Emprint SX Ablation Platform with Thermosphere Technology

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency responsible for regulating food and drug products in the United States. December 17, 2020 Medtronic Inc. Liron Bar-Yaakov Senior Manager of Regulatory Affairs 5920 Longbow Dr. Boulder, Colorado 80301 Re: K203303 Trade/Device Name: Emprint SX Ablation Platform with Thermosphere Technology Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NEY Dated: November 4, 2020 Received: November 9, 2020 Dear Liron Bar-Yaakov: 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. 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. 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Sincerely, 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K203303 Device Name The Emprint™ SX Ablation Platform with Thermosphere™ Technology ### Indications for Use (Describe) The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures. The system's optional 3D navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted trajectory on a computer monitor. The size and shape of the predicted zone relative to the position of the antenna are displayed on the enhanced ultrasound image. Type of Use (Select one or both, as applicable) | <span style="font-size:10pt;"> <svg height="10" width="10"> <rect height="10" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="0" y2="10"></line> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="10" y2="0"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt;"> <svg height="10" width="10"> <rect height="10" style="fill:white;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ ### K203303 Covidien LLC Special 510(k) Submission Emprint™ SX Ablation Platform with Thermosphere™ Technology Emprint™ SX 1.1.1 Software Update ## 510(k) Summary #### l. Submitter Medtronic Inc 5920 Longbow Dr. Boulder, CO 80301 Contact: Liron Bar-Yaakov Senior Manager of Regulatory Affairs 5920 Longbow Dr Boulder, CO 80301 Telephone: (508) 261-8000 Email: Liron.Baryaakov@medtronic.com Date of Summary Preparation: November 05, 2020 #### ll. Devices ### Table 5.1 Devices: | Device Trade Name | Emprint™ SX Ablation Platform with Thermosphere™ Technology | |---------------------|-------------------------------------------------------------| | Device Common Name | Microwave Ablation System | | Classification Name | System, Ablation, Microwave and Accessories | | Regulatory Class | II | | Product Code | NEY | #### III. Predicate Devices This Special 510(k) submission describes enhancements to the software of the previously cleared Emprint™ SX Ablation Platform with Thermosphere™ Technology. ### Table 5.2 Predicate Devices | Device Name | Classification Name and Class | 510(k) Clearance No | |-----------------------------------------------------|----------------------------------------------------------|---------------------| | Emprint™ SX Ablation Platform with<br>Thermosphere™ | System, Ablation, Microwave<br>and Accessories; Class II | K171358 | #### IV. Device Description The Emprint™ SX Ablation Platform with Thermosphere™ Technology is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined tissue volume. The Emprint™ SX Ablation Platform utilizes a 2450 MHz 100W generator to deliver power to a single microwave ablation antenna. The platform is software-controlled and a touchscreen Graphical User Interface is used to select the desired ablation time (up to 10 minutes) and power (5 to 100W) settings. Using an optional temperature probe, the ablation platform can be set to monitor the temperature of a desired target and to automatically turn the generator off, when the target reaches a pre-set temperature. The ablation platform uses circulating, room-temperature, normal saline to cool the non-radiating portion of the antenna shaft and to provide a consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system. {4}------------------------------------------------ Covidien LLC Special 510(k) Submission Emprint™ SX Ablation Platform with Thermosphere™ Technology Emprint™ SX 1.1.1 Software Update Using an optional/selectable navigation feature, the Emprint™ SX Ablation Platform assists physicians in the accurate placement of the trackable Emprint™ SX Navigation Antenna into a target anatomical structure by overlaying the image of the antenna and its trajectory onto an ultrasound image in real time. Sensors are attached to platform-compatible, open and laparoscopic ultrasound probes and to the platform's trackable antenna. These sensors detect fluctuations in an electromagnetic field emitted from the system's Table Top Field Generator (TTFG). The TTFG is placed underneath the patient and transmits positional information that is processed by the system's navigation hardware and interpreted by its software. The platform's software allows the surgeon to see a representation of the ablation zone on an auxiliary display and the system's operator to control the ablation system via the touchscreen interface. | Table 5.3 EmprintTM SX Ablation Platform components: | | |-------------------------------------------------------------------------------|-------------| | Component Name | Catalog No. | | EmprintTM SX Ablation Platform with ThermosphereTM Technology | CASYS100 | | EmprintTM SX Ultrasound Surgical Navigation (software) Application | CAUS1SN | | EmprintTM Ablation Reusable Cable | CA190RC1 | | EmprintTM SX Table Top Field Generator | CAFG1 | | EmprintTM SX Table Top Field Generator Cart | CAFGCART1 | | EmprintTM SX Field Generator Spacers (Bed Pads) | CAFGSP1 | | EmprintTM SX Short Navigation Antenna with ThermosphereTM Technology, 15cm | CA15L2N | | EmprintTM SX Standard Navigation Antenna with ThermosphereTM Technology, 20cm | CA20L2N | | EmprintTM SX Long Navigation Antenna with ThermosphereTM Technology, 30cm | CA30L3N | | EmprintTM SX Open Ultrasound Tracking Sensor | CABK8816 | | EmprintTM SX Open Ultrasound Tracking Sensor | CAAL9132 | | EmprintTM SX Laparoscopic Ultrasound Tracking Sensor | CAAL9150L | | EmprintTM SX Laparoscopic Ultrasound Tracking Sensor | CABK8666L | | Remote Temperature Probe | RTP20 | | Ablation Footswitch | RFASW | ### Table 5.3 Emprint™ SX Ablation Platform components: #### V. Description of Changes Modifications have been made only to the software of the Emprint™ SX Ablation Platform with Thermosphere™ Technology. Enhancements were made to the Software to allow the user to clear a general system error without power-cycling the system in order to deliver ablation therapy, mitigating any risk of delay in procedure. These software changes, do not affect the Emprint™ SX Ablation Platform with Thermosphere™ Technology indication for use, essential function, performance, or underlying principles of operation. {5}------------------------------------------------ Covidien LLC Special 510(k) Submission Emprint™ SX Ablation Platform with Thermosphere™ Technology Emprint™ SX 1.1.1 Software Update #### VI. Indications for use The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures. The system's optional, 3-D navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted trajectory on a computer monitor. The size and shape of the predicted ablation zone relative to the position of the antenna is displayed on the enhanced ultrasound image. #### VII. Comparison of technological characteristics with the predicate device Emprint™ SX Ablation Platform with Thermosphere™ Technology current software (predicate device) and the updated software update share the same underlying technology. Both devices are used to deliver microwave energy to soft tissue in a highly controlled way. Signal frequency, power and exposure time are controlled by the system's 2450 MHz generator. The design of the radiating portion of the accessory and continuous cooling of the accessory during the ablation procedure determines the shape (near spherical) and size of the resulting ablations. The enhancement to CAUS1SN software allows the user to avoid power cycling the system removing a delay to the procedure due to the receipt of a general system error. This is completed through a feature update to the Emprint API code, responsible for processing messages from the generator. There are no effects on any other portion of the software architecture, or on the systems underlying technological characteristics. #### VIII. Performance Data Comprehensive SW Verification testing was performed by Medtronic in support of the proposed change. No additional pre-clinical or clinical data is required to support the substantial equivalence determination for this software update. #### IX. Conclusions The Modified Emprint™ SX Ablation Platform with Thermosphere™ Technology software (CAUS1SN) update is nearly identical to the predicate Emprint™ SX Ablation Platform with Thermosphere™ Technology software. The subject and predicate devices share intended use, technological characteristics, and meet identical performance requirements. The results of comprehensive verification testing raised no new questions of safety or effectiveness. The current Emprint™ SX Ablation Platform with Thermosphere™ Technology software version, and the Emprint™ SX Ablation Platform with Thermosphere™ Technology new software version are substantially equivalent.