(152 days)
The NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing a cranial surgical procedure using stereotactic techniques.
The NavSuite®3 Kit is a computer workstation that, when used with SpineMap 3D Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing an orthopaedic spinal surgical procedure using stereotactic techniques.
The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized. The Computer Monitor displays the navigation information to the user.
The NavSuite®3 Kit is a minor modification of the previously cleared Stryker NAV3i Platform. The NavSuite®3 Kit consists of the same main components that were cleared as the NAV3i Platform in K130874. The NAV3i Platform (K130874) consisted of a mobile cart, a computer system, a monitor, an IO Tablet and a navigation camera. The subject of this Special 510(k) is that the system is now modified to provide these same components, without the mobile cart and without the monitor. The computer, IO Tablet and navigation camera are now provided as separate components that can be configured and affixed in the operation room suite based on user preferences. The monitor that was provided with the NAV3i Platform is not provided with the NavSuite®3 Kit. The NavSuite®3 Kit is compatible with any monitor that meets the specifications provided in the Instructions for Use.
Like the predicate Nav3i platform, the NavSuite3 Kit platform is compatible with the following previously cleared Stryker Software Application Modules:
The provided text describes a 510(k) premarket notification for the Stryker NavSuite®3 Kit, which is a computer workstation used with navigation software for cranial and orthopedic spinal surgical procedures. The notification asserts substantial equivalence to a predicate device (Stryker NAV3i Platform K130874), focusing on minor modifications to the physical components rather than the core navigation algorithms.
Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device under review, the NavSuite®3 Kit, is a modified version of a previously cleared device (NAV3i Platform, K130874). The modifications primarily involve the physical components (e.g., removing the mobile cart and monitor, changing camera mounting and cabling, removing the UPS and LiveCAM). The core navigation software and its functionalities (CranialMap Neuro Navigation and SpineMap 3D Navigation) are stated to be compatible and previously cleared.
Therefore, the "acceptance criteria" here are not about specific performance metrics for a novel algorithm's accuracy, sensitivity, or specificity, but rather about demonstrating that the physical modifications do not introduce new risks or alter the fundamental scientific technology or intended use, and therefore the device remains as safe and effective as the predicate.
The acceptance criteria implicitly derive from ensuring that the modified components function as intended and do not compromise the safety or performance of the integrated system.
| Acceptance Criteria (Implicit) | Reported Device Performance and Study Findings |
|---|---|
| No new risks introduced by modifications. | A functional risk analysis was conducted according to ISO 14971, 2nd Edition (2007). The results determined that the device modifications do not introduce any new risks compared to the predicate device. All existing risks were identified and mitigated to a level "as low as reasonably possible." The effectiveness of these mitigation measures was verified by the detailed testing. |
| Power Supply (Removal of UPS): System stability and behavior during power events must not be compromised. | System Test: Shutdown and crash behavior was tested with the Navigation Software Application Modules integration tests to ensure stability without the UPS. The justification for removing the UPS is that the subject device is a fixed installation and not intended to be mobile, hence the UPS is not needed. |
| Operating System (Minor configuration changes): OS must remain effective and compatible with navigation software. | Component Test: Showed that configurations were implemented and effective. System Test: Showed that fixed resolution was used on several monitors, verifying compatibility and functionality. |
| Monitor (No longer provided, user-supplied compatible monitor): Display quality and compatibility maintained. | System Test: Various compatible monitors (meeting 1920x1080 pixels native resolution, DVI signal) were tested with Native Resolution and with the Navigation Software Application Modules integration tests, confirming proper display and functionality. The instructions for use specify the required monitor specifications, which are the same as the predicate device's monitor. |
| Navigation Camera Mounting (Ceiling-mounted arm): Robustness, reliability, and range of motion must be maintained. | System Test: Automated mechanical stress tests were performed to demonstrate reliability through simulated intraoperative use over the device's lifetime. This included rotational and vertical adjustment capabilities and ensuring the camera joint could move without restrictions within its range of motion. Statistical methods were used. A lifetime of 1000 movement cycles was estimated for a camera joint. Tests were conducted on five test samples, each over 5687 test cycles, exceeding the estimated lifetime. |
| Navigation Camera Cables (Optical fibers, extended length): Data transfer and power supply must be reliable. | Component Test: Verified voltage and data transfer for the new optical fiber cables. System Tests: Automated mechanical stress tests demonstrated the reliability of the Navigation camera cables (power and data) through simulated intraoperative use over their specified lifetime using statistical methods. A lifetime of 1000 movement cycles was estimated for a camera cable set. Tests were conducted on five test samples of camera cable sets, each over 5687 test cycles, exceeding the estimated lifetime. |
| LiveCAM (Not provided): Absence must not affect navigation software functionality. | System Test: Verified that the applicable Software Application Module (CranialMap Neuro Navigation, SpineMap 3D Navigation) was not affected by the absence of LiveCAM. This was tested with Navigation Software Application Module integration tests. The LiveCAM was an optional component in the predicate and not required for optimal system performance. |
| Cart with Castors (Not provided): The absence of mobility must align with the intended fixed installation. | No testing was required for the absence of the cart. The justification is that the NavSuite®3 Kit components are intended for fixed installation in the OR and not for mobility, differentiating it from the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the mechanical stress tests on the camera mounting and cables, five test samples of camera joints and five test samples of camera cable sets were used. Each of these samples underwent 5687 test cycles. For other system and component tests (UPS, OS, Monitor, LiveCAM), the documentation refers to "integration tests" or "various compatible monitors," implying testing across the system's operational parameters rather than a specific number of unique cases or patients.
- Data Provenance: Not explicitly stated for all tests. For the hardware component and system tests, it is reasonable to assume these were conducted in a laboratory or engineering testing environment by the manufacturer (Stryker Leibinger GmbH & Co. KG in Germany). The studies are primarily engineering validation tests for hardware modifications, not clinical efficacy studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth) is not applicable to the performance data presented. The studies described are engineering and functional tests to confirm the hardware modifications do not negatively impact the system's performance or safety from an engineering perspective. They do not involve clinical diagnosis or interpretation of medical images where expert consensus would establish ground truth for algorithm performance.
4. Adjudication Method for the Test Set
This is not applicable as the studies are engineering validation tests for hardware components, not clinical studies requiring adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or is mentioned. The submission is for hardware modifications to an existing navigation system, not for a novel diagnostic AI algorithm that would typically undergo such a study. The "AI" component (the navigation software) was previously cleared.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "algorithm only" performance (i.e., the navigation software's accuracy in tracking instruments and displaying images) was implicitly addressed during the prior 510(k) clearances for the CranialMap Neuro Navigation (K131214) and SpineMap 3D Navigation (K141941) software modules and the predicate NAV3i Platform (K130874). This current submission is not focused on re-evaluating the standalone performance of the navigation algorithms themselves, but rather on demonstrating that the new hardware configuration does not degrade that previously established performance.
7. The Type of Ground Truth Used
For the engineering tests conducted:
- For the robustness and lifetime tests of the camera arm and cables, the "ground truth" was the expected physical durability and functionality of the components under simulated stress, often defined by engineering specifications and industry standards.
- For the system integration tests (UPS, OS, Monitor, LiveCAM), the "ground truth" was the expected functional behavior and compatibility with the existing navigation software, verified against predefined system requirements and successful operation of the software.
8. The Sample Size for the Training Set
Not applicable. This submission is for hardware modifications and engineering validation. There is no mention of a "training set" in the context of machine learning or AI algorithm development for this specific 510(k). The navigation software itself would have had its own development and validation processes, but that is not the subject of this document.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated in point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2015
Stryker Leibinger GmbH & Co. KG Robin Rowe Director, Regulatory/Clinical Affairs Boetzinger Strasse 41 Freiburg, Baden-Wuerttemberg D-79111 Germany
Re: K150301
Trade/Device Name: NavSuite3 Kit Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: June 5, 2015 Received: June 8, 2015
Dear Ms. Rowe:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena =5/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150301
Device Name NavSuite®3 Kit
Indications for Use (Describe)
The NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing a cranial surgical procedure using stereotactic techniques.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Indications for Use
510(k) Number (if known) K150301
Device Name NavSuite®3 Kit
Indications for Use (Describe)
The NavSuite®3 Kit is a computer workstation that, when used with SpineMap 3D Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing an orthopaedic spinal surgical procedure using stereotactic techniques.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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."
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510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the NavSuite®3 Kit is provided below.
| Device Common Name: | Neurological Stereotaxic Instrument | |
|---|---|---|
| Device Proprietary Name: | NavSuite®3 Kit | |
| Applicant: | Stryker Leibinger GmbH & Co. KG – NavigationBoetzinger Strasse 41D-79111 Freiburg, Baden-Wuerttemberg, Germany | |
| Contact: | Robin L. Rowe, MS, RACDirector, Regulatory/Clinical AffairsStryker Corporation4100 E. Milham Ave.Kalamazoo MI 49001Phone: 269.389.3893Cell: 269.806.5779Fax: 269-389-2375 | |
| Date Prepared: | June 5, 2015 | |
| Classification Regulation: | Stereotaxic Instrument, 21 CFR 882.4560, Class II | |
| Panel: | Neurology | |
| Primary Product Code: | HAW - Neurological Stereotaxic Instrument | |
| Secondary Product Code: | OLO - Orthopedic Stereotaxic Instrument | |
| Predicate Device: | Stryker NAV3i Platform (K130874) |
Indication for Use:
The NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing a cranial surgical procedure using stereotactic techniques.
The NavSuite®3 Kit is a computer workstation that, when used with SpineMap 3D Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing an orthopaedic spinal surgical procedure using stereotactic techniques.
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Device Description:
The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized. The Computer Monitor displays the navigation information to the user.
The NavSuite®3 Kit is a minor modification of the previously cleared Stryker NAV3i Platform. The NavSuite®3 Kit consists of the same main components that were cleared as the NAV3i Platform in K130874. The NAV3i Platform (K130874) consisted of a mobile cart, a computer system, a monitor, an IO Tablet and a navigation camera. The subject of this Special 510(k) is that the system is now modified to provide these same components, without the mobile cart and without the monitor. The computer, IO Tablet and navigation camera are now provided as separate components that can be configured and affixed in the operation room suite based on user preferences. The monitor that was provided with the NAV3i Platform is not provided with the NavSuite®3 Kit. The NavSuite®3 Kit is compatible with any monitor that meets the specifications provided in the Instructions for Use.
Like the predicate Nav3i platform, the NavSuite3 Kit platform is compatible with the following previously cleared Stryker Software Application Modules:
Performance Data:
A functional risk analysis for the NavSuite®3 Kit was conducted and applied in accordance with ISO 14971, 2nd Edition: Medical Devices – Application of Risk Management to Medical Devices (2007).
The results of the risk analysis for the NavSuite®3 Kit determined that the device modifications which are the subject of this 510(k) do not introduce any new risks compared to the predicate device. All existing risks that were identified for the predicate device are the same for the subject device and are mitigated to a risk level as low as reasonably possible. The effectiveness of all mitigation measures is verified per the testing detailed in Table 1.
| Modification | Description | Tests Performed |
|---|---|---|
| Cart withCastors | Cart is not used in the NavSuite®3 Kit. | No testing required. |
| UPS | No UPS is included in NavSuite®3 Kit. | System test:Shutdown and crash behavior was tested withNavigation Software Application Modulesintegration tests |
| Modification | Description | Tests Performed |
| OperatingSystem | Same as the NAV3i OS, with minorconfiguration changes. | Component test:To show that the configurations areimplemented and effectiveSystem test:To show that fixed resolution was used onseveral monitors |
| Monitor | No monitor is provided with NavSuite®3 Kit.Any compatible monitor that meets thespecifications provided in the Instructions forUse can be used. | System test:Various compatible monitors were tested withnative resolution of 1920 x 1080 pixels, dividedon the Navigation Software ApplicationModules integration tests |
| NavigationCameraMounting | Camera will be fixed on ceiling-mounted armusing an adapted camera joint. | System test:Automated mechanical stress tests to showreliability by simulated intraoperative use overlifetime, rotational and vertical adjustment andthat the camera joint can be moved withoutrestrictions within the range of motion, usingstatistical methodsA lifetime of 1000 movement cycles wasestimated for a camera joint. This resulted intests with five test samples of camera joints,each over 5687 test cycles. |
| NavigationCameraCables | Additional Navigation camera data and powercables are needed.Navigation camera data cables include opticalfibers.Camera will be fixed on ceiling-mountedarms | Component Test:To verify voltage and data transfer.System Tests:Automated mechanical stress tests to showreliability of the Navigation camera cables bysimulated intraoperative use over specifiedlifetime using statistical methodsFor a camera cable set (power and data), alifetime of 1000 movement cycles wasestimated. This resulted in tests with five testsamples of camera cable sets (power and data),each over 5687 test cycles. |
| LiveCAM | Not provided with NavSuite®3 Kit | System test:Verify that applicable Software ApplicationModule is not affected.Tested with Navigation Software ApplicationModule integration test. |
Table 1: Summary of Performance Testing
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Substantial Equivalence:
Table 2 provides a comparison of the technological characteristics of the subject device to the predicate device and an assessment of the equivalence of each characteristic.
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| Proposed Device | Predicate Device | Equivalence Assessment | |
|---|---|---|---|
| Device Name | NavSuite®3 Kit | NAV3i Platform | N/A |
| 510(k) Number | TBD | K130874 | N/A |
| Submitter | Stryker Corporate | Stryker Corporate | Identical |
| ClassificationRegulation | 882.4560 | 882.4560 | Identical |
| Product Code | HAW, OLO | HAW, OLO | Identical |
| Indication | The NavSuite®3 Kit is a computerworkstation that, when used withCranialMap Neuro Navigationsoftware, displays patient specificimages and/or patient specificanatomical landmark informationand tracks the position andmovement of surgical instrumentsin relation to a target anatomicalsite on a patient. The clinicalsetting and target population forthe NavSuite®3 Kit is that of apatient undergoing a cranialsurgical procedure usingstereotactic techniques.The NavSuite®3 Kit is a computerworkstation that, when used withSpineMap 3D Navigation software,displays patient specific imagesand/or patient specific anatomicallandmark information and tracksthe position and movement ofsurgical instruments in relation to atarget anatomical site on a patient.The clinical setting and targetpopulation for the NavSuite®3 Kitis that of a patient undergoing anorthopaedic spinal surgicalprocedure using stereotactictechniques. | The NAV3i is a computerworkstation that, when used withspecific Stryker Navigation surgicalsoftware, displays patient specificimages and/or patient specificanatomical landmark informationand tracks the position andmovement of surgical instrumentsin relation to a target anatomical siteon a patient.The clinical setting and targetpopulation for the NAV3i is that ofa patient undergoing a surgicalprocedure using stereotactictechniques. | Identical |
| Contraindication | The NavSuite®3 Kit is not intendedfor use in an MR environment. TheNavSuite®3 Kit is MR unsafe. | The NAV3i Platform is not intendedfor use in a MRI environment. TheNAV3i Platform is MR unsafe. | Identical |
| Proposed Device | Predicate Device | Equivalence Assessment | |
| Power Supply | External power source:AC Power supply, 100/240V,50/60Hz.No UPS provided. | External power source:AC Power supply, 100/240V,50/60Hz.The system is equipped with an off-the-shelf uninterruptible powersupply (UPS) for powerinterruptions less than or equal to 6minutes. | Equivalent:The subject device andpredicate device use thesame power supply. TheUPS is not needed for thesubject device based on itbeing a fixed installation ofthe components. |
| Computer | Windows XP, Intel I5 Platformwith WLAN capability | Windows XP, Intel I5 Platform withWLAN capability | Identical |
| IO-Tablet andRFID Reader | Touch screen tablet with USBports and CD/DVD drive andRFID Reader | Touch screen tablet with USB portsand CD/DVD drive and RFIDReader | Identical |
| Monitor Arm | Not provided. | Weight balanced articulated arm,swing range of 300° | Equivalent:The monitor arm is notneeded for the subject devicebecause a monitor is notprovided. |
| Monitor | The NavSuite®3 Kit is compatiblewith any monitor that meets thespecifications provided in theInstructions for Use. (Resolution of1920x1080 pixels, DVI signal) | 32" flat screen, 16:9 aspect ratio,Resolution of 1920x1080 pixels,DVI signal | Equivalent:Although the subject devicedoes not provide a monitor,the labeling states that it iscompatible with any monitorthat meets the samespecifications stated in theinstructions for use. Theseare the same specificationsas that of the monitorprovided with the predicatedevice. |
| Proposed Device | Predicate Device | Equivalence Assessment | |
| NavigationCamera | Navigation System Camera(FP6000)LiveCAM Not provided. | Navigation System Camera(FP6000)With LiveCAM feature. | Equivalent:The subject device and thepredicate device use thesame navigation camera(FP6000). The LiveCAMwas an optional componentof the NAV3i used to assistthe user in orienting theNavigation Camera to thesurgical field. The LiveCAMis not required for optimalperformance of the system.The color of the enclosure iswhite compared to the darkgrey enclosure of theNAV3i. This is a cosmeticchange only and has noeffect on device performanceand is not a patientcontacting component.The cabling for theNavigation camera has beenchanged from copper basedcables to optical fibers. Thefiber optic cable providesbetter signal integrity overthe extended distance. |
| Camera Arm | Camera joint, swing range of 330°when connected to fixed cameraarm in the OR | Weight balanced articulated arm,swing range of 330° | Equivalent:The purpose of thearticulated arm and camerajoint are the same; to allowadjustment of the cameraposition. When fixed to aceiling mounted arm in theOR, the camera jointprovided with theNavSuite®3 Kit provides thesame degrees of freedom asthe articulated camera arm ofthe NAV3i predicate device. |
| Cart withCastors | Not provided | Stainless steel, plastic and fiberglasscart with castors for mobility | Equivalent:A cart is not provided withthe NavSuite®3 Kit becausethe components are in a fixedconfiguration in the OR andare not intended to bemobile. |
Table 2: Device Comparison Table
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Substantial Equivalence Conclusion:
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Based on the identical indications for use and the technological comparison between the subject device and the predicate device, the minor modifications made to the NavSuite®3 Kit since its previous clearance in K130784 do not alter the intended use or the fundamental scientific technology, and do not raise new questions of safety or effectiveness. Therefore the subject device can be found substantially equivalent to the predicate device.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).