline Industries, Inc. · GEI · May 6, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190643
• Device Name: Medline Electrocautery Pencil
• Applicant: Medline Industries, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medline Electrocautery Pencil is intended to be used in electrosurgical procedures to remove tissue and control bleeding by use of high frequency electrical current. The device can be used for both cutting and coagulating.

Device Story

Medline Electrocautery Pencil is a handheld electrosurgical accessory; used by surgeons in clinical/OR settings. Device delivers high-frequency electrical current to a tip to perform tissue cutting and coagulation. Operates by connecting to an electrosurgical generator; energy is controlled by the surgeon via buttons or switches on the pencil handle. Provides localized thermal effect to achieve hemostasis and tissue resection. Benefits include precise tissue management and bleeding control during surgical procedures.

Clinical Evidence

bench testing only

Technological Characteristics

Handheld electrosurgical pencil; utilizes high-frequency electrical current for cutting and coagulation. Connects to standard electrosurgical generators. Form factor is a pen-like handle with integrated controls.

Indications for Use

Indicated for use in electrosurgical procedures to remove tissue and control bleeding via high frequency electrical current in patients requiring surgical cutting or coagulation.

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 shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

May 6, 2019

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

Re: K190643

Trade/Device Name: Medline Electrocautery Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 21, 2019 Received: March 13, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,

for

Jennifer R. Stevenson Acting Director Division of General Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Devices

Enclosure

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## Indications for Use

510(k) Number (if known) K190643

Device Name Medline Electrocautery Pencil

Indications for Use (Describe)

The Medline Electrocautery Pencil is intended to be used in electrosurgical procedures to remove tissue and control bleeding by use of high frequency electrical current. The device can be used for both cutting and coagulating.

Type of Use (Select one or both, as applicable):

| <span style="text-decoration: underline;"></span> | Prescription Use (Part 21 CER 801 Subpart D) |
|---------------------------------------------------|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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