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.

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 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 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.

AI/ML Overview

The provided document outlines the software updates for two electrosurgical generators, the Valleylab FT10 Energy Platform and the Valleylab FX8 Energy Platform. The submission is a Bundled Special 510(k) Notification, focusing on "incremental improvements while maintaining the same basic functionality and intended use."

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Tests Conducted	Reported Device Performance (New Device vs. Predicate)
Similar Functionality	Maintain basic functionality and intended use.	Proposed software modifications provide incremental improvements over the predicate while maintaining the same basic functionality and intended use.
Thermal Effects	Comparable performance in ex vivo testing.	Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects.
System Functionality	Device has all required functionality and meets system specifications.	System verification showed that the device (VLFT10GEN / VLFX8GEN) has all required functionality and that it meets system specifications.
Software Verification	Conducted according to FDA guidance and IEC 62304.	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.
Electrical Safety	Conformance to IEC 60601-1:2012.	Evaluation determined proposed changes do not require additional electrical safety testing and the device continues to meet the requirements of IEC 60601-1:2012.
Electromagnetic Compatibility (EMC)	Conformance to IEC 60601-1-2:2014.	Evaluation determined proposed changes do not require additional electromagnetic compatibility testing and the device continues to meet the requirements of IEC 60601-1-2:2014.
Safety and Performance	Modifications do not affect safety or performance.	Verification and validation testing confirmed that the modifications do not affect safety or performance.

2. Sample Size for Test Set and Data Provenance:

The document mentions "ex vivo testing using porcine tissue." However, it does not specify the sample size for this ex vivo testing. The provenance of this data is described as "ex vivo using porcine tissue," implying laboratory-based testing on animal tissue rather than human data. It is inherently retrospective in the sense that it's a controlled lab study, not collected from real-world clinical application.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide information on the use of experts to establish ground truth or their qualifications. The ex vivo testing relies on objective measurements of thermal effects and system performance against pre-defined specifications.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. Given the nature of the ex vivo and system verification tests, which involve objective measurements against specifications, a traditional adjudication method for subjective interpretation (like in imaging studies) would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." The improvements are software-based and evaluated through engineering verification and validation, and ex vivo testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

This question is not applicable in the context of an electrosurgical generator. The devices are tools used by surgeons; there isn't an "algorithm only" performance that operates independently of human interaction. The "software updates" are integral to the device's function, not a separate diagnostic algorithm.

7. Type of Ground Truth Used:

The ground truth used for the performance evaluations primarily involved:

Objective measurements of thermal effects on porcine tissue.
System specifications for functionality.
Adherence to recognized industry safety and performance standards (e.g., IEC 60601-1, IEC 62304).

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable in this context. These are electrosurgical generators with software updates, not AI/machine learning models that undergo a training phase with a distinct dataset. The software changes are refined and verified against specifications and performance criteria.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" in the machine learning sense, this question is not applicable. The software updates were developed and verified against engineering specifications and relevant regulatory standards.

Summary

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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 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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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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"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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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)
-------------------------------------------------

☑ 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.

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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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 CFR878.4400, 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 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 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

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.

Regulation Number and Section

§ 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.