Valleylab FT10 Electrosurgical Platform

K151649 · Covidien · GEI · Sep 10, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151649
• Device Name: Valleylab FT10 Electrosurgical Platform
• Applicant: Covidien
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valleylab FT10 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. 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 coagulation for sterilization procedures. Do not use this function for these procedures.

Device Story

Valleylab FT10 is a high-frequency electrosurgical generator providing RF energy for monopolar/bipolar surgery and LigaSure vessel sealing. Used in hospitals/surgical facilities by surgeons/clinical staff. Device inputs include electrical mains power and tissue impedance signals via connected instruments; outputs include RF energy for cutting, desiccation, fulguration, and vessel sealing. Generator senses tissue characteristics to modulate energy delivery and determine seal completion. Includes RFID for instrument identification/usage tracking. Healthcare providers operate via footswitches and instrument controls; output effects (thermal tissue modification) are observed directly during surgery. Benefits include improved procedural speed and refined tissue sensing compared to predicate.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), system verification, software V&V, usability testing (IEC 62366), and ex vivo/in vivo porcine tissue studies demonstrating comparable thermal effects and vessel sealing performance.

Technological Characteristics

RF electrosurgical generator; monopolar/bipolar/LigaSure outputs. Features upgraded tissue sensing algorithms, Soft Coag mode, and RFID instrument identification. Standards: IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2014, IEC 60601-2-2:2009. Connectivity: RFID for instrument tracking. Power: 47-63 Hz mains input.

Indications for Use

Indicated for patients requiring electrosurgical cutting, coagulation, or vessel sealing (up to 7mm, tissue bundles, lymphatics) during surgical procedures. Compatible with monopolar, bipolar, and resectoscope accessories. Contraindicated for tubal coagulation for 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

• ForceTriad™ Energy Platform (K110268)

Reference Devices

• ERBE VIO® 300 D

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2015

Covidien Ms. Sharon McDermott Senior Regulatory Affairs Product Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K151649

Trade/Device Name: Valleylab™ FT10 Electrosurgical Platform Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 17, 2015 Received: June 18, 2015

Dear Ms. McDermott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K151649

Device Name Valleylab™ FT10 Electrosurgical Platform

#### Indications for Use (Describe)

The Valleylab FT10 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. 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 coagulation for sterilization procedures. Do not use this function for these procedures.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### 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 [e-mail]

"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}------------------------------------------------

# 6 510(k) Summary

### 510(k) Summary

Date summary prepared: September 10, 2015

#### 510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

#### Contact

Sharon McDermott Sr. Regulatory Affairs Product Specialist Telephone: [phone] Fax: [phone] Email: [e-mail]

#### Name of Device

| Trade Name: | Valleylab™ FT10 Energy Platform |
|----------------------|------------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21 CFR § 878.4400, class II, GEI) |

#### Predicate Device

| Trade Name: | ForceTriad™ Energy Platform |
|-----------------|-----------------------------|
| Common Name: | Electrosurgical Generator |
| Catalog Number: | FORCETRIAD |
| 510(k) Number: | K110268 |
| Manufacturer: | Covidien |

## Device Description

The Valleylab™ FT10 Electrosurgical Platform (VLFT10) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications (LigaSure function). It is a combination of a full-featured general-surgery electrosurgical unit and a LigaSure vessel sealing system. The monopolar and bipolar sections, including the advanced bipolar/LigaSure section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. The LigaSure section of the system provides power for vessel sealing.

The VLFT10 is used in hospitals and other health care facilities where surgical procedures are carried out.

The VLFT10 can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10 connects to electrical mains and operates at an input line frequency of 47-63 Hz.

{4}------------------------------------------------

### Principle of Operation

The Valleylab FT10 is a radio-frequency (RF) electrosurgical generator that delivers energy to compatible surgical instruments. The concentration of energy at the instrument in conjunction with tissue characteristics produces heat. The heating of tissue provides the desired surgical effect (cutting, coagulation, sealing). Variations in the waveform result in the different surgical effects achieved by different modes. In the case of LigaSure vessel sealing, the generator senses changes in tissue characteristics to determine when a seal cycle is complete.

#### Indications for Use

The Valleylab FT10 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. 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.

#### Technological Characteristics

The technological characteristics of the proposed VLFT10 are the same as the predicate, ForceTriad; both are a combination of a full-featured general-surgery electrosurgical unit and a LigaSure vessel sealing system. The VLFT10 provides several incremental improvements over the predicate while maintaining the same basic functionality and intended use. These are summarized below.

- . Tissue sensing algorithms have been upgraded to sense electrical impedance at a faster rate.
- Monopolar capabilities have been expanded with the addition of a Soft Coag mode, a mode that . has been available in other electrosurgical generators such as the ERBE VIO® 300 D.
- . The LigaSure algorithm has been refined to improve clip detection and to respond more quickly to changes in tissue impedance.
- . The VLFT10 includes RFID technology to identify LigaSure instruments and to write usage information to the tags.

#### Performance Characteristics

Extensive verification and validation activities were successfully completed that establish that the VLFT10 performs as intended and is substantially equivalent to its predicate, ForceTriad. Testing included the following:

- Compliance with Electrical Safety and EMC standards: .

| | IEC 60601-1:2005/A1:2012 Medical electrical equipment – Part 1: General requirements for<br>basic safety and essential performance – Edition 3.1 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:2014 | Medical electrical equipment, Part 1-2: General requirements<br>for basic safety and essential performance – Collateral<br>standard: Electromagnetic compatibility – Requirements and<br>tests |

{5}------------------------------------------------

- IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories -Edition 5.0
- . Ex vivo and in vivo testing using porcine tissue and a porcine model showed comparable performance with regard to thermal effects, and vessel sealing capabilities. Some incremental improvements in procedural speed were seen with the VLFT10.
- . System verification (Non-IEC electrical, instrument compatibility, basic functionality) showed that the VLFT10 has all required functionality and that it meets system specifications.
- . Software verification and validation testing was conducted and documentation provided in accordance with FDA's, Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices
- Usability testing in accordance with IEC 62366: 2007 Medical devices Application of . usability engineering to medical devices showed that representative users understood the user interface and could use the VLFT10 to complete typical surgical tasks.

The minor differences that were seen during testing are consistent with design changes (such as the improved tissue sensing capabilities) and do not raise safety or effectiveness concerns.

#### Clinical Studies

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

## Conclusion

Verification and validation testing demonstrates the proposed Valleylab™ FT10 Energy Platform is substantially equivalent to the predicate, the ForceTriad™ Energy Platform. The two electrosurgical generators have the same intended use and fundamental technology. The new generator has similar performance with minor incremental improvements. The differences do not raise any new questions of safety and efficacy when compared with the predicate.