Cardioblate CryoFlex Surgical Ablation System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 1, 2019 Medtronic, Inc. Choua Thao Senior Regulatory Affairs Specialist 3800 Annapolis Lane Plymouth, Minnesota 55447 Re: K191526 Trade/Device Name: Cardioblate CryoFlex Surgical Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: July 2, 2019 Received: July 5, 2019 Dear Choua Thao: 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). 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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) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-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, Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191526 #### Device Name Cardioblate CryoFlex Surgical Ablation System #### Indications for Use (Describe) ### For models 60SF2, 60SF3, and 60SF7: The Cardioblate CryoFlex surgical ablation system is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis. For model 60CM1: The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex Clamp and Surgical Ablation Probe and the Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> Registration Use (Part 21 CFR 201.2, Subpart B) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> On-The-Counter Use (21 CFR 201.2, Subpart C) | X 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}------------------------------------------------ # 5.0 510(k) Summary of Safety and Effectiveness | Date Prepared: | June 7, 2019 | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Medtronic, Inc.<br>3800 Annapolis Lane<br>Minneapolis, MN 55447<br>Establishment Registration Number: 3008592544 | | Contact Person(s): | Choua Thao<br>Senior Regulatory Affairs Specialist<br>Medtronic Cardiac Surgery<br>Phone: 763.514.9842<br>Email: choua.thao@medtronic.com | | | Alternate Contact:<br>Mike Green<br>Senior Regulatory Affairs Manager<br>Medtronic Cardiac Surgery<br>Phone: 763.514.9774<br>Email: mike.green@medtronic.com | | Device Name and Classification | | | Trade Name: | Cardioblate™ CryoFlex™ Surgical Ablation System | | Common Name: | Cryosurgical System | | Product Code: | OCL | | Common Name: | Cryosurgical System | |-------------------------|-------------------------------------------------| | Product Code: | OCL | | Regulation Number: | 21 CFR 878.4400 | | Product Classification: | Class II | | Classification Name: | Surgical Device, for Ablation of Cardiac Tissue | ### Predicate Device K123733 Cardioblate™ CryoFlex™ Surgical Ablation System {4}------------------------------------------------ # Device Description # System and Accessories The Medtronic Cardioblate™ CryoFlex™ Console, Cardioblate™ CryoFlex™ surgical ablation probes, and accessories are used together as a system. The system is comprised of the following components: | 510(k) Number &<br>Clearance Date | Model Number | Device Description | |-----------------------------------|--------------|---------------------------------------------------------------------| | K123733 | 65CS1 | Cardioblate™ CryoFlex™ Surgical Ablation Console | | | R65CS1 | Cardioblate™ CryoFlex™ Surgical Ablation Console,<br>Refurbished | | | 60SF2 | Cardioblate™ CryoFlex™ Surgical Ablation Probe, 10 cm | | | 60SF3 | Cardioblate™ CryoFlex™ Surgical Ablation Probe, 10-S cm | | | 60SF7 | Cardioblate™ CryoFlex™ Surgical Ablation Probe, 7 cm | | | 60CM1 | Cardioblate™ CryoFlex™ Surgical Ablation Probe with<br>Clamp, 10 cm | | Clearance Date:<br>01-Apr-2013 | 67RAXNA | Tank Regulator | | | R67RAXNA | Tank Regulator, Refurbished | | | 65TC1 | Tank Carrier | | | 67H08 | Gas Hose | | | 671PCNA | Power Cord, North America | | | 67PS6 | Pressure Transducer Cable, 6ft | Table 5-1: Cardioblate™ CryoFlex™ Surgical Ablation Probes, Console, and Accessories # System Overview The Medtronic Cardioblate™ CryoFlex™ Surgical Ablation System is an argon based cryosurgical system intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate™ CryoFlex™ 7 cm, 10 cm, and 10-S probes, the Cardioblate™ CryoFlex™ clamp, and the Cardioblate™ CryoFlex™ Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis. The system utilizes an argon-based cryogen for fast, controlled freezing. # Cardioblate™ CryoFlex™ Surgical Ablation Probes The Cardioblate™ CryoFlex™ clamp and surgical ablation probes are single use, disposable cryoablation probes that are designed for use with the Cardioblate™ CryoFlex™ surgical ablation system. The probes include integrated thermocouple for monitoring temperature at the ablation segment. The clamp and surgical ablation probes are supplied sterile and cannot be reused or re-sterilized. The probe's shaft and ablation segment are made of specially heat-treated stainless steel. The shaft is designed with enough malleability that the surgeon can shape it, while still maintaining enough stiffness to ensure its stability in the operating field. The malleable ablation segment has a bellows configuration, which provides kink resistance and thermal performance. A moveable insulative sleeve on the shaft allows the surgeon to vary the size of the ablation zone. {5}------------------------------------------------ The probe has a 3-m (10 ft) connection hose which is to be handed out of the sterile field to an operating room nurse for connection to the control panel. | Indications for Use | | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 60SF2, 60SF3, 60SF7: | The Cardioblate CryoFlex surgical ablation system is intended for<br>minimally invasive cardiac surgical procedures, including the<br>treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm,<br>10 cm, and 10-S probes and the Surgical Ablation Console freeze<br>target tissue and block the electrical conduction pathways by<br>creating an inflammatory response and cryonecrosis. | | 60CM1: | The Cardioblate CryoFlex Surgical Ablation System is intended for<br>minimally invasive cardiac surgical procedures, including the<br>treatment of cardiac arrhythmias. The Cardioblate CryoFlex Clamp<br>and Surgical Ablation Probe and the Surgical Ablation Console<br>freeze target tissue and block the electrical conduction pathways by<br>creating an inflammatory response and cryonecrosis | ### Contraindications The Cardioblate™ CryoFlex™ surgical ablation probe is not designed for use inside a beating heart. ### Comparison to Predicate Devices The Medtronic Cardioblate™ CryoFlex™ Surgical Ablation System is substantially equivalent to the predicate surgical ablation system (K123733). A comparison of the proposed modified devices to the currently marketed predicate devices indicates the following similarities: - Same intended use ● - Same technological characteristics ● - Same shelf life ● - Same operating principle ● - Substantially equivalent material ● - The connector of the Cardioblate™ CryoFlex™ Surgical Ablation Probe is changing; therefore, new components are necessary for the updated design - Substantially equivalent design features ● - The internal design feature of the probe is not changing (the electrical contacts are still in physical contact with the console); only the external design is changing, the new design allows for easier one-handed attachment and removal of the probe to the console connector {6}------------------------------------------------ | Device Characteristics and<br>Features | Predicate<br>(K123733) | This Submission<br>(K191526) | Substantial<br>Equivalence | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------|----------------------------| | | Cardioblate™ CryoFlex™<br>Disposable Probes | Cardioblate™ CryoFlex™<br>Disposable Probes | | | Therapy Delivery | | | | | Facilitates pneumatic connection<br>to the console | ✓ | ✓ | Yes | | Secures the electrical connection<br>of the probe's thermocouple to the<br>console | ✓ | ✓ | Yes | | Argon gas is transferred from the<br>console through the pneumatic<br>stem in the connector and into the<br>probe to provide a cooling effect | ✓ | ✓ | Yes | | User Interface | | | | | Same console connection port | ✓ | ✓ | Yes | | Connection to console | ✓ | ✓ | Yes | | Pneumatic stem that locks into a<br>female quick disconnect fitting on<br>the console | ✓ | ✓ | Yes | | Connectors are pushed onto the<br>console to form the connection and<br>a pin must be removed prior to use | ✓ | ✓ | Yes | | External Pull Pin | ✓ | ✓ | Yes | | Connector is removed by<br>achieving both hands by<br>depressing the "clips" with one<br>hand and retracting the console's<br>female quick disconnect fitting<br>with the other hand | ✓ | --- | Yes | | Connector is removed by using a<br>single hand by depressing a button<br>that automatically rises during<br>connection | --- | ✓ | Yes | | Connector | Image: blue connector | Image: blue connector | Yes | # Table 5-2: Device Characteristics and Features Summary ## Conclusion In conclusion, the information included in this submission demonstrates that the Cardioblate™ CryoFlex™ surgical ablation probe, with the updated connector to facilitate gas connection and disconnection to the console is substantially equivalent to the legally marketed predicate devices.