(76 days)
Not Found
No
The document describes a standard electrosurgical handpiece and generator system. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or performance testing summary.
Yes
The device is intended for cutting, coagulation, and ablation of soft tissue during surgical procedures, which are direct therapeutic interventions.
No
Explanation: The device is intended for cutting, coagulation, and ablation of soft tissue during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly outlines physical hardware components (handpieces, cutting blade tip, cables, connectors) and their mechanical and electrical functionality testing. It also mentions biocompatibility testing, which is relevant to physical materials in contact with the body. There is no indication that the device is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, coagulation of soft tissue during open and laparoscopic surgical procedures" and "cutting, coagulation and ablation of soft tissue during open surgical procedures." This describes a surgical tool used directly on the patient's tissue in vivo.
- Device Description: The description details an electrosurgical accessory that delivers helium plasma for cutting and coagulating tissue. This is consistent with a surgical device, not a device used to test samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is to physically alter tissue during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Renuvion/J-Plasma Handpieces are sterile, single use electrosurgical accessories intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Handpieces are available with a retractable cutting blade tip for excising tissue. The blade tip serves as an electrode to generate helium plasma.
The Renuvion/J-Plasma Precise devices are available in 15cm, 27cm and 33cm lengths for use in laparoscopic or open surgical procedures. The 27cm are standard lengths for laparoscopic instruments and are compatible with standard 5mm trocars.
The Renuvion/J-Plasma Precise Open devices are available in 44mm and 150mm for used in open surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (during open and laparoscopic surgical procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing to assure that the Renuvion/J-Plasma Precise and Precise Open Handpieces met performance requirements were performed and are summarized in the following table:
Test: Mechanical & Electrical Verification and Functionality
Objective: Verify the mechanical and electrical functionality of the handpiece
Pneumatic Testing
Electrical Continuity test
Perform Cable Flexure / Tension Test
Connector Dielectric Strength Test
Mold Stress Test
Free-fall Drop Test
Insertion/Extraction Integrity
Test: Usability Evaluation
Objective: The purpose of this protocol is to verify and validate the usability of the J-Plasma Pistol Grip Handpiece as it relates to safety.
Biocompatibility Testing:
The biocompatibility evaluation for the Renuvion/J-Plasma Handpieces was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of evaluations included the following testing:
- l Cytotoxicity
- I Sensitization
- Irritation
- Systemic toxicity
- Hemolysis
- Material Mediated Pyrogen
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 12, 2019
Bovie Medical Corporation Topaz Kirlew Executive Director of OA & RA 5115 Ulmerton Road Clearwater, Florida 33760
Re: K183610
Trade/Device Name: Renuvion/J-Plasma Precise Handpiece and Renuvion/J-Plasma Precise Open Handpieces Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 11, 2019 Received: January 15, 2019
Dear Dr. Topaz Kirlew:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Long Long H. H. Chen -S Date: 2019.03.12 Chen -S 13:26:07 -04'00' 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) K183610
Device Name
The Renuvion®/J-Plasma® Precise Handpiece and The Renuvion®/J-Plasma® Precise Open Handpiece
Indications for Use (Describe)
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of helium plasma for cutting, coagulation of soft tissue during open and laparoscopic surgical procedures.
The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Open® Handpieces are compatible with electrosurgical Generators BVX-200H, and BVX-200P.
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
Bovie.
510(k) Summary
| Submitted by: | Bovie Medical Corporation
5115 Ulmerton Road Clearwater, Florida 33760 -4004
United States of America |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rubiela Maldonado
Regulatory Affairs Manager
Phone: (727) 803-8508
Fax: (727) 803-4491 |
| Submission Correspondent: | Topaz Kirlew
VP, Quality Assurance & Regulatory Affairs
Phone: (727) 803-8617
Email: topaz.kirlew@apyxmedical.com |
| Date Prepared: | December 21, 2018 |
| Trade Name: | Renuvion®/J-Plasma® Precise Handpiece and
Precise Open Handpiece |
| Common Name: | Electrosurgical Handpiece |
| Classification: | Class II per 21CFR 878.4400 -Electrosurgical
Cutting and Coagulation Device and Accessories
Product Code GEI |
| Predicate Devices: | Bovie J-Plasma Handpiece K151325 &
Bovie J-Plasma Precise Open K170188 |
Intended Use / Indications for Use:
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P.
4
Image /page/4/Picture/0 description: The image shows the word "Bovie" in a bold, blue font. There is a curved line above the word, also in blue, with a dot at the end. The font is sans-serif and the word is slightly italicized.
Device Description Renuvion/J-Plasma Handpieces (J-Plasma Precise and Precise Open):
The Renuvion/J-Plasma Handpieces are sterile, single use electrosurgical accessories intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Handpieces are available with a retractable cutting blade tip for excising tissue. The blade tip serves as an electrode to generate helium plasma.
The Renuvion/J-Plasma Precise devices are available in 15cm, 27cm and 33cm lengths for use in laparoscopic or open surgical procedures. The 27cm are standard lengths for laparoscopic instruments and are compatible with standard 5mm trocars.
The Renuvion/J-Plasma Precise Open devices are available in 44mm and 150mm for used in open surgical procedures.
Intended Use & Technological Characteristics
The handpieces have the same intended use as the predicate devices. There are no technological differences or changes to the principle of operation or to the method of application. There are no changes to sterilization methods.
The design of Handpieces compared to the predicate devices are identical except for the following differences:
- . The plug connector to the generator is dimensioned so that it will establish a pneumatic seal connection before an electrical connection (pins shortened, and O-ring added to replace silicone seal).
- Reduced insertion/extraction force to pluq/unplug the device to/from the generator.
Performance Data
Performance testing to assure that the Renuvion/J-Plasma Precise and Precise Open Handpieces met performance requirements were performed and are summarized in the following table:
| Test | Objective |
|---|---|
| Mechanical & Electrical | |
| Verification and | |
| Functionality | Verify the mechanical and electrical functionality of |
| the handpiece Pneumatic Testing Electrical Continuity test Perform Cable Flexure / Tension Test Connector Dielectric Strength Test Mold Stress Test Free-fall Drop Test Insertion/Extraction Integrity | |
| 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. |
5
Image /page/5/Picture/0 description: The image shows the word "Bovie" in a bold, blue font. There is a curved, light blue line above the word, and a small, blue dot above the "i". The word appears to be a logo or brand name.
Biocompatibility Testing
The biocompatibility evaluation for the Renuvion/J-Plasma Handpieces was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of evaluations included the following testing:
- l Cytotoxicity
- I Sensitization
- Irritation
- Systemic toxicity
- 트 Hemolysis
- . Material Mediated Pyrogen
The Renuvion/J-Plasma handpieces are an external communicating device with an indirect blood path contact for a duration of less than 24 hours; Biocompatibility has been established per ISO 10993 guidelines for this category. Due to the redesign of the plug connector, changes on materials were made to two patient contacting components, flow tube coupler and O-ring. Biocompatibility verification testing was satisfactorily conducted for these components.
Conclusion
There is no difference between the predicates, Precise J-Plasma handpiece and Precise Open handpiece and the Subject devices in terms of intended use, principle of operation, and the technology used for device performance. There is no new technology and there are no differences that would raise new or different questions of safety or efficacy.
Verification and validation testing of the Renuvion/J-Plasma handpieces demonstrate that the devices perform as intended.