Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
Device Facts
| Record ID | K181389 |
|---|---|
| Device Name | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform |
| Applicant | Covidien |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jun 19, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures. The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Device Story
Valleylab FT10 and FX8 are high-frequency electrosurgical generators providing RF energy for cutting, desiccating, and fulgurating tissue. FT10 includes additional LigaSure tissue-fusion/vessel-sealing capabilities. Used in hospitals/surgical facilities by surgeons/clinical staff. Devices connect to electrical mains (47-63 Hz) and interface with monopolar/bipolar instruments, footswitches, and return electrode pads. Output energy is delivered to tissue via accessories; clinicians monitor surgical progress visually. Software updates (FT10 v2.1, FX8 v1.1) refine monopolar energy delivery, enable selectable smoke evacuation port activation, and fix bugs. These platforms assist in achieving hemostasis and tissue separation, potentially reducing surgical time and improving patient outcomes through controlled energy delivery.
Clinical Evidence
No clinical data provided. Substantial equivalence demonstrated via bench testing, including ex vivo porcine tissue thermal effect analysis and system-level verification/validation of software modifications.
Technological Characteristics
High-frequency electrosurgical generator; RF energy output. FT10 includes LigaSure vessel sealing. Connectivity: electrical mains (47-63 Hz). Standards: IEC 60601-1:2012 (safety), IEC 60601-1-2:2014 (EMC), IEC 62304 (software lifecycle). Software: embedded firmware (FT10 v2.1, FX8 v1.1).
Indications for Use
Indicated for patients requiring electrosurgical cutting and coagulation of tissue via monopolar or bipolar accessories. FT10 model indicated for vessel sealing (up to 7mm), tissue bundles, lymphatics, and endoscopic resection using 0.9% NaCl. Contraindicated for tubal sterilization/coagulation.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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June 19, 2018
Covidien Celso Duran Principal Specialist, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K181389
Trade/Device Name: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 24, 2018 Received: May 25, 2018
Dear Celso Duran:
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, 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
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801); medical device reporting of medical 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.
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 mediation-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, Jennifer R. Stevenson -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
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# Indications for Use
510(k) Number (if known) K181389
Device Name Valleylab FT10 Energy Platform
#### Indications for Use (Describe)
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The tissue fusion function has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use this function for these procedures.
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.*
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:
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# Indications for Use
510(k) Number (if known) K181389
Device Name Valleylab FX8 FX Series Energy Platform
#### Indications for Use (Describe)
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:10px">☐</span> 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."
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Image /page/4/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle in the center and a vertical blue line running through it. To the right of the square is the word "COVIDIEN" in blue, with each letter clearly visible.
# 510(k) Summary
Date summary prepared: June 14, 2018
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact: Celso Duran Telephone: 303-350-6445 Fax: 303-530-6313 Email: celso.duran@medtronic.com
This Bundled Special 510(k) Notification proposes updates to the software for the Valleylab FT10 Energy Platform (VLFT10GEN) and Valleylab FX8 Energy Platform (VLFX8GEN). The software updates will provide incremental improvements while maintaining the same basic functionality and intended use. The improvements common to both platforms are listed below.
- Refinement of monopolar energy
- Enable selectable smoke activation from either smoke evacuation port
- Miscellaneous software changes and bug (anomalies) fixes
#### Name of Device #1
| Trade Name: | Valleylab FT10 Energy Platform |
|----------------------|----------------------------------------------------------------------------------------------------|
| Catalog Numbers: | VLFT10GEN |
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR<br>878.4400, Class II, GEI) |
| Trade Name: | Valleylab FT10 Energy Platform |
| Catalog Number: | VLFT10GEN |
| Common Name: | Electrosurgical Generator |
| 510(k) Number: | K170170 (cleared 02/16/2017) |
| Manufacturer: | Covidien |
| Recalls: | This device has not been subject to a design-related recall |
#### Predicate Device
#### Name of Device #2
Valleylab FX8 Energy Platform Trade Name: Catalog Numbers: VLFX8GEN Common Name: Electrosurgical Generator Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Class II, GEI)
#### Predicate Device
| Trade Name: | Valleylab FX8 Energy Platform |
|-----------------|-------------------------------------------------------------|
| Catalog Number: | VLFX8GEN |
| Common Name: | Electrosurgical Generator |
| 510(k) Number: | K172757 (cleared 11/02/2017) |
| Manufacturer: | Covidien |
| Recalls: | This device has not been subject to a design-related recall |
BUNDLED Special 510(k): Valleylab FT10 Energy Platform Valleylab FX8 Energy Platform
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# Valleylab FT10 Energy Platform
# Device Description
The Valleylab™ FT10 Energy Platform (VLFT10GEN) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications (LigaSure/vessel-sealing function). It is a combination of a full-featured general-surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. The LigaSure/vessel-sealing section of the system provides power for vessel sealing.
The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.
The VLFT10GEN can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10GEN connects to electrical mains and operates at an input line frequency of 47-63 Hz.
# Indications for Use
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
# Comparison of Technological Characteristics with the Predicate Device
The Valleylab FT10 Energy Platform with the proposed software modifications has similar technological and performance characteristics as the predicate Valleylab FT10 Energy Platform cleared in K170170. Both versions of the energy platform are a combination of a full-featured general-surgery electrosurgical system and a vessel sealing system. The VLFT10GEN with software version 2.1 provides increments over the predicate while maintaining the same basic functionality and intended use. These improvements are summarized below.
- Refinement of monopolar energy
- Enable selectable smoke activation from either smoke evacuation port
- . Miscellaneous software changes and bug (anomalies) fixes
- Updates to User's Guide including re-phrasing and relocation of precautions and warnings
# Performance Characteristics
Verification and validation testing confirmed that the modifications to the Valleylab FT10 Energy Platform do not affect safety or performance. The testing confirmed the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:
- . Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects.
- . System verification showed that the VLFT10GEN has all required functionality and that it meets system specifications.
BUNDLED Special 510(k): Valleylab FT10 Energy Platform Valleylab FX8 Energy Platform
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- Software verification and validation testing was conducted in accordance with FDA's, ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304, Medical device software – Software life cycle processes
The changes were evaluated for impact on electrical safety and electromagnetic compatibility (EMC). The evaluation determined that the proposed changes do not require additional electrical safety testing in accordance with IEC 60601-1:2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" or electromagnetic magnetic compatibility in accordance with IEC 60601-1-2:2014, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). Although new electrical safety and EMC testing was not required, the Valleylab FT10 continues to meet the requirements of both standards.
# Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
# Conclusions
Verification and validation activities demonstrate that the Valleylab FT10 with software version 2.1 is substantially equivalent to the predicate Valleylab FT10 Energy Platform (SW 2.0) cleared in K170170. The intended use of the Valleylab FT10 Energy Platform has not changed. Moreover, the results of testing demonstrate that the software modifications do not affect the safety or performance of the energy platform.
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# Valleylab FX8 Energy Platform
# Device Description
The Valleylab FX8 Energy Platform provides radio frequency (RF) energy for monopolar and bipolar surgical applications. Unlike the Valleylab FT10, the VLFX8 does not include the tissuefusion and vessel-sealing applications (LigaSure function). It is a high-frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
# Indications for Use
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
# Comparison of Technological Characteristics with the Predicate Device
The Valleylab FX8 with the proposed software modifications has the similar technological and performance characteristics as the predicate Valleylab FX8 cleared in K172757. Both versions of the Valleylab FX8 Energy Platform provide radio frequency (RF) energy for monopolar and bipolar surgical applications. The VLFX8 with software version 1.1 provides incremental improvements over the predicate while maintaining the same basic functionality and intended use. These improvements are summarized below.
- . Refinement of monopolar energy
- . Enable selectable smoke activation from either smoke evacuation port
- . Miscellaneous software changes and bug (anomalies) fixes
# Performance Characteristics
Verification and validation testing confirmed that the modifications to the Valleylab FX8 Energy Platform do not affect safety or performance. The testing confirmed the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:
- . Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects.
- . System verification showed that the VLFX8GEN has all required functionality and that it meets system specifications.
- Software verification and validation testing was conducted in accordance with FDA's, ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304, Medical device software – Software life cycle processes
The changes were evaluated for impact on electrical safety and electromagnetic compatibility (EMC). The evaluation determined that the proposed changes do not require additional electrical safety testing in accordance with IEC 60601-1:2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" or electromagnetic magnetic compatibility in accordance with IEC 60601-1-2:2014, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). Although new electrical safety and EMC testing was not required, the Valleylab FX8 continues to meet the requirements of both standards.
BUNDLED Special 510(k): Valleylab FT10 Energy Platform Valleylab FX8 Energy Platform
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#### Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
#### Conclusions
Verification and validation activities demonstrate that the Valleylab FX8 with software version 1.1 is substantially equivalent to the predicate Valleylab FX8 Energy Platform (SW 1.0) cleared in K172757. The intended use of the Valleylab FX8 Energy Platform has not changed. Moreover, the results of testing demonstrate that the software modifications do not affect the safety or performance of the energy platform.
