CAUTERY TIP CLEANER, MODEL 30500

K053433 · Xodus Medical, Inc. · GEI · Jan 19, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053433
• Device Name: CAUTERY TIP CLEANER, MODEL 30500
• Applicant: Xodus Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The disposable Cautery Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

Device Story

Disposable 2" x 2" polyurethane foam pad with textile abrasive layer and adhesive backing; includes radiopaque strip for x-ray detectability. Used in sterile field (e.g., mayo stand) during surgery. Clinician scratches electrosurgical cautery tip against abrasive surface to remove eschar buildup; ensures continued device functionality. Single-use, sterile, non-patient-contact accessory.

Clinical Evidence

Bench testing only.

Technological Characteristics

2" x 2" x 0.25" polyurethane foam pad; textile abrasive layer; adhesive backing; radiopaque strip for x-ray detection. Sterile, single-use.

Indications for Use

Indicated for use as an electrosurgical accessory to clean uncoated cautery blades of electrosurgical pencils during surgical procedures to remove eschar build-up. Not for patient contact.

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.

Predicate Devices

• Electro-Cautery Tip Cleaner (K030339)

Submission Summary (Full Text)

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# 510(k) Summary

510(k) Owner: Xodus Medical, Inc. Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: [phone] Fax: [phone] Contact: Craig Kaforey (President)

Establishment Registration Number: 2530138

Date Prepared: 12/05/05

#### Device Information

Trade/Device Name: Cautery Tip Cleaner Common Name: Cautery Tip Cleaner Classification Name: Electrosurgical, Cutting & Coagulation Device & Accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Regulatory Class: II

#### Predicate Device

Device Name: Electro-Cautery Tip Cleaner Common Namc: Cautery Tip Cleaner 510 (k) Number: K030339 510 (k) Owner: Aspen Surgical Products Classification Name: Electrosurgical, Cutting & Coagulation Device & Accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Regulatory Class: II

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# 510(k) Summary

#### Device Description

The disposable Cautery Tip Cleaner is a small 2" x 2" square polyurethane foam pad which features a textile abrasive layer with an adhesive backing. A radiopaque strip within the adhesive makes the device x-ray detectable. The adhesive backing allows for universal placement as well as allowing the device to remain in place while the tip of the electrosurgical cauterization device is "scratched" on the abrasive surface to remove eschar buildup.

### Intended Use

The disposable Cautery Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

#### Technological Characteristics Comparison

Xodus Medical Inc.'s cautery tip cleaner has the same physical characteristics, material and design as the predicate device. The Xodus Medical Cautery Tip Cleaner is a 2" X 2" x ¼' square polyurethane foam pad featuring a textile abrasive layer with an adhesive backing containing an x-ray detectable radiopaque strip. Aspen Surgicals' Cautery Tip Cleaner has the same design but is a little smaller measuring 1½" x 1½" x ¼". Both the predicate device and Xodus Medicals' device are used for the cleaning of electrosurgical cautery tips during surgical procedures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

Mr. Craig Kaforey President Xodus Medical, Inc. 702 Prominence Drive New Kensington, Pennsylvania 15068

Re: K053433

Trade/Device Name: Cautery Tip Cleaner Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 5, 2005 Received: December 9, 2005

Dear Mr. Kaforey:

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 Mav 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 electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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#### Page 2 - Mr. Kaforey

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" (21 CFR 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/industry/support/index.html.

Sincerely yours,

fabare Ryelund

Mark N. Melkerson Acting 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

K053433 510(k) Number (if known):

Device Name: Cautery Tip Cleaner

Indications for Use:

The disposable Cautery Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODF.)

Darbare Buelunds for LNM

Division of General, Restorative. and Neurological Devices

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510(k) Number_