VFS1 Bipolar Electrosurgical Generator

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May 14, 2020 FHC, Inc. % Craig Pagan, Consultant C2C Development, LLC 1135 W NASA Blvd, Suite 500 Melbourne, Florida 32901 Re: K200169 Trade/Device Name: VFS1 Bipolar 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: April 10, 2020 Received: April 14, 2020 Dear Craig Pagan: 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). 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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-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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). 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Sincerely, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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) K200169 #### Device Name VFS1 Bipolar Electrosurgical Generator #### Indications for Use (Describe) The VFS1 Bipolar Electrosurgical Generator is indicated for use in micro, and endoscopic bipolar irrigation, cutting and coagulating of tissue and the coagulation of blood vessels in all types of surgery. Type of Use (Select one or both, as applicable) [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. 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Submitter's name, address, telephone number, a contact person, and the date the summary was prepared: FHC, Inc. 1201 Main Street Bowdoin, ME-04287 Tel: 207-666-5651 Fax: 207-666-8292 Contact: Kelly Moeykens Preparation Date: April 6th, 2020 ### 2. Name(s) of the Device: | Proprietary/Trade Name: | VFS1 Bipolar Electrosurgical Generator | |-------------------------|---------------------------------------------------------------| | Common Name: | Bipolar Electrosurgical Generator or Electrosurgical Generato | | Regulation Number | 21 CFR 878.4400 | | Regulation Name: | Electrosurgical device | | Classification Panel | General and Plastic Surgery | | Product Code: | GEI | | Regulatory Class: | II | ### 3. Legally Marked Predicate Device to which the submitter claims substantial equivalence: | Trade Name: | Malis Bipolar 2000 Electrosurgical Generator | |----------------|----------------------------------------------| | 510(k) #: | K050364 | | Product Code: | GEI | | Decision Date: | March 9th, 2005 | | Trade Name: | MALISTM Irrigation Module 1000 | | 510(k) #: | K033499 | | Product Code: | GEI | | Decision Date: | November 28th, 2003 | {4}------------------------------------------------ ## 4. Description of device: The VFS1 Bipolar Electrosurgical Generator (referred to as generator or VFS1 Generator) is designed to cut and coagulate living human tissue during surgical procedures. The system provides 1 MHz Radio Frequency (RF) energy that is user/operator selectable based on the surgical procedure undertaken. The generator is configured for bipolar output and is earth isolated, to minimize leakage current, thus providing increased patient comfort and safety. The system will be provided with safety features that are continuously monitored and will provide warnings and/ or alerts when critical parameters exceed specified limits. The VFS1 Generator is designed to cut and coagulate living tissue during surgical procedures. The system includes a bipedal footswitch. The generator is equipped with a tone generator to provide audible feedback each time cutting, or coagulation is performed. The generator incorporates a variable-rate irrigation pump to provide saline flow during procedures. The VFS1 Generator is compatible with a variety of reusable bipolar products; i.e., insulated mirror finish bipolar forceps, disposable nonstick bipolar instruments as well as disposable bipolar cords and tubing products. ltems that are included in the system are: - VFS1 generator -CO 840 - . Footpedal- CO 841 | C0840 | Valley Forge Scientific<br>VFS1 Bipolar<br>Electrosurgical<br>Generator | |-------|-------------------------------------------------------------------------| | C0841 | Electrosurgical Foot<br>Pedal | {5}------------------------------------------------ # 5. Statement of Indications for Use: The VFS1 Bipolar Electrosurgical Generator is indicated for use in micro, macro, and endoscopic bipolar irrigation, cutting and coagulating of tissue and the coagulation of blood vessels in all types of surgery. # 6. Intended Use The VFS1 Bipolar Generator is intended for use in surgical procedures for cutting tissue and coagulating blood vessels. Procedures must be performed by a surgeon with experience in the use of electrosurgical devices and generators. | Technological<br>Characteristics | Valley Forge Scientific<br>(division of FHC Inc.)<br>VFS1 Electrosurgical<br>Generator | Valley Forge Scientific<br>Corp.<br>Malis 2000 Bipolar<br>Electrosurgical System | PREDICATE<br>Malis Irrigation Module<br>1000 | |----------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------| | Modalities | Electrosurgical Cutting<br>and Coagulation<br>Irrigation | Electrosurgical Cutting<br>and Coagulation | Irrigation | | Environment of<br>Use | Hospitals and Clinical<br>Settings where<br>electrosurgery is used. | Hospitals and Clinical<br>Settings where<br>electrosurgery is used. | Hospitals and Clinical<br>Settings where<br>electrosurgery is used. | | Power Source | AC Voltage from wall<br>receptacle | AC Voltage from wall<br>receptacle | AC Voltage from wall<br>receptacle | | Device (System)<br>Components | - Generator<br>- Foot pedal<br>- Power Cord<br>- Cord/Tubing Set<br>- Irrigation<br>Module(check) | - Generator<br>- Foot pedal<br>- Power Cord<br>- Cord/Tubing Set | - Peristaltic Pump<br>- Foot Pedal | | | LCD Display, displays: | LCD Display, displays: | | | | Cut and Coag Power<br>Settings | Cut and Coag Power<br>Settings | | | | Power Units | Power Units | | | Display Screen<br>Details | Tone Volume and<br>Brightness Settings | Tone and Voice Volume<br>and Brightness Settings | Built in Numeric display | | | System Errors and<br>Warnings | System Errors and<br>Warnings | | | | Irrigation Setting | Absent | | # 7. Comparison of Technological Characteristics to Predicate Devices {6}------------------------------------------------ | Technological<br>Characteristics | Valley Forge Scientific<br>(division of FHC Inc.)<br>VFS1 Electrosurgical<br>Generator | PREDICATE<br>Valley Forge Scientific<br>Malis 2000 Bipolar<br>Electrosurgical System | PREDICATE<br>Malis Irrigation Module<br>1000 | |----------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------| | Pump Head Type | Peristaltic | N/A | Peristaltic | | Motor Type | DC electric motor | N/A | DC electric motor | | Irrigation<br>Delivery Method | Tubing set with industry<br>standard connectors | N/A | Tubing set with industry<br>standard connectors | | Patient interface | Bipolar forceps | N/A | Bipolar forceps | | Liquid Source | Saline bag | N/A | Saline bag | | Delivery Rate | Slow drip, medium drip,<br>fast drip | N/A | Slow drip, medium drip,<br>fast drip | | RF Output Mode | Bipolar | Bipolar | N/A | | RF Output Power<br>Range | Cut: 0 to 100 Watts<br>Coag: 0 to 50 Watts | Cut: 0 to 300 Watts<br>Coag: 0 to 50 Watts | N/A | | RF Output<br>Waveforms | Cut: 1 MHz sinewave<br>Coag: 1 MHz damped<br>aperiodic | Cut: 1 MHz sinewave<br>Coag: 1 MHz damped<br>aperiodic | N/A | | Output Power<br>Controls | Rotary Switches<br>Pushbutton Switches | Rotary Switches | Rotary Switches | | Power Activation | Foot pedal | Foot pedal and Finger<br>switches | Foot pedal | ## 8. Performance Data Non-clinical: Basic mechanical and functional capabilities were tested for the subject electrosurgical generator to determine substantial equivalence to the predicate device. This also includes a Comparibility Study of the subject device and the predicate device. Report Refer to section 18 for details. The following is a summary of components and testing performed: #### . VCP-09-103 – VFS1 Hardware Verification Testing Testing and inspection performed on the VFS1 Electrosurgical Generator, to verify compliance with the Product Development Specification, DSI-09-100. Testing included: - о Input Voltage - Input Frequency o - Input Protection o {7}------------------------------------------------ - Output Waveform O - RF Power Output O - RF Output vs Load Resistance O - O RF Overcurrent Protection - Over-dosage Protection O - Irrigation O - Real Time Clock O - Mechanical O - Operating Conditions O - Storage Conditions O - O Cooling - Transportation O - Shock O - Cleaning O - Front Panel Connections O - Rear Panel Connections O - Power Cord O - O Front Panel Controls - O Rear Panel Controls - Display O All testing met specifications. #### VCP-09-109 – VFS1 Comparibility Study Report ● Testing was performed on the VFS1 Electrosurgical Generator to verify proper operation of the generator with all the components and accessories working together as a system. Testing included Ex Vivo testing for Cut and Coag using steak, liver and kidney tissue samples. All testing was found to be acceptable. #### ● ROH-09-100 - VFS1 ROHS Verification Report RoHS Compliance was verified for all components and subassemblies of the VFS1 Surgical Generator, Model CO840. #### VDP-09-100 – Shipping Test Report ● Testing was performed to confirm that the external packaging configuration for the VFS1 Electrosurgical Generator provides a high probability of safe and intact arrival at the destination by confirming that the integrity of the packaging and its components withstand simulated shipping and handling stress and by demonstrating that the shipping and handling stresses have no adverse effect on the VFS1 Generator performance. Testing was performed per ISTA-3A Shipping Test and met all requirements. Clinical: No clinical data was used to determine substantial equivalence. {8}------------------------------------------------ # 9. Conclusion Based on the non-clinical performance data performed comparing the VFS1 Electrosurgical Generator to the predicate devices (Malis 2000 Bipolar Electrosurgical System and the Malis Irrigation Module 1000), it is concluded that the device is as safe, as effective, and performs as well as or better than the predicate device.