The indications for use include general (including urologic, thoracic, plastic and reconstructive, and arthroscopic), laparoscopic, and gynecologic procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopically assisted vaginal hysterectomies, laparoscopic cholecystectomy procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. Vessels (arteries, veins, lymph) 7 mm and smaller in diameter, and tissue bundles as large as will fit in the LigaSure™ vessel sealing device jaws, may be sealed with the LigaSure™ vessel sealing (tissue fusion) output.

Device Description

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and Valleylab LigaSure™ vessel sealing outputs. The generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.

Available output modes include:

Monopolar

Cut : clean, precise cut in tissue, with little or no hemostasis .
Blend: blended waveform for slower cutting and additional hemostasis
Hemostasis with division (HWD): optimized division of tissue with controlled . hemostasis and minimal thermal damage to adjacent tissue
Fulgurate: tissue coagulation by sparking .
Spray: fulguration with shallower penetration over larger tissue areas t Bipolar
Low: precise, controlled desiccation of tissue .
Standard: general bipolar desiccation with consistent tissue effect .
Macro: rapid coagulation and bipolar cutting in a wide range of tissues . LigaSure™ vessel sealing
Seals vessels (arteries, veins, lymph) 7mm and less, and tissue bundles. .

The monopolar Cut, Blend, Fulgurate, and Spray output modes are designed for use with conventional handswitching or footswitching electrosurgical devices. The three bipolar output modes are designed for use with conventional handswitching or footswitching electrosurgical bipolar forceps. When using conventional electrosurgical devices, the user selects the mode and desired power using a touch screen display on the generator.

All monopolar output modes, including HWD, are also designed for use with Valleylab electrosurgical devices with surgeon power control. The surgeon power control devices utilize Valleylab Smart™ connector technology that allgows the generator to identify the type of device in use. After recognizing the device type, the generator establishes five power zones for each output mode. The generator defaults to power zone 3, but the surgeon may select an alternate power zone using the touch screen. From the sterile field, the surgeon then uses the slider switch on the device to select the desired power setting within the selected power zome. The surgeon activates the desired output mode (CUT, HWD, COAG) using the buttons on the device. The surgeon also has the option of using the touch screen controls to select power levels outside the pre-established power zones to accommodate unusual surgical situations.

Monopolar electrosurgery requires the use of a patient return electrode ("return pad" or "grounding pad") with Valleylab REM™ return electrode monitoring. The REM™ system continuously verifies contact between the patient and pad togs one headsite burns. (Valleylab REM™ electrodes were initially cleared for marketion on K822572, and have been used on all Valleylab electrosurgical generators since that time.) Bipolar devices and LigaSure™ vessel sealing devices do not require patient return electrodes.

The ForceTriad™ vessel sealing mode is designed for use with LigaSure™ vessel sealing devices. The LigaSure™ devices utilize Smart™ connector technology to allow the generator to recognize the device in use and set the generator output accordingly. (Refer to K981916, LigaSure™ Vessel Sealing System.)

AI/ML Overview

The provided document is a 510(k) summary for the Valleylab ForceTriad™ Electrosurgical Generator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with detailed performance criteria as might be seen in a PMA (Pre-Market Approval) application. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, or expert consensus will not be explicitly present in this document.

However, I can extract the information that is available and explain what is missing and why, based on the nature of a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary states:

"Performance testing was performed to ensure that the ForceTriad™ Electrosurgical Generator functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to legally marketed predicate devices, and meets safety and effectiveness criteria."

This statement confirms that internal performance criteria related to "design specifications" and "safety and effectiveness criteria" were met, and that the device was deemed "substantially equivalent" to its predicates. However, the document does not provide specific, quantifiable acceptance criteria or the reported performance metrics in a detailed table format. This level of detail is typically summarized internally by the manufacturer for the FDA's review of the 510(k) rather than being published in the public 510(k) summary.

The "performance" described refers to the device's ability to replicate the functions and outputs of the predicate devices (Valleylab Force FX™ Electrosurgical Generator and Valleylab LigaSure™ Vessel Sealing System). The document highlights that the ForceTriad™ generator has "the same basic technological characteristics as the predicate devices," and its output power and voltage for LigaSure™ vessel sealing are "equivalent" to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for a "test set" in the context of a clinical study or specific data provenance (country of origin, retrospective/prospective).

For a 510(k) submission, "performance data" typically refers to:

Bench testing: Verifying electrical outputs (power, voltage, waveform), impedance matching, safety features (e.g., REM™ system for patient return electrode monitoring), and mechanical integrity. This would involve testing of device units.
Animal studies (if applicable): To demonstrate typical tissue effects without human subjects.
Comparison to predicate device specifications: Ensuring the new device performs within the established parameters of the equivalent marketed device.

The study type is not explicitly described as a "clinical study" in the sense of a trial involving human patients for effectiveness data, but rather as "performance testing" to ensure it "functions as intended." Given the nature of a 510(k) for an electrosurgical generator, the primary evidence relies heavily on engineering verification and validation (V&V) and comparison to predicate devices, rather than large-scale clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the involvement of external experts to establish ground truth for a test set. This type of expert review is more common for diagnostic devices (e.g., imaging devices) where human interpretation is a critical part of the ground truth establishment. For an electrosurgical generator, the "ground truth" for performance would be based on objective physical measurements (e.g., electrical outputs) and tissue effects verified in controlled environments, often by engineers and medical professionals within the development team.

4. Adjudication Method for the Test Set:

As no specific "test set" in the clinical sense is described with expert review, there is no mention of an adjudication method like 2+1 or 3+1.

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

An MRMC study is typically conducted for diagnostic devices (especially those involving image interpretation) to assess how human readers' performance (e.g., accuracy, detection rate) changes with or without AI assistance. The ForceTriad™ Electrosurgical Generator is a therapeutic device, not a diagnostic one that requires human readers to interpret outputs for diagnosis. Therefore, an MRMC study was not performed or is not applicable in this context. There is no mention of "human readers" or "AI assistance" in the document.

6. Standalone Performance Study:

The document states, "Performance testing was performed to ensure that the ForceTrial ™ Electrosurgical Generator functions as intended, and meets design specifications." This indicates that the device's performance was evaluated independently to ensure it met its engineering and safety requirements. However, the evaluation framework is primarily one of substantial equivalence to existing devices rather than demonstrating novel "standalone" efficacy that is significantly different from established predicate devices. The performance data demonstrates substantial equivalence, meaning it can perform the same functions as the predicate devices safely and effectively.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing would primarily be based on:

Engineering specifications and standards: Confirming that electrical outputs (power, voltage, current, waveform) meet predefined ranges for each mode (Cut, Blend, HWD, Fulgurate, Spray, Bipolar Low, Standard, Macro, LigaSure™).
Biophysical effects: Observing and quantifying tissue effects (e.g., cutting precision, coagulation depth, vessel sealing strength) in controlled laboratory or animal settings, often compared to the known effects of the predicate devices.
Safety parameters: Verification of safety features like the REM™ system for patient return electrode monitoring.

There is no mention of "pathology" or "outcomes data" in the sense of long-term human clinical outcomes being used as ground truth for this 510(k) submission.

8. Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or artificial intelligence algorithms. The ForceTriad™ is an electrosurgical generator controlled by microcontroller firmware using closed-loop control and Instant Response™ technology. While this involves algorithms, it's not described as an AI system that undergoes "training" with a dataset in the modern sense. Therefore, there is no mention of a training set or its size. The "algorithms" are likely deterministic control systems based on established electrosurgical principles.

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

Since there is no "training set" as described in question 8, this question is not applicable. The "ground truth" for the device's control algorithms would be rooted in fundamental electrophysics, physiological tissue responses to electrical energy, and engineering specifications for desired output characteristics and safety.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS Valleylab ForceTriad™ Electrosurqical Generator

1. Submitter Information
  K051644

Page 1 of 4

Valleylab, a Division of Tyco Healthcare Group L.P 5920 Longbow Drive Boulder, CO 80301 Contact: Herbert Vinson Telephone: 303-530-6469

Date summary prepared: June 17, 2005

2. Name of Device

Trade or Proprietary Name: Valleylab ForceTriad™ Electrosurgical Generator

Common Name: Electrosurgical Generator

Classification Name:

Class II, 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device . and Accessories, Panel 79, General and Plastic Surgery
Class II, 21 CFR 884.4120, Gynecologic Electrocautery and Accessories .

3. Predicate Devices

The ForceTriad™ Electrosurgical Generator is substantially equivalent in function and intended use to the following legally marketed devices: Valleylab Force FX ™ Electrosurgical Generator (K944602) and the Valleylab LigaSure™ Vessel Sealing System (K981916). The ForceTriad™ generator and the Force FX™ generator both have monopolar and bipolar electrosurgical outputs and are intended for all types of surgical procedures where electrosurgery is desired. Both have a selection of CUT and COAG monopolar outputs, and can be used with conventional electrosurgical devices. The ForceTriad™ generator has an additional monopolar output, Hemostasis with Division, that allows the surgeon to maintain controlled hemostasis while dividing tissue. The HWD output has power output and maximum voltage output in the same range as the other monopolar outputs. It is available when using the Valleylab G3000 electrosurgical device.

The ForceTriad™ generator and the LigaSure™ vessel sealing generator both have outputs for LigaSure™ vessel sealing devices. The output power and voltage of the generators are equivalent.

4. Device Description

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and Valleylab LigaSure™ vessel sealing outputs. The generator

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051644

Page 2 of ④

is an electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.

Available output modes include:

Monopolar

Cut : clean, precise cut in tissue, with little or no hemostasis .
Blend: blended waveform for slower cutting and additional hemostasis
Hemostasis with division (HWD): optimized division of tissue with controlled . hemostasis and minimal thermal damage to adjacent tissue
Fulgurate: tissue coagulation by sparking .
Spray: fulguration with shallower penetration over larger tissue areas t Bipolar
Low: precise, controlled desiccation of tissue .
Standard: general bipolar desiccation with consistent tissue effect .
Macro: rapid coagulation and bipolar cutting in a wide range of tissues . LigaSure™ vessel sealing
Seals vessels (arteries, veins, lymph) 7mm and less, and tissue bundles. .

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K051644

Page 3 of (4)

time.) Bipolar devices and LigaSure™ vessel sealing devices do not require patient return electrodes.

5. Intended Use

The ForceTriad™ generator is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting, coagulation, or vessel sealing (tissue fusion) in general, urologic, thoracic, plastic and reconstructive, arthroscopic, gynecologic and similar surgery. The ForceTriad™ generator is intended for use in the operating room, surgery center, or clinic. The generator has both monopolar and bipolar outputs that accommodate standard electrosurgical devices and Valleylab electrosurgical devices with surgeon power control. The ForceTriad™ generator also incorporates the functionality of the Valleylab LigaSure™ vessel sealing system, and accepts Valleylab LigaSure™ devices.

Valleylab makes the following recommendations with regard to the use of the ForceTriad™ electrosurgical generator.

Use electrosurgery with caution in the presence of internal or external . pacemakers. Interference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of electrosurgical or tissue fusion appliances is planned in patients with cardiac pacemakers.
If the patient has an implantable cardioverter defibrillator (ICD), contact the ICD . manufacturer for instructions before performing an electrosurgical or tissue fusion procedure. Electrosurgery or tissue fusion may cause multiple activations of ICDs.

Valleylab recommends against the use of laparoscopic surgery on preqnant patients.

LigaSure™ tissue fusion has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

6. Summary of Technological Characteristics

The ForceTriad™ Electrosurgical Generator has the same basic technological characteristics as the predicate devices noted above.

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051644

Page 4 of (4)

7. Performance Data

Performance testing was performed to ensure that the ForceTrial ™ Electrosurgical
Generator functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivaliento. Curinionit data devices, and meets safety and effectiveness criteria.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized representation of three human profiles facing to the right, arranged in a row. The profiles are depicted with simple, curved lines, giving them a modern and abstract appearance. Encircling the profiles is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

AUG 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Valleylab Division of Tyco Healthcare Group LP Mr. Herbert Vinson Senior Regulatory Associate 5920 Longbow Drive Boulder, Colorado 80301

Re: K051644

Trade/Device Name: Force Triad™ Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 17, 2005 Received: June 20, 2005

Dear Mr. Vinson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Mr. Herbert Vinson

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket notification. The PDA inding of backance of a casification for your device to proceed to the market.

If you desire specific advice for your device on our lated in regulation (21.4ER Part 801), please If you desire specific atvice ior your act (240) 276-0115. Also, please note the regulation entitled, contact the Office of Comphaliso at (21 to the cation" (21CFR Part 807.97). You may obtain "Misbranding by responsibilities to promantovisibilities under the Act from the Division of Small other general Information on your responsible in the toll-free number (800) 638-2041 or Manufacturers, International and Coness http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Kamara buchner
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

051644

ﺔ ﺍﻟ

510(k) Number (if known):

Device Name: ForceTriad™ Electrosurgical Generator

. - . - .

Indications For Use:

The indications for use include general (including urologic, thoracic, The Indications for use intelade good in throscopic), laparoscopic, and plastic and reconomatics, where electrosurgical cutting and gynecologic procedures interving (fusion) of vessels and tissue Coagulation of tissue, ancluding such procedures as bowel Dundles is penomiou, inea (both vaginal and abdominal), resections, Trystcrectornies (boom ragonically assisted vaginal laparoscopic choicsyotoctor procedures, Nissen fundoplication, nysterectomies, gall Bladdor etc. Vessels (arteries, veins, lymph)
adhesiolysis, oophorectorny, etc. Vessels (arteries, veins, lymph) adnesiolysis, oophorectorny, oter bundles as large as will fit in the / mm and smaller in diamotor, and beth the LigaSure™ vessel sealing (tissue fusion) output.

Prescription Use	X
(Per 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Bertram-Buckhurst fox

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of and Neuro

Section 510(k) Notification--Valleylab ForceTriad™ Electrosurgical Generator June 17, 2005

10(k) Number K051644

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.