(47 days)
No
The summary describes a handpiece for delivering electrosurgical energy and helium plasma, focusing on its mechanical flexibility and compatibility with existing generators. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is used for electrosurgical cutting and coagulation of soft tissue, which are therapeutic interventions.
No
Explanation: The device is described as an electrosurgical accessory used for cutting and coagulation of soft tissue, which are therapeutic rather than diagnostic functions.
No
The device is a physical handpiece that delivers energy and gas plasma, clearly indicating it is a hardware device, not software only.
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 used for "electrosurgical cutting, coagulation of soft tissue" during "minimally invasive surgical procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description reinforces this by explaining it's an "electrosurgical accessory" that delivers energy and plasma for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
Therefore, the Bovie J-Plasma Precise Flex Handpiece is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, intra-oral tissues
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 to assure that the Bovie J-Plasma Precise Flex Handpiece meets performance requirements was performed:
- Electrical Verification: Verify the electrical functionality and safety of the handpiece. Protocol: VR-1510.
- Bench Equivalency: Measure effect of generator settings on the plasma stream, plasma stream characterization. Protocol: VR-1511.
- Mechanical Performance: Verify the mechanical functionality of the handpiece. Protocol: VP 1529.
- Electromagnetic Compatibility: EMC testing for emissions and immunity. Protocol: VR-1512.
Simulated use testing demonstrated the ability of the J-Plasma Precise Flex device to be grasped and maneuvered.
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.
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
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
1
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 (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
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)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CER 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: | 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 |
| Accessories | |
| Model Numbers: | Multiple |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed | |
| Predicate Device(s): | 510(k) Numbers: K152325, K152570, K170188 |
| Predicate Device Name: Bovie J-Plasma Precise | |
| 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 | |
| handpiece | VR-1510 | |
| Bench Equivalency | Measure effect of generator settings on the plasma | |
| stream, plasma stream characterization | VR-1511 | |
| Mechanical | ||
| Performance | Verify the mechanical functionality of the handpiece | VP 1529 |
| Electromagnetic | ||
| 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/
Characteristic | Bovie J-Plasma Precise® Flex | Predicate Bovie® J-Plasma
Handpiece
(K170188, K151325,
K152570) | OmniGuide Laser System
with FlexGuide Ultra
K140378 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Bovie J-Plasma Precise®
Flexible Handpiece is used for
the delivery of radiofrequency
energy and/or a helium gas
plasma for electrosurgical
cutting, coagulation, and
ablation of soft tissue. It is
intended for use with a
grasping instruments during
minimally invasive surgical
procedures.
The Bovie J-Plasma Precise
Open Handpiece is compatible
with Bovie Ultimate Generators
BVX-200H and BVX-200P. | K170188- 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. | The OmniGuide Laser
System with FlexGuide™
Ultra, which includes the
FELS 25A Laser, BeamPath
Fibers and the
FlexGuide™ Ultra
handpiece, is indicated for
use to enable the surgeon
to perform incision,
excision, ablation,
vaporization and
coagulation of body soft
tissues including intra-oral
tissues. This system is
intended for use with a
grasper in the following
medical specialties: general
laparoscopic surgical
procedures, gynecologic
laparoscopic surgical
procedures, urologic
surgical procedures,
otorhinolaryngology |
| General Description
of Procedures | Laparoscopic or minimally
invasive surgical procedures | Open and Laparascopic,
minimally invasive
procedure through cannula | surgical procedures.
Medical specialties: general
laparoscopic surgical
procedures, gynecologic
laparoscopic surgical
procedures, urologic
surgical procedures,
otorhinolaryngology
surgical procedures. |
| Energy Type | Helium gas plasma
Monopolar coagulation | Helium gas plasma
Monopolar coagulation | Laser |
| Device Activation | Footswitch activation only, no
hand activation | Hand Activation or
Footswitch Activation | Footswitch activation only,
no hand activation |
| Feature/
Characteristic | Bovie J-Plasma Precise® Flex | Predicate Bovie® J-Plasma
Handpiece
(K170188, K151325,
K152570) | OmniGuide Laser System
with FlexGuide Ultra
K140378 |
| Grasping Feature | Yes | No | Yes |
| Shaft | Flexible | Straight | Flexible |
| Shaft Working Length | 500mm | 18mm, 270mm, 150mm,
330mm, 450mm | 600mm |
| Compatible Cannula
diameter | 8mm | 5mm | 12mm |
| Tip Configuration | Blade, Needle | Same | Spatula |
| Blade Extension | Maximum 10mm in 2mm
increments | Same | N/A |
| Blade Width x
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
gas flow | Same | N/A |
| Compatibility | Compatible only with Bovie
Ultimate Generator (BVX-300H,
BVX-200P) | Compatible with Original
Ultimate (BVX-100H) and
Ultimate Generators (BVX-
200H, BVX-200P) | OmniGuide Laser System |
| Connector | Bovie Proprietary | Same | OmniGuide |
| Electrical Safety | Complies with IEC Electrical
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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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.