The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

Device Description

The disposable cautery tip cleaner is a 50mm by 50mm small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.

AI/ML Overview

The document discusses the Key Surgical® Cautery Tip Cleaner and its substantial equivalence to a predicate device. It addresses performance data primarily for sterility, functional aspects, and packaging, rather than diagnostic accuracy or AI assistance.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Requirement	Specification	Reported Performance
Sterility	SAL 10-6	Pass
Functional Requirements	Product adhesive backing must be easily removed	Pass
Packaging (Vacuum leak test)	ISO 11607, ASTMF 1980	Pass
Packaging (Dye penetration test)	ASTMF 1929, ASTMF 1980	Pass
Packaging (Agar contact-attack test)	ISO 11607, ASTMF 1980	Pass
Packaging (Tensile seal strength test)	ASTMF 88, ASTMF 1980	Pass
Packaging (Accelerated aging test)	ASTMF 1980, ISO 11737	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each test or the data provenance (country of origin, retrospective/prospective). The tests listed are for device manufacturing and packaging quality, not for clinical performance on patients directly.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests performed are engineering and manufacturing quality control tests (e.g., sterility, adhesive function, packaging integrity), not clinical studies requiring expert interpretation of results to establish ground truth for a diagnostic or AI-assisted device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically relevant for clinical studies where multiple experts evaluate cases and discrepancies need to be resolved. This document describes tests for product quality where results are determined by standardized methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a "Cautery Tip Cleaner," a physical accessory for surgical tools, not a diagnostic imaging device or an AI-assisted tool requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or software; it is a physical medical accessory.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests described are the established specifications and methods outlined in recognized standards (e.g., ISO 11137-2, ISO 11607, ASTM F series). For example:

Sterility: Ground truth is defined by the SAL 10-6 specification, confirmed using ISO 11137-2 methods.
Functional (adhesive removal): Ground truth is the observable characteristic of being "easily removed," likely assessed against internal engineering standards.
Packaging: Ground truth is the successful adherence to specific physical properties and integrity tests as defined by the cited ISO and ASTM standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable. Since there is no training set, there is no ground truth to establish for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2015

Key Surgical Incorporated Ms. Amy Yanta Regulatory Affairs 8101 Wallace Road Eden Prairie, Minnesota 55344

Re: K151222

Trade/Device Name: Key Surgical® Cautery Tip Cleaner Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 6, 2015 Received: May 13, 2015

Dear Ms. Yanta:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151222

Device Name

Key Surgical® Cautery Tip Cleaner

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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Image /page/3/Picture/0 description: The image shows the logo for Key Surgical. The logo consists of a blue circle with a white "K" inside, followed by the word "KEY" in gray and "SURGICAL" in blue. There is a registered trademark symbol to the right of the word "SURGICAL".

SECTION 5: 510(k) Summary

Key Surgical® Cautery Tip Cleaners

The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements as required by 21 CFR 807.92.

Date:	May 06, 2015
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Administrative Information

Submitter:	Key Surgical, Inc.
Establishment Registration Number:	2183785
Contact Person:	Amy Yanta8101 Wallace RoadEden Prairie, MN 55344Regulatory Affairs952.288.2269

Device Identification

Device Name:	Cautery Tip Cleaners
Common Name:	Cautery Tip Cleaners
Device Classification Name:	Electrosurgical cutting and coagulation device and accessories
Device Classification:	Class II
Panel:	General & Plastic Surgery
Classification Regulation:	878.4400
Product Code:	GEI
Performance Standards:	No Recognized Consensus Standards
Predicate Device:	Cautery Tip Cleaner, cleared on 01/19/2006 via K053433
Trade Name:	None

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Image /page/4/Picture/0 description: The image shows the logo for Key Surgical. The logo consists of a blue circle with a white "K" inside, followed by the word "KEY" in gray and "SURGICAL" in blue. There is a registered trademark symbol to the right of the word "SURGICAL".

SECTION 5: 510(k) Summary

Device Description

Statement of Intended Use

Substantial Equivalence Discussion

The Key Surgical Cautery Tip Cleaner predicate device is the Xodus Medical, Inc., K053433, cleared on January 19, 2006. The following illustrates the similarities in the product design.

	Proposed Device:	Predicate Device:Cautery Tip Cleaner
Property or Characteristic	Key Surgical® Cautery Tip Cleaner
Intended Use/Indications for Use	A device intended to be used to aid	The disposable Cautery Tip Cleaner
	in the removal of eschar buildup on	is a single use sterile product. Its
	electrosurgical blades during	intended use is as an electrosurgical
	surgical procedures. The cautery tip	accessory to clean uncoated cautery
	cleaner is sterile and a single use	blades that are part of an
	device.	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.
Conditions of Use	Single Use, disposable	Single Use, disposable
Materials	Aluminum oxide 'gravel', with a	Square polyurethane foam pad
	polyurethane foam pad and	featuring a textile abrasive layer
	polyurethane adhesive layer	with an adhesive backing containing
	containing a barium monofilament	an x-ray detectable radiopaque
	for x-ray detection	strip.
Adhesive back	Yes, for universal placement and aid	Yes, for universal placement and aid
	in keeping the device in place	in keeping the device in place

Table 2: Substantial Equivalence

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Image /page/5/Picture/0 description: The image shows the logo for Key Surgical. The logo consists of a blue circle with a white "K" inside, followed by the text "KEY" in gray and "SURGICAL" in blue. A registered trademark symbol is located to the right of the word "SURGICAL".

SECTION 5: 510(k) Summary

Sterility	Provided Sterile	Provided Sterile
Principle of Operation	The cautery tip cleaner is used toaid in the removal of eschar onelectrosurgical blades duringsurgical procedures	Electrosurgical accessory to cleanuncoated blades that are part of aelectrosurgical pencil
Interface with ElectrosurgicalCauterization Blade	The Cautery Tip Cleaner does notimpact the function of theelectrosurgical cauterization blades.It is not required for use with theblades, but an accessory that aids inthe removal of eschar buildup.	Used for the cleaning ofelectrosurgical cautery tips duringsurgical procedures.

Performance Data Summary

Table 3: Performance Data Summary of Cautery Tip Cleaners

Requirement	Specification	Method	Result
Sterility	SAL 10-6	ISO 11137-2	Pass
FunctionalRequirements	Product adhesive backing mustbe easily removed	Removed adhesive backingfrom tip cleaner	Pass
Packaging	Vacuum leak test	ISO 11607, ASTMF 1980	Pass
	Dye penetration test	ASTMF 1929, ASTMF 1980	Pass
	Agar contact-attack test	ISO 11607, ASTMF 1980	Pass
	Tensile seal strength test	ASTMF 88, ASTMF 1980	Pass
	Accelerated aging test	ASTMF 1980, ISO 11737	Pass

Substantial Equivalence Conclusion

The differences between the Cautery Tip Cleaners and the predicate device do not constitute a new intended use, and do not raise different questions of safety and effectiveness. They are both designed to aid in the cleaning of electrosurgical blades during surgical procedures.

The Cautery Tip Cleaners are substantially equivalent to the predicate device cleared under K053433.

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Regulation Number and Section

§ 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.