(217 days)
No
The description mentions "microcontroller-based device, incorporating closed-loop control" and "Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output". While this involves real-time adjustments based on data, it describes a traditional control system, not AI/ML. There are no mentions of AI, ML, DNN, or training/test sets for such algorithms.
Yes.
The device's intended use is for electrosurgical cutting and coagulation of tissue, and sealing of vessels and tissue bundles in various surgical procedures, which constitutes a therapeutic application.
No
The device description indicates it is an electrosurgical generator used for cutting, coagulation, and sealing tissue and vessels, implying therapeutic rather than diagnostic function. It measures electrical impedance to adjust power, which is for controlling the surgical output, not for diagnosing a medical condition.
No
The device description clearly states it is a "full-featured electrosurgical generator" which is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is an electrosurgical generator used for cutting, coagulation, and sealing tissue and vessels during surgical procedures. This is an in vivo (within the living body) application.
- Intended Use: The intended use describes surgical procedures performed directly on the patient's body.
- Device Description: The description focuses on the electrical outputs and control mechanisms for surgical intervention.
The device is a surgical tool used directly on the patient, not for testing samples taken from the patient.
N/A
Intended Use / Indications for Use
The ForceTriad™ generator is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurqical 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.
The indications for use include general (including urologic, thoracic, plastic and reconstructive, 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). laparoscopic cholesystectomies, laparoscopically assisted vaqinal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesilysis, oophorectomy, etc. Vessels (arternes, veins, pulmonary arteries, pulmonary veins, lymph) 7mm and smaller in diameter, and bundles as large as will fit in the jaws of the devices can be sealed with the LigaSure™ vessel sealing (tissue fusion) output.
Product codes
GEI
Device Description
The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and 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 hemostatis
- 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
Bipolar
- Low: precise, controlled desiccation of tissue.
- Standard: general bipolar desiccation with consistent tissue o effect
- Macro: rapid coagulation and bipolar cutting in a wide range . of tissues
LigaSure vessel sealing
- Seals vessels (arteries, veins, pulmonary arteries, pulmonary 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, may be used with Valleylab electrosurgical devices with surgeon power control. The surgeon power control devices utilize Covidien EbD Smart™ connector technology that allows 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 can then use the slider switch on instruments so equipped to select the desired power setting within the selected power zone. 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 to prevent pad site burns. (Valleylab REM™ electrodes were initially cleared for marketing 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.
No changes are being made to the design operation, or intended use of the any of the current systems except a revision to the software to allow the ForceTriad to interface with an Integrated Operating Room (OR) system. As of this date, the only cleared system which has demonstrated compatibility with the ForceTriad is the Olympus EndoAlpha endosurgery system, cleared on February 15, 2011. Refer to 510(k) K102763.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room, surgery center, or clinic; intended for use by a surgeon.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing with a simulated Integrated OR System was conducted as well as testing with an actual system, the Olympus Medical Systems EndoAlpha system. The EndoAlpha system received 510(k) clearance on February 15, 2011. Refer to K102763. In addition, any new testing required by the new revisions of the relevant safety standards was also conducted.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive software validation was conducted to qualify the software changes. Bench testing with a simulated Integrated OR System was conducted as well as testing with an actual system, the Olympus Medical Systems EndoAlpha system. The EndoAlpha system received 510(k) clearance on February 15, 2011. Refer to K102763. In addition, any new testing required by the new revisions of the relevant safety standards was also conducted.
No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Page 1 of 5
6 2011
510(k) Summary
510(k) Summary Date Prepared: 4/28/2011
Submitter Information: 1.
Covidien Energy-based Devices Formerly known as Valleylab, a Division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO 80301
Contact: Ben Cordileone Regulatory Affairs Manager Phone: 303-530-6396 Fax: 303-516-8307 Email: ben.cordileone@Covidien.com
Name of Device 2.
Trade name: ForceTriad™ Electrosurgical Generator Common/Classification name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)
- Predicate Device
The ForceTriad™ is substantially equivalent to the original ForceTriad™ submitted under K051644. The intended use, basic features and operation remain the same as the previously cleared ForceTriad™.
- Device Description
The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and 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.
5920 Losgnow Drive Bourder, CO SO301
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Page 2 of 5
Available output modes include:
Monopolar
- Cut: clean, precise cut in tissue, with little or no hemostasis o
- Blend: blended waveform for slower cutting and additional . hemostatis
- Hemostasis with division (HWD): optimized division of tissue � with controlled hemostasis and minimal thermal damage to adjacent tissue
- Fulgurate: tissue coagulation by sparking o
- o Spray: fulguration with shallower penetration over larger tissue areas
Bipolar
- Low: precise, controlled desiccation of tissue .
- Standard: general bipolar desiccation with consistent tissue o effect
- Macro: rapid coagulation and bipolar cutting in a wide range . of tissues
LigaSure vessel sealing
- Seals vessels (arteries, veins, pulmonary arteries, pulmonary . 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, may be used with Valleylab electrosurgical devices with surgeon power control. The surgeon power control devices utilize Covidien EbD Smart™ connector technology that allows 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 can then use the slider switch on instruments so equipped to select the desired power setting within the selected power zone. 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
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K 102913
Page 3 of 5
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 to prevent pad site burns. (Valleylab REM™ electrodes were initially cleared for marketing 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.
No changes are being made to the design operation, or intended use of the any of the current systems except a revision to the software to allow the ForceTriad to interface with an Integrated Operating Room (OR) system. As of this date, the only cleared system which has demonstrated compatibility with the ForceTriad is the Olympus EndoAlpha endosurgery system, cleared on February 15, 2011. Refer to 510(k) K102763.
- Intended Use
The ForceTriad™ generator is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurqical 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.
Covidien 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
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K102 913
an asynchronous mode or 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 ﻩ (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.
Covidien recommends against the use of laparoscopic surgery on pregnant patients.
LigaSure tissue fusion has not been shown to be effective for tubal sterilization or tubal coaqulations for sterilization procedures. Do not use this function for these procedures.
Summary of Technology Characteristics 6.
The only change associated with this 510(k) is a software change. The software change allows the generator to interface with the Olympus EndoAlpha endosurgery system, manufactured by Olympus Medical Systems Corporation, Center Valley, PA. This Integrated OR system is used to control multiple pieces of equipment in the OR environment. The Technological Characteristics of the ForceTriad™ have not changed.
- Summary of Non-clinical testing
Extensive software validation was conducted to qualify the software changes. Bench testing with a simulated Integrated OR System was conducted as well as testing with an actual system, the Olympus Medical Systems EndoAlpha system. The EndoAlpha system received 510(k) clearance on February 15, 2011. Refer to K102763. In addition, any new testing required by the new revisions of the relevant safety standards was also conducted.
4
- Summary of Clinical testing
No clinical testing was conducted
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9. Conclusion
Based on the information provided, Covidien concludes that the modification to the ForceTriad that adds the Integrated OR feature is substantially equivalent to the predicate device. The software modifications that allow communication of the ForceTriad with the Olympus EndoAlpha endosurgery system add no new questions of Safety and Efficacy, and these changes have no impact on the performance, function or intended use of the ForceTriad.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings, positioned to the right of a circular inscription. The inscription reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the bird figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien % Mr. Ben Cordileone Regulatory Affairs Manager 5920 Longbow Drive Boulder, Colorado 80301
MAY - 6 2011
Re: K102913
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: April 15, 2011 Received: April 18, 2011
Dear Mr. Cordileone:
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 -
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Page 2 - Mr. Ben Cordileone
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 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" (24GFR-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 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.
A
B.
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known): KLO29 / 3
Device Name: Force Triad™ Electrosurgical Generator
Indications for Use:
The indications for use include general (including urologic, thoracic, plastic and reconstructive, 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). laparoscopic cholesystectomies, laparoscopically assisted vaqinal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesilysis, oophorectomy, etc. Vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) 7mm and smaller in diameter, and bundles as large as will fit in the jaws of the devices can be sealed with the LigaSure™ vessel sealing (tissue fusion) output.
Prescription Use X Over-The-Counter Use - Prescription Use ___________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Divis Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102913