(25 days)
Not Found
No
The summary describes a standard electrosurgical generator and does not mention any AI or ML capabilities. The software verification and validation testing is standard for medical device software and does not indicate the presence of AI/ML.
Yes
The device is described as an electrosurgical generator intended for cutting, coagulating, and sealing tissue, which are direct therapeutic actions performed during surgical procedures.
No
The device is described as an electrosurgical generator intended for cutting, coagulating, and sealing tissue, not for diagnosing conditions.
No
The device is described as a "high frequency electrosurgical generator" that provides "radio frequency (RF) energy" and is a "combination of a full-featured general-surgery electrosurgical unit and a bipolar vessel sealing system." This clearly indicates a hardware device that generates and delivers energy, not a software-only device. While software is mentioned for verification and validation, it is software contained in the medical device, not the device itself.
Based on the provided text, the Valleylab FT10 Energy Platform and the Valleylab FX8 Energy Platform are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that these devices are high frequency electrosurgical generators used for cutting, coagulating, and sealing tissue within the body during surgical procedures. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description reinforces their function as energy platforms for surgical applications, not for analyzing samples like blood, urine, or tissue outside the body to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status based on sample analysis.
- Using reagents or calibrators.
Therefore, these devices are surgical instruments used for therapeutic purposes, not IVDs used for diagnosis.
N/A
Intended Use / Indications for Use
Valleylab FT10 Energy Platform:
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. 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.
Valleylab FX8 FX Series Energy Platform:
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Valleylab FT10 Energy Platform:
The Valleylab™ FT10 Energy Platform (VLFT10GEN) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications (LigaSure/vessel-sealing function). 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 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/vessel-sealing section of the system provides power for vessel sealing.
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 FX8 Energy Platform:
The Valleylab FX8 Energy Platform provides radio frequency (RF) energy for monopolar and bipolar surgical applications. Unlike the Valleylab FT10, the VLFX8 does not include the tissuefusion and vessel-sealing applications (LigaSure function). It is a high-frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Valleylab FT10 Energy Platform:
The VLFT10GEN is used in 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Valleylab FT10 Energy Platform:
Verification and validation testing confirmed that the modifications to the Valleylab FT10 Energy Platform do not affect safety or performance. 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:
- Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects.
- System verification showed that the VLFT10GEN has all required functionality and that it meets system specifications.
- Software verification and validation testing was conducted in accordance with FDA's, ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304, Medical device software – Software life cycle processes
The changes were evaluated for impact on electrical safety and electromagnetic compatibility (EMC). The evaluation determined that the proposed changes do not require additional electrical safety testing in accordance with IEC 60601-1:2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" or electromagnetic magnetic compatibility in accordance with IEC 60601-1-2:2014, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). Although new electrical safety and EMC testing was not required, the Valleylab FT10 continues to meet the requirements of both standards.
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Valleylab FX8 Energy Platform:
Verification and validation testing confirmed that the modifications to the Valleylab FX8 Energy Platform do not affect safety or performance. 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:
- Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects.
- System verification showed that the VLFX8GEN has all required functionality and that it meets system specifications.
- Software verification and validation testing was conducted in accordance with FDA's, ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304, Medical device software – Software life cycle processes
The changes were evaluated for impact on electrical safety and electromagnetic compatibility (EMC). The evaluation determined that the proposed changes do not require additional electrical safety testing in accordance with IEC 60601-1:2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" or electromagnetic magnetic compatibility in accordance with IEC 60601-1-2:2014, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). Although new electrical safety and EMC testing was not required, the Valleylab FX8 continues to meet the requirements of both standards.
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
June 19, 2018
Covidien Celso Duran Principal Specialist, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K181389
Trade/Device Name: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 24, 2018 Received: May 25, 2018
Dear Celso Duran:
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, 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K181389
Device Name Valleylab FT10 Energy Platform
Indications for Use (Describe)
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. 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)
| 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
Indications for Use
510(k) Number (if known) K181389
Device Name Valleylab FX8 FX Series Energy Platform
Indications for Use (Describe)
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
| 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."
4
Image /page/4/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle in the center and a vertical blue line running through it. To the right of the square is the word "COVIDIEN" in blue, with each letter clearly visible.
510(k) Summary
Date summary prepared: June 14, 2018
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact: Celso Duran Telephone: 303-350-6445 Fax: 303-530-6313 Email: celso.duran@medtronic.com
This Bundled Special 510(k) Notification proposes updates to the software for the Valleylab FT10 Energy Platform (VLFT10GEN) and Valleylab FX8 Energy Platform (VLFX8GEN). The software updates will provide incremental improvements while maintaining the same basic functionality and intended use. The improvements common to both platforms are listed below.
- Refinement of monopolar energy
- Enable selectable smoke activation from either smoke evacuation port
- Miscellaneous software changes and bug (anomalies) fixes
Name of Device #1
| Trade Name: | Valleylab FT10 Energy Platform |
|---|---|
| Catalog Numbers: | VLFT10GEN |
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR |
| 878.4400, Class II, GEI) | |
| Trade Name: | Valleylab FT10 Energy Platform |
| Catalog Number: | VLFT10GEN |
| Common Name: | Electrosurgical Generator |
| 510(k) Number: | K170170 (cleared 02/16/2017) |
| Manufacturer: | Covidien |
| Recalls: | This device has not been subject to a design-related recall |
Predicate Device
Name of Device #2
Valleylab FX8 Energy Platform Trade Name: Catalog Numbers: VLFX8GEN Common Name: Electrosurgical Generator Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Class II, GEI)
Predicate Device
| Trade Name: | Valleylab FX8 Energy Platform |
|---|---|
| Catalog Number: | VLFX8GEN |
| Common Name: | Electrosurgical Generator |
| 510(k) Number: | K172757 (cleared 11/02/2017) |
| Manufacturer: | Covidien |
| Recalls: | This device has not been subject to a design-related recall |
BUNDLED Special 510(k): Valleylab FT10 Energy Platform Valleylab FX8 Energy Platform
5
Valleylab FT10 Energy Platform
Device Description
The Valleylab™ FT10 Energy Platform (VLFT10GEN) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications (LigaSure/vessel-sealing function). 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 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/vessel-sealing section of the system provides power for vessel sealing.
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.
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, 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.
Comparison of Technological Characteristics with the Predicate Device
The Valleylab FT10 Energy Platform with the proposed software modifications has similar technological and performance characteristics as the predicate Valleylab FT10 Energy Platform cleared in K170170. Both versions of the energy platform are a combination of a full-featured general-surgery electrosurgical system and a vessel sealing system. The VLFT10GEN with software version 2.1 provides increments over the predicate while maintaining the same basic functionality and intended use. These improvements are summarized below.
- Refinement of monopolar energy
- Enable selectable smoke activation from either smoke evacuation port
- . Miscellaneous software changes and bug (anomalies) fixes
- Updates to User's Guide including re-phrasing and relocation of precautions and warnings
Performance Characteristics
Verification and validation testing confirmed that the modifications to the Valleylab FT10 Energy Platform do not affect safety or performance. 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:
- . Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects.
- . System verification showed that the VLFT10GEN has all required functionality and that it meets system specifications.
BUNDLED Special 510(k): Valleylab FT10 Energy Platform Valleylab FX8 Energy Platform
6
- Software verification and validation testing was conducted in accordance with FDA's, ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304, Medical device software – Software life cycle processes
The changes were evaluated for impact on electrical safety and electromagnetic compatibility (EMC). The evaluation determined that the proposed changes do not require additional electrical safety testing in accordance with IEC 60601-1:2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" or electromagnetic magnetic compatibility in accordance with IEC 60601-1-2:2014, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). Although new electrical safety and EMC testing was not required, the Valleylab FT10 continues to meet the requirements of both standards.
Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusions
Verification and validation activities demonstrate that the Valleylab FT10 with software version 2.1 is substantially equivalent to the predicate Valleylab FT10 Energy Platform (SW 2.0) cleared in K170170. The intended use of the Valleylab FT10 Energy Platform has not changed. Moreover, the results of testing demonstrate that the software modifications do not affect the safety or performance of the energy platform.
7
Valleylab FX8 Energy Platform
Device Description
The Valleylab FX8 Energy Platform provides radio frequency (RF) energy for monopolar and bipolar surgical applications. Unlike the Valleylab FT10, the VLFX8 does not include the tissuefusion and vessel-sealing applications (LigaSure function). It is a high-frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Indications for Use
The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
Comparison of Technological Characteristics with the Predicate Device
The Valleylab FX8 with the proposed software modifications has the similar technological and performance characteristics as the predicate Valleylab FX8 cleared in K172757. Both versions of the Valleylab FX8 Energy Platform provide radio frequency (RF) energy for monopolar and bipolar surgical applications. The VLFX8 with software version 1.1 provides incremental improvements over the predicate while maintaining the same basic functionality and intended use. These improvements are summarized below.
- . Refinement of monopolar energy
- . Enable selectable smoke activation from either smoke evacuation port
- . Miscellaneous software changes and bug (anomalies) fixes
Performance Characteristics
Verification and validation testing confirmed that the modifications to the Valleylab FX8 Energy Platform do not affect safety or performance. 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:
- . Ex vivo testing using porcine tissue showed comparable performance with regard to thermal effects.
- . System verification showed that the VLFX8GEN has all required functionality and that it meets system specifications.
- Software verification and validation testing was conducted in accordance with FDA's, ● Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304, Medical device software – Software life cycle processes
The changes were evaluated for impact on electrical safety and electromagnetic compatibility (EMC). The evaluation determined that the proposed changes do not require additional electrical safety testing in accordance with IEC 60601-1:2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" or electromagnetic magnetic compatibility in accordance with IEC 60601-1-2:2014, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). Although new electrical safety and EMC testing was not required, the Valleylab FX8 continues to meet the requirements of both standards.
BUNDLED Special 510(k): Valleylab FT10 Energy Platform Valleylab FX8 Energy Platform
8
Clinical Studies
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusions
Verification and validation activities demonstrate that the Valleylab FX8 with software version 1.1 is substantially equivalent to the predicate Valleylab FX8 Energy Platform (SW 1.0) cleared in K172757. The intended use of the Valleylab FX8 Energy Platform has not changed. Moreover, the results of testing demonstrate that the software modifications do not affect the safety or performance of the energy platform.