(44 days)
Not Found
No
The document describes a standard electrosurgical generator and handpiece, focusing on the delivery of radiofrequency and helium gas plasma energy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies listed are standard engineering and electrical verification tests.
Yes
The device is indicated for medical procedures (cut, coagulate, ablate soft tissue) to treat medical conditions.
No
The device is used for cutting, coagulation, and ablation of soft tissue during surgical procedures, not for identifying the presence or nature of a disease or condition.
No
The device description clearly details hardware components, including an electrosurgical generator and a handpiece with a retractable blade or needle electrode, which are physical devices used to deliver energy and create plasma.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures." This describes a surgical tool used directly on the patient's tissue.
- Device Description: The description reinforces this by detailing how the device delivers electrical and plasma energy for cutting, coagulation, and ablation of soft tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgical procedures.
N/A
Intended Use / Indications for Use
The Bovie Ultimate® Electrosurgical Generators are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures. The J-plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces.
The Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Bovie Ultimate® Gen 2 Electrosurgical Generator is a multipurpose electrosurgical device that delivers high frequency electrical energy to cut and coagulate soft tissue. It can also deliver Helium gas plasma energy (J-Plasma) for the cutting, coagulation, and ablation of soft tissue.
The Ultimate Gen 2 electrosurgical generator is the next generation of the original Bovie Ultimate®. The Ultimate Gen 2 has offers the same electrosurgical modes and has the same performance specifications as the original Bovie Ultimate, but the Ultimate Gen 2 will be compatible with the new Bovie J-Plasma Precise Open handpiece passive accessory.
The Bovie J-Plasma Precise Open Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with the Bovie Ultimate Gen 2 electrosurgical generator for the delivery of radiofrequency energy and/or a helium plasma gas for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The handpiece utilizes a retractable blade or needle electrode to ignite the helium gas to create the plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open and laparascopic surgical procedures
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 to assure that the Bovie J-Plasma Precise Open Handpiece and the Ultimate Gen 2 meet performance requirements were performed. Tests included Mechanical Verification and Functionality (VR-1476, VR-1496), Electrical Verification for the handpiece (VR-1476) and Ultimate Gen 2 Generator (VR-1610031), Inspectional Verification for the Ultimate Gen 2 generator (VR-1610032), Plasma Characteristics (VR-1496), FPGA Validation for the Main Board (VR-1491), FPGA Validation for the Display Board (VR-1490), and Performance Evaluation on various tissue types (VR-1496).
Key results: The Bovie Ultimate® Gen 2 Electrosurgical Generator has the same intended use, principles of operation, and utilizes the same technology as the predicate device. It provides standard electrosurgical energy and J-Plasma energy, same as the original. There are no changes to performance specifications, electrosurgical modes, or maximum power settings. The Ultimate Gen 2 performs identically to the original when connected to an active handpiece accessory. The primary difference is compatibility with a J-Plasma passive handpiece accessory, which involves supplying standard monopolar coagulation energy and providing a passive J-Plasma mode. The Ultimate Gen 2 is compatible with both active and passive accessories. The Bovie J-Plasma Precise Open Handpiece has the same intended use and energy source as the predicate device, with no technological differences, or changes to principle of operation or method of application. The differences are related to shape, removal of the transformer to reduce weight, and addition of a coagulation button and blade rotation capability. Verification testing confirmed device performance and demonstrated equivalent tissue effect between the J-Plasma passive accessory and active accessory. No new technology or differences raise new or different questions of safety or efficacy.
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.
K112233, K151325, K152570, K142975
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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle, with three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2017
Bovie Medical Corporation Ms. Rubiela Maldonado Regulatory Affairs Manager 5115 Ulmerton Road Clearwater, Florida 33760
Re: K170188
Trade/Device Name: Bovie J-Plasma Precise Open Handpieces & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 23, 2017 Received: January 24, 2017
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 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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
The Bovie Ultimate® Electrosurgical Generators, and Bovie J-Plasma Precise Open® Handpiece
Indications for Use (Describe)
The Bovie Ultimate® Electrosurgical Generators are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures. The J-plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces.
The Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/2 description: The image contains the word "Bovie" in a bold, sans-serif font. The word is in a dark blue color. Above the word is a light blue curved line with a dot at the end.
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 | |
| Contact email: | Rubiela.Maldonado@boviemed.com |
| Date Prepared: | January 10, 2017 |
DEVICE IDENTIFICATION:
| Proprietary Name: | Bovie J-Plasma Precise Open® Handpiece & Bovie
Ultimate® Gen 2 High Frequency Electrosurgical
Generator |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Generator, Accessory |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and
Accessories |
| Model Numbers: | Multiple |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed Predicate Device(s): | 510(k) Numbers: K112233, K151325, K152570 & K142975
Predicate Device Name: Bovie J-Plasma Handpiece & Bovie Ultimate High Frequency Electrosurgical Generator |
4
Image /page/4/Picture/2 description: The image shows the logo for Bovie. The logo is in blue and features the word "Bovie" in a bold, sans-serif font. Above the word "Bovie" is a curved blue line with a blue dot at the end. The logo is simple and modern.
INTENDED USE/INDICATIONS
The Bovie Ultimate® Electrosurgical Generators are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures. The J-plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces.
The Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.
BOVIE ULTIMATE GEN 2 ELECTROSURGICAL GENERATOR
DEVICE DESCRIPTION
Bovie Ultimate® Gen 2 Electrosurgical Generator is a multipurpose electrosurgical device that delivers high frequency electrical energy to cut and coagulate soft tissue. It can also deliver Helium gas plasma energy (J-Plasma) for the cutting, coagulation, and ablation of soft tissue.
The Ultimate Gen 2 electrosurgical generator is the next generation of the original Bovie Ultimate®. The Ultimate Gen 2 has offers the same electrosurgical modes and has the same performance specifications as the original Bovie Ultimate, but the Ultimate Gen 2 will be compatible with the new Bovie J-Plasma Precise Open handpiece passive accessory.
5
Image /page/5/Picture/2 description: The image shows a Bovie Ultimate electrosurgical unit. The unit has multiple settings for different surgical procedures, including cut, coag, bipolar, and J-plasma. The display shows the power settings for each mode, with values such as 300 for cut, 820 for coag, 850 for bipolar, and 100 for J-plasma. The unit also has settings for gas flow and pulsing, with values of 5.0 L/min and 100 for on/off time, respectively.
Figure 1. Ultimate Gen 2 BVX-200H
Ultimate electrosurgical generators features two (2) cut modes up to 300 watts, three (3) blend modes, three (3) coagulation modes, three (3) bipolar modes and J-plasma mode adjustable up to 40W power (100%) and 1-5 LPM helium gas flow. The generator offers one (1) monopolar handpiece output, one (1) monopolar foot controlled output, one (1) bipolar handpiece output, one (1) bipolar foot controlled output, and one J Plasma (helium) gas outlet.
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, and is designed to meet the requirements of the European Restriction of Hazardous Substances Directive (2011/65/EU) directive.
BOVIE J-PLASMA PRECISE OPEN HANDPIECE
DEVICE DESCRIPTION
The Bovie J-Plasma Precise Open Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with the Bovie Ultimate Gen 2 electrosurgical generator for the delivery of radiofrequency energy and/or a helium plasma gas for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The handpiece utilizes a retractable blade or needle electrode to ignite the helium gas to create the plasma.
The Bovie J-Plasma Precise Open handpiece represents an enhancement of the original Bovie I-Plasma Handpiece:
6
Image /page/6/Picture/2 description: The image shows the word "Bovie" in a bold, dark blue font. Above the word is a light blue curved line with a dot at the end. The word is the main focus of the image and is easily readable.
- Ergonomic shape
- Lighter, due to removal of internal transformer
- . Has 2 buttons to select either standard monopolar coagulation or J-Plasma. Original handpiece has only one button for activation of J-Plasma.
- . The shaft on the new Bovie J-Plasma Precise Open Handpiece with blade electrode can be rotated which can be used rotate the blade. This enables the user to place the blade in the desired orientation.
Image /page/6/Picture/8 description: The image shows a dental curing light. The curing light is black and purple with a gray switch and two buttons, one blue and one purple. The light has a long, thin tip and a curved end.
Figure 1. Bovie J-Plasma Precise Open Handpiece
There are no technological differences or changes to principle of operation. An additional button on the device gives the user the ability to use the monopolar coagulation mode on the Bovie Ultimate Electrosurgical Generator.
There are no changes to the principle of operation or the method of application, and no changes to sterilization methods.
PERFORMANCE TESTING
Performance testing to assure that the Bovie J-Plasma Precise Open Handpiece and the Ultimate Gen 2 meet performance requirements were performed and are summarized in the following tables:
7
Image /page/7/Picture/2 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 in all caps except for the "ie" at the end. There is a small registered trademark symbol to the bottom right of the word.
| Test | Objective | Protocols |
|---|---|---|
| Mechanical Verification | ||
| and Functionality | Verify the mechanical functionality of the handpiece | VR-1476 |
| VR-1496 | ||
| Electrical Verification | Verify the electrical functionality and safety of the | |
| handpiece | VR-1476 | |
| Electrical Verification | Verify the electrical functionality and safety of the | |
| Ultimate Gen 2 Generator. | VR-1610031 | |
| Inspectional Verification | Document parameters that can be verified through | |
| inspection for the Ultimate Gen 2 generator. | VR-1610032 | |
| Plasma Characteristics | Measure effect of generator settings on the plasma | |
| stream, plasma stream characterization | VR-1496 | |
| FPGA Validation for the | ||
| Main Board | Perform testing required to verify Main Board FPGA. | VR-1491 |
| FPGA Validation for the | ||
| Display Board | Perform testing required to verify Display Board FPGA. | VR-1490 |
| Performance Evaluation | Confirm device performance on various tissue types | VR-1496 |
BOVIE ULTIMATE GEN 2 ELECTROSURGICAL GENERATOR SUBSTANTIAL EQUIVALENCE
| Feature/
Characteristic | Bovie Ultimate Gen 2
Electrosurgical Generator
(This Submission) | Bovie Ultimate
Electrosurgical Generator
(Predicate device 510(k)
K142975 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications
for Use | The Bovie Ultimate® Electrosurgical
Generators are indicated for delivery
of radiofrequency energy and/or
helium gas plasma to cut, coagulate
and ablate soft tissue during open and
laparascopic surgical procedures. The
J-plasma portion of the generator can
be used only with dedicated Bovie J-
Plasma handpieces. | The Bovie Ultimate
Electrosurgical Generators
are used for the delivery of
helium gas plasma for
cutting, coagulation, and
ablation of soft tissue during
open and laparascopic
surgical procedures.
The Bovie J-Plasma
Handpiece is compatible only
with Bovie Ultimate
generators. |
8
Image /page/8/Picture/2 description: The image shows the word "Bovie" in a bold, dark blue font. A light blue curved line is above the word, with a dot at the end of the line. The word appears to be a logo for a company or product.
| Feature/
Characteristic | Bovie Ultimate Gen 2
Electrosurgical Generator
(This Submission) | Bovie Ultimate
Electrosurgical Generator
(Predicate device 510(k)
K142975 |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology / Energy Used,
Delivered | Uses High Frequency Radiofrequency (RF) energy to create clinical effect. The electrical properties of the waveform (frequency, peak, and duration) produce the clinical effect (i.e. coagulation and cutting). For soft tissue coagulation using Helium gas, the flow rate produces clinical effect (i.e. coagulation and ablation). | Uses High Frequency Radiofrequency (RF) energy to create clinical effect. The electrical properties of the waveform (frequency, peak, and duration) produce the clinical effect (i.e. coagulation and cutting). For soft tissue coagulation using Helium gas, the flow rate produces clinical effect (i.e. coagulation and ablation). |
| User Interface | Push buttons, Seven segment display and LEDs. | Push buttons, Seven segment display and LEDs. |
| Available Modes | Cut (2), Blend (3), Coagulation (3: pinpoint, spray, gentle), Bipolar (3: Macro, Micro, Standard ), and J-Plasma (2 -with Active accessory and with Passive accessory) | Cut (2), Blend (3), Coagulation (3: pinpoint, spray, gentle), Bipolar (3: Macro, Micro, Standard), and J-Plasma (1) |
| Electrical Safety Standards/
Compatibility with Other
Devices | Complies with IEC60601-1 (third edition), IEC60601-2(electromagnetic compatibility), and IEC60601-2-2 standard for the safety of electrosurgical equipment. | Complies with IEC60601-1 (third edition), IEC60601-2(electromagnetic compatibility), and IEC60601-2-2 standard for the safety of electrosurgical equipment. |
9
Image /page/9/Picture/2 description: The image shows the word "Bovie" in a bold, dark blue font. A light blue curved line extends over the word, ending in a circular dot above the "i". The logo appears to be a company logo.
| Feature/Characteristic | Bovie Ultimate Gen 2
Electrosurgical
Generator
(This Submission) | Bovie Ultimate
Electrosurgical Generator
(Predicate device 510(k)
K142975 |
|------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Product
Dimensions | Length
14.75"
Depth
18.1"
Height
6.5"
Weight
20lbs. | Length
14.75"
Depth
18.1"
Height
6.5"
Weight
20lbs. |
| Power Input | Mains Frequency
50-60Hz
Mains Voltage
100-240VAC +/- 10%
Maximum Power
Consumption
650VA | Mains Frequency
50-60Hz
Mains Voltage
100-240VAC +/- 10%
Maximum Power
Consumption
504 VA |
BOVIE J-PLASMA PRECISE OPEN HANDPIECE
SUBSTANTIAL EQUIVALENCE
| Feature/
Characteristic | Bovie J-Plasma Precise Open Handpiece | Bovie J-Plasma Handpiece
(Predicate K112233, K151325,
K152570) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Bovie J-Plasma Precise Open®
Handpiece is intended to be used in
conjunction with the Bovie Ultimate®
electrosurgical generator for the
delivery of radiofrequency energy
and/or a helium gas plasma for
electrosurgical cutting, coagulation and
ablation of soft tissue during open
surgical procedures. The Bovie J-Plasma
Precise Open® Handpiece is compatible
with Bovie Ultimate® Electrosurgical
Generators BVX-200H, and BVX-200P. | K112233- 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.
K151325, K152570- The Bovie J-
Plasma Precise Open® Handpiece
is used for the delivery of helium
gas plasma for cutting,
coagulation, and ablation of soft
tissue during open surgical
procedures.
The Bovie J-Plasma Handpiece is
compatible only with Bovie |
10
Image /page/10/Picture/2 description: The image shows the word "Bovie" in a bold, sans-serif font. The letters are a dark blue color. Above the word is a light blue curved line with a dot at the end. The "R" in Bovie has a registered trademark symbol next to it.
| Ultimate Generators. | ||
|---|---|---|
| Procedures | Open | Open and Laparascopic |
| Energy Type | Helium gas plasma | Helium gas plasma |
| Output | Monopolar | Monopolar |
| User Interface | Straight | Straight |
| Shaft Working Lengths | 44mm, 150mm | 18mm, 150mm, 270mm 330mm, 450mm |
| Shaft Outer Diameter | 5mm | 5mm |
| Tip Configuration | Blade, Needle | Blade |
| Blade Extension | Maximum 10mm | Maximum 10mm |
| Blade Width x Thickness | 0.4mm x 0.08mm | 0.4mm x 0.08mm |
| Compatibility | Only with Bovie Ultimate Gen 2 Generators | Only with Bovie Ultimate Generators |
| Connector | Bovie Proprietary | Bovie Proprietary |
CONCLUSION
The Bovie Ultimate® Gen 2 Electrosurgical Generator has the same intended use, principles of operation, and utilizes the same technology as the predicate device. The Bovie Ultimate Gen 2 Electrosurgical Generator provides standard electrosurgical energy and J-Plasma energy, the same as the original Bovie Ultimate Generator.
There are no changes to the performance specifications, electrosurgical modes, or maximum power settings of the new generator compared to the original. When connected to an active handpiece accessory, the Bovie Ultimate Gen 2 performs identically to the original Ultimate. The primary difference between the Ultimate Gen 2 and the original Ultimate is that the Ultimate Gen 2 offers compatibility with a J-Plasma passive handpiece accessory. This involves supplying standard monopolar coagulation energy to the J-Plasma handpiece connection and providing a passive J-Plasma mode. The Ultimate Gen 2 is compatible with both active and passive accessories.
The Bovie J-Plasma Precise Open Handpiece is intended for cutting, coagulation, and ablation of soft tissue. The Bovie J-Plasma Precise Open Handpiece has the same intended use and energy source as the predicate device. There are no technological differences, no changes to the principle of operation or the method of application.
11
Image /page/11/Picture/2 description: The image shows the word "Bovie" in a dark blue font. There is a light blue curved line above the word, with a dot at the end of the line. The word is in a sans-serif font and is slightly italicized. There is a small "R" in a circle in the bottom right corner of the image.
The differences between the predicate and subject handpieces are related to the shape, the removal of the transformer to reduce weight for easier handling, and the addition of a coagulation button on the handpiece to give the user the ability to use coagulation mode on the Bovie Ultimate Electrosurgical generator without having to switch to a secondary electrode handpiece. The new handpiece also offers the ability to rotate the blade electrode for optimal positioning.
The Bovie J-Plasma Precise® Open Handpiece and Ultimate Gen 2 were subjected to verification testing that confirmed device performance and demonstrated equivalent tissue effect between the J-Plasma passive accessory and active accessory. There is no new technology or any differences that would raise new or different questions of safety or efficacy.