SeaSpine Navigation System

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May 11, 2018 SeaSpine Orthopedics Corporation Gina Flores Sr. Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008 Re: K172517 Trade/Device Name: SeaSpine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 5, 2018 Received: April 6, 2018 Dear Gina Flores: We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-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, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172517 Device Name SeaSpine Navigation System #### Indications for Use (Describe) The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</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 ## K172517 ## Contact Details | Applicant Name: | SeaSpine Orthopedics Corporation | |------------------------------------------|--------------------------------------------------------------------| | Address:<br>Phone number:<br>Fax number: | 5770 Armada Drive, Carlsbad CA<br>(760) 216-5136<br>(760) 683-6874 | | Contact person:<br>Email address: | Gina Flores, Sr. Regulatory Specialist<br>gina.flores@seaspine.com | | Date Prepared: | April 5, 2018 | | Device Name: | | | Trade Name: | SeaSpine Navigation System | | Common Name: | Orthopedic Stereotaxic Instrument | | Classification Name: | Stereotaxic Instrument | | Class: | II | | Product Code: | OLO | ## Legally Marketed Predicate Devices | 510(k) | Product Code | Trade Name | Manufacturer | |-----------------------------|--------------|------------------------------------------------------|--------------------------------------| | Number | | | | | PRIMARY PREDICATE Device | | | | | K124004<br>K140454 | OLO, HBE | Navigated CD Horizon Solera<br>Screwdrivers and Taps | Medtronic Sofamor<br>Danek, USA Inc. | | SECONDARY PREDICATE Devices | | | | | K143628 | OLO | Navigated VERTEX SELECT<br>Instruments | Medtronic Sofamor<br>Danek, USA Inc. | | K153603 | OLO | Alphatec Navigation<br>Instruments | Alphatec Spine Inc. | {4}------------------------------------------------ ### Device Description The SeaSpine Navigation System reusable instruments are Class II, manual, surgical instruments for use with the Medtronic StealthStation Navigation System S7 (v.2.1.0) and NavLock Tracker, to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of SeaSpine implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The instruments are manufactured from stainless steel per ASTM F899. The SeaSpine Navigation Instruments include the following: - Taps . - Awl/Tap - Probe ● - Drills ● - Drill/Tap Guides The SeaSpine Navigation Instruments are to be used with the following FDA cleared SeaSpine Spinal Systems: - Atoll - Coral/Coral MIS ● - Malibu Spinal System/Daytona ● - Malibu Spinal System - Daytona Small Stature ● - Mariner Spinal System - NewPort MIS ● - . Sierra ### Intended Use/Indications for use The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation System reusable instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. ### Summary of Technological Characteristics The SeaSpine Navigation System is equivalent to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance. {5}------------------------------------------------ ### Non-Clinical Testing Engineering analysis demonstrate that the subject SeaSpine Navigation System reusable instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance. Engineering analysis includes dimensional measurements of both predicate and subject devices. | Test | Description | |-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Registration | Registration testing was performed to ensure the SeaSpine<br>Navigation Instruments can be registered to the<br>StealthStation | | Navigation Accuracy | Accuracy testing was completed for comparison to the<br>reference instruments | | Anatomical Simulated Use | Confirmed instrument functionality under expected use<br>conditions | | Navigation Simulated Use | Confirmed the SeaSpine Navigation System functionality<br>under expected use conditions | | CAD Model Evaluation | Verified the CAD models are accurately reflected in the<br>application software | | Rigidity | Rigidity testing evaluate the connection between the<br>tracker and the instruments. | | Implant/Instruments<br>Mating Conditions | Verified the instruments can be assembled with the<br>appropriate devices according to their intended use | | Compatibility with the<br>Medtronic StealthStation<br>Navigation System | Compatibility has been evaluated to ensure the SeaSpine<br>Navigation Instruments are compatible with the Medtronic<br>StealthStation Navigation System | Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject SeaSpine Navigation System instruments are substantially equivalent to the predicate navigation instruments when used with the Medtronic StealthStation System. ### Clinical Testing Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data. ### Conclusions The submitted data demonstrate that the SeaSpine Navigation System is substantially equivalent to the cited legally marketed predicate.