(52 days)
Not Found
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". This describes traditional control systems and feedback loops, not AI/ML. There is no mention of learning, training data, or complex algorithms typically associated with AI/ML.
Yes
The device is used for electrosurgical cutting and coagulation of tissue, and sealing of vessels, which are direct therapeutic interventions on the body for medical purposes.
No
Explanation: The device description clearly states its purpose is for electrosurgical cutting and coagulation, and sealing of vessels and tissue bundles, which are therapeutic functions, not diagnostic.
No
The device description clearly outlines a hardware-based electrosurgical generator with various output modes and physical components (touch screen display, connectors, etc.). While it incorporates microcontroller firmware and closed-loop control, these are integral to the hardware's function, not a standalone software medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an electrosurgical generator used for cutting, coagulating, and sealing tissue and vessels during surgical procedures. It directly interacts with the patient's body.
- Intended Use: The intended use describes surgical procedures performed on the patient, not the analysis of samples from the patient.
- Device Description: The description focuses on the electrical outputs and how they are used with surgical instruments (electrosurgical devices, bipolar forceps, LigaSure™ devices) to manipulate tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the ForceTriad™ generator is a surgical device, not an In Vitro Diagnostic device.
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 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.
The Indications for Use include general (including urologic, thoracic, arthroscopic), laparoscopic, and plastic and reconstructive 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, cholecystectomies, Nissen fundoplication, gall bladder, adhesiolysis, oophorectomy, etc. Vessels (arteries, veins, lymph) 7 mm and smaller in diameter, and tissue bundles are included for use 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general, urologic, thoracic, plastic and reconstructive, arthroscopic, gynecologic, bowel, vaginal, abdominal, gall bladder, vessels (arteries, veins, lymph), tissue bundles.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room, Surgery Center, Clinic
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
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Valleylab Force FX ™ Electrosurgical Generator (K944602), Valleylab LigaSure™ Vessel Sealing System (K981916)
Reference Device(s)
Not Found
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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS Valleylab ForceTriad™ Electrosurqical Generator
-
- Submitter Information
K051644
- Submitter Information
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
1
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. .
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
2
Page 3 of (4)
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.)
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.
4
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.
5
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
6
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