VLFT10GEN: 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 7mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation. 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.

Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN): The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN): The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

Device Description

Valleylab™ FT10 Energy Platform (VLFT10GEN): The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. The generator provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications (LigaSure/vessel sealing function) and cardiac applications. 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/Bipolar section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.

Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN): The Valleylab™ FT10 Electrosurgical Generator is a high frequency electrosurgical only version of the VLFT10GEN Energy Platform. It is intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN): The Valleylab™ FT10 Vessel Sealing Generator is the vessel sealing only version of the VLFT10GEN Energy Platform. It is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Valleylab™ FT10 Energy Platform Software Version 5.0. It describes the device, its intended use, a comparison to a predicate device, and performance data. However, this document does not contain details about a study evaluating a device based on AI/ML. Instead, it describes an electrosurgical generator and highlights performance data related to electrical safety, EMC, software verification/validation, and mechanical testing.

Therefore, I cannot extract information pertaining to:

A table of acceptance criteria and the reported device performance regarding AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The document refers to "acceptance criteria" for engineering and safety tests, not for AI performance.
Sample sizes used for the test set and the data provenance for AI/ML evaluation.
Number of experts used to establish the ground truth for an AI/ML test set and their qualifications.
Adjudication method for an AI/ML test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done for AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
The sample size for the training set for an AI/ML algorithm.
How the ground truth for the training set was established for an AI/ML algorithm.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means that no clinical studies (which would typically involve human readers for an MRMC study or large datasets for standalone AI performance) were conducted or included in this 510(k) submission. The "Software verification and validation testing" mentioned is general software quality assurance, not specific to AI/ML model performance.

In summary, the provided text does not contain the information requested about AI/ML device performance and testing.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the Department of Health & Human Services logo.

July 12, 2024

Covidien LLC Aliva Mahunta Sr. Regulatory Affairs Specialist 200 Medtronic Drive Lafayette, Colorado 80026

Re: K241085

Trade/Device Name: Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, OCL Dated: May 23, 2024 Received: May 24, 2024

Dear Aliva Mahunta:

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 H. Chen -> Digitally signed by Long H.Chen -S
Date: 2024.07.12 16:00:47 -04'00'

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

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Indications for Use

Submission Number (if known)

K241085

Device Name

Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)

Indications for Use (Describe)

VLFT10GEN

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 7mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation.

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.

Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN)

The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN)

The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

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)

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K241085

510(k) Summary Complying with 21 CFR 807.92

l. SUBMITTER

Covidien IIc. 200 Medtronic Drive Lafayette, CO, 80026

Contact: Aliva Mahunta, Sr. Regulatory Affairs Specialist Phone Number : 800-255-6774 Email: aliva.mahunta@medtronic.com Date Summary Prepared: May 20, 2024

ll. PROPOSED DEVICE

Trade Name:	Valleylab FT10 Energy Platform with Software Version 5.0
Catalog Numbers:	VLFT10GEN; VLFT10FXGEN; VLFT10LSGEN
Common Name:	Electrosurgical Generator
Classification Name:	Electrosurgical cutting and coagulating device and accessories (21 CFR 878.4400)
Regulatory Class:	II
Product Code:	GEI, OCL

PREDICATE DEVICE

Trade Name:	Valleylab FT10 Energy Platform with Software Version 4.0
Catalog Numbers:	VLFT10GEN
Common Name:	Electrosurgical Generator
Classification Name:	Electrosurgical cutting and coagulating device and accessories (21 CFR 878.4400)
510(k) Number:	K191601
Regulatory Class:	II
Product Code:	GEI, OCL

lll. DEVICE DESCRIPTION

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K241085

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.

IV. INDICATIONS FOR USE

Valleylab™ FT10 Energy Platform (VLFT10GEN):

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 thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. 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.

Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN):

The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN):

The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, thick tissue (tissue bundles), and lymphatics.

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.

V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Valleylab FT10 Energy Platform with the proposed software modifications has the same technological and performance characteristics as the predicate Valleylab FT10 Energy Platform with software version 4.0 cleared in K191601. Both versions of the energy platform are a combination of a full-featured general surgery electrosurgical system, a vessel sealing system, and a cardiac ablation system. The proposed device VLFT10GEN with software version 5.0 (VLFT10GEN SW v5.0) provides

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incremental improvements over the predicate while maintaining the same basic functionality and intended use.

Characteristic	Proposed DeviceValleylab™ FT10 EnergyPlatform with Softwareversion 5.0	Predicate DeviceValleylab™ FT10 EnergyPlatform with Softwareversion 4.0 (K191601)	Comparison
Classification	878.4400	878.4400	Same
Regulation
Class	II	II	Same
Product Code	GEI	GEI	Same
Indications for Use	The Valleylab FT10 EnergyPlatform is a high frequencyelectrosurgical generatorintended for use withmonopolar and bipolaraccessories for cutting andcoagulating tissue. When usedwith compatible sealing devices,it is indicated for sealing vesselsup to and including 7 mm thicktissue (tissue bundles), andlymphatics. When used withcompatible ablation devices it isindicated for cardiac tissueablation. The generator can beused with compatibleresectoscopes forendoscopically controlledremoval or coagulation of tissueusing 0.9% NaCl solution as theirrigation medium.The tissue fusion function hasnot been shown to be effectivefor tubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use thisfunction for these procedures.VLFT10FXGEN Indications forUseThe VLFT10FXGEN EnergyPlatform is a high frequencyelectrosurgical generatorintended for use withmonopolar and bipolaraccessories for cutting andcoagulating tissue.	The Valleylab FT10 EnergyPlatform is a high frequencyelectrosurgicalGenerator intended for usewith monopolar and bipolaraccessories for cutting andcoagulating tissue. Whenused with compatiblesealing devices, it isindicated for sealing vesselsup to and including 7 mm,tissue bundles, andlymphatics. When used withcompatible ablationdevices, it is indicated forcardiac tissue ablation. Thegenerator can also be usedwith compatibleresectoscopes forendoscopically controlledremoval or coagulation oftissue using 0.9% NaClsolution as the irrigationmedium.The tissue fusion functionhas not been shown to beeffective for tubalsterilization or tubalcoagulation for sterilizationprocedures. Do not use thisfunction for theseprocedures	SameThere is no change tothe intended use orindications for use of thedevice. The indicationsfor use for the separateVLFT10FXGEN andVLFT10LSGEN functionsare simply a subset ofthe fully functionalVLFT10GEN indicationsfor use, which are notchanging.The intended use wasrevised to add thicktissue (tissue bundles)while keeping tissuebundles.This revision is forclarification purposesonly for the benefit ofthe surgeon.There is no change tothe intended use of thegenerator, but rather aclarification of terms forthe benefit of thesurgeon.
	VLFT10LSGEN Indications forUseThe VLFT10LSGEN EnergyPlatform is a high frequencyelectrosurgical generator. Whenused with compatible sealingdevices, it is indicated forsealing vessels up to andincluding 7 mm tissue bundles,and lymphatics.
Contraindications	The cardiac tissue ablationfeature is contraindicated forpatients that have activeendocarditis at the time ofsurgery.Ablation in a pool of blood iscontraindicated (for examplethrough a purse string suture).	The cardiac tissue ablationfeature is contraindicatedfor patients that have activeendocarditis at the time ofsurgery.Ablation in a pool of bloodis contraindicated (forexample through a pursestring suture).	Same
Physical Characteristics(approximate	Height: 7 in. (17.78 cm)Width: 14.5 in. (35.8 cm)Length: 18.2 in. (46.2 m)Weight: 22.3 lbs. (10.1 kg)	Height: 7 in. (17.78 cm)Width: 14.5 in. (35.8 cm)Length: 18.2 in. (46.2 m)Weight: 22.3 lbs. (10.1 kg)	Same
Touchscreen	LCD; Resistive Technology	LCD; Resistive Technology	Same
Connector Receptacles	LED Illuminated connectorreaders	LED Illuminated connectorreaders	Same
Monopolar Ports	2	2	Same
Bipolar/LigaSure Ports	2	2	Same
Hand switch Activation	Yes	Yes	Same
Footswitch Activation	Yes	Yes	Same
REM Quality ContactMonitoring	Yes	Yes	Same
Wireless Connectivity	No	No	Same
Instrumentldentification	Barcode/RFID	Barcode/RFID	Same

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VI. PERFORMANCE DATA

The following performance data were conducted in support of the substantial equivalence determination. Verification and Validation testing confirmed that the modifications to the Valleylab™ FT10 Energy Platform do not raise any different issues of safety and effectiveness. 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:

System Verification showed that VLFT10GEN with SW v.5.0 possesses all required functionality and meets system specifications.
. Confirmatory Electrical safety and EMC testing were conducted on the Proposed Device and showed that the system complies with IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
. Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions" [2023] and IEC 62304 Medical Device Software- Software life cycle processes".
Mechanical Testing in the form of Environmental and Packaging Test and Chemical Soak and Abrasion Test was conducted and met all the acceptance criteria.

VII. CLINICAL STUDIES

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

VIII. CONCLUSIONS

Verification and Validation activities demonstrate that the Valleylab™FT10 Energy Platform with software version 5.0 (VLFT10GEN SW v5.0) is substantially equivalent to the predicate Valleylab™FT10 Energy Platform with software version (VLFT10GEN SW v4.0) cleared in K191601. The intended use of the Valleylab™FT10 Energy Platform has not changed. The non-clinical data support the safety of the device and the hardware and software verification, and validation demonstrate that the Proposed Device Valleylab™FT10 Energy Platform with software version 5.0 (VLFT10GEN SW v5.0) should perform as intended in the specified use conditions.

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.