(84 days)
No
The summary describes a standard electrosurgical generator and its variations, focusing on RF energy delivery for cutting, coagulation, and sealing. There is no mention of AI, ML, or any features that would suggest the use of such technologies for decision-making, analysis, or control. The performance studies focus on electrical safety, EMC, and software verification against specifications, not on the performance of an AI/ML algorithm.
Yes
The device is described as an electrosurgical generator intended for cutting, coagulating, sealing tissue, and cardiac ablation, which are all therapeutic functions.
No
The device is an electrosurgical generator designed for cutting, coagulating, sealing, and ablating tissue, not for diagnosing conditions.
No
The device is described as a "high frequency electrosurgical generator" and mentions "hardware components" and "mechanical testing," indicating it is a physical device with software control, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the device is for "cutting and coagulating tissue," "sealing vessels," and "cardiac tissue ablation." These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description reinforces that the device provides "radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications." This is consistent with surgical intervention, not diagnostic testing of samples.
- Lack of IVD Language: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Valleylab FT10 is a surgical tool used directly on the patient.
N/A
Intended Use / Indications for Use
VLFT10GEN
The Valleylab FT10 energy platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation.
The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.
Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN)
The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN)
The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.
Product codes
GEI, OCL
Device Description
Valleylab™ FT10 Energy Platform (VLFT10GEN): The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. The generator provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications (LigaSure/vessel sealing function) and cardiac applications. It is a combination of a full-featured general surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure/Bipolar section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.
The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.
The VLFT10GEN can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10GEN connects to electrical mains and operates at an input line frequency of 47-63 Hz.
Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN): The Valleylab™ FT10 Electrosurgical Generator is a high frequency electrosurgical only version of the VLFT10GEN Energy Platform. It is intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN): The Valleylab™ FT10 Vessel Sealing Generator is the vessel sealing only version of the VLFT10GEN Energy Platform. It is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tissue, vessels, lymphatics, cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals and other health care facilities where surgical procedures are carried out.
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
System Verification showed that VLFT10GEN with SW v.5.0 possesses all required functionality and meets system specifications.
Confirmatory Electrical safety and EMC testing were conducted on the Proposed Device and showed that the system complies with IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions" [2023] and IEC 62304 Medical Device Software- Software life cycle processes".
Mechanical Testing in the form of Environmental and Packaging Test and Chemical Soak and Abrasion Test was conducted and met all the acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the Department of Health & Human Services logo.
July 12, 2024
Covidien LLC Aliva Mahunta Sr. Regulatory Affairs Specialist 200 Medtronic Drive Lafayette, Colorado 80026
Re: K241085
Trade/Device Name: Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, OCL Dated: May 23, 2024 Received: May 24, 2024
Dear Aliva Mahunta:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long H. Chen -> Digitally signed by Long H.Chen -S
Date: 2024.07.12 16:00:47 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
Indications for Use (Describe)
VLFT10GEN
The Valleylab FT10 energy platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation.
The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.
Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN)
The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN)
The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.
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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3
K241085
510(k) Summary Complying with 21 CFR 807.92
l. SUBMITTER
Covidien IIc. 200 Medtronic Drive Lafayette, CO, 80026
Contact: Aliva Mahunta, Sr. Regulatory Affairs Specialist Phone Number : 800-255-6774 Email: aliva.mahunta@medtronic.com Date Summary Prepared: May 20, 2024
ll. PROPOSED DEVICE
| Trade Name: | Valleylab FT10 Energy Platform with Software Version 5.0 |
|---|---|
| Catalog Numbers: | VLFT10GEN; VLFT10FXGEN; VLFT10LSGEN |
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical cutting and coagulating device and accessories (21 CFR 878.4400) |
| Regulatory Class: | II |
| Product Code: | GEI, OCL |
PREDICATE DEVICE
| Trade Name: | Valleylab FT10 Energy Platform with Software Version 4.0 |
|---|---|
| Catalog Numbers: | VLFT10GEN |
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical cutting and coagulating device and accessories (21 CFR 878.4400) |
| 510(k) Number: | K191601 |
| Regulatory Class: | II |
| Product Code: | GEI, OCL |
lll. DEVICE DESCRIPTION
Valleylab™ FT10 Energy Platform (VLFT10GEN): The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. The generator provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications (LigaSure/vessel sealing function) and cardiac applications. It is a combination of a full-featured general surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure/Bipolar section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.
4
K241085
The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.
The VLFT10GEN can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10GEN connects to electrical mains and operates at an input line frequency of 47-63 Hz.
Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN): The Valleylab™ FT10 Electrosurgical Generator is a high frequency electrosurgical only version of the VLFT10GEN Energy Platform. It is intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN): The Valleylab™ FT10 Vessel Sealing Generator is the vessel sealing only version of the VLFT10GEN Energy Platform. It is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.
IV. INDICATIONS FOR USE
Valleylab™ FT10 Energy Platform (VLFT10GEN):
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.
The 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.
Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN):
The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN):
The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, thick tissue (tissue bundles), and lymphatics.
The 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.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Valleylab FT10 Energy Platform with the proposed software modifications has the same technological and performance characteristics as the predicate Valleylab FT10 Energy Platform with software version 4.0 cleared in K191601. Both versions of the energy platform are a combination of a full-featured general surgery electrosurgical system, a vessel sealing system, and a cardiac ablation system. The proposed device VLFT10GEN with software version 5.0 (VLFT10GEN SW v5.0) provides
5
incremental improvements over the predicate while maintaining the same basic functionality and intended use.
| Characteristic | Proposed Device
Valleylab™ FT10 Energy
Platform with Software
version 5.0 | Predicate Device
Valleylab™ FT10 Energy
Platform with Software
version 4.0 (K191601) | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 878.4400 | 878.4400 | Same |
| Regulation | | | |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| Indications for Use | The Valleylab FT10 Energy
Platform is a high frequency
electrosurgical generator
intended for use with
monopolar and bipolar
accessories for cutting and
coagulating tissue. When used
with compatible sealing devices,
it is indicated for sealing vessels
up to and including 7 mm thick
tissue (tissue bundles), and
lymphatics. When used with
compatible ablation devices it is
indicated for cardiac tissue
ablation. The generator can be
used with compatible
resectoscopes for
endoscopically controlled
removal or coagulation of tissue
using 0.9% NaCl solution as the
irrigation medium.
The 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.
VLFT10FXGEN Indications for
Use
The VLFT10FXGEN Energy
Platform is a high frequency
electrosurgical generator
intended for use with
monopolar and bipolar
accessories for cutting and
coagulating tissue. | The Valleylab FT10 Energy
Platform is a high frequency
electrosurgical
Generator intended for use
with monopolar and bipolar
accessories for cutting and
coagulating tissue. When
used with compatible
sealing devices, it is
indicated for sealing vessels
up to and including 7 mm,
tissue bundles, and
lymphatics. When used with
compatible ablation
devices, it is indicated for
cardiac tissue ablation. The
generator can also be used
with compatible
resectoscopes for
endoscopically controlled
removal or coagulation of
tissue using 0.9% NaCl
solution as the irrigation
medium.
The 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 | Same
There is no change to
the intended use or
indications for use of the
device. The indications
for use for the separate
VLFT10FXGEN and
VLFT10LSGEN functions
are simply a subset of
the fully functional
VLFT10GEN indications
for use, which are not
changing.
The intended use was
revised to add thick
tissue (tissue bundles)
while keeping tissue
bundles.
This revision is for
clarification purposes
only for the benefit of
the surgeon.
There is no change to
the intended use of the
generator, but rather a
clarification of terms for
the benefit of the
surgeon. |
| | VLFT10LSGEN Indications for
Use
The VLFT10LSGEN Energy
Platform is a high frequency
electrosurgical generator. When
used with compatible sealing
devices, it is indicated for
sealing vessels up to and
including 7 mm tissue bundles,
and lymphatics. | | |
| Contraindications | The cardiac tissue ablation
feature is contraindicated for
patients that have active
endocarditis at the time of
surgery.
Ablation in a pool of blood is
contraindicated (for example
through a purse string suture). | The cardiac tissue ablation
feature is contraindicated
for patients that have active
endocarditis at the time of
surgery.
Ablation in a pool of blood
is contraindicated (for
example through a purse
string suture). | Same |
| Physical Characteristics
(approximate | Height: 7 in. (17.78 cm)
Width: 14.5 in. (35.8 cm)
Length: 18.2 in. (46.2 m)
Weight: 22.3 lbs. (10.1 kg) | Height: 7 in. (17.78 cm)
Width: 14.5 in. (35.8 cm)
Length: 18.2 in. (46.2 m)
Weight: 22.3 lbs. (10.1 kg) | Same |
| Touchscreen | LCD; Resistive Technology | LCD; Resistive Technology | Same |
| Connector Receptacles | LED Illuminated connector
readers | LED Illuminated connector
readers | Same |
| Monopolar Ports | 2 | 2 | Same |
| Bipolar/LigaSure Ports | 2 | 2 | Same |
| Hand switch Activation | Yes | Yes | Same |
| Footswitch Activation | Yes | Yes | Same |
| REM Quality Contact
Monitoring | Yes | Yes | Same |
| Wireless Connectivity | No | No | Same |
| Instrument
ldentification | Barcode/RFID | Barcode/RFID | Same |
6
7
VI. PERFORMANCE DATA
The following performance data were conducted in support of the substantial equivalence determination. Verification and Validation testing confirmed that the modifications to the Valleylab™ FT10 Energy Platform do not raise any different issues of safety and effectiveness. The testing confirmed the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:
- System Verification showed that VLFT10GEN with SW v.5.0 possesses all required functionality and meets system specifications.
- . Confirmatory Electrical safety and EMC testing were conducted on the Proposed Device and showed that the system complies with IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
- . Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions" [2023] and IEC 62304 Medical Device Software- Software life cycle processes".
- Mechanical Testing in the form of Environmental and Packaging Test and Chemical Soak and Abrasion Test was conducted and met all the acceptance criteria.
VII. CLINICAL STUDIES
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
VIII. CONCLUSIONS
Verification and Validation activities demonstrate that the Valleylab™FT10 Energy Platform with software version 5.0 (VLFT10GEN SW v5.0) is substantially equivalent to the predicate Valleylab™FT10 Energy Platform with software version (VLFT10GEN SW v4.0) cleared in K191601. The intended use of the Valleylab™FT10 Energy Platform has not changed. The non-clinical data support the safety of the device and the hardware and software verification, and validation demonstrate that the Proposed Device Valleylab™FT10 Energy Platform with software version 5.0 (VLFT10GEN SW v5.0) should perform as intended in the specified use conditions.