Bovie J-Plasma Precise FLEX Handpiece

K170777 · Bovie Medical Corporation · GEI · May 1, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170777
• Device Name: Bovie J-Plasma Precise FLEX Handpiece
• Applicant: Bovie Medical Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bovie J-Plasma Precise Flex Handpiece is used for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The Bovie J-Plasma Precise Flex Handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.

Device Story

Electrosurgical accessory; connects to Bovie Ultimate Electrosurgical Generators (BVX-200H, BVX-200P). Delivers helium gas plasma (J-Plasma) and monopolar coagulation energy to soft tissue. Features flexible shaft for advancement through cannula; manipulated by graspers/forceps during minimally invasive surgery. Activated via generator footswitch. Enables surgeon to perform cutting, coagulation, and ablation. Benefits include precise tissue effect in minimally invasive settings.

Clinical Evidence

Bench testing only. Included electrical verification, plasma stream characterization, mechanical functionality, and electromagnetic compatibility (EMC) testing. Simulated use testing demonstrated device maneuverability with grasping accessories.

Technological Characteristics

Flexible shaft electrosurgical handpiece; ceramic nozzle tip; blade/needle tip configurations. Energy: helium gas plasma and monopolar coagulation. Compatible with Bovie Ultimate Generators. Footswitch activation. 500mm working length; 8mm cannula diameter. Complies with IEC electrical safety standards.

Indications for Use

Indicated for cutting, coagulation, and ablation of soft tissue during minimally invasive surgical procedures using a grasper.

Regulatory Classification

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.

Predicate Devices

• Bovie J-Plasma Precise Handpieces (K152325, K152570, K170188)
• OmniGuide Laser System with FlexGuide Ultra (K140378)

Submission Summary (Full Text)

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

May 1, 2017

Bovie Medical Corporation Ms. Rubiela Maldonado Regulatory Affairs Manager 5115 Ulmerton Road Clearwater, Florida 33760

Re: K170777

Trade/Device Name: Bovie J-Plasma Precise Flex Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 14, 2017 Received: March 15, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known) K170777

Device Name Bovie J-Plasma Precise Flex Handpiece

#### Indications for Use (Describe)

The Bovie J-Plasma Precise Flex Handpiece is used for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.

The Bovie J-Plasma Precise Flex Handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CER 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the word "Bovie" in a bold, blue font. Above the word is a curved, light blue line with a blue dot at the end. The "®" symbol is located at the bottom right of the word.

# 510(k) SUMMARY

### (Submitted As Required per 21 CFR 807.92)

#### GENERAL INFORMATION:

| Submitter Name: | Bovie Medical Corporation |
|------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 3007593903 |
| Submitter Address: | 5115 Ulmerton Road<br>Clearwater, Florida 33760-4004<br>United States of America |
| Submitter Telephone Number: | [phone] |
| Submitter FAX Number: | [phone] |
| Contact Person: | Rubiela Maldonado<br>Regulatory Affairs Manager |
| Date Prepared: | March 14, 2017 |
| DEVICE IDENTIFICATION: | |
| Proprietary Name: | Bovie® J-Plasma® Precise Flex Handpiece |
| Common Name: | Electrosurgical Generator Accessory |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Model Numbers: | Multiple |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed<br>Predicate Device(s): | 510(k) Numbers: K152325, K152570, K170188<br>Predicate Device Name: Bovie J-Plasma Precise<br>Handpieces |

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B

510(k) K170777

# 510(k) SUMMARY

510(k) Number: K140378

Predicate Device Name: OmniGuide Laser System with FlexGuide™ Ultra

Manufacturer: OmniGuide Incorporated

#### INTENDED USE/INDICATIONS

The Bovie J-Plasma Precise Flex handpiece is used for the delivery of radiofrequency energy and/or helium gas plasma for electrosurgical cutting, coagulation, and ablation of soft tissue. It is intended for use with grasping instruments during minimally invasive surgical procedures.

The Bovie J-Plasma Precise Flex handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.

#### DEVICE DESCRIPTION

The Bovie J-Plasma Precise Flex handpiece, is an electrosurgical accessory that is connected to a Bovie Ultimate Electrosurgical Generator and used to deliver helium gas plasma (J-Plasma) and standard electrosurgical monopolar coagulation during surgical procedures. The accessory has a flexible shaft that can be advanced through a cannula during minimally invasive surgical procedures. The handpiece is activated by the generator footswitch.

The primary difference between the Bovie J-Plasma Precise Flex handpiece and currently available Bovie J-Plasma handpieces is that the Bovie J-Plasma Precise Flex handpiece has a flexible shaft that can be controlled with graspers, forceps, or grasping instruments during minimally invasive surgical procedures.

The Bovie J-Plasma Precise Flex handpiece uses the same basic technology and delivers the same J-Plasma helium plasma energy as currently available J-Plasma handpieces (K151325, K152570, K170188) and are compatible only with Bovie Ultimate electrosurgical generators.

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Image /page/5/Picture/1 description: The image shows the word "Bovie" in a bold, sans-serif font. The word is a dark blue color. Above the word is a light blue curved line with a dot at the end. The registered trademark symbol is located to the bottom right of the word.

# 510(k) SUMMARY

#### PERFORMANCE TESTING

Performance testing to assure that the Bovie J-Plasma Precise Flex Handpiece meets performance requirements was performed and is summarized in the following tables:

| Test | Objective | Protocols |
|----------------------------------|----------------------------------------------------------------------------------------------|-----------|
| Electrical Verification | Verify the electrical functionality and safety of the<br>handpiece | VR-1510 |
| Bench Equivalency | Measure effect of generator settings on the plasma<br>stream, plasma stream characterization | VR-1511 |
| Mechanical<br>Performance | Verify the mechanical functionality of the handpiece | VP 1529 |
| Electromagnetic<br>Compatibility | EMC testing for emissions and immunity | VR-1512 |

### SUBSTANTIAL EQUIVALENCE

The Bovie J-Plasma Precise Flex handpiece is intended for cutting, coagulation, and ablation of soft tissue. The Bovie J-Plasma Precise FlexHandpiece has the same intended use and energy source as the predicate device, J-Plasma Handpiece. There are no changes to the principle of operation or the method of application. There is no new technology or differences that would raise new or different questions of safety or efficacy and no changes to the principle of operation.

The Bovie J-Plasma Precise Flex handpiece it is intended for use with a grasping accessory during minimally invasive surgical procedures as the other predicate device, OmniGuide Laser System with FleGuide™ Ultra.

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# 510(k) SUMMARY

| Feature/<br>Characteristic | Bovie J-Plasma Precise® Flex | Predicate Bovie® J-Plasma<br>Handpiece<br>(K170188, K151325,<br>K152570) | OmniGuide Laser System<br>with FlexGuide Ultra<br>K140378 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for Use | The Bovie J-Plasma Precise®<br>Flexible Handpiece is used for<br>the delivery of radiofrequency<br>energy and/or a helium gas<br>plasma for electrosurgical<br>cutting, coagulation, and<br>ablation of soft tissue. It is<br>intended for use with a<br>grasping instruments during<br>minimally invasive surgical<br>procedures.<br>The Bovie J-Plasma Precise<br>Open Handpiece is compatible<br>with Bovie Ultimate Generators<br>BVX-200H and BVX-200P. | K170188- intended to be<br>used in conjunction with<br>the Bovie Ultimate®<br>electrosurgical generator<br>for the delivery of<br>radiofrequency energy<br>and/or a helium gas<br>plasma for electrosurgical<br>cutting,<br>coagulation and ablation of<br>soft tissue during open<br>surgical procedures.<br>The Bovie J-Plasma Precise<br>Open® Handpiece is<br>compatible with Bovie<br>Ultimate® Electrosurgical<br>Generators BVX-200H, and<br>BVX-200P. | The OmniGuide Laser<br>System with FlexGuide™<br>Ultra, which includes the<br>FELS 25A Laser, BeamPath<br>Fibers and the<br>FlexGuide™ Ultra<br>handpiece, is indicated for<br>use to enable the surgeon<br>to perform incision,<br>excision, ablation,<br>vaporization and<br>coagulation of body soft<br>tissues including intra-oral<br>tissues. This system is<br>intended for use with a<br>grasper in the following<br>medical specialties: general<br>laparoscopic surgical<br>procedures, gynecologic<br>laparoscopic surgical<br>procedures, urologic<br>surgical procedures,<br>otorhinolaryngology |
| General Description<br>of Procedures | Laparoscopic or minimally<br>invasive surgical procedures | Open and Laparascopic,<br>minimally invasive<br>procedure through cannula | surgical procedures.<br>Medical specialties: general<br>laparoscopic surgical<br>procedures, gynecologic<br>laparoscopic surgical<br>procedures, urologic<br>surgical procedures,<br>otorhinolaryngology<br>surgical procedures. |
| Energy Type | Helium gas plasma<br>Monopolar coagulation | Helium gas plasma<br>Monopolar coagulation | Laser |
| Device Activation | Footswitch activation only, no<br>hand activation | Hand Activation or<br>Footswitch Activation | Footswitch activation only,<br>no hand activation |
| Feature/<br>Characteristic | Bovie J-Plasma Precise® Flex | Predicate Bovie® J-Plasma<br>Handpiece<br>(K170188, K151325,<br>K152570) | OmniGuide Laser System<br>with FlexGuide Ultra<br>K140378 |
| Grasping Feature | Yes | No | Yes |
| Shaft | Flexible | Straight | Flexible |
| Shaft Working Length | 500mm | 18mm, 270mm, 150mm,<br>330mm, 450mm | 600mm |
| Compatible Cannula<br>diameter | 8mm | 5mm | 12mm |
| Tip Configuration | Blade, Needle | Same | Spatula |
| Blade Extension | Maximum 10mm in 2mm<br>increments | Same | N/A |
| Blade Width x<br>Thickness | 0.4mm x 0.08mm | Same | 4 mm |
| Tip protector | Ceramic nozzle | Same | Cycloolefin Polymer (COP) |
| Plasma Settings | Maximum 40 watts, 1-5 lpm<br>gas flow | Same | N/A |
| Compatibility | Compatible only with Bovie<br>Ultimate Generator (BVX-300H,<br>BVX-200P) | Compatible with Original<br>Ultimate (BVX-100H) and<br>Ultimate Generators (BVX-<br>200H, BVX-200P) | OmniGuide Laser System |
| Connector | Bovie Proprietary | Same | OmniGuide |
| Electrical Safety | Complies with IEC Electrical<br>Safety Standards | Same | Same |
| Transformer | None | None — K170188 | N/A |

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## 510(k) SUMMARY

### CONCLUSION

The Bovie J-Plasma Precise Flex Handpiece is intended for cutting, coagulation, and ablation of soft tissue. The Bovie J-Plasma Precise Flex Handpiece has the same intended use and energy source as the predicate device, J-Plasma Handpiece. There are no changes to the principle of operation and there is no new technology or technology differences that would raise new or different questions of safety or efficacy.

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Image /page/8/Picture/1 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 word "Bovie" is the logo for a company.

## 510(k) SUMMARY

The primary differences between the subject device J-Plasma handpiece and the predicate J-Plasma handpieces is the flexible shaft that can be manipulated via grasping accessories. The grasping feature is the same as the predicate device OmniGuide Laser System with FlexGuide Ultra.

The Bovie J-Plasma Precise® Flex Handpiece was subjected to verification testing that confirmed device performance and demonstrated equivalent tissue effect as the predicate device J-Plasma handpiece. Simulated use testing demonstrated the ability of the J-Plasma Precise Flex device to be grasped and maneuvered.