(53 days)
Not Found
No
The description focuses on the mechanical and electrical components and performance testing related to tissue cutting, vaporization, and coagulation, with no mention of AI or ML.
Yes.
The device is intended for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures, which are therapeutic actions.
No
The device is described as an electrosurgical tool for cutting, vaporization, and coagulation of soft tissue during surgery. It is
intended for therapeutic use, not for diagnosing conditions.
No
The device description clearly outlines physical components such as an insulated handle, active electrode, aspiration tubing, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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 in vivo.
- Device Description: The description details a surgical instrument with an electrode, handle, and connections for an electrosurgical generator. This is consistent with a surgical device, not a device used to test samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any process that would be performed outside of the body to diagnose a condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform a surgical procedure directly on the patient.
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 shaft diameters of 3.3mm, 2.4mm, and 1.8mm. The larger size is available in aspirating and non-aspirating version. 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 55 degrees, and 90 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.
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was completed to demonstrate substantial equivalence of the subject device to the predicates. The devices were subjected to the following verification and validation tests, as applicable: Mechanical testing, Electrical testing, Electromagnetic compatibility, Biocompatibility, INE Testing, and Bench-top validation testing which included: 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
Bovie Medical Corporation Ms. Rubiela Maldonado Regulatory Affairs Manager 5115 Ulmerton Road Clearwater, Florida 33760
Re: K161558
Trade/Device Name: Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Nonaspirating: Bovie 2.4mm Disposable Bipolar Ablator 55° , Non-aspirating; Bovie 1.8mm Disposable Bipolar Ablator 60° . Non-aspirating. Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 3, 2016 Received: June 6, 2016
Dear Ms. Maldonado:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (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.
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.
Christopher J. Ronk -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
2
Indications for Use
510(k) Number (if known) K161558
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) 803-8508 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | Rubiela Maldonado |
| Regulatory Affairs Manager | |
| Date Prepared: | July 26, 2016 |
| 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 |
|---|---|
| BA3390A | 3.3mm Disposable Bipolar Ablator 90°, Aspirating |
| BA3390NA | 3.3mm Disposable Bipolar Ablator 90°, Non-Aspirating |
| BA2455NA | 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating |
| BA1860NA | 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating |
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Image /page/4/Picture/0 description: The image shows the word "Bovie" in a dark blue font. Above the word is a light blue curved line with a dot at the end. The font is sans-serif and the word is slightly italicized. There is a registered trademark symbol in the bottom right corner of the image.
21CFR 878.4400; Class II; Product Code GEI
Legally Marketed Predicate Device(s):
Classification:
- K120791, K083306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Arthrocare ArthroWand® 2.3mm 35° Short Bevel and Microblator 30 With Integrated Cable
- . K152777 Bovie Disposable Bipolar Ablator
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 shaft diameters of 3.3mm, 2.4mm, and 1.8mm. The larger size is available in aspirating and non-aspirating version. 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 55 degrees, and 90 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.
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
5
Performance testing was completed to demonstrate substantial equivalence of the subject device to the predicates. 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
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.
INE Testing
Testing was conducted to demonstrate that the Bovie Disposable Bipolar RF Arthroscopy Ablator is able to withstand the insertion / navigation / extraction actions during a procedure.
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:
6
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.
- . 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 |
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| 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 |
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Image /page/8/Picture/0 description: The image shows the word "Bovie" in a bold, dark blue font. Above the word is a curved, light blue line with a dot at the end. The registered trademark symbol is located at the bottom right of the word.
SUBSTANTIAL EQUIVALENCE SUMMARY
| Feature/
Characteristic | Bovie Disposable Bipolar
Ablator | ArthroCare
SuperTurbo Vac, Turbovac 90
Arthrocare ArthroWand®
2.3mm 35° Short Bevel
Arthrocare ArthroWand®
Microblator 30 With
Integrated Cable | Bovie Disposable Bipolar
Ablator BA3350NA,
BA3350A |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 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 to be used for
cutting, vaporization,
and coagulation of soft
tissue during
arthroscopic surgical
procedures. |
| 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 | To be used with a
standard electrosurgical
generator with
footswitch control and a
standard return
electrode connection |
| Use only in
Conductive
Media | The electrode is to be
activated only when
immersed in a conductive
media such as standard
saline solution | Same | The electrode is to be
activated only when
immersed in a
conductive media such
as standard saline
solution |
| Mode | Bipolar | Bipolar | Bipolar |
| User Interface | Footswitch | Footswitch and Hand | Footswitch |
| Aspirating and
Non-Aspirating
Models | Yes | Yes | Yes |
| Shaft Diameter | 3.3mm, 2.4mm, 1.8mm | 3.75mm
2.3mm and 1.4mm | 3.3mm |
| Electrode Face
Angle | 90, 55, 60 degrees | 90,35, 30 degrees | 50 degrees |
| Working
Length | 160mm | 160mm | 160mm |
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CONCLUSION
In summary, the only differences between the subject and the predicate devices are:
- Generator compability .
- user interface
- . Shaft diameter
- . Electrode Face angle
These differences between the Bovie Disposable Bipolar Ablator and the predicate devices do not raise new or different questions of safety and efficacy. 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.
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.