(41 days)
No
The device description and intended use clearly describe a physical, non-electronic accessory for cleaning surgical tools. There is no mention of software, data processing, or any technology that would involve AI or ML.
No
The device is described as an electrosurgical accessory used to clean cautery blades, not to directly treat or diagnose a medical condition in a patient. It is a tool for maintaining the functionality of another surgical instrument.
No
This device is designed to clean cautery blades during surgical procedures to maintain functionality, not to diagnose medical conditions or provide diagnostic information.
No
The device is a physical product made of polyurethane foam, textile abrasive, and adhesive, designed to be used as an accessory to an electrosurgical pencil. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
- Device Function: The described device is a Cautery Tip Cleaner. Its function is to physically clean a surgical instrument (a cautery blade) during a surgical procedure. It does not interact with or analyze any biological specimens from the patient.
- Intended Use: The intended use clearly states it's an "electrosurgical accessory to clean uncoated cautery blades." It's used on the instrument, not on the patient or their specimens.
- Patient Contact: The description explicitly states, "This product does not come in contact with the patient." This is a key differentiator from most IVDs, which involve patient specimens.
Therefore, the Cautery Tip Cleaner falls under the category of a surgical accessory or instrument cleaner, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
510(k) Summary
510(k) Owner: Xodus Medical, Inc. Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: 724-337-5500 Fax: 724-337-0555 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a wavy line, possibly symbolizing water or movement. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
Page 2.1
510(k) Number_