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

Valleylab FX8 FX Series Energy Platform is a radio-frequency (RF) electrosurgical generator that delivers energy to compatible surgical instruments. The concentration of energy at the tip of the instrument in conjunction with tissue characteristics produces heat. The heating of tissue provides the desired surgical effect (cutting, coagulation, sealing). Variations in the waveform result in the different surgical effects achieved by different modes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Valleylab FX8 FX Series Energy Platform, an electrosurgical generator. The submission aims to demonstrate substantial equivalence to a predicate device, the Valleylab FT10 Energy Platform.

However, the documentation does not include a study proving the device meets specific performance acceptance criteria in the way one might expect for an AI/ML medical device, which would typically involve metrics like sensitivity, specificity, or AUC against a ground truth.

Instead, the provided text describes the verification and validation activities performed to demonstrate that the Valleylab FX8 FX Series Energy Platform performs as intended and is substantially equivalent to its predicate. These activities focus on safety, functionality, and performance equivalence, rather than a clinical effectiveness study with human readers or a standalone algorithm.

Here's a breakdown based on the information available, addressing the requested points:

Acceptance Criteria and Device Performance Study (as described in the document)

The document primarily focuses on demonstrating substantial equivalence through engineering and laboratory testing, rather than a clinical performance study with defined "acceptance criteria" and "reported device performance" in terms of classification metrics (e.g., sensitivity, specificity) against a clinical ground truth.

The "acceptance criteria" for this device are implicitly tied to:

Compliance with specific electrical safety and EMC standards.
Comparable performance to the predicate device in ex vivo tissue testing.
Meeting system specifications.
Successful software verification and validation.

1. Table of acceptance criteria and reported device performance:

Based on the provided text, a table like this would represent the types of tests done and the general outcomes, rather than quantitative performance metrics against a clinical outcome.

Acceptance Criteria Category	Description of Acceptance Criteria (Implicit)	Reported Device Performance/Outcome
Electrical Safety & EMC Standards	Compliance with IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2014, and IEC 60601-2-2:2009.	Met: "Compliance with Electrical Safety and EMC standards."
Ex Vivo Testing	Comparable performance to predicate (Valleylab FT10) regarding thermal effects on porcine tissue.	Met: "Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects."
System Functionality	All required functionality and meeting system specifications.	Met: "System verification showed that the Valleylab FX8 FX Series Energy Platform has all required functionality and that it meets system specifications."
Software Verification & Validation	Documentation and testing in accordance with FDA guidance for software in medical devices.	Met: "Software verification and validation testing was conducted and documentation provided in accordance with FDA’s, Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices."
Overall Substantial Equivalence	Differences compared to predicate do not raise new questions of safety or effectiveness.	Met: "The new generator has similar performance when compared to the predicate device. The differences do not raise any new questions of safety and efficacy when compared with the predicate."

2. Sample size used for the test set and data provenance:

Test Set Sample Size: Not specified quantitatively. The ex vivo testing mentions "porcine tissue" but does not give a sample size (e.g., number of tissue samples, number of tests performed).
Data Provenance: The ex vivo testing was performed using "porcine tissue," implying a laboratory setting. The country of origin and whether it was retrospective or prospective is not stated, but it's clearly a controlled, pre-market lab-based testing scenario, not a retrospective analysis of clinical patient data.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not Applicable. For this type of electrosurgical generator, "ground truth" concerning thermal effects or system functionality would be established through physical measurements, engineering specifications, and validated test methods, not by expert consensus on clinical images or diagnoses.

4. Adjudication method for the test set:

Not Applicable. As there are no human experts classifying outcomes on a test set, no adjudication method (like 2+1 or 3+1) was used.

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

No. An MRMC study was explicitly not performed. The document states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This type of study is typically done for diagnostic AI devices, not electrosurgical generators.

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

No, not in the context of an AI algorithm. This device is an electrosurgical generator, not a diagnostic algorithm. Its "performance" is evaluated based on its physical characteristics, energy delivery, safety, and functionality, not its ability to interpret data independently.

7. The type of ground truth used:

For electrical safety and EMC: Engineering standards and measured electrical characteristics.
For ex vivo testing: Physical measurements of thermal effects on porcine tissue.
For system verification: Engineering specifications and functional tests.
For software: Software requirements, design specifications, and standard software quality assurance testing.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that uses a "training set" in the conventional sense. The device's "training" is its design, engineering, and manufacturing process.

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

Not Applicable. As this is not an AI/ML device, there is no "training set" or ground truth for it. Its operational parameters are determined by electrosurgical principles and engineering design.

In summary: The provided document is a 510(k) summary for an electrosurgical generator, which is a physical medical device, not a software algorithm or AI-powered diagnostic tool. Therefore, the "study that proves the device meets the acceptance criteria" is fundamentally different from what would be expected for an AI/ML product. The "acceptance criteria" discussed are related to engineering and safety standards, and performance equivalence to a predicate device, rather than diagnostic accuracy metrics.

Summary

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November 2, 2017

Covidien LLC Ms. Sharon McDermott Sr. Specialist, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301

Re: K172757

Trade/Device Name: 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: September 11, 2017 Received: September 13, 2017

Dear Sharon McDermott:

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 practice, 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); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -S3

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) K172757

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)

لله | Prescription Use (Part 21 CFR 801 Subpart D)

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

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6 510(k) Summary

510(k) Summary

Date summary prepared: November 1, 2017

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Sharon McDermott Sr. Regulatory Affairs Product Specialist Telephone: 303-581-6789 Fax: 303-530-6313 Email: sharon.mcdermott@medtronic.com

Identification of Device

Trade Name:	Valleylab™ FX8 FX Series Energy Platform
Catalog Number:	VLFX8GEN
Common Name:	Electrosurgical Generator
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR
	878.4400, Class II, GEI)

ldentification of Predicate Device

Trade/Proprietary Name:	Valleylab FT10 Energy Platform
Common/Usual Name:	Electrosurgical Generator
Classification Name:	Electrosurgical Cutting and Coagulation Device and Accessories
Class/Panel:	Class II, General and Plastic Surgery
Regulation:	21 CFR 878.4400
Product Code:	GEI
510(k) Submitter / Holder:	Covidien
	5920 Longbow Drive
	Boulder, CO, 80301
Predicate 510(k) #:	K151649, K170170

Identification of Reference Predicate

Trade/Proprietary Name:	Force FX Generators
Common/Usual Name:	Electrosurgical Generator
Classification Name:	Electrosurgical Cutting and Coagulation Device and Accessories
Class/Panel:	Class II, GEI, 21 CFR 878.4400

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006_510(k) Summary	K172757	Page 2 of 3
510(k) Submitter / Holder:	Covidien
	5920 Longbow Drive
	Boulder, CO, 80301
510(k) #:	K944602, K143161

A reference predicate, Force FX Electrosurgical Generators, (K944602, K143161) was used for comparison testing of the "FX Bipola" modes included on the subject Valleylab FX8 FX Series Energy Platform.

Substantial Equivalence Overview

The proposed Valleylab FX8 FX Series Energy Platform was compared and found to be substantially equivalent to the predicate Valleylab FT10 Energy Platform. Characteristics identified as important for substantial equivalence comparison purposes are shown in the tables below, and similarities and differences of aspects found to be relevant to the potential impact on safety and performance are discussed in this section. None of the differences raise new questions of safety or effectiveness when compared to the predicate device.

Valleylab FX8 FX Series Energy Platform is used in hospitals and other health care facilities where surgical procedures are carried out.

Valleylab FX8 FX Series Energy Platform can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The Valleylab FX8 FX Series Energy Platform connects to electrical mains and operates at an input line frequency of 47-63 Hz.

Principle of Operation

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.

Technological Characteristics

The technological characteristics of the proposed Valleylab FX8 FX Series Energy Platform are the same as the predicate, VLFT10. Both are full-featured general-surgery energy platform. The monopolar and bipolar sections of the generator are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.

During monopolar electrosurgery, radio frequency (RF) energy exits/enters a monopolar pencil and electrode in high concentration and disperses as it enters/exits the return pad. The concentration of energy at the monopolar pencil in conjunction with tissue characteristics produces heat that provides the desired surgical effect.

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Performance Characteristics

Extensive verification and validation activities were successfully completed that the Valleylab FX8 FX Series Energy Platform performs as intended and is substantially equivalent to its predicate, VLFT10. Testing included the following:

Compliance with Electrical Safety and EMC standards:

IEC 60601-1:2005/A1:2012	Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance – Edition 3.1
IEC 60601-1-2:2014	Medical electrical equipment, Part 1-2: General requirementsfor basic safety and essential performance – Collateralstandard: Electromagnetic compatibility – Requirements andtests
IEC 60601-2-2:2009	Medical electrical equipment – Part 2-2: Particular requirementsfor the basic safety and essential performance of high frequencysurgical equipment and high frequency surgical accessories -Edition 5.0

Ex vivo testing using porcine tissue showed comparable performance with regard to thermal ● effects.
System verification showed that the Valleylab FX8 FX Series Energy Platform has all required functionality and that it meets system specifications.
Software verification and validation testing was conducted and documentation provided in accordance with FDA's, Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices

The minor differences that were seen during testing are consistent with design changes and do not raise safety or effectiveness concerns.

Clinical Studies

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

Conclusion

Verification and validation testing demonstrates the proposed Valleylab FX8 FX Series Energy Platform is substantially equivalent to the predicate, Valleylab VLFT10 Energy Platform. The two electrosurgical generators have the same intended use and fundamental technology with the exception that the subject platform does not include vessel sealing functionality. The new generator has similar performance when compared to the predicate device. The differences do not raise any new questions of safety and efficacy when compared with the predicate.

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.