Bovie Resistick II Electrosurgical Electrodes ("electrodes") consist of coated blade, needle, and ball configured electrodes, sold sterile and bulk non-sterile, and are designed for single-use. These electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and coagulate soft tissues during open surgical procedures. The intended use of these electrodes is the same as that of previously cleared Resistick II electrodes. The coating is designed to reduce friction and to minimize the buildup of burned tissue. Although the coating is chemically different from that of predicate devices, biocompatibility analyses are being performed to demonstrate safety.

Each electrode consists of a stainless steel shaft and tip, a coating, and an insulation on the electrode meets the requirements for electrical safety testing of electrosurgical accessories.

Bovie Resistick II Electrosurgical Electrodes include three tip configurations; blade, needle, and ball. Within each configuration there are models that differ by length of the electrode shaft and whether the tips are partially exposed ("modified"). Eleven electrode configurations are the same shape and size as predicate devices cleared in premarket notification number K974735. There are an additional nine electrode configurations, each comprised of the same materials and having the same intended use. All electrodes are also to be available for sale as non-sterile components for subsequent placement into kits and trays.

AI/ML Overview

This 510(k) summary (K093025) describes Bovie Medical's Resistick™ II Coated Electrosurgical Electrodes. The submission outlines the device's intended use for cutting and coagulating soft tissues during open surgical procedures, its components, and its operation. It also clarifies that the device includes various tip configurations and is made of the same materials as the predicate device (Resistick™ II Electrosurgical Electrode, K974735), with the key difference being a new coating designed to reduce friction and tissue buildup. The FDA's letter of December 22, 2009, indicates that the device has been found substantially equivalent to the predicate device.

Based on the provided information, the following can be extracted:

1. Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria for performance metrics such as coating effectiveness, tissue adhesion reduction, or electrical safety in a tabular format. The general acceptance appears to be based on demonstrating substantial equivalence to the predicate device, Resistick™ II Electrosurgical Electrode (K974735), and meeting general safety requirements through biocompatibility analyses and electrical safety testing.

The "reported device performance" is primarily qualitative, focusing on the claims that the new coating is "designed to reduce friction and to minimize the buildup of burned tissue." The submission states, "Although the coating is chemically different from that of predicate devices, biocompatibility analyses are being performed to demonstrate safety." And, "an insulation on the electrode meets the requirements for electrical safety testing of electrosurgical accessories."

Given the provided text, a table of acceptance criteria and reported device performance cannot be generated with specific quantitative metrics.

2. Sample Size and Data Provenance

The document does not provide information on sample sizes for any specific tests or studies. It also does not specify the country of origin of data or whether it was retrospective or prospective.

3. Number and Qualifications of Experts

The document does not mention the use of experts to establish ground truth or for any other aspect related to the performance evaluation in this 510(k) summary.

4. Adjudication Method

The document does not specify any adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study in the provided text. The device is an electrosurgical electrode, and such studies are typically not relevant for this type of medical device.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is an electrosurgical electrode, not an algorithm or AI-driven system. Therefore, no standalone algorithm performance study would have been conducted.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied in AI/image analysis studies is not relevant to this device submission. The evaluation of this device focuses on demonstrating substantial equivalence to a predicate device and meeting safety and performance standards relevant to electrosurgical electrodes (e.g., biocompatibility, electrical safety, coating effectiveness).

8. Sample Size for Training Set

This is not applicable as the device is an electrosurgical electrode, not an AI/machine learning system that requires a training set.

9. How Ground Truth for Training Set was Established

This is not applicable for the same reasons mentioned above.

Summary

{0}------------------------------------------------

K093025

510(k) SUMMARY (As Required per 21 CFR 807.92(c))

GENERAL INFORMATION:

510k Owner's NameAddress	Bovie Medical5115 Ulmerton RoadClearwater, Florida 33760	DEC 22 2009
Contact Person	Richard A. KozloffVice-President; Quality Assurance/Regulatory AffairsTelephone #: (727) 803-8513FAX Number: (727) 322-4665
Date Prepared:	September 25, 2009

DEVICE DESCRIPTION:

Trade Name: Bovie Resistick™ II Coated Electrosurgical Electrodes Common Name: Electrosurgical Electrodes Electrosurgical Cutting and Coagulation Devices and Classification Name: Accessories (21CFR 878.4400; Class II; Product Code GEI) Predicate Devices: Resistick™ II Electrosurgical Electrode (K974735)

{1}------------------------------------------------

510(k) SUMMARY (As Required per 21 CFR 807.92(c))

INTENDED USE:

Boyie Resistick™ II Coated Electrosurgical Electrodes are used for cutting and coagulating soft tissues during open surgical procedures.

DEVICE COMPONENTS AND OPERATION:

Each electrode consists of a stainless steel shaft and tip, a coating, and an insulation on the electrode meets the requirements for electrical safety testing of electrosurgical accessories.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Bovie Medical % Mr. Richard Kozloff 5115 Ulmerton Road Clearwater, Florida 33760

DEC 22 2009

Re: K093025

Trade/Device Name: Bovie Resistick™ II Coated Electrosurgical Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 25, 2009 Received: September 29, 2009

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 includions for use stated in the enclosure) to legally marketed predicate devices market (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, Dr to 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 additional controls. Existing major regulations affecting your davine 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

{3}------------------------------------------------

Page 2 - Mr. Richard Kozloff

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the election in product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1000.

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/CDRHOffices/ucr1118001/phn flast 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/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 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,

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Bovie Resistick™ II Coated Electrosurgical Electrodes Device Name:

Indications for Use:

Bovie Resistick™ II Coated Electrosurgical Electrodes are used for cutting and coagulating soft tissues during open surgical procedures.

Prescription Use _ V (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)

FOR M.MELKERSON

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

510(k) Number K093025

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.