The Force FX™ Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating) and coagulating (hemostasis).

Device Description

The Force FX™ Electrosurgical Generators are microcontroller-based isolated output generators that provide power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. Features included are:

. Instant Response™ Technology - Automatically senses resistance and adjusts the output voltage to maintain a consistent effect across different tissue density.
Three bipolar modes: precise, standard, and macro Low voltage, continuous current provides faster . desiccation without sparking.
Three monopolar Cut modes: low, pure, blend Allows a wide range of power settings necessary to ● perform diverse surgical procedures.
. Three monopolar Coag modes: desiccate, fulgurate, and spray - Helps control the size of the area and the depth of penetration during tissue coagulation.
Support for Simultaneous Activation ●
Covidien Energy-based Devices REM™ Contact Quality Monitoring System Monitors the quality . of electrical contact between the return electrode and the patient to eliminate risk of pad site burns.
Handswitch or footswitch activation
. Recall of most recently used mode and power settings
Adjustable activation tone volume
An RF activation port, RS-232 serial port, and expansion port .

The precise and standard bipolar modes of the Force FX™-8CA(S) models are equipped with an Autobipolar function. The autobipolar feature senses tissue impedance between the two bipolar electrodes and then uses the impedance information to automatically start or stop bipolar RF activation. Optionally, the user may choose between footswitch start and auto start, or program a delay between auto start and RF activation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device compliance, structured according to your request:

Device Name: Force FX Generators (Electrosurgical cutting and coagulation device and accessories)
510(k) Number: K143161

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

Acceptance Criteria (Performance Requirements)	Reported Device Performance
Conformance to IEC 60601-1:2005 (Basic safety and essential performance)	Design verification testing confirmed conformance.
Conformance to IEC 60601-2-2:2009 (Safety and performance for electrosurgical units)	Design verification testing confirmed conformance.
Conformance to IEC 60601-1-2:2007 (Electromagnetic compatibility)	Design verification testing confirmed conformance.
Performance under varying environmental conditions (multiple AC mains voltages and temperatures)	Design verification testing, including application of multiple AC mains voltages and temperatures, ensured the proposed modifications perform within design parameters under varying environmental conditions.
Software Regression/Validation	Software regression/validation was performed.
No alteration of intended use	The intended use of the Force FX generator was not altered (electrosurgical cutting and coagulating during surgical procedures). The device continues to provide monopolar and bipolar technology.
No adverse effect on safety or performance due to modifications.	"The modifications made to the Force FX generator were found to not affect safety or performance through design verification testing, which continued conformance to applicable technical design specifications and performance requirements..."

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

The document describes "design verification testing" and "software regression/validation" but does not specify the sample size used for these tests. It also does not mention the data provenance in terms of country of origin or whether the data 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)

The document does not mention the use of experts to establish ground truth for the test set. The evaluation relies on technical design specifications, performance requirements, and industry standards, rather than expert-derived ground truth.

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

The document does not describe any adjudication method for a test set, as the evaluation type is primarily engineering verification against predefined standards and specifications.

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

No MRMC comparative effectiveness study was done. The device (electrosurgical generator) is not an AI-assisted diagnostic or interpretative tool, and no human reader performance is mentioned.

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

The evaluation was a standalone technical performance assessment of the device (Force FX Generators) against technical specifications and industry standards. There is no "algorithm only" performance in the context of AI, as this is a hardware-based medical device with integrated software. The "standalone" aspect refers to the device's inherent functional capabilities.

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

The "ground truth" for this device's performance evaluation is based on conformance to established technical design specifications, performance requirements, and industry safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2). This is not a clinical ground truth like pathology or outcomes data, but rather an engineering and regulatory compliance ground truth.

8. The sample size for the training set

The device is an electrosurgical generator, not a machine learning or AI-driven system in the context of image analysis or diagnostics that typically requires a "training set." Therefore, no training set sample size is applicable or mentioned.

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

As there is no training set for this type of device, this question is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2014

Covidien Ms. Sharon McDermott Senior Product Regulatory Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K143161 Trade/Device Name: Force FX Generators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2014 Received: December 5, 2014

Dear Ms. 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, 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.

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 (reporting of medical

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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.

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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 yours,

Binita SDAshar -S

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) K143161

Device Name Force FX Generators

Indications for Use (Describe)

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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510(k) Summary

Date summary prepared: December 18, 2014

510(k) Submitter/Holder

Covidien (formerly Valleylab, Inc.) 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@covidien.com

Name of Device

Trade Name:	Force FX TM electrosurgical generators
Common Name:	Electrosurgical Generator
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, class II, GEI)

Predicate Device

Trade Name:	Force FX
Common Name:	Electrosurgical Generator
Catalog Number:	Force FX
510(k) Number:	K944602 (cleared 6/5/1995)
Manufacturer:	Covidien

Device Description

. Instant Response™ Technology - Automatically senses resistance and adjusts the output voltage to maintain a consistent effect across different tissue density.
Three bipolar modes: precise, standard, and macro Low voltage, continuous current provides faster . desiccation without sparking.
Three monopolar Cut modes: low, pure, blend Allows a wide range of power settings necessary to ● perform diverse surgical procedures.
. Three monopolar Coag modes: desiccate, fulgurate, and spray - Helps control the size of the area and the depth of penetration during tissue coagulation.
Support for Simultaneous Activation ●
Covidien Energy-based Devices REM™ Contact Quality Monitoring System Monitors the quality . of electrical contact between the return electrode and the patient to eliminate risk of pad site burns.
Handswitch or footswitch activation
. Recall of most recently used mode and power settings

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Adjustable activation tone volume
An RF activation port, RS-232 serial port, and expansion port .

Indications for Use

Technological Characteristics

The Force FX generators have the same technological and performance characteristics as the predicate, K944602. This Special 510(k) proposes changes to five printed circuit board assemblies (PCBAs), firmware/software, and a minor modification to the simultaneous (coag) activation tone. The function of the devices has not changed.

Performance Characteristics

The modifications made to the Force FX generator were found to not affect safety or performance through design verification testing, which continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:

Basic safety and essential performance in accordance with IEC 60601-1:2005 and IEC 60601-2-. 2:2009
Electromagnetic compatibility in accordance with IEC 60601-1-2:2007
. Design verification testing including application of multiple AC mains voltages and temperatures to ensure the proposed modifications perform within design parameters under varying environmental conditions.
. Software regression/validation

Clinical Studies

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

Conclusions

The intended use of the Force FX generator was not altered. In addition, the results of testing demonstrate that the modifications to the Force FX generator do not affect the safety or performance of the generator which is substantially equivalent to the predicate Force FX.

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.