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. 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.

Device Description

The Valleylab™ FT10 Energy Platform (VLFT10GEN) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion and vessel-sealing applications (LigaSure vessel-sealing function), and cardiac ablation. It is a combination of a full-featured general-surgery electrosurgical unit, a bipolar vessel sealing system, and an ablation unit. 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 cardiac ablation feature of the device is only available when used with compatible Cardioblate™ instruments.

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.

AI/ML Overview

This FDA 510(k) summary does not contain the information requested for a detailed description of acceptance criteria and a study proving a device meets them.

The document is a regulatory approval letter for the Valleylab FT10 Energy Platform, indicating its substantial equivalence to a predicate device. It describes the device, its intended use, and general performance characteristics, but it explicitly states that no clinical performance data was relied upon for this premarket submission.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to the performance evaluation of a device through specific studies, which this summary confirms were not clinically focused.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document describes general performance characteristics and compliance with standards (e.g., thermal spread, system functionality, electrical safety, usability), but it does not list specific quantitative acceptance criteria or corresponding reported device performance metrics in a table format.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document mentions "ex vivo testing using porcine tissue" for thermal spread, but it does not specify the sample size for this testing (e.g., number of porcine tissue samples). It also does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. Since no clinical performance study involving human interpretation or "ground truth" establishment is detailed, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. Similar to point 3, without a clinical performance study involving multiple human readers and ground truth, there is no adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. The document does not mention any MRMC study, AI assistance, or human reader improvement. The device described is an electrosurgical generator, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. The device is an electrosurgical generator; the concept of "standalone algorithm performance" is not applicable in the context presented.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No clinical "ground truth" is discussed for the performance evaluation in this document. The "ground truth" for the ex vivo testing would likely relate to objective measurements of thermal spread in the tissue samples, but the methodology is not detailed.

8. The sample size for the training set

Cannot be provided. The document discusses software verification and validation, but it does not mention a "training set" in the context of an AI/ML algorithm or a similar data-driven model. The software testing mentioned is for embedded device software, not a learning algorithm.

9. How the ground truth for the training set was established

Cannot be provided. As there is no mention of a "training set," this information is not applicable.

In summary, the provided document focuses on regulatory clearance based on substantial equivalence and non-clinical verification and validation activities (e.g., bench testing, software testing, electrical safety). It explicitly states that clinical performance data was not used for this submission, which means the detailed information about acceptance criteria, specific study designs, sample sizes, and ground truth methodologies (especially as they relate to human or AI performance) is absent.

Summary

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July 12, 2019

Covidien Ms. Jennie van Diemen Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K191601

Trade/Device Name: Vallevlab FT10 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: June 13, 2019 Received: June 17, 2019

Dear Ms. Jennie van Diemen:

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.

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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 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

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Indications for Use

510(k) Number (if known) K191601

Device Name Valleylab FT10 Energy Platfom

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date summary prepared: July 5, 2019

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact:

Ms. Jennie van Diemen Regulatory Affairs Specialist Telephone: 303-581-7037 Fax: 303-530-6313 Email: jennie.vandiemen@medtronic.com

Name of Device

Trade Name:	Valleylab FT10 Energy Platform
Catalog Numbers:	VLFT10GEN
Common Name:	Electrosurgical Generator
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Class II, GEI, OCL)

Predicate Device

Trade Name:	Valleylab FT10 Energy Platform
Catalog Number:	VLFT10GEN
Common Name:	Electrosurgical Generator
510(k) Number:	K182610 (cleared 12/19/2018)
Manufacturer:	Covidien
Recalls:	This device has not been subject to a design-related recall

Reference Device

Trade Name:	Valleylab FX8 Energy Platform
Catalog Number:	VLFX8GEN
Common Name:	Electrosurgical Generator
510(k) Number:	K181389 (cleared 06/25/2018)
Manufacturer:	Covidien
Recalls:	This device has not been subject to a design-related recall

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Device Description

The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.

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.

Contraindications

The cardiac tissue ablation feature is contraindicated for patients that have active endocarditis at the time of surgery.

Ablation in a pool of blood is contraindicated (for example, through a purse string suture).

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 K182610. 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 Valleylab FX8 Energy Platform, cleared by K181389, serves as a reference device and test control device for the adoption of bipolar modes by the proposed device. The proposed Valleylab FT10 Energy Platform provides increments over the predicate while maintaining the same basic functionality and intended use. These improvements are summarized below.

Addition of bipolar modes Precise, Standard, and Macro
Improved Bipolar Resection Cut mode initiation speed
. Feature allowing the user to save settings and access recent settings
Bug fixes associated with non-safety related issues

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Performance Characteristics

Verification and validation testing confirmed that the modifications to the Valleylab FT10 Energy Platform do not raise different questions 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:

Ex vivo testing using porcine tissue showed comparable performance with regards to thermal spread
. System verification showed the VLFT10GEN possesses all required functionality and meets system specifications
. Software verification and validation testing was conducted in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices [2005]and IEC 62304 Medical device software – Software life cycle processes
. Confirmatory electrical safety testing showed the VLFT10GEN complies with the 2017 version of IEC 60601-2-2 Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories - Edition 6.0
Validation testing was conducted in accordance with FDA Guidance Applying Human ● Factors and Usability Engineering to Medical Devices [2016] and IEC 62366-1:2015 Medical Devices – Application of Usability Engineering to Medical Devices

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 Energy Platform is substantially equivalent to the predicate Valleylab FT10 Energy Platform cleared in K182610. 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.

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.