This device is intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution.

Device Description

The device is comprised of the following major components: an insulated handle, an active electrode, a length of aspiration tubing, a standard foot-switch RF connector, and a standard return connector. The hand piece is designed to connect to electrosurgical generators that feature a standard foot switch controlled monopolar connector and a standard return connector.

A stainless steel electrode tip is surrounded by a ceramic thermal insulator. The product is available in a shaft diameters of 3.3mm and is available in aspirating and non-aspirating versions. The aspirating versions use suction to remove saline irrigant during the surgical procedure for the dissipation of heat and improved vision.

The device is available in electrode face angles of 50 degrees. There is a feature on the handle that lets the operator easily determine the orientation of the active electrode face. The wedgeshaped tapered tip allows access to difficult to reach locations. The working length is 160mm. The cable from the handle is 126" +/- 6" in length.

The device operates in bipolar mode. The return electrode is located on the device and does not require the use of an external grounding pad or return electrode. The device has a simple user interface that uses a footswitch to activate the device.

The primary difference between the Bovie Disposable Bipolar Ablator and the predicate device is that the Bovie Disposable Bipolar Ablator does not require the use of a dedicated electrosurgical generator but is compatible with standard electrosurgical generators.

The Bovie Disposable Bipolar Ablator has the same intended use and energy type as the predicate device. There are no technological differences, no changes to the principle of operation or the method of application.

AI/ML Overview

The Bovie Disposable Bipolar Ablator is designed for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. The provided document focuses on demonstrating the substantial equivalence of the Bovie Disposable Bipolar Ablator to legally marketed predicate devices rather than providing a detailed study that proves a specific quantitative acceptance criterion. The performance testing outlined primarily verifies compliance with various safety and performance standards for electrosurgical equipment.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnosis device. Instead, the acceptance criteria are implicitly that the device meets applicable standards and requirements for safety, electrical performance, biocompatibility, and functional integrity.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Safety	Met: "Mechanical verification testing was conducted for the proposed device to ensure compliance with mechanical requirements of IEC-60601-1, Edition 3.1, IEC 60601-2-2: 2009, and Bovie self-enforced requirements." (Page 4-5) Specific tests: Visual Inspection & Electrical Continuity, Mold Stress Relief, Cable Strain Relief, Cable Impulse, Cable Flexure/Tension, Drop Testing, Rigidity Testing of Handle and Shaft.
Electrical Safety	Met: "Electrical verification testing was conducted for the relevant components of the proposed device to ensure compliance with current electrical standard requirements." (Page 5) Specific tests: Visual Inspection & Electrical Continuity, Front Panel Connection Verification, Connector Insertion/Extraction Force.
Electromagnetic Compatibility (EMC)	Met: "The results demonstrated compliance of the proposed device to current IEC 60601-1-2 standard requirements." (Page 5)
Biocompatibility	Met: "Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines in accordance with FDA's blue book memorandum #G95-1 on biocompatibility." (Page 5)
Thermal Performance (Aspirating Model)	Met: "Testing was conducted to: Assess the maximum temperature that ablator handle can achieve during a worst case use scenario." (Page 5)
Thermal Performance (Non-Aspirating Model)	Met: "Testing was conducted to: Assess the maximum temperature that ablator handle can achieve during a worst case use scenario." (Page 5) "Testing was conducted to: Assess the fluid temperature near the active electrode during activation of an ablator. The electrosurgical generator is to be set at the maximum allowable power for ablator model in order to simulate the worst case scenario." (Page 6)
Aspiration Flow Rate	Met: "Testing was conducted to: Verify aspiration flow rate under specific vacuum conditions." (Page 6)
Thermal Performance & Clogging (Overall Ablator Function)	Met: "Testing was conducted to: Verify the performance of the Bovie Disposable Bipolar RF Arthroscopic Ablator in terms of 1) thermal performance (the temperature of irrigation fluid near the active electrode during activation of a device); 2) tissue removal, 3) clogging, and 4) ignition delay." (Page 6)
Compatibility with Standard Electrosurgical Generators	Met: "Testing was conducted to: Verify that the ablator is able to function as intended when connected to a compatible electrosurgical generators." (Page 5)
General Workmanship	Met: "Testing was conducted to: Meet general workmanship requirement. Pass electrical continuity test." (Page 5)

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in the context of a dataset for an AI algorithm. The performance testing described involves bench-top validation testing of the device's physical and electrical properties, as well as its functional performance. The "sample size" would refer to the number of devices or components tested. This is not explicitly stated but is implicitly sufficient to demonstrate compliance with the referenced standards.

Sample Size: Not explicitly stated for each test, but typically several units/components would be tested for each verification.
Data Provenance: The tests are described as bench-top validation testing performed by the manufacturer (Bovie Medical Corporation), indicating they are internal, prospective tests on manufactured devices/components. No country of origin for specific "data" is mentioned beyond the manufacturing location of the company (Clearwater, Florida, USA).

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable in the context of the provided document. The device is a surgical instrument, not an AI diagnostic tool that requires expert-established ground truth from images or data. The "ground truth" for this device's performance is compliance with established engineering, electrical, and safety standards (e.g., IEC, ISO, FDA guidelines for biocompatibility) and its ability to perform its intended function in a simulated environment. The "experts" involved would be engineers, quality assurance personnel, and regulatory affairs specialists within Bovie Medical, along with the independent testing labs that certify compliance to the standards. Their qualifications are inherent in their professional roles and certifications to conduct such tests.

4. Adjudication Method

Not applicable. This is not a study assessing diagnostic performance where adjudication of disagreement among experts would be necessary. The tests are objective measurements against defined standards.

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

Not applicable. This is not a study of an AI-assisted diagnostic tool or an imaging device to compare human reader performance with and without AI assistance. The study described focuses on the standalone performance and safety of a electrosurgical ablator.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical electrosurgical tool, not an algorithm. Its "standalone performance" is what is described in the bench-top testing, demonstrating its functional capabilities without human in-the-loop diagnostic interpretation. The device's "standalone" performance means it performs its intended function (cutting, vaporization, coagulation) when activated.

7. Type of Ground Truth Used

The "ground truth" for the performance testing is based on:

International Standards: Compliance with specific standards such as IEC-60601-1, IEC 60601-1-2, IEC-60601-2-2, ISO 10993-1, ISO 11135-1, and ISO 10993-7. These standards define acceptable limits and methodologies for testing.
Bovie Self-Enforced Requirements: Internal specifications set by the manufacturer.
Functional Verification: Demonstrating the device performs its intended functions (e.g., aspiration flow rate, tissue removal, temperature during use) under specified conditions.

Essentially, the "ground truth" is defined by established engineering and medical device safety requirements.

8. Sample Size for Training Set

Not applicable. The device is not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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

January 15, 2016

Bovie Medical Corporation Mr. Brian Kunst Vice President Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760

Re: K152777

Trade/Device Name: Bovie Disposable Bipolar Ablator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 14, 2015 Received: December 15, 2015

Dear Mr. Kunst:

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 of medical devicerelated 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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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" (21 CFR 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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Indications for Use

510(k) Number (if known) K152777

Device Name Bovie Disposable Bipolar Ablator

Indications for Use (Describe)

This device is intended to be used for cutting, vaporization of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution.

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)
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510(k) SUMMARY

(Submitted As Required per 21 CFR 807.92)

GENERAL INFORMATION:

Submitter Name:	Bovie Medical Corporation
Establishment RegistrationNumber:	3007593903
Submitter Address:	5115 Ulmerton RoadClearwater, Florida 33760-4004United States of America
Submitter Telephone Number:	727) 803-8617
Submitter FAX Number:	(727) 322-4465
Contact Person:	Brian KunstVice President, Regulatory Affairs and Quality Assurance
Date Prepared:	January 13, 2016
DEVICE IDENTIFICATION:

DEVICE IDENTIFICATION:

Proprietary Name:	Bovie Disposable Bipolar Ablator
Common Name:	Electrosurgical Generator Accessory
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories

Model Numbers:

Catalog #	Description
BA3350A	3.3mm Disposable Bipolar Ablator 50°, Aspirating
BA3350NA	3.3mm Disposable Bipolar Ablator 50°, Non-Aspirating

Classification:

21CFR 878.4400; Class II; Product Code GEI

Legally Marketed Predicate Device(s):

. K120791, K083306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Super MultiVac 50, and Arthrowand Devices
. K992406 DePuy Synthes VAPR Suction Electrodes, 2.3mm
. K113545, K100638 DePuy Synthes CoolPulse 90 Electrode
. K122425 DePuy Synthes VAPR P50 Electrode

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INTENDED USE/INDICATIONS

DEVICE DESCRIPTION

PERFORMANCE TESTING

Performance testing was completed to demonstrate substantial equivalence of the subject device to the predicate (K120791). The devices were subjected to the following verification and validation tests, as applicable:

Mechanical testing

Mechanical verification testing was conducted for the proposed device to ensure compliance with mechanical requirements of IEC-60601-1, Edition 3.1, IEC 60601-2-2: 2009, and Bovie self-enforced requirements.

Electrical testing

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K152777

Electrical verification testing was conducted for the relevant components of the proposed device to ensure compliance with current electrical standard requirements.

Electromagnetic compatibility

Electromagnetic compatibility (EMC) testing has been completed for the applicable components of the proposed device. The results demonstrated compliance of the proposed device to current IEC 60601-1-2 standard requirements.

Biocompatibility

Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines in accordance with FDA's blue book memorandum #G95-1 on biocompatibility

Bench-top validation testing

Visual Inspection & Electrical Continuity Testing: ● Testing was conducted to: Meet general workmanship requirement. Pass electrical continuity test.
. Mold Stress Relief Testing:

Testing was conducted to demonstrate : Any shrinkage or distortion of the molded thermoplastic components due to release of internal stresses caused by the molding operation does not result in an unacceptable risk.

. Cable Strain (steady pull) Relief Testing: Testing was conducted to demonstrate : The ablator cable and its connections are capable of withstanding mechanical stress from a steady pull
. Cable Impulse Testing and Post-impulse continuity testing: Testing was conducted to demonstrate : The ablator cable and its connections are capable of withstanding mechanical stress from an impulse of force.
. Cable Flexure / Tension and Post-Flexure-testing Electrical Continuity Testing: Testing was conducted to: Evaluate the integrity of the anchorage (fastening, termination) of electrical conductors and insulation by exercising the cable / cords by flexing and applying specified tension.
. Drop Testing:

Testing was conducted to: Verify the ablator will not present a safety hazard as a result of a free fall onto a hard surface.

. Front Panel Connection Verification Testing: Testing was conducted to: Verify that Proximal End (brass sockets) of the ablator cable connects to a compatible generator.
. Connector Insertion / Extraction Force Testing: Testing was conducted to: Verify that the insertion / Extraction force for inserting / extracting ablator cable connector into or from a compatible generator is within specified range.
. Measurement and Maximum Temperature During Use (Aspirating Model): Testing was conducted to: Assess the maximum temperature that ablator handle can achieve during a worst case use scenario
. Measurement and Maximum Temperature During Use (Non-Aspirating Model): Testing was conducted to: Assess the maximum temperature that ablator handle can achieve during a worst case use scenario
Rigidity Testing of Handle and Shaft: Testing was conducted to: Verify that handle of an ablator is able to support a static weight located at the distal position on the shaft without permanently deforming
. Compatibility Verification Testing: Testing was conducted to: Verify that the ablator is able to function as intended when connected to a compatible electrosurgical generators.

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Aspiration Flow Testing: Testing was conducted to: Verify aspiration flow rate under specific vacuum conditions.
. Thermal Performance & clogging Testing: Testing was conducted to: Verify the performance of the Bovie Disposable Bipolar RF Arthroscopic Ablator in terms of 1) thermal performance (the temperature of irrigation fluid near the active electrode during activation of a device); 2) tissue removal, 3) clogging, and 4) ignition delay
. Thermal Performance Testing (Non-Aspirating ablator): Testing was conducted to: Assess the fluid temperature near the active electrode during activation of an ablator. The electrosurgical generator is to be set at the maximum allowable power for ablator model in order to simulate the worst case scenario.

All test requirements were met as specified by applicable standards and the test protocols.

The Bovie Disposable Bipolar Ablator was designed in accordance with the following standards:

International Standard	Description
IEC-60601-1, Edition 3.1	Medical Electrical Equipment - Part 1: General RequirementsFor Safety
IEC 60601-1-2:2007	Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - CollateralStandard: Electromagnetic disturbances - Requirements andtests
IEC-60601-2-2 : 2009	Particular requirements for the safety of high frequencysurgical equipment
ANSI / AAMI / ISO 10993-1:2009	Biological Evaluation of Medical Devices – Part 1: Evaluationand Testing
ANSI/AAMI/ISO 11135-1: 2007	Sterilization of Healthcare Products – Ethylene Oxide – Part 1:Requirements for the development, validation, and routinecontrol of a sterilization process for medical devices.
ANSI / AAMI / ISO 10993-7:2008	Biological Evaluation of Medical Devices - Part 7: EthyleneOxide Residuals

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SUBSTANTIAL EQUIVALENCE SUMMARY

Feature/	Bovie Disposable Bipolar	ArthroCare	Depuy Synthes VAPR,
Characteristic	Ablator	SuperTurbo Vac, MultiVac	CoolPulse
Intended Use	Intended to be used forcutting, vaporization, andcoagulation of soft tissueduring arthroscopic surgicalprocedures.	Intended to be used forresection, ablation, andcoagulation of soft tissue andhemostasis of blood vesselsin arthroscopic andorthopedic procedures.	Intended for resection,ablation, excision of softtissue, hemostasis ofblood vessels andcoagulation of soft tissuein patient requiringarthroscopic surgery
Energy Type	Radiofrequency	Radiofrequency	Radiofrequency
GeneratorCompatibility	To be used with a standardelectrosurgical generatorwith footswitch control anda standard return electrodeconnection	Dedicated generator	Dedicated Generator
Use only inConductiveMedia	The electrode is to beactivated only whenimmersed in a conductivemedia such as standardsaline solution	Same	Same
Mode	Bipolar	Bipolar	Bipolar
User Interface	Footswitch	Footswitch and Hand	Footswitch and Hand,CoolPulse available inFootswitch only
Aspirating andNon-AspiratingModels	Yes	Yes	Yes
Shaft Diameter	3.3mm	3.75mm	3.7mm
Electrode FaceAngle	50 degrees	50 degrees	50 degrees
WorkingLength	160mm	160mm	160mm

CONCLUSION

There is no difference between the Bovie Disposable Bipolar Ablator and the predicate devices in terms of intended use, principle of operation, and the technology used for device performance. The Bovie Disposable Bipolar Ablator was subjected to verification testing to confirm device performance. There is no new technology and no difference that would raise new or different questions of safety or efficacy. Comparative performance testing demonstrated the device performed as well as, or better than, the predicate device. The primary difference is that the Bovie Disposable Bipolar Ablator does not require the use of a dedicated electrosurgical generator but is compatible with standard electrosurgical generators.

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.