The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas and a retractable blade for cutting and coagulation of soft tissue for use during both open and laparoscopic surgical procedures.

Device Description

The Bovie® J-Plasma Handpiece with Retractable Cutting Tip are single use devices designed to be compatible only with the ICON GS generator (GS100) and reusable cable (GS-807-RC) cleared under 510k K-090586. There are device models for both open and laparoscopic surgical procedures (GS-018C and GS-270C respectively). These handpieces contain a programmable memory device that requires a unique code for the generator to operate. Each handpiece has a button for finger activation of the generator. Once activated, helium gas flows out the distal end of the device where gas molecules are excited by the high electric field resulting in a plasma stream. The handpiece that is intended for open procedures does not have an extended shaft. The handpiece intended for laparoscopic procedures has a 27 cm extended tip. Both handpieces contain a retractable cutting blade that can be extended manually for excising tissue.

AI/ML Overview

This FDA 510(k) summary describes a device that is an electrosurgical tool, and therefore, the acceptance criteria and study information typically associated with AI/ML-driven diagnostics or imaging devices are not provided in this document. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of design, materials, and performance characteristics for electrosurgical functionality.

Here's a breakdown of the information that can be extracted from the document, and what cannot be found due to the nature of the device:

Device: Bovie® J-Plasma Handpiece with Retractable Cutting Blade

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present quantitative acceptance criteria or detailed performance metrics in the format typically seen for AI/ML diagnostic tools. Instead, it focuses on demonstrating equivalence to a predicate device through shared characteristics and compliance with electrical safety standards.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use	Equivalent or broader than predicate device.	"The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas plasma for coagulation of soft tissue during both open and laparoscopic surgical procedures. ... utilizes a retractable blade for cutting of soft tissue during both open and laparoscopic surgical procedures." (Covers both plasma coagulation and blade cutting, for both open and laparoscopic procedures, expanding on the predicate's "coagulation of soft tissues during open soft tissue surgery.")
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2-2.	"Both named devices and the predicate are designed to comply with the following electrical standards: IEC 60601-1: ... General Requirements for Safety (2005) IEC 60601-2-2: ... Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories (2009)"
Output Energy (Coagulation)	Equivalent to predicate device.	"40 Watts (100% Setting on ICON GS Generator)" (Same as predicate)
Delivery System	Equivalent to predicate device.	"Monopolar" (Same as predicate)

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

Not Applicable. This information is relevant for studies involving data-driven algorithms (like AI/ML models). This document pertains to an electrosurgical hardware device, and thus, this type of data is not generated or tested in the same manner. The "testing" for this device would involve engineering verification and validation, performance testing (e.g., power output, safety features), and biocompatibility, not data set evaluation.

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

Not Applicable. As this is not an AI/ML diagnostic or imaging device, there is no "ground truth" in the sense of expert consensus on medical image interpretation. The ground truth for this device would relate to its physical performance and safety (e.g., does it cut tissue as intended, does it coagulate effectively, does it meet electrical safety standards).

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

Not Applicable. Adjudication methods are used to resolve disagreements among human annotators or diagnosticians creating a ground truth for AI model training or evaluation. This is not relevant for an electrosurgical device.

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. An MRMC study is specific to diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance. This device is a surgical tool, not an imaging or diagnostic AI.

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

Not Applicable. This device is a manual surgical tool; it does not operate as an "algorithm only" or in a "standalone" fashion without human interaction.

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

Not Applicable. As mentioned above, there isn't a "ground truth" of this nature for an electrosurgical device. The "truth" is established through engineering and performance testing against predefined specifications and safety standards (e.g., power meter readings, tissue ablation tests, sterility testing).

8. The sample size for the training set:

Not Applicable. This device does not use a "training set" as it is not an AI/ML device.

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

Not Applicable. This device does not have a "training set" or "ground truth" to be established in the context of AI/ML.

Summary

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JAN 2 7 2012

K 112233 PAGE LOF 3

510(k) SUMMARY

(As Required per 21 CFR 807.92(c))

GENERAL INFORMATION:

510k Owner's Name	Bovie Medical Corporation
Address	5115 Ulmerton RoadClearwater, Florida 33760-4004
Telephone Number:	(727) 384-2323
FAX Number:	(727) 322-4465
Contact Person	Richard A. KozloffVice-President; Quality Assurance/Regulatory Affairs
Date Prepared:	August 2, 2011

DEVICE DESCRIPTION:

Trade Name:	Bovie® J-Plasma Handpiece with Retractable Cutting Blade
Common Name:	Cutting and Coagulation Electrosurgical Device
Classification Name:	Electrosurgical Cutting and Coagulation Devices andAccessories
Classification:	21CFR 878.4400; Class II; Product Code GEI
Legally Marketed
Predicate Device(s):	Bovie® ICON GS Electrosurgical Handpiece (K090586)

Included Accessories:

	J-Plasma Handpiece with Retractable Cutting Blade	Bovie® ICON GS Electrosurgical Handpiece(Predicate Device)
Reusable Handpiece Cable	GS807-RC(510k K090586)	GS807-RC(510k K090586)

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510(k) SUMMARY

(As Required per 21 CFR 807.92(c))

DEVICE FUNCTION, TECHNOLOGY, AND INTENDED USE:

INTENDED USE:

Plasma:

The Bovie J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes helium gas plasma for coagulation of soft tissue during both open and laparoscopic surgical procedures.

Blade:

The Bovie® J-Plasma Handpiece with Retractable Cutting Blade is an electrosurgical device that utilizes a retractable blade for cutting of soft tissue during both open and laparoscopic surgical procedures.

ELECTRICAL STANDARDS:

Both named devices and the predicate are designed to comply with the following electrical standards:

IEC 60601-1:	Standard for Safety Medical Electrical Equipment, Part 1: GeneralRequirements for Safety (2005)
IEC 60601-2-2:	Medical Electrical Equipment - Part 2-2: Particular Requirements for theBasic Safety and Essential Performance of High Frequency SurgicalEquipment and High Frequency Surgical Accessories (2009)

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510(k) SUMMARY

(As Required per 21 CFR 807.92(c))

Characteristics	Bovie® J-Plasma Handpiecewith Retractable CuttingBlade(This Submission)	Bovie® ICON GSElectrosurgical Handpiece(K-090586)
Indications forUse	Plasma:The Bovie® J-PlasmaHandpiece with RetractableCutting Blade is anelectrosurgical device thatutilizes helium gas plasmafor coagulation of soft tissueduring both open andlaparoscopic surgicalprocedures.Blade:The Bovie® J-PlasmaHandpiece with RetractableCutting Blade is anelectrosurgical device thatutilizes a retractable bladefor cutting of soft tissueduring both open andlaparoscopic surgicalprocedures.	An electrosurgical devicethat utilizes Helium gas forthe coagulation of softtissues during open softtissue surgery.
Electrical SafetyStandards	IEC60601-2-2, IEC60601-1	IEC60601-2-2, IEC60601-1
Output Energy
Coagulation	40 Watts (100% Setting onICON GS Generator)	40 Watts (100% Setting onICON GS Generator)
Delivery System	Monopolar	Monopolar

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bodies, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the department's name, which is written in a circular fashion around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

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

JAN 2 7 2012

Re: K112233

Trade/Device Name: BOVIE® J-Plasma Handpiece with Retraceable Cutting Blade Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI

Dated: January 19, 2012

Received: January 20, 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 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.

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Page 2 - Mr. Richard A. Kozloff

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/ucm115809.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/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/ResourcesforYou/Industry/defaultshtm./

Sincerely vours,

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Bovie® J-Plasma Handpiece with Retractable Cutting Blade

Indications for Use:

Prescription Use ✔ (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)

Sign-

(Division (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112233

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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.