EnVisio Navigation Sytem

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March 22, 2019 Elucent Medical, Inc Ms. Debra Kridner Vice President of Regulatory and Quality 7480 Flying Cloud Drive, Suite 110 Eden Prairie, Minnesota 55344 Re: K183400 Trade/Device Name: EnVisio Navigation System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: February 20, 2019 Received: February 22, 2019 Dear Ms. Kridner: 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. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/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, Digitally signed by David Krause David Krause -S Date: 2019.03.22 14:41:33 -04'00' 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) K183400 Device Name EnVisio™ Navigation System #### Indications for Use (Describe) The SmartClip Soft Tissue Marker is intended to be placed percutaneously in soft tissue to permanently mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (EnVisio Navigation System); the SmartClip is located and surgically removed with the target tissue. The EnVisio Navigation System is intended only for the non-imaging detection and localization (by navigation) of the SmartClip that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> <path d="M2,2 L13,13 M13,2 L2,13" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:white;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> </svg> </span> 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}------------------------------------------------ #### 510(k) Summary | Date Prepared: | March 20, 2019 | |-------------------------|---------------------------------------------------------------------------------------------| | 1. APPLICANT | Elucent Medical, Inc.<br>7480 Flying Cloud Drive, Suite 110<br>Eden Prairie, MN 55344 USA | | Official Correspondent: | Debra Kridner<br>Tel: (844) 417 1700 / Fax: (952) 314-7105<br>debra.kridner@elucent.com | | 2. DEVICE | | | Trade Name: | EnVisio™ Navigation System | | 510(k) | K183400 | | Common Name: | Implanted, Radiographic, Tissue Marker | | Classification Number: | 21 CFR 878.4300 | | Classification Name: | Implantable Clip | | Device Class: | Class II | | Product Code: | NEU | | Review Panel: | General and Plastic Surgery | ## 3. PREDICATE DEVICE (PRIMARY) | Trade Name: | Cianna Medical SAVI Scout Reflector and SAVI Scout System | |------------------------|-----------------------------------------------------------| | 510(k) | K181007 | | Common Name: | Implanted, Radiographic, Tissue Marker | | Classification Number: | 21 CFR 878.4300 | | Classification Name: | Implantable Clip | | Device Class: | Class II | | Product Code: | NEU | | Review Panel: | General and Plastic Surgery | ### 4. DEVICE DESCRIPTION (for the device subject to this 510(k) notification) The EnVisio™ Navigation System is a medical device that detects the presence of the SmartClip™ Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery. The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClips™ within the surgeon's field of view {4}------------------------------------------------ during the procedure. The EnVisio™ Navigation System will be utilized in an operating room where surgical excision of soft tissue is performed. The EnVisio™ system can detect and provide real-time three-dimensional navigation for up to three separate SmartClips™ each programmed to emit a unique electromagnetic signature. The EnVisio™ Navigation System equipment components are the Console, Heads Up Display, Patient Pad and Foot Pedal. The EnVisio™ Navigation System Navigator and Calibration Disk are sterile, non-patient contacting single use devices which are available separately. ### 5. INDICATIONS FOR USE (for the Device Subject to this 510(k) Notification) The SmartClip™ Soft Tissue Marker is intended to be placed percutaneously in soft tissue to permanently mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (EnVisio™ Navigation System) the SmartClip™ is located and surgically removed with the target tissue. The EnVisio™ Navigation System is intended only for the non-imaging detection and localization (by navigation) of the SmartClip™ that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal. | Comparison of<br>Subject Device<br>to Predicate<br>Device | Subject Device<br>EnVisio™ Navigation System<br>(K183400) | Predicate Device:<br>Cianna Medical SAVI Scout Reflector<br>and SAVI Scout System (K181007) | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The SmartClip™ Soft Tissue Marker is<br>intended to be placed percutaneously in<br>soft tissue to permanently mark a biopsy<br>site or a soft tissue site intended for<br>surgical removal. Using imaging guidance<br>(such as ultrasound, MRI, or radiography)<br>or aided by non-imaging guidance<br>(EnVisio™ Navigation System) the<br>SmartClip™ is located and surgically<br>removed with the target tissue. The<br>EnVisio™ Navigation System is intended<br>only for the non-imaging detection and<br>localization (by navigation) of the<br>SmartClip™ that has been implanted in a<br>soft tissue biopsy site or a soft tissue site<br>intended for surgical removal. | The SAVI Scout Reflector is intended to be<br>placed percutaneously in soft tissue to mark<br>(>30 days) a biopsy site or a soft tissue site<br>intended for surgical removal. Using<br>imaging guidance (such as ultrasound, MRI,<br>or radiography) or aided by non-imaging<br>guidance (SAVI Scout System) the SAVI<br>Scout Reflector is located and surgically<br>removed with the target tissue. The SAVI<br>Scout System is intended only for the non-<br>imaging detection and localization of the<br>SAVI Scout Reflector that has been<br>implanted in a soft tissue biopsy site or a soft<br>tissue site intended for surgical removal. | | Intended Use | Detect and Navigate to the implanted<br>SmartClip - Soft Tissue Marker | Detect and Navigate to the implanted<br>Reflector - Soft Tissue Marker | | Use<br>Environment | Intra-operative, guided surgical procedure | Intra-operative, guided surgical procedure | | Anatomical Site | Soft Tissue | Soft Tissue | | Patient<br>Population | Adult | Adult | | Comparison of Subject<br>Device to Predicate<br>Device | Subject Device<br>EnVisio™ Navigation System<br>(K183400) | Predicate Device:<br>Cianna Medical SAVI Scout<br>Reflector and SAVI Scout System<br>(K181007) | | Manufacturer | Elucent Medical, Inc. | Cianna Medical, Inc. | | Device Name | EnVisio™ Navigation System | SAVI Scout Reflector and Scout System | | 510(k) Number | K183400 | K181007 | | Principles of Operation | Electromagnetic wave technology to<br>detect and navigate to the soft tissue<br>marker | Electromagnetic wave technology to<br>detect and navigate to the soft tissue<br>marker | | Intraoperative<br>Localization Energy | Electromagnetic, passive marker | Electromagnetic, passive marker | | Audible Location<br>Indication | Yes | Yes | | Visual Location<br>Indication | Yes | Yes | | Visualization<br>Compatibility | Using imaging guidance (such as<br>ultrasound, MRI, or radiography) or<br>aided by non-imaging guidance<br>(EnVisio Navigation System) | Using imaging guidance (such as<br>ultrasound, MRI, or radiography) or<br>aided by non-imaging guidance (SAVI<br>Scout System) | | System Components<br>(Equipment) | Console<br>• Heads-Up Display<br>• Patient Pad<br>• Foot Pedal (optional)<br>• Cart | • Console | | System Components<br>(Sterile) | Navigator<br>• Calibration Disk | • Hand piece<br>• Sterile Sheath applied to<br>nonsterile Handpiece | | Sterilization Method | Ethylene oxide | Ethylene oxide | | Implanted Soft Tissue<br>Marker | Yes - SmartClip | Yes - Reflector | | Biocompatibility | Not applicable for Navigator and<br>Calibration Disk - no direct or<br>indirect patient contact | Yes -Handpiece has direct patient<br>contact | ### Indications for Use Comparison: {5}------------------------------------------------ ## 6. TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS COMPARISON ### Performance Testing: Performance testing was conducted to evaluate and characterize the performance of the EnVisio Navigation System. The following performance testing was conducted on the EnVisio Navigation System to support a determination of substantial equivalence to the predicate device. - System Design Verification - Navigation Performance Verification ● - Navigation Performance Validation ● {6}------------------------------------------------ - EMC/Safety Testing ● - Packaging/Shelf Life ● - . Sterilization Validation ### Conclusion: The EnVisio Navigation System met all specified criteria and did not raise new safety or performance questions. ### Basis for Determination of Substantial Equivalence: The Indications for Use, Intended Use, Fundamental Scientific Technology and Principles of Operation for the EnVisio Navigation System are the same as those described for the predicate device. In summary, the EnVisio Navigation System has the following similarities to the predicate device which has previously received 510(k) clearance: - Has substantially equivalent indications for use ● - Has substantially equivalent intended use ● - Used in substantially equivalent anatomical sites ● - Uses substantially equivalent technological characteristics ● - Uses substantially equivalent principles of operation - Uses substantially equivalent sterilization methodology ● Therefore, the conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device predicate. The EnVisio Navigation System is substantially equivalent to the predicate device.