(89 days)
Not Found
No
The summary describes a standard electrosurgical generator and ablation devices. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, decision-making, or control. The software mentioned is for verification and validation, not for AI/ML functionality.
Yes.
The device is specifically intended to "ablate cardiac tissue," which is a therapeutic intervention aimed at treating medical conditions.
No
The device is an electrosurgical generator and ablation device used for cutting, coagulating, sealing, and ablating tissue. Its intended uses are therapeutic, not diagnostic.
No
The device description clearly outlines a physical generator (Valleylab FT10 Energy Platform) and physical surgical ablation devices (Cardioblate BP2 and LP). While software is mentioned as being verified and validated, it is part of a larger hardware system that delivers radio frequency energy.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for cutting and coagulating tissue, sealing vessels, cardiac tissue ablation, and endoscopically controlled removal or coagulation of tissue. These are all procedures performed on the patient's body (in vivo).
- Device Description: The description reinforces that the device provides radio frequency (RF) energy for surgical applications and is used in hospitals and other health care facilities where surgical procedures are carried out.
- Anatomical Site: The specified anatomical site is cardiac tissue and both atria of the heart, which are internal parts of the living body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
In summary, the device is an electrosurgical and ablation system used directly on a patient's tissue during surgical procedures, which is the definition of an in vivo medical device, not an in vitro diagnostic device.
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. 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 coagulation for sterilization procedures. Do not use this function for these procedures.
Cardioblate BP2 49321 Surgical Ablation Device:
The Cardioblate® BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Cardioblate LP 49341 Surgical Ablation Device:
The Cardioblate® LP surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Product codes (comma separated list FDA assigned to the subject device)
OCL, GEI
Device Description
Valleylab FT10 Energy Platform (VLFT10GEN)
The Valleylab™ FT10 Energy Platform (VLFT10GEN) is a multifunction generator which provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissuefusion and vessel-sealing applications (LigaSure/vessel-sealing function), and cardiac tissue ablation. The Cardioblate™ instruments that allow the cardiac ablation capability (49321, 49341) are single use. The Cardioblate ablation energy delivery is only available when using compatible instruments.
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.
Cardioblate BP2 (49321) and LP (49341) Surgical Ablation Devices:
The Cardioblate BP2 and LP Surgical Ablation Devices are hand held, single use, bipolar, RF ablation device for use in cardiac surgery. They have a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. The devices are intended for intermittent operation. The Cardioblate BP2 and LP devices are dual linear electrode devices that have integral fluid delivery to both electrodes. They rapidly create linear transmural lesions in both atria of the heart during cardiac surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in hospitals and other healthcare 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)
Performance testing was completed to demonstrate substantial equivalence of the system (the proposed Cardioblate BP2 and LP surgical ablation devices, used with the Valleylab FT10GEN Energy Platform, software version 3.0 or higher) to the identified predicate system. Clinical and non-clinical animal testing was not required to establish substantial equivalence. The system components were subjected to the following verification testing, as applicable:
Mechanical: Mechanical verification testing was conducted for components of the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 standard requirements and Medtronic self-enforced requirements.
Electrical: Electrical verification testing was conducted for the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 electrical requirements.
Electromagnetic compatibility: Electromagnetic compatibility testing was completed for the subject devices to ensure compliance with current IEC 60601-1-2 standard requirements.
Benchtop Lesion Verification: Comparative lesion verification testing was performed using a soft tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate systems.
Usability: Testing was performed to verify and validate the usability requirements of the subject devices as a system. Elements captured included normal use cases, a foreseeable worst-case use scenario, and testable requirements for primary operating functions.
Software: Software verification and validation was completed. FDA's current "Guidance for the content of premarket submissions for software contained in Medical Devices" was used to determine the Level of Concern for the software in the subject devices.
All test requirements were met as specified by applicable standards and the test protocols.
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). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below it.
December 19, 2018
Medtronic Kari Christianson Principal Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428
Re: K182610
Trade/Device Name: Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OCL, GEI Dated: November 12, 2018 Received: November 13, 2018
Dear Kari Christianson:
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 mav, 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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).
Sincerelv
Mark Jellison
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K182610
Device Name Valleylab FT10 Energy Platform Cardioblate BP2 49321 Surgical Ablation Device Cardioblate LP 49341 Surgical Ablation Device
Indications for Use (Describe)
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. 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 coagulation for sterilization procedures. Do not use this function for these procedures.
Cardioblate BP2 49321 Surgical Ablation Device:
The Cardioblate® BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Cardioblate LP 49341 Surgical Ablation Device:
The Cardioblate® LP surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
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."
FORM FDA 3881 (7/17)
PSC Publiching Services (301) 443-6740 ព្រះ
3
Medtronic
510(k) Summary
| Date Prepared: | September 19, 2018 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Cardiac Surgery | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Kari Christianson |
| Principal Regulatory Affairs Systems | |
| Medtronic Cardiovascular, Cardiac Surgery | |
| Phone: (763) 514-9529 | |
| Email: kari.j.christianson@medtronic.com | |
| Alternate: | Mike Green |
| Sr. Regulatory Affairs Manager | |
| Medtronic Cardiovascular, Cardiac Surgery | |
| Phone: (763) 514-9774 | |
| Email: mike.green@medtronic.com | |
| Common Name: | Electrosurgical device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Trade Name: | Cardioblate Surgical Ablation System |
| Classification: | Class II |
| Panel: | Cardiovascular |
| Regulation: | 21 CFR 878.4400 |
| Product Code: | OCL |
| Predicate Devices: | Cardioblate 68000 Generator (68000) |
| K080509, cleared 05/05/2008 |
Valleylab FT10 Energy Platform (VLFT10GEN),
K080509, cleared 05/05/2008
K181389, cleared 06/19/2018 |
4
Cardioblate Surgical Ablation System (60831, 60841), K080509 K093203, cleared 02/26/2010
Device Description
Valleylab FT10 Energy Platform (VLFT10GEN)
The Valleylab™ FT10 Energy Platform (VLFT10GEN) is a multifunction generator which provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissuefusion and vessel-sealing applications (LigaSure/vessel-sealing function), and cardiac tissue ablation. The Cardioblate™ instruments that allow the cardiac ablation capability (49321, 49341) are single use. The Cardioblate ablation energy delivery is only available when using compatible instruments.
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.
Cardioblate BP2 (49321) and LP (49341) Surgical Ablation Devices:
The Cardioblate BP2 and LP Surgical Ablation Devices are hand held, single use, bipolar, RF ablation device for use in cardiac surgery. They have a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. The devices are intended for intermittent operation. The Cardioblate BP2 and LP devices are dual linear electrode devices that have integral fluid delivery to both electrodes. They rapidly create linear transmural lesions in both atria of the heart during cardiac surgical procedures.
Description of Changes
The following design changes are being made to the devices:
- VLFT10GEN
- o Addition of a Cardioblate software module
- Addition of cardiac tissue ablation to Indications for Use o
- IFU and Labeling updates o
- Cardioblate BP2 and LP Devices .
- New connectors for VLFT10GEN compatibility O
- RFID, rather than EPROM, device tracking O
- IFU and Labeling updates O
- Branding change O
- eIFU rather than paper IFU O
5
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, 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.
Cardioblate BP2 (49321):
The Cardioblate BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Cardioblate LP (49341):
The Cardioblate LP surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Contraindications
Valleylab FT10 Energy Platform (VLFT10GEN):
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).
Cardioblate BP2 (49321):
The Cardioblate BP2 surgical ablation device should not be used for:
- Patients that have active endocarditis at time of surgery. .
- Ablation in a pool of blood (e.g., through a purse string suture on a beating heart). ● Effects of this type of ablation are unknown.
Cardioblate LP (49341):
The Cardioblate LP Surgical Ablation devices should not be used for:
- Patients that have active endocarditis at time of surgery .
- Ablation in a pool of blood (for example, through a purse string suture on a beating ● heart) (Effects of this type of ablation are unknown.)
6
Comparison to Predicate Devices
When compared to predicate devices (K080509, K181389, K923203), the Valleylab FT10GEN Energy Platform used with Cardioblate BP2 and LP surgical ablation devices presented in this submission have the same:
- Same Intended Use (Models 49321 and 49341) ●
- Same technological characteristics and operating principle ●
- . Same design features
- Same performance specifications
- . Same patient contacting components and materials (Models 49321 and 49341)
- Same shelf life (Models 49321 and 49341) ●
Performance Testing
Performance testing was completed to demonstrate substantial equivalence of the system (the proposed Cardioblate BP2 and LP surgical ablation devices, used with the Valleylab FT10GEN Energy Platform, software version 3.0 or higher) to the identified predicate system. Clinical and non-clinical animal testing was not required to establish substantial equivalence. The system components were subjected to the following verification testing, as applicable:
Mechanical: Mechanical verification testing was conducted for components of the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 standard requirements and Medtronic self-enforced requirements.
Electrical: Electrical verification testing was conducted for the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 electrical requirements.
Electromagnetic compatibility: Electromagnetic compatibility testing was completed for the subject devices to ensure compliance with current IEC 60601-1-2 standard requirements.
Benchtop Lesion Verification: Comparative lesion verification testing was performed using a soft tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate systems.
Usability: Testing was performed to verify and validate the usability requirements of the subject devices as a system. Elements captured included normal use cases, a foreseeable worst-case use scenario, and testable requirements for primary operating functions.
Software: Software verification and validation was completed. FDA's current "Guidance for the content of premarket submissions for software contained in Medical Devices" was used to determine the Level of Concern for the software in the subject devices.
All test requirements were met as specified by applicable standards and the test protocols.
Conclusion
The fundamental scientific technology of the Cardioblate BP2 and LP surgical ablation devices when used with the Valleylab FT10GEN Energy Platform, including principles of operation and mechanism of action, is the same as the predicate devices. Differences in design and technological characteristics between the proposed and predicate devices do not raise any new
7
types of questions of safety and effectiveness. Verification test results support the substantial equivalence of the system, as compared to the predicate system.
The data included in this submission is sufficient to provide reasonable assurance of the safety and effectiveness of the subject devices with proposed design changes and they are substantially equivalent to the marketed predicate devices.