Who can help prepare an FDA 510(k) submission like Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)

Q: Who is the manufacturer of Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)?

Covidien, LLC filed the 510(k) submission for Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) (K241085).

Q: What is the FDA product code for Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)?

510(k) clearance (submission type: Traditional).

K241085 · Covidien, LLC · GEI · Jul 12, 2024 · General, Plastic Surgery

Device Facts

Record ID	K241085
Device Name	Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
Applicant	Covidien, LLC
Product Code	GEI · General, Plastic Surgery
Decision Date	Jul 12, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended 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 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. The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. 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.

Device Story

High-frequency electrosurgical generator; provides RF energy for monopolar/bipolar surgery, tissue fusion, vessel sealing, and cardiac ablation. Used in hospitals/healthcare facilities by surgeons. Inputs: monopolar/bipolar instruments, footswitches, return electrode pads. Device processes electrical signals to deliver controlled power for cutting, desiccating, and fulgurating tissue. Output: RF energy delivered to surgical site via compatible accessories. Healthcare providers use device interface to select modes; output affects tissue state (cutting/coagulation/sealing). Benefits: enables precise surgical tissue management and vessel hemostasis.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including system verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software verification/validation (IEC 62304), and mechanical/environmental testing.

Technological Characteristics

High-frequency electrosurgical generator; resistive LCD touchscreen; LED-illuminated connector readers; 2 monopolar and 2 bipolar/LigaSure ports. Supports barcode/RFID instrument identification. Connectivity: wired (no wireless). Power: 47-63 Hz mains. Software: v5.0. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle).

Indications for Use

Indicated for patients requiring electrosurgical cutting, coagulation, vessel sealing (up to 7mm tissue bundles/lymphatics), or cardiac tissue ablation. Contraindicated for patients with active endocarditis or for ablation in a pool of blood. Not indicated for tubal sterilization.

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

Valleylab FT10 Energy Platform with Software Version 4.0 (K191601)

Related Devices

K191601 — Valleylab FT10 Electrosurgical Platform · Covidien · Jul 12, 2019
K172757 — Valleylab FX8 Electrosurgical Platform · Covidien, LLC · Nov 2, 2017
K151649 — Valleylab FT10 Electrosurgical Platform · Covidien · Sep 10, 2015
K201221 — Electrosurgical Generator · New Deantronics Taiwan , Ltd. · Sep 28, 2020
K170170 — Valleylab FT10 Electrosurgical Platform · Covidien, LLC · Feb 16, 2017

Submission Summary (Full Text)

{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) K241085 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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.