(112 days)
Not Found
No
The summary describes a standard electrosurgical generator with safety features and user-selectable RF energy. There is no mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML technology in medical devices.
Yes
The device is designed to cut and coagulate living tissue during surgical procedures, which is a treatment for certain conditions.
No
This device is an electrosurgical generator designed to cut and coagulate tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components like a generator, footswitch, tone generator, and irrigation pump, and the performance studies include hardware verification testing.
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 and coagulating of tissue and the coagulation of blood vessels in all types of surgery." This describes a surgical procedure performed on a living patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a device that delivers RF energy to living tissue during surgery. It mentions a footswitch, tone generator, and irrigation pump, all consistent with a surgical electrosurgical generator.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to directly interact with and modify living tissue during surgery.
N/A
Intended Use / 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.
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.
Product codes
GEI
Device Description
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.
Items that are included in the system are:
- VFS1 generator -CO 840
- . Footpedal- CO 841
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals and Clinical Settings where electrosurgery is used.
Procedures must be performed by a surgeon with experience in the use of electrosurgical devices and generators.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
. 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:
- o Input Voltage
- Input Frequency o
- Input Protection o
- 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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
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). 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 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). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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)
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3
510(K) SUMMARY SECTION 5
- 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
VFS1 Bipolar
Electrosurgical
Generator |
|-------|-------------------------------------------------------------------------|
| C0841 | Electrosurgical Foot
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
Characteristics | Valley Forge Scientific
(division of FHC Inc.)
VFS1 Electrosurgical
Generator | Valley Forge Scientific
Corp.
Malis 2000 Bipolar
Electrosurgical System | PREDICATE
Malis Irrigation Module
1000 |
|----------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Modalities | Electrosurgical Cutting
and Coagulation
Irrigation | Electrosurgical Cutting
and Coagulation | Irrigation |
| Environment of
Use | Hospitals and Clinical
Settings where
electrosurgery is used. | Hospitals and Clinical
Settings where
electrosurgery is used. | Hospitals and Clinical
Settings where
electrosurgery is used. |
| Power Source | AC Voltage from wall
receptacle | AC Voltage from wall
receptacle | AC Voltage from wall
receptacle |
| Device (System)
Components | - Generator
- Foot pedal
- Power Cord
- Cord/Tubing Set
- Irrigation
Module(check) | - Generator - Foot pedal
- Power Cord
- Cord/Tubing Set | - Peristaltic Pump
- Foot Pedal |
| | LCD Display, displays: | LCD Display, displays: | |
| | Cut and Coag Power
Settings | Cut and Coag Power
Settings | |
| | Power Units | Power Units | |
| Display Screen
Details | Tone Volume and
Brightness Settings | Tone and Voice Volume
and Brightness Settings | Built in Numeric display |
| | System Errors and
Warnings | System Errors and
Warnings | |
| | Irrigation Setting | Absent | |
7. Comparison of Technological Characteristics to Predicate Devices
6
| Technological
Characteristics | Valley Forge Scientific
(division of FHC Inc.)
VFS1 Electrosurgical
Generator | PREDICATE
Valley Forge Scientific
Malis 2000 Bipolar
Electrosurgical System | PREDICATE
Malis Irrigation Module
1000 |
|----------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------|
| Pump Head Type | Peristaltic | N/A | Peristaltic |
| Motor Type | DC electric motor | N/A | DC electric motor |
| Irrigation
Delivery Method | Tubing set with industry
standard connectors | N/A | Tubing set with industry
standard connectors |
| Patient interface | Bipolar forceps | N/A | Bipolar forceps |
| Liquid Source | Saline bag | N/A | Saline bag |
| Delivery Rate | Slow drip, medium drip,
fast drip | N/A | Slow drip, medium drip,
fast drip |
| RF Output Mode | Bipolar | Bipolar | N/A |
| RF Output Power
Range | Cut: 0 to 100 Watts
Coag: 0 to 50 Watts | Cut: 0 to 300 Watts
Coag: 0 to 50 Watts | N/A |
| RF Output
Waveforms | Cut: 1 MHz sinewave
Coag: 1 MHz damped
aperiodic | Cut: 1 MHz sinewave
Coag: 1 MHz damped
aperiodic | N/A |
| Output Power
Controls | Rotary Switches
Pushbutton Switches | Rotary Switches | Rotary Switches |
| Power Activation | Foot pedal | Foot pedal and Finger
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.