FORCETRIAD ELECTROSURGICAL GENERATOR
Device Facts
| Record ID | K110268 |
|---|---|
| Device Name | FORCETRIAD ELECTROSURGICAL GENERATOR |
| Applicant | Covidien Lp, Formerly Know AS Valleylab, A Divison |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | May 31, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing (sealing or fusing). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where vessel sealing (ligation of vessels, pulmonary vasculature, or lymph vessels), is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coaqulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired or with compatible resectoscopes for endoscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCl solution (saline) as the irrigation medium. The indications for use include general (including urologic, thoracic, plastic, and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic choles, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectorny, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments. The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures. Do not use this function for these procedures.
Device Story
ForceTriad Electrosurgical Generator provides monopolar, bipolar, and LigaSure vessel sealing RF energy for open and laparoscopic surgery. Device uses microcontroller-based closed-loop control; Instant Response technology measures tissue impedance to adjust power output. For vessel sealing, system monitors tissue properties to fuse collagen/elastin in vessels up to 7mm. New bipolar resection mode enables endoscopically controlled tissue removal using 0.9% NaCl saline irrigation. Operated by surgeons in OR settings. Output displayed via GUI; provides feedback on seal completion. Benefits include precise hemostasis and tissue resection. Software update (v3.30+) enables third-party resectoscope compatibility via adaptor cables and specific footswitch.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing and software validation. Bench testing included porcine models (prostate simulation and kidney hemostasis) and safety standard compliance testing. All results met acceptance criteria.
Technological Characteristics
Microcontroller-based electrosurgical generator; RF energy output. Features Instant Response impedance-sensing technology. Supports monopolar, bipolar, and LigaSure modes. Bipolar resection mode supports saline irrigation. Connectivity via LigaSure 2 port for adaptor cables. Software version 3.30+; GUI updated for resection modes. Power output up to 375 Watts for bipolar modes.
Indications for Use
Indicated for patients undergoing open, laparoscopic, or gynecologic surgical procedures requiring electrosurgical cutting, coagulation, or vessel sealing. Applicable to general, urologic, thoracic, plastic, and reconstructive surgeries. Contraindicated for tubal sterilization or tubal coagulation procedures using the LigaSure function.
Regulatory Classification
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.
Predicate Devices
- ForceTriad Electrosurgical Generators (K051644)
- ForceTriad Electrosurgical Generators (K070162)
- ERBE VIO 300 D generator (K060484)
- Karl Storz Endocopy Autocon II 400 Electrosurgical Generator (K062464)
- Gyrus ACMI PlasmaKinetic SuperPulse Generator (K100816)
- Wolf resectoscope (K062720)
Reference Devices
- Karl Storz (KSEA) Bipolar Electrotome resectoscope (K061541)
- Sutter Electrosurgical Cables (K073450)
Submission Summary (Full Text)
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K110268
MAY 3 1 2011
#### Submitter Information: 1.1
Covidien, formerly Valleylab, a division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO 80301 Contact: Donald Henton Regulatory Affairs Manager Phone: 303-530-6451 Fax: 303-516-8307 Email: donald.henton@Covidien.com
#### 1.2 Name of Device
Trade name: ForceTriad™ Electrosurgical Generator
Common/Classification name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)
Product Code: GEI
Additional Classification name: Endoscopic electrosurgical unit and accessories. (21 CFR 876.4300)
Subsequent Product Code: KNS
#### 1.3 Predicate Devices
This version of the ForceTriad™ Electrosurgical Generator is substantially equivalent to the ForceTriad™ Electrosurgical Generators cleared under K051644 and K070162. The purpose of this submission is to notify FDA of the software updates to the ForceTriad™ Electrosurgical Generator that activates a bipolar resection feature. This mode is substantially equivalent to the resectoscope use feature on the ERBE™ VIO 300 D generator (K060484, including accessories), the Karl Storz Endocopy Autocon II 400 Electrosurgical Generator (K062464), and the Gyrus ACMI PlasmaKinetic™ SuperPulse Generator (K100816). This feature is compatible with the Karl Storz (KSEA) Bipolar Electrotome resectoscope (K061541) and the newly designed adaptor cable (with predicate cables from Sutter Electrosurgical Cables (K073450)) that connects the ForceTriad™ Electrosurgical Generator to the Karl Storz bipolar resectoscope.
The intended use for the ForceTriad Electrosurgical Generator remains the same as the previous ForceTriad generators. The change to the indications for use includes definitions for "cut" and "coagulating" that are recognized as ways to further describe and clarify the meaning of "cut (resecting, dividing, or separating)" and "coagulating (hemostasis, coagulating, desiccating, or ablating)." Additionally, the proposed indications for use statement includes the clause from the Wolf resectoscope predicate (K062720) "for endoscopically controlled removal of tissue using 0.9% NaCl solution (saline) as the irrigation medium."
#### Device Description 1.4
The ForceTriad™ Electrosurgical Generator is a full-featured electrosurgical generator with monopolar, bipolar, and LigaSure™ vessel sealing output modes. TThe 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
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Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.
The generator is used with a selection of electrosurgical instruments designed for use with the ForceTriad and the LigaSure Vessel Sealing generator. All of the LigaSure instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.
No changes are being made to the design, operation, or intended use of any of the current system except the software modifications to create the Bipolar Resection modes and to allow the ForceTriad to output system data to a computer. The subject of this 510(k) notification is in regards to the addition of specific definitions for "cut" and "coagulating" and the addition to the indications statement of a bipolar resection function for use with resectoscopes "for endoscopically controlled removal of tissue using 0.9% NaCl solution (saline) as the irrigation medium" and the hardware and software associated with the activation of this feature.
#### 1.5 Intended Use
The ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing (sealing or fusing). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where vessel sealing (ligation of vessels, pulmonary vasculature, or lymph vessels), is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coaqulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired or with compatible resectoscopes for endoscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCl solution (saline) as the irrigation medium.
The indications for use include general (including urologic, thoracic, plastic, and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic choles, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectorny, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments.
The LigaSure tissue fusion function has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures. Do not use this function for these procedures.
#### 1.6 Summary of Technological Characteristics
The technological characteristics of the ForceTriad generator have not changed, except additional software updates to allow additional instruments to be recognized by the ForceTriad™ Electrosurgical Generator. These instruments include an adaptor cable to allow a third party resectoscope to connect to the ForceTriad™, a two (2) pedal footswitch specific to bipolar resection for CUT and COAG effect, and an activation kit that allows users to activate
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the bipolar resection feature on their ForceTriad Electrosurgical Generator. This software change includes a user interface for the ForceTriad generator to work with third party resectoscopes in a bipolar modifications have been implemented that allow adaptor cables to be recognized by the ForceTriad™ generator, through the LigaSure 2 port, for the connection to a third party bipolar resectoscope. A new graphical user interface has been created for the newly available bipolar resection mode in a saline environment. There are six (6) effect settings (power modes) for both the bipolar CUT and COAG effect modes, with an increased bipolar power output of up to 375 Watts.
An updated User Guide has been provided for the generator, as well as Instructions for Use for the bioolar resection Activation Kit, bipolar resection adaptor cord, and the bipolar resection footswitch. This bioolar resection mode will be available starting in software version 3.30 and higher. For generators in the field that do not have software version 3.30 or higher, a software update is available through Valleylab Exchange.
#### Preclinical Performance 1.7
Software validation was conducted to qualify the software changes. Bench testing using a pork model (to simulate prostate) and live porcine model using kidney (for hemostasis) was also conducted. In addition testing required by the relevant safety standards was conducted. Results were acceptable.
### Clinical Performance 1.8
This premarket notification report does not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
### 1.9 Conclusion
Based on the information provided, Covidien concludes that the modified device is substantially equivalent to the predicate devices. The software modifications made to the ForceTriad™ detailed in this Traditional 510(k) have not introduced any new questions of Safety and Efficacy. The new software was developed and tested in accordance with the Design Control requlations and internal procedures. Testing found that the software met acceptance criteria. The testing results at the system and individual accessories levels have met the pass-fail criteria.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien % Mr. Donald Henton Regulatory Affairs Manger 5920 Longbow Drive Boulder, Colorado 80301
MAY 3 1 2011
Re: K110268
Trade/Device Name: ForceTriad Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Name: GEI Regulatory Class: Class II Dated: May 24, 2011 Received: May 25, 2011
Dear Mr. Henton:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Donald Henton
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours
Fer Pete O'Hara
Del D.R
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Hcalth
Enclosure
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# Indications for Use Statement
510(k) Number (if known): K110268
Device Name: Force Triad™ Electrosurgical Generator
Indications for Use:
The ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing or fusing.). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired or with compatible resectoscopes for endoscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCl solution (saline) as the irrigation medium.
The indications for use include general (including urologic, thoracic, plastic, and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectorny, etc. The devices can be used on vessels (arteries, veins. pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments.
The LigaSure 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.
Prescription Use × -- AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter (21 CFR 801 Subpart C)
Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number. K110268
