(59 days)
Not Found
No
The device description explicitly states that the single software component is "solely used to support the user interface." There is no mention of AI, ML, or any functionality beyond basic control and display.
Yes
The device is indicated for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures, which are therapeutic actions.
No
Explanation: The device is an electrosurgical generator used to cut, coagulate, and ablate soft tissue, which are therapeutic functions. It does not perform any diagnostic functions like detection, diagnosis, or monitoring of a disease or condition.
No
The device is a physical electrosurgical generator with hardware components (power cord, front/back panels, internal components like circuit boards, speakers, cabling) that deliver RF energy and helium gas plasma. While it contains a software component, it is explicitly stated that this software is "solely used to support the user interface," indicating it is not the primary functional component of the medical device itself.
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 RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic surgical procedures." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details an electrosurgical generator used for cutting, coagulation, and ablation of soft tissue. It describes outputs for handpieces, footswitches, and gas, all consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly modify tissue during surgery.
N/A
Intended Use / Indications for Use
The Bovie Ultimate™ High Frequency Electrosurgical Generator is indicated for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic sucrival procedures. The J-Plasm portion of the generator can be used only with dedicated Bovie J-Plasma handpieces
Product codes
GEI
Device Description
The Bovie Ultimate™ High Frequency Electrosurgical Generator is a multipurpose electrosurgical device used for delivery of RF 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 generator combines the features of two cleared electrosurgical generators. The device is intended to be used in the Hospital Operating Room environment.
It features two (2) cut modes up to 300 watts, three (3) blend modes, three (3) coagulation modes, and three (3) bipolar modes. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. 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 has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The padsensing feature allows the user to use either a split or solid return electrode. This feature is not required when using Helium gas mode for soft tissue coagulation. The Bovie Ultimate™ High Frequency Electrosurgical Generator contains a single software component that is solely used to support the user interface.
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. It is also designed to meet the requirements of the European Restriction of Hazardous Substances Directive (2011/65/EU) directive.
The device consists of the generator, power cord, and a User's Guide. The main device components are a front panel containing the power button, wattage selection buttons, gas flow (rate) selection buttons, pulsing, LED numeric displays, alarm and return electrode indicator lights, and connector ports for accessories. The back panel consists of Helium gas access ports, footswitch ports, volume controls, a power cord outlet, and a fuse. Internal components include printed circuit boards, speakers, and cabling.
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
Hospital Operating Room environment
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)
Bench testing was performed to demonstrate that the generator met design specifications and to establish substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance with the following:
- IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- IEC 60601-2-2: 2007 Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2014
Bovie Medical Corporation Mr. Moshe Citronowicz Senior Vice-President 5115 Ulmerton Road Clearwater, Florida 33760
Re: K142975
Trade/Device Name: Bovie Ultimate " 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: October 2, 2014 Received: October 14, 2014
Dear Mr. Citronowicz:
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 (reporting of medical
1
device-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/Resourcesfor You/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.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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
510(k) Number (if known)
Device Name
Bovie Ultimate™ High Frequency Electrosurgical Generator
Indications for Use (Describe)
The Bovie Ultimate™ High Frequency Electrosurgical Generator is indicated for delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparascopic sucrival procedures. The J-Plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces
| 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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3
K142975 Page 1 of 5
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) 803-8521 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | Moshe Citronowicz |
| Senior Vice-President | |
| Date Prepared: | October 2, 2014 |
DEVICE IDENTIFICATION:
| Proprietary Name: | Bovie Ultimate™ High Frequency Electrosurgical
Generator |
|------------------------------------------|-------------------------------------------------------------------|
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and
Accessories |
| Model Number: | BVX-100H |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed
Predicate Device(s): | 510(k) Number: K134054 |
| | Primary Predicate Device Name: |
| | Bovie IDS-310 High Frequency Electrosurgical
Generator |
| | Manufacturer: Bovie Medical Corporation |
| | 510(k) Number: K090586 |
| | Secondary Predicate Name: |
| | Bovie ICON GS Generator |
4
K142975 Page 2 of 5
Manufacturer: Bovie Medical Corporation 510(k) SUMMARY
(Submitted As Required per 21 CFR 807.92)
Indications
The Bovie Ultimate™ High Frequency Electrosurgical Generator is used for delivery of RF 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.
Device Description/Characteristics
The Bovie Ultimate™ High Frequency Electrosurgical Generator (BVX-100H) is a multipurpose electrosurgical device used for delivery of RF 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 generator combines the features of two cleared electrosurgical generators. The device is intended to be used in the Hospital Operating Room environment.
It features two (2) cut modes up to 300 watts, three (3) blend modes, three (3) coagulation modes, and three (3) bipolar modes. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. 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 has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The padsensing feature allows the user to use either a split or solid return electrode. This feature is not required when using Helium gas mode for soft tissue coagulation. The Bovie Ultimate™ High Frequency Electrosurgical Generator contains a single software component that is solely used to support the user interface.
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. It is also designed to meet the requirements of the European Restriction of Hazardous Substances Directive (2011/65/EU) directive.
The device consists of the generator, power cord, and a User's Guide. The main device components are a front panel containing the power button, wattage selection buttons, gas flow (rate) selection buttons, pulsing, LED numeric displays, alarm and return electrode indicator lights, and connector ports for accessories. The back panel consists of Helium
5
K142975 Page 3 of 5
gas access ports, footswitch ports, volume controls, a power cord outlet, and a fuse. Internal components include printed circuit boards, speakers, and cabling.
Bench testing was performed to demonstrate that the generator met design specifications and to establish substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance with the following:
IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
510(k) SUMMARY
(Submitted As Required per 21 CFR 807.92)
IEC 60601-1-2: 2007
Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
IEC 60601-2-2: 2007
Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Substantial Equivalence:
| Characteristic | Bovie Ultimate™
High Frequency
Electrosurgical
Generator
(This Submission) | Bovie IDS-310
High Frequency
Electrosurgical
Generator
(K134054)
Primary Predicate | Bovie ICON GS
Generator
(K090586)
Secondary
Predicate |
|--------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Regulation and
Product Code | 21 CFR 878.4400 /
GEI | 21 CFR 878.4400 /
GEI | 21 CFR 878.4400 /
GEI |
6
| K142975 Page 4 of 5 | |||
|---|---|---|---|
| Intended Use | Is used for delivery of RF 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. | Is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. | Utilizes helium gas for the coagulation of soft tissues during open soft tissue surgery. |
| Energy Type | High Frequency (RF) | High Frequency (RF) | High Frequency (RF) |
| Output | Monopolar and Bipolar | Monopolar and Bipolar | Monopolar and Bipolar |
7
510(k) SUMMARY
(Submitted As Required per 21 CFR 807.92)
Substantial Equivalence:
| Characteristic | Bovie Ultimate™
High Frequency
Electrosurgical
Generator
(BVX-100H)
(This Submission) | Bovie IDS-310
High Frequency
Electrosurgical
Generator
(K134054)
Primary Predicate | Bovie ICON GS
Generator
(GS100)
(K090586)
Secondary
Predicate |
|---------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Cut Modes | Has Two Cut Modes | Has Two Cut Modes | Not Applicable to
this Device |
| Blend Modes | Has Three Blend
Modes | Has Four Blend
Modes | Not Applicable to
this Device |
| Monopolar
Connectors | One | Dual | Not Applicable to
this Device |
| Plasma Connector | One | Not Applicable to
this Device | One |
| Auto Bipolar | Does Not Have
Auto Bipolar | Has Auto Bipolar | Not Applicable to
this Device |
| Bovie Bipolar | Does Not Have
Bovie Bipolar | Has Bovie Bipolar | Not Applicable to
this Device |
| Output Gas Flow | 1.0 - 5.0
Liters/minute | Not Applicable to
this Device | 1.0 - 5.0
Liters/minute |
| Bipolar Handpiece
Activation | Supported | Supported | Not Applicable to
this Device |
| Gas In Use Indicator | Present | Not Applicable to
this Device | Not Present |
Conclusions
The Bovie Ultimate™ High Frequency Electrosurgical Generator has the same intended use, operating procedures, principles of operation, and utilizes the same technology as the predicate devices. The Bovie Ultimate™ High Frequency Electrosurgical Generator does not raise additional issues of safety or efficacy compared to the predicate devices.