(78 days)
Not Found
No
The summary describes a standard electrosurgical handpiece and does not mention any AI or ML components, algorithms, or data processing related to learning or adaptation.
Yes
The device is described as being used for "cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures," which are therapeutic interventions.
No
The device is described as an electrosurgical accessory used for "cutting, coagulation, and ablation of soft tissue," which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a "sterile, single use electrosurgical accessory" and describes physical components like a "retractable cutting blade tip" and "needle tip," indicating it is a hardware device. The performance studies also include "Mechanical Verification" and "Electrical Verification," further confirming it is 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 is for "cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a "sterile, single use electrosurgical accessory" that delivers "helium gas plasma" for surgical procedures. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly designed for therapeutic and surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Bovie J-Plasma Handpiece is 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 J-Plasma generators.
Product codes
GEI
Device Description
The Bovie J-Plasma Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with Bovie J-Plasma electrosurgical for the delivery of helium gas plasma for cutting, coagulating, and ablating soft tissue.
The Bovie J-Plasma Handpiece is available with a retractable cutting blade tip for excising tissue or a needle tip. Both tip configurations serve as electrodes to generate helium plasma. The device is available in 15cm, 33cm, and 45cm lengths. The device can be used in laparascopic or open surgical procedures.
The primary differences between the proposed J-Plasma handpieces and predicate J-Plasma handpieces are:
- Pistol grip shape
- Available in 15cm, 33cm, and 45cm shaft lengths for open and laparoscopic procedures, compared to the predicate 18cm and 27cm lengths
- . Available with blade or needle electrode instead of only blade electrode
There are no technological differences or changes to principle of operation. There are no changes to intended use, design, material, chemical composition, or energy source. Both devices require a Bovie J-Plasma generator and channel helium gas flow over an energized inner electrode to create a plasma stream.
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 Laparoscopic 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 Handpiece meets performance requirements was performed and is summarized in the following table:
| Test | Objective | Protocols |
|---|---|---|
| Mechanical Verification and Functionality | Verify the mechanical functionality of the handpiece. | VR-1191 VR-1323 |
| Electrical Verification | Verify the electrical functionality and safety of the handpiece. | VR-1191 |
| Plasma Characteristics | Measure effect of generator settings on the plasma stream, plasma stream characterization | VR-1323 |
| Performance Evaluation | Confirm device performance on various tissue types. | VR-1323 |
| Usability Evaluation | The purpose of this protocol is to verify and validate the usability of the J-Plasma Pistol Grip Handpiece as it relates to safety. | VR-1216 |
| Shipping Study | Verify the device meets requirements after shipping and handling. | VR-1191 |
The handpiece, and the predicate handpiece, was designed in accordance with the following standards:
| International Standard | Description |
|---|---|
| IEC-60601-1, Edition 3.1 | Medical Electrical Equipment - Part 1: General Requirements For Safety |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC-60601-2-2 : 2009 | Particular requirements for the safety of high frequency surgical equipment |
| ANSI / AAMI / ISO 10993-1:2009 | Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing |
| ANSI / AAMI / ISO 11135-1: 2007 | Sterilization of Healthcare Products – Ethylene Oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. |
| ANSI / AAMI / ISO 10993-7:2008 | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Residuals |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Bovie Medical Corporation Mr. Brian Kunst Vice President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760
August 4, 2015
Re: K151325
Trade/Device Name: Bovie J-Plasma Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 15, 2015 Received: May 18, 2015
Dear Mr. Kunst:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (21CFR 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.
Sincerelv vours.
Joshua C. Nipper -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) K151325
Device Name Bovie J-Plasma Handpiece
Indications for Use (Describe)
The Bovie J-Plasma Handpiece is 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 J-Plasma generators.
| 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) |
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/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is written in a light blue color. There is a line that underlines the word. The registered trademark symbol is located to the right of the letter "e".
510(k) SUMMARY
K151325
(Submitted As Required per 21 CFR 807.92)
GENERAL INFORMATION:
| Submitter Name: | Bovie Medical Corporation |
|---|---|
| Establishment Registration | |
| Number: | 3007593903 |
| Submitter Address: | 5115 Ulmerton Road |
| Clearwater, Florida 33760-4004 | |
| United States of America | |
| Submitter Telephone Number: | (727) 803-8617 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | Brian Kunst |
| Vice President, Regulatory Affairs and Quality | |
| Assurance | |
| Date Prepared: | May 15, 2015 |
| DEVICE IDENTIFICATION: | |
| Proprietary Name: | Bovie J-Plasma 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) Number: K112233 |
| Predicate Device Name: Bovie J-Plasma Handpiece | |
| Manufacturer: Bovie Medical Corporation |
4
Image /page/4/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The color of the text is a light blue. A registered trademark symbol is located to the right of the word.
510(k) SUMMARY
INTENDED USE/INDICATIONS
The Bovie J-Plasma Handpiece is 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 J-Plasma generators.
DEVICE DESCRIPTION
The Bovie J-Plasma Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with Bovie J-Plasma electrosurgical for the delivery of helium gas plasma for cutting, coagulating, and ablating soft tissue.
The Bovie J-Plasma Handpiece is available with a retractable cutting blade tip for excising tissue or a needle tip. Both tip configurations serve as electrodes to generate helium plasma. The device is available in 15cm, 33cm, and 45cm lengths. The device can be used in laparascopic or open surgical procedures.
Image /page/4/Figure/8 description: The image shows a medical device that is white and blue. The device has a long, thin metal rod extending from the front. The handle of the device is shaped like a pistol grip, and there are several buttons and switches on the device.
The primary differences between the proposed J-Plasma handpieces and predicate J-Plasma handpieces are:
- Pistol grip shape
- Available in 15cm, 33cm, and 45cm shaft lengths for open and laparoscopic procedures, compared to the predicate 18cm and 27cm lengths
- . Available with blade or needle electrode instead of only blade electrode
There are no technological differences or changes to principle of operation. There are no changes to intended use, design, material, chemical composition, or energy source. Both devices require a Bovie J-Plasma generator and channel helium gas flow over an energized inner electrode to create a plasma stream.
5
Image /page/5/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is a light blue color, and there is a line extending from the bottom of the "B" that underlines the rest of the word. There is a registered trademark symbol to the right of the "e".
510(k) SUMMARY
PERFORMANCE TESTING
Performance testing to assure that the Bovie J-Plasma Handpiece meets performance requirements was performed and is summarized in the following table:
| Test | Objective | Protocols |
|---|---|---|
| Mechanical Verification and | ||
| Functionality | Verify the mechanical functionality of | |
| the handpiece. | VR-1191 | |
| VR-1323 | ||
| Electrical Verification | Verify the electrical functionality and | |
| safety of the handpiece. | VR-1191 | |
| Plasma Characteristics | Measure effect of generator settings on | |
| the plasma stream, plasma stream | ||
| characterization | VR-1323 | |
| Performance Evaluation | Confirm device performance on | |
| various tissue types. | VR-1323 | |
| Usability Evaluation | The purpose of this protocol is to | |
| verify and validate the usability of the | ||
| J-Plasma Pistol Grip Handpiece as it | ||
| relates to safety. | VR-1216 | |
| Shipping Study | Verify the device meets requirements | |
| after shipping and handling. | VR-1191 |
The handpiece, and the predicate handpiece, was designed in accordance with the following standards:
| International Standard | Description |
|---|---|
| IEC-60601-1, Edition 3.1 | Medical Electrical Equipment - Part 1: General Requirements |
| For Safety | |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements |
| for basic safety and essential performance - Collateral Standard: | |
| Electromagnetic disturbances - Requirements and tests | |
| IEC-60601-2-2 : 2009 | Particular requirements for the safety of high frequency surgical |
| equipment | |
| ANSI / AAMI / ISO 10993-1:2009 | Biological Evaluation of Medical Devices – Part 1: Evaluation |
| and Testing | |
| ANSI / AAMI / ISO 11135-1: 2007 | Sterilization of Healthcare Products – Ethylene Oxide - Part 1: |
| Requirements for the development, validation, and routine | |
| control of a sterilization process for medical devices. | |
| ANSI / AAMI / ISO 10993-7:2008 | Biological Evaluation of Medical Devices - Part 7: Ethylene |
| Oxide Residuals |
6
Image /page/6/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font, with a swooping line underlining the word. The text "510(k) SUMMARY" is located below the word "Bovie" and the swooping line. The text "510(k) SUMMARY" is underlined.
SUBSTANTIAL EQUIVALENCE
| Feature/
Characteristic | Bovie J-Plasma Handpiece
Current Submission | Bovie J-Plasma Handpiece
(Predicate K112233) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Bovie J-Plasma Handpiece is
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 J-Plasma
generators | 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. |
| Procedures | Open and Laparascopic | Open and Laparascopic |
| Energy Type | Helium gas plasma | Helium gas plasma |
| Output | Monopolar | Monopolar |
| User Interface | Pistol grip | Straight |
| Shaft Working Lengths | 15cm, 33cm, 45cm | 18cm, 27cm |
| 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 J-Plasma Generators | Only with Bovie J-Plasma Generators |
| Connector | Bovie Proprietary | Bovie Proprietary |
7
Image /page/7/Picture/0 description: The image features the word "Bovie" in a stylized, cursive font. The color of the text is a bright, light blue. A curved line underlines the word, adding to the dynamic and flowing feel of the design. A registered trademark symbol is present to the right of the word.
CONCLUSION
The Bovie J-Plasma Handpiece has the same intended use, principle of operation, and utilizes the same technology as the predicate device. There is no new technology and no difference that would raise new or different questions of safety or efficacy. The differences between the subject device and the predicate device are mainly dimensional. Substantial equivalence was demonstrated through comparative bench testing.
Although there are slight difference in the wording of the indications statement between the subject device and the predicate device, the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and the differences do not affect the safety and effectiveness of the device when used as labeled. The devices are still used for the delivery of helium gas plasma for application on soft tissue during open and laparascopic procedures.