Bovie Cauteries are single use, battery operated devices. The device is activated by pressing the green button on the cautery body and is deactivated by releasing the button (in the default position, the cautery does not operate). Once the button is pressed, an internal circuit is completed that directs power from an internal battery to the cautery tip which in turn heats. The heated tip is introduced to the surgical site and the heat vaporizes the water component in blood/tissue, causing a clot that halts the bleeding.

AI/ML Overview

The provided text is a 510(k) summary for the Bovie® Cautery Device. It mostly focuses on describing the device, its intended use, and comparing it to predicate devices, particularly highlighting safety enhancements. It does not contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from the provided text. The device is a cautery device, not an AI/algorithm-based diagnostic tool, so many of the questions related to AI performance metrics, ground truth, and expert studies are not applicable in this context.

Here's a breakdown of what can be inferred or directly stated from the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document describes the device, its function, technology, and intended use, and compares its characteristics (materials, energy source, design for safety, disposal instructions, sterility) to predicate devices. It does not provide specific performance metrics (e.g., specific coagulation time, temperature output, or other quantitative performance benchmarks) or acceptance criteria for those metrics.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a medical device submission for a physical, battery-operated cautery device, not a software algorithm tested on a dataset. There is no "test set" in the context of diagnostic data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. See point 2.

4. Adjudication Method for the Test Set

Not applicable. See point 2.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This is not an AI-assisted diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

Not applicable. See point 2.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary of what is available in the document regarding the device validation:

The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance. This means the manufacturer is asserting that the new device is as safe and effective as existing devices on the market.

The primary method of "proving" the device meets criteria (implicitly, the criteria of safety and effectiveness similar to predicates) is through:

Comparison of Device Characteristics: The document provides a detailed comparison table (Page 3 of 3 in the 510(k) summary) showing that the Bovie® Cautery Device shares indications for use, sterilization method, materials (patient-contacting tips and handle), and energy source with predicate devices.
Safety Enhancements: The submission highlights design changes made for enhanced safety, specifically:
- Easily removable battery pack (allowing for easy battery recycling and prevention of device activation after disposal).
- Recessed activation button (to prevent inadvertent activation).
Unchanged Core Technology: The document explicitly states that the "Cautery device technology remains mostly unchanged" and that "Apart from the added safety features, these cautery devices remain mostly unchanged from those previously cleared" (Page 2 of 3). The patient-contacting tip component, cautery handle materials, and cautery tip configurations are also stated to be unchanged.

In essence, the "study" proving the device meets criteria is the detailed technical and functional comparison to already cleared predicate devices, asserting that the new device performs its intended function (stopping small bleeders in hemostasis) at least as safely and effectively, with added safety features. There are no clinical trial results or performance statistics presented in this 510(k) summary for a "test set" in the context of data analysis.

Summary

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JUL 20 2012

K 121441

Page 1 of 3

510(k) SUMMARY

(As Required per 21 CFR 807.92(c))

Bovie Medical Corporation

GENERAL INFORMATION:

510k Owner's Name

Address

Telephone Number: FAX Number:

Contact Person

5115 Ulmerton Road Clearwater, Florida 33760-4004 (727) 384-2323 (727) 322-4465

Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs

Date Prepared:

May 9, 2012

DEVICE DESCRIPTION:

Trade Name:	Bovie® Cautery Device
Common Name:	Battery Operated Cautery; Cauterizer
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories
Classification:	21CFR 878.4400; Class II; Product Code GEI
Legally Marketed
Predicate Device(s):	Various Hand Held, Battery Operated Cautery Devices(K945757, K945765, K945492, K945764, K810909)

K810017, K945760, K945759, K945493, K945762, K945763)

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510(k) SUMMARY

. Pge 2 of 3

(As Required per 21 CFR 807.92(c))

DEVICE FUNCTION, TECHNOLOGY, AND INTENDED USE:

Cautery device technology remains mostly unchanged from those manufactured and sold over the last 30 years. These devices incorporate one or two 1.5 volt batteries as a power source and an internal conductor strip to direct power to the tip. The devices that are the subject of this submission have been designed with additional safety enhancements, including a recessed activation button (to prevent inadvertent activation if the device is placed on a surface without the protective cap in place) and easily removable batteries that prevents activation of the device after its disposal. The batteries may also be recycled rather than discarded in the user facility biohazard waste stream. Safety enhancements were made to prevent inadvertent device activation in the event that the user does not comply with the recommended disposal instructions after use.

Apart from the added safety features, these cautery devices remain mostly unchanged from those previously cleared. The patient contacting tip component and the cautery handle materials remain the same. Cautery tip configurations (shapes) are also unchanged from those previously cleared. A change to improve manufacturability was made to eliminate the cautery head component and to install cautery tip tubes directly into the cautery handle. The previous cautery head design was not patient contacting. Warnings and Cautionary labeling are carried through to the new design. Device packaging is also unchanged.

INTENDED USE:

Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.

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K 1 2 1 4 4 1

510(k) SUMMARY

Page 3 of 3

(As Required per 21 CFR 807.92(c))

Characteristics	Bovie® Cauteries	Battery Operated Cauteries
	(This Submission)	(Various Submissions)
Indications forUse	Bovie® Cautery Devices areused for stopping smallbleeders in hemostasis andother similar uses.	Used for stopping smallbleeders in hemostasis andother similar uses.
DisposalInstructions	Cut tip or remove tip usinghemostats. Replace the covercap to prevent buttonactivation.Twist the batterycompartment to remove andseparate batteries.	Cut tip or remove tip usinghemostats. Replace the covercap to prevent buttonactivation.
Sterility	Single Use; Sterilized byEthylene Oxide; SterilityAssurance Level of 10-6.	Single Use; Sterilized byEthylene Oxide; SterilityAssurance Level of 10-6.
Design forSafety	Easily removal battery packand recessed activationbutton.	Non-removable batteries andnon-recessed activationbutton.
Materials	Patient contacting tipsconstructed of Nichrome 80and Kanthal A-1. Cauteryhandles constructed ofAcrylonitrile ButadieneStyrene (ABS).	Patient contacting tipsconstructed of Nichrome 80and Kanthal A-1. Cauteryhandles constructed ofAcrylonitrile ButadieneStyrene (ABS).
	Cautery tip tubes areembedded in the handle.	Cautery tip tubes areembedded in a Delrin®cautery head that is placedinto the handle.
Energy Source	Device is powered by one ortwo 1.5 volt alkalinebatteries.	Device is powered by one ortwo 1.5 volt alkaline batteries.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Bovie Medical Corporation % Mr. Richard Kozloff Vice President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760

JUL 2 0 2012

Re: K121441

Trade/Device Name: Bovie® Cautery Device Regulation Number: 21 CFR 886.4115 Regulation Name: Thermal cautery unit Regulatory Class: Class II Product Code: HQP Dated: July 05, 2012 Received: July 06, 2012

Dear Mr. Kozloff:

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

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Page 2- Mr. Richard Kozloff

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/icm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely, yours,

Erich Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121441

Device Name: Bovie® Cautery Device

Indications for Use:

Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.

Neil R.P. Ogle Forman

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number j<12144(

Prescription Use く (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 886.4115 Thermal cautery unit.

(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.