(112 days)
Not Found
No
The description focuses on the electrosurgical function and mechanical components, with no mention of AI or ML capabilities. The performance studies are standard engineering and biocompatibility tests, not related to AI/ML model validation.
Yes
The device is used for "cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures," which directly addresses a medical condition or applies a medical treatment, thereby classifying it as a therapeutic device.
No
The device is described as being used for "cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures." These are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly outlines multiple hardware components including an insulated handle, active electrode, aspiration tubing, and connectors. The performance studies also detail mechanical and electrical testing, further indicating a hardware-based device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures." This describes a surgical tool used directly on the patient's tissue, not a device used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a surgical handpiece with an electrode, tubing, and connectors for an electrosurgical generator. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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 wedge-shaped 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (during arthroscopic surgical procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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, Electrical testing, Electromagnetic compatibility, Biocompatibility, Bench-top validation testing (Visual Inspection & Electrical Continuity Testing, Mold Stress Relief Testing, Cable Strain (steady pull) Relief Testing, Cable Impulse Testing and Post-impulse continuity testing, Cable Flexure / Tension and Post-Flexure-testing Electrical Continuity Testing, Drop Testing, Front Panel Connection Verification Testing, Connector Insertion / Extraction Force Testing, Measurement and Maximum Temperature During Use (Aspirating Model), Measurement and Maximum Temperature During Use (Non-Aspirating Model), Rigidity Testing of Handle and Shaft, Compatibility Verification Testing, Aspiration Flow Testing, Thermal Performance & clogging Testing, Thermal Performance Testing (Non-Aspirating ablator)).
All test requirements were met as specified by applicable standards and the test protocols.
Key Metrics
Not Found
Predicate Device(s)
K120791, K083306, K992406, K113545, K100638, K122425
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
1
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 Registration | |
| Number: | 3007593903 |
| Submitter Address: | 5115 Ulmerton Road |
| Clearwater, Florida 33760-4004 | |
| United States of America | |
| Submitter Telephone Number: | 727) 803-8617 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | Brian Kunst |
| Vice 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 and |
| Accessories |
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
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.
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 Requirements |
| For Safety | |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements |
| for basic safety and essential performance - Collateral | |
| Standard: Electromagnetic disturbances - Requirements and | |
| tests | |
| IEC-60601-2-2 : 2009 | Particular requirements for the safety of high frequency |
| surgical equipment | |
| ANSI / AAMI / ISO 10993-1:2009 | Biological Evaluation of Medical Devices – Part 1: Evaluation |
| and Testing | |
| ANSI/AAMI/ISO 11135-1: 2007 | Sterilization of Healthcare Products – Ethylene Oxide – Part 1: |
| Requirements for the development, validation, and routine | |
| control of a sterilization process for medical devices. | |
| ANSI / AAMI / ISO 10993-7:2008 | Biological Evaluation of Medical Devices - Part 7: Ethylene |
| Oxide Residuals |
7
SUBSTANTIAL EQUIVALENCE SUMMARY
| Feature/ | Bovie Disposable Bipolar | ArthroCare | Depuy Synthes VAPR, |
|---|---|---|---|
| Characteristic | Ablator | SuperTurbo Vac, MultiVac | CoolPulse |
| Intended Use | Intended to be used for | ||
| cutting, vaporization, and | |||
| coagulation of soft tissue | |||
| during arthroscopic surgical | |||
| procedures. | Intended to be used for | ||
| resection, ablation, and | |||
| coagulation of soft tissue and | |||
| hemostasis of blood vessels | |||
| in arthroscopic and | |||
| orthopedic procedures. | Intended for resection, | ||
| ablation, excision of soft | |||
| tissue, hemostasis of | |||
| blood vessels and | |||
| coagulation of soft tissue | |||
| in patient requiring | |||
| arthroscopic surgery | |||
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency |
| Generator | |||
| Compatibility | To be used with a standard | ||
| electrosurgical generator | |||
| with footswitch control and | |||
| a standard return electrode | |||
| connection | Dedicated generator | Dedicated Generator | |
| Use only in | |||
| Conductive | |||
| Media | The electrode is to be | ||
| activated only when | |||
| immersed in a conductive | |||
| media such as standard | |||
| saline solution | Same | Same | |
| Mode | Bipolar | Bipolar | Bipolar |
| User Interface | Footswitch | Footswitch and Hand | Footswitch and Hand, |
| CoolPulse available in | |||
| Footswitch only | |||
| Aspirating and | |||
| Non-Aspirating | |||
| Models | Yes | Yes | Yes |
| Shaft Diameter | 3.3mm | 3.75mm | 3.7mm |
| Electrode Face | |||
| Angle | 50 degrees | 50 degrees | 50 degrees |
| Working | |||
| Length | 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.