Spine & Trauma Navigation

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June 11, 2019 Brainlab AG Julia Mehltretter Manager Product Surveillance Olof-Palme-Str. 9 Munich, 81829 De Re: K191285 Trade/Device Name: Spine & Trauma Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 10, 2019 Received: May 13, 2019 ## Dear Julia Mehltretter: 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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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). 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Sincerely, For; Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K191285 #### Device Name Spine & Trauma Navigation System #### Indications for Use (Describe) Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. Spine & Trauma Navigation System enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. 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}------------------------------------------------ ## K191285 # SPECIAL 510(K) CORRECTIVE ACTION BEING EFFECTED SUMMARY ## SPINE & TRAUMA NAVIGATION SYSTEM IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92 | Manufacturer: | Brainlab AG<br>Olof-Palme-Str. 9<br>81829 Munich<br>Germany | |--------------------------------------|----------------------------------------------------------------| | | Phone: +49 89 99 15 68 0<br>Fax: +49 89 99 15 68 5033 | | Submitter: | Rainer Birkenbach | | Contact person: | Julia Mehltretter | | Summary date: | 6/11/2019 | | Device: | Spine & Trauma Navigation System | | Trade name: | Spine & Trauma 3D | | Common Name: | Brainlab Image Guided Surgery System / Instrument, Stereotaxic | | Device Classification<br>Regulation: | 21 CFR 882.4560 | | Classification Name: | Orthopedic Stereotaxic Instrument | | Regulatory Class: | Class II | | Product Code: | OLO | | Predicate Device: | VectorVision Fluoro 3D (K070106) | #### INTENDED USE: 1 Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative 2D or 3D image data. Spine & Trauma Navigation System enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. {4}------------------------------------------------ #### DEVICE DESCRIPTION: 2 This device is an image guided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use 3D image data based on CT, MR or XT. The Software supports the surgeon in clinical procedures by displaying tracked instruments in patient image data. ### Operator profile The operator's profile for this devices are Neuro / Ortho / Spine / Trauma surgeons or their assistants having a 3D image acquisition system (such as CT or 3D C-arm) in combination with a Brainlab navigation system. #### Patient population The patient population includes any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction). #### Intended use environment The application shall be used in an operating room / suite. #### Operating principle Infrared passive marker based tracking as provided by the optical tracking camera unit of the navigation station is used to determine the instrument's and patient's position between the patient and the reference attached to the patient is realized with a registration (manually or automatic). #### Primary operating functions | Primary Operating Function | Frequently<br>used<br>function | Safety<br>related<br>function | |--------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------------------| | Set up system, start software | ✓ | | | Loading of already (automatically or manually) registered pre-/ intra-<br>operatively acquired CT or Fluoro3D data | ✓ | ✓ | | Registration of intra-operatively acquired Fluoro 3D data | ✓ | ✓ | | Navigate on fused pre- / or intra-operatively acquired 3D spinal data<br>(CT/ XT fused to MR/ XT/ CT/ PET) | | ✓ | | Navigating CT/ XT and fused MR/XT/ CT/PET data with pre-<br>planned content (objects, screws, etc.) | | ✓ | | General navigation in 3D datasets | ✓ | | | Navigation of manually calibrated instruments | ✓ | ✓ | | Navigation of pre-calibrated instruments | ✓ | ✓ | | Verification of registration accuracy | ✓ | ✓ | | Verification of instrument accuracy | ✓ | ✓ | | Store data, shut down system, store system | ✓ | ✓ | {5}------------------------------------------------ #### Use scenarios The system is placed in a way that the surgeon can easily watch the screen(s) and interact with the system during the procedure, but sterility is not compromised. The camera is positioned in a way that it has an unobstructed view on the surgical field. The patient is positioned and draped in the usual manner, taking into account that the reference geomety has to be attached to the relevant anatomical structure in a way that it is not disturbing the latter workflow. The surgical approach is performed. A reference arrav is attached to the relevant bony structure using conventional surgical techniques (either under sight or minimally invasive). The 3D dataset is either acquired or loaded and subsequently registered. After the scan has been transmitted to the navigation system or the registration computation has been performed, the surgeon is asked to verify the success of the registration with a general instrument or a dedicated pointer. After successful verification the surgeon is able to access pre-planned objects, to plan or re-plan screws / trajectories and to visualize manually or pre-calibrated surgical instruments. #### Intended part of the body or type of tissue applied to or interacted with This system has different components, whereas most of them are software. Therefore, only instruments may get in contact with a patient, some instruments are included to perform the surgery. All Instruments are used temporarily for orientation within the situs or for preparations to be able to implant 3rd party devices, which are not part of this system. Such instruments can be used at rigid bony structures, such as a long bone or vertebra, where the user wants to use this navigation software according to the indications for use. #### SUBSTANTIAL EQUIVALENCE ന The Spine & Trauma Navigation System has similar functionality, intended use, technological characteristics, and typical users as the predicate device. The proposed software modification was performed to correct a display issue within the Spine & Trauma Navigation System software that can occur when a user changes navigation workflows. The issue was caused by an erroneous orientation of the anatomical slices that were displayed together with a projected instrument representation within axial and coronal/sagittal views of the image data, while the instrument tip was permanently correctly displayed. The proposed software modification required a local software consisting of 14 lines of code and is restricted to two source files. Since the programming structure for the current display logic was already intended in the detailed design, the software correction did not require any change to the existing software architecture or to the unit tests. There was no change of intended use, technological characteristics or typical users. {6}------------------------------------------------ #### VERIFICATION/VALIDATION SUMMARY ব ### Performance Testing The following verification methods were successfully applied: - Interactive tests according to verification documents related to changed software parts (software . code change verification) - . Interactive tests according to verification documents related to unchanged software parts (regression tests) - Code review of the software change - Software memory leakage tests using VLD (Visual Leak Detector) - . Static code analysis (Lint) for changed software parts Worst case scenarios were considered. New verification activities were performed after extension of existing test cases. They cover switching between different applications within one navigation session and now additionally comprise the missing test scenario for the display issue which caused the software modification request. In order to prevent software changes to have impact on non-changed design parts, regression tests were included to the test protocols. Design verification testing that was performed to support modifications to the Spine & Trauma Navigation System software met all design and performance requirements. #### CONCLUSION 5 The modified device is substantially equivalent to the currently marketed Spine & Trauma Navigation System based upon design verification test results and the indications for use.