NaviNetics D1 Stereotactic System

{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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. June 17, 2021 NaviNetics, Inc Patrick Gora V.P. Regulatory Affairs and Quality 206 S Broadway, Suite 700 Rochester, Minnesota 55904 Re: K210700 Trade/Device Name: NaviNetics D1 Stereotactic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 17, 2021 Received: May 18, 2021 #### Dear Patrick Gora: 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. 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Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210700 Device Name NaviNetics D1 Stereotactic System #### Indications for Use (Describe) The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </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}------------------------------------------------ # NaviNetics D1 Stereotactic System 510(k) Summary ### Date Prepared: June 17, 2021 #### Submitter's Name / Contact Person | Manufacturer | Contact Person | |----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | NaviNetics, Inc.<br>206 South Broadway, Suite 700<br>Rochester, MN 55904<br>Tel 507.361.3570 | Patrick Gora<br>VP Regulatory Affairs and Quality<br>gora.patrick@navinetics.com<br>507.361.3570 | #### General Information | Device Trade Name | NaviNetics D1 Stereotactic System | |---------------------|-------------------------------------------------------------------------------| | Common / Usual Name | Stereotaxic Instrument | | Classification Name | Stereotaxic Instrument, 21 CFR 882.4560 Class II | | Product Code | HAW | | Predicate Device(s) | K190887 – Leksell® Vantage™ Stereotactic System<br>(clearance August 1, 2019) | #### Device Description The NaviNetics D1 Stereotactic System is a device used for minimally invasive neurosurgical procedures. During image acquisition and treatment, the system's Skull Anchor Key ("Key") achieves reduced weight and patient invasiveness versus common stereotactic head frames that travel extensively around the patient's head and are restrictive to the airway access when positioned. The system consists of a Key that is affixed to the patient's skull with three titanium stand-off pins and four self-tapping bone anchor screws. The Key serves as the common attachment platform for the D1 Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible interventional instruments rely on the active working length of 150 mm (arc radius) with stops and guide holders to ensure proper trajectory angle to the brain target. The two degrees of freedom of the arc-quadrant, the Arc and Collar angles, can be manipulated allowing the device to approach the target from a multitude of directions. Linear adjustments can move the arc-quadrant, medial/lateral (X), anterior/posterior (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of the third-party planning software provides the values of the target coordinates (XT, YT, ZT) and the surgical trajectory (CT, AT) which dictate the settings of the D1 stereotactic device. #### Intended Use The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections and minimal invasive tumor treatments. {4}------------------------------------------------ ## Summary of Technological Characteristics Compared to Predicate The NaviNetics D1 Stereotactic System has equivalent technological characteristics as its predicate device, Leksell® Vantage™ Stereotactic System. It utilizes the same coordinate system and center-ofarc principle which allows guidance of compatible interventional instruments at any trajectory angle to the brain target. #### Substantial Equivalence The NaviNetics D1 Stereotactic System has equivalent technology, features, and characteristics as the predicate device. K190887, the Leksell® Vantage™ Stereotactic System. The table below provides a comparison of technological characteristics between the NaviNetics D1 Stereotactic System (subject device) and the Leksell® Vantage™ Stereotactic System (predicate device). | | Subject Device | Predicate Device | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | NaviNetics D1 Stereotactic System | K190887<br>Leksell® Vantage™ Stereotactic System | | Regulation Number | 21 CFR 882.4560 | 21 CFR 882.4560 | | Product Code | HAW | HAW | | Product Class | II | II | | Indications for use | The Intended Purpose of the<br>NaviNetics D1 Stereotactic System is<br>intended to be used for target<br>localization and fixation of the patient<br>head in a coordinate system in order<br>to perform stereotactic neurosurgical<br>procedures, for example; deep brain<br>stimulation, lesioning, biopsies,<br>targeted injections, aspirations and<br>minimal invasive tumor treatments. | The Intended Purpose of Leksell®<br>Vantage™ Stereotactic System is<br>intended to be used for target<br>localization and fixation of the patient<br>head in a coordinate system in order<br>to perform stereotactic neurosurgical<br>procedures, for example; deep brain<br>stimulation, lesioning, biopsies,<br>targeted injections, aspirations and<br>minimal invasive tumor treatments. | | Description | The NaviNetics D1 Stereotactic<br>System is included in the arc<br>centered category of stereotactic<br>frames which provide an arc<br>quadrant and a 3D slide to move the<br>arc quadrant about the head. A<br>minimally intrusive Skull Anchor Key<br>attaches to the patient's skull with the<br>use of four (4) skull anchor screws.<br>used to affix the arc centered device<br>to the skull of the patient. The D1<br>Stereotactic device mounts to the<br>Skull Anchor Key allowing it to<br>pinpoint intracranial targets and<br>guide neurosurgical instruments to<br>these brain targets. | The Leksell® Vantage™ Stereotactic<br>System is a device used for<br>minimally invasive neurosurgical<br>procedures. It enables coordinate<br>referencing and fixation of the<br>patient's skull and brain during image<br>acquisition and treatment. The<br>coordinate referencing enables target<br>localization and accurate stereotactic<br>treatment of brain targets.<br>The system consists of a head frame<br>that is fixated to the patient skull by<br>minimally invasive disposable fixation<br>pins and a number of accessories for<br>frame application and imaging as<br>well as a stereotactic arc and | | | Subject Device | Predicate Device | | | | operating room accessories for the<br>sterile surgical procedure. | | Coordinate System | NaviNetics Coordinate System using<br>Cartesian coordinates. The X axis<br>runs left/right, the Y axis runs<br>anterior/posterior and the Z axis runs<br>inferior posterior. The origin of the<br>coordinate system is located to the<br>right, posteriorly, and superiorly to<br>the patient's head. The center of the<br>work envelope, located near the<br>center of the cranial cavity, has a<br>coordinate of (100,100,100) | Leksell Coordinate System using<br>Cartesian coordinates. The X axis<br>runs left/right, the Y axis runs<br>anterior/posterior and the Z axis runs<br>inferior posterior. The origin of the<br>coordinate system is located to the<br>right, posteriorly, and superiorly to<br>the patient's head. The center of the<br>work envelope, located near the<br>center of the cranial cavity, has a<br>coordinate of (100,100,100) | | Fixation | Minimally intrusive Skull Anchor Key<br>with three fixation pins and four self-<br>tapping screws. | Head frame attached to patient skull<br>with four fixation pins driven into the<br>outer table of the skull. | | Fixation Pins/Screws | Single use titanium pins and self-<br>tapping titanium screws that secure<br>the minimally intrusive Skull Anchor<br>Key to the patient skull. | Single use fixation pins and inserts<br>that secure the Vantage head frame<br>to the patient skull using Leksell<br>Vantage keys. | | Principles of Use | The NaviNetics D1 Stereotactic<br>System uses arc center stereotactic<br>principle in which the two angular<br>degrees of freedom rotate<br>orthogonally to each other about a<br>single point called the "focus. A 3D<br>slide alters the position of the focus<br>within the brain. The D1 System has<br>an arc radius of 150mm. This is<br>40mm less that the predicate which<br>helps reduce the mechanical error by<br>reducing the length of instruments<br>being projected from the arc.<br>The D1 Skull Anchor Key<br>immobilizes the patient within the<br>stereotactic coordinate system called<br>the work envelope. The Skull Anchor<br>Key provides the common<br>attachment site for all components of<br>the D1 System.<br>comprises a Skull Anchor key, a<br>3D slide, and arc is target centered defines the surgical targets as<br>Cartesian (x,y,z) coordinates<br>within the work envelope of the<br>system | Leksell® Vantage™ Stereotactic<br>System is Center of the arc principle<br>stereotactic device in which the two<br>angular degrees of freedom rotate<br>orthogonally to each other about a<br>single point called the "focus. The<br>working radius of the arc is 190mm.<br>The head frame of the Leksell<br>system immobilizes the patient within<br>the stereotactic coordinate system<br>called the work envelope. The<br>headframe provides the common<br>attachment site for all components of<br>the Leksell system. Cartesian<br>coordinates applied to the brain of<br>the patient by the use of a head<br>frame fixated to the skull. comprises a headframe, a 3D<br>slide and arc is target centered defines the surgical targets as<br>Cartesian (x,y,z) coordinates<br>within the work envelope of the<br>system utilizes fiducial markers on CT<br>and/or MRI images to locate the | | | Subject Device | Predicate Device | | | utilizes fiducial markers on CT and/or MRI images to locate the images within the stereotactic coordinate system. provides support and accessories for surgical instruments to the target | images within the stereotactic coordinate system. provides support and accessories for surgical instruments to the target | | Materials | Invasive components: | Invasive components: | | | Titanium | PEEK with Aluminum tip | | | Skull Anchor Key:<br>Delrin®<br>Arc:<br>Aluminum | Head Frame:<br>Glass fiber reinforced Epoxy<br>Arc:<br>Aluminum | | Accuracy | 0.9mm (mechanical) | 0.9mm (mechanical) | | Accessories | Neurosurgical instruments designed<br>for a 150 mm working length | Neurosurgical instruments designed<br>for a 190 mm working length | {5}------------------------------------------------ {6}------------------------------------------------ ## Summary of Non-Clinical Performance Data | Test | Method/Summary | Results | |----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Accuracy | • Mechanical: assembly to position<br>known stereotactic test points at<br>the focus of the arc-quadrant | All test cases were shown acceptable<br>for expected outcome. Overall<br>system accuracy is equivalent to the<br>predicate device. | | | • Systemic Image: Accuracy of<br>selecting an image target on CT or<br>MRI and positioning the selected<br>point at the focus of the arc-<br>quadrant | | | | • Systemic Surgical: Accuracy of<br>placing a DBS lead, including<br>implantation technique, as verified<br>by post-implant CT scan | | | | • Handling and process step<br>accuracy (e.g., repeated mounting<br>of parts to each other and scale<br>setting accuracy) during<br>mechanical and repeatability<br>accuracy testing | | | | Skull anchor key design renders<br>displacement due to head weight as<br>inconsequential | | {7}------------------------------------------------ | Test | Method/Summary | Results | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | MR Safety Testing | The device was subjected to and<br>complies with all FDA guidance for<br>MR environment safety and<br>compatibility, including the following<br>safety standards: | Substantial equivalence to the<br>predicate device is demonstrated<br>through passing results to FDA<br>guidance and these consensus<br>standards. | | | • ASTM F2052<br>• ASTM F2119<br>• ASTM F2182<br>• ASTM F2213<br>• ASTM F2503 | | | Cleaning- reusable<br>parts | Validated for manual cleaning and<br>cleaning with a washer-disinfector<br>Manual and washer/disinfector<br>cleaning methods were validated<br>using instructions in the IFU using<br>artificial blood | Parts passed final validation and met<br>all pre-determined acceptance<br>criteria while demonstrating predicate<br>device substantial evidence. | | Sterilization- reusable<br>parts | Performed on the subject device,<br>reusable parts were validated for<br>steam sterilization. The validation<br>was used to show the device can<br>obtain a sterility assurance level<br>(SAL) of at least 10-6 when steam<br>sterilized at 132°C (270°F) for 4<br>minutes | Parts passed final validation and met<br>all pre-determined acceptance<br>criteria while demonstrating predicate<br>device substantial evidence. | | Biocompatibility | Patient-contacting materials were<br>evaluated for biocompatibility to the<br>following tests: ISO10993-1,<br>ISO10993-5, ISO10993-10 and<br>ISO10993-11 | Parts passed final validation and met<br>all pre-determined acceptance<br>criteria while demonstrating predicate<br>device substantial evidence. | #### Summary of Clinical Performance Data Based on product classification and predicate devices, clinical testing is not required to demonstrate substantial equivalence. ### Conclusion The performance testing presented demonstrates the NaviNetics D1 Stereotactic System is substantially equivalent with the predicate device, the Leksell® Vantage™ Stereotactic System cleared under K190887.