(172 days)
The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system should be operated only by trained personnel such as surgeons and clinic staff. The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures: - Cranial biopsies - Puncture of abscesses - Craniotomies - Craniectomies - Resection of tumors and other lesions - Removal of foreign objects - Skull base procedures - Transnasal neurosurgical procedures - Transphenoidal pituitary surgery - Shunt placement, including pediatric shunt placement - Placement of electrodes for recording, stimulation and lesion generation - Endoscopic Sinus Surgery (ESS) - Intranasal procedures - Ear implant procedures - Craniofacial procedures - Skull reconstruction procedures - Orbital cavity reconstruction procedures.
The Stryker Navigation System - CranialMap Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified. The CranialMap Neuro Module is the Stryker Navigation System for cranial surgeries as described in the indications for use statement. The subject device is the Stryker Navigation Software - CranialMap Neuro which together with the Stryker Navigation Platform, Smart Instruments and Accessories forms the Stryker Navigation System - CranialMap Module. It is therefore regarded as a component of the Stryker Navigation System - CranialMap Neuro Module. The design modifications introduced with the Stryker Navigation Software CranialMap Neuro are intended to increase the user comfort, to enhance the look and feel of the software and to simplify and extend the provided functions using the latest system platform technology.
The provided text describes the CranialMap Neuro Module, a navigation surgical software, and its substantial equivalence to a predicate device. However, it does NOT contain the specific details required to answer all parts of your request, especially regarding acceptance criteria derived from a study proving device performance against those criteria.
Here's an breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
What's Available: The document states an "Accuracy Statement" for both the Predicate Device (iNtellect Cranial Software) and the Subject Device (CranialMap Neuro Software). This appears to be a key performance metric.
What's MISSING:
- A formal "acceptance criteria" table explicitly stating quantifiable thresholds the device must meet for various performance metrics.
- A "reported device performance" table that systematically presents the device's actual measured performance against these criteria.
- Other common performance metrics for navigation systems, such as registration accuracy (beyond just RMS display), latency, tracking stability, clinical accuracy in specific scenarios, etc.
| Acceptance Criteria (Inferred from Predicate Device Accuracy Statement) | Reported Device Performance (for CranialMap Neuro Software) |
|---|---|
| Mean accuracy of 2 mm for translation | Mean accuracy of 2 mm for translation |
| Mean accuracy of 2° for rotation | Mean accuracy of 2° for rotation |
Note: The document states that the accuracy statement is "Identical" for both predicate and subject devices. This implies that the CranialMap Neuro Software is expected to meet the same accuracy as the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
What's MISSING: The document explicitly states "No clinical testing has been conducted." (Section 8). It does not describe any specific "test set" in the context of clinical or performance data to validate the algorithm against real patient data. The non-clinical testing refers to "Validation activities, including human factors validation testing" and "system software validation acc, to IEC 62304," but these are general statements about software development processes, not specific studies with sample sizes or data provenance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
What's MISSING: Since no clinical testing or a formal test set is described, there's no information about experts used to establish ground truth.
4. Adjudication Method
What's MISSING: No information on adjudication methods, as no specific test set or expert review process is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
What's MISSING: No MRMC study is mentioned. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and indications for use, without a comparative effectiveness study involving human readers with/without AI assistance.
6. Standalone (Algorithm Only) Performance
What's Available: The "Accuracy Statement" provided (mean accuracy of 2 mm for translation and 2° for rotation "Within the camera working space") refers to the system's accuracy, which would include the algorithm's contribution to tracking and spatial information computation. This is likely a standalone performance metric for the navigation system.
What's MISSING: Further details on how this "mean accuracy" was measured (e.g., phantom studies, specific methods used).
7. Type of Ground Truth Used
What's MISSING: For the accuracy statement, the document itself does not specify the ground truth mechanism (e.g., direct measurement with a CMM, high-precision phantom, etc.). Given it's a navigation system for surgical guidance, the ground truth for such accuracy measurements typically comes from high-precision physical measurements on phantoms or test setups.
8. Sample Size for the Training Set
What's MISSING: This device is a surgical navigation software module, not primarily an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for image analysis or diagnostics. The software's function is guidance based on predetermined anatomical structures and real-time tracking, not learning from a large dataset to make predictions or classifications. Therefore, the concept of a "training set" as typically understood in AI/ML is not applicable here.
9. How the Ground Truth for the Training Set Was Established
What's MISSING: As explained above, the concept of a training set and its ground truth is not applicable in the context of this traditional surgical navigation software.
Summary of the Study (as described in the document):
The "study" presented is primarily a substantial equivalence comparison between the CranialMap Neuro Software (subject device) and the iNtellect Cranial Software (predicate device). This is a regulatory pathway (510(k)) where the manufacturer demonstrates that a new device is as safe and effective as a legally marketed predicate device.
The "study" to meet acceptance criteria, in this context, involves:
- Non-clinical testing: This includes "Validation activities, including human factors validation testing" and "system software validation acc, to IEC 62304 'Medical device software - Software life cycle processes'." These are general statements about software development, quality assurance, and usability.
- Comparison of Technical Characteristics: A detailed table comparing aspects like indications for use, user interface, modes of operation, control mechanisms, operating principle, accuracy statement, registration accuracy, system components, etc. The claim of "Identical" for the accuracy statement (2mm translation, 2° rotation) is central to demonstrating equivalence in this critical performance aspect.
Conclusion:
The provided document details a regulatory submission for substantial equivalence. While it clarifies the intended performance (specifically the stated accuracy), it does not describe a conventional clinical or performance study with detailed acceptance criteria, test sets, expert ground truth, or MRMC studies that would typically be associated with AI/ML-driven diagnostic or prescriptive devices. The "proof" relies on demonstrating that the new device's technological characteristics, including its accuracy, are identical or equivalent to a previously cleared predicate device, along with general software validation activities.
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KB1214
Image /page/0/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are closely spaced together, and the word appears to be a logo or brand name. There is a small superscript symbol after the "r" in "stryker".
Navigation
510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
1. Contact Details
| Applicant Name: | Stryker Leibinger GmbH & Co. KG - NavigationBoetzinger Strasse 41D-79111 Freiburg, GermanyPhone number: +49-761-4512 117Fax number: +49-761-4512 49117 |
|---|---|
| Registration No.: | 3007582679 |
| Name of Contact Person: | Lilian Eckertlilian.eckert@stryker.com |
| Date prepared: | 12 September 2013 |
2. Device Name
| Trade Name: | CranialMap Neuro | ||||
|---|---|---|---|---|---|
| Common Name: | Navigation software for cranial surgeries | ||||
| Classification Name: | Product Code | Device | Regulation Number | Class | Review Panel |
| Primary Code:HAW | Neurologic stereotaxic instrument | 21 CFR §882.4560 | II | Neurology |
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3. Legally Marketed Predicate Device
The legally marketed predicate device is the Cranial Module as cleared in K062640 Stryker Navigation System - Cranial Module.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K062640 | HAW | iNtellect CranialiNtellect ENT | Stryker Leibinger GmbH &Co. KG - NavigationBoetzinger Strasse 41D-79111 Freiburg,Germany |
4. Device Description
The Stryker Navigation System - CranialMap Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified.
The CranialMap Neuro Module is the Stryker Navigation System for cranial surgeries as described in the indications for use statement.
The subject device is the Stryker Navigation Software - CranialMap Neuro which together with the Stryker Navigation Platform, Smart Instruments and Accessories forms the Stryker Navigation System - CranialMap Module. It is therefore regarded as a component of the Stryker Navigation System - CranialMap Neuro Module. The design modifications introduced with the Stryker Navigation Software CranialMap Neuro are intended to increase the user comfort, to enhance the look and feel of the software and to simplify and extend the provided functions using the latest system platform technology.
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5. Indications for use
The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as a planning and intraoperative quidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The system should be operated only by trained personnel such as surgeons and clinic staff. The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures:
- . Cranial biopsies
- Puncture of abscesses .
- Craniotomies .
- . Craniectomies
- Resection of tumors and other lesions ●
- . Removal of foreign objects
- � Skull base procedures
- Transnasal neurosurgical procedures .
- Transphenoidal pituitary surgery .
- Shunt placement, including pediatric shunt placement .
- Placement of electrodes for recording, stimulation and lesion generation .
- . Endoscopic Sinus Surgery (ESS)
- Intranasal procedures .
- Ear implant procedures .
- Craniofacial procedures .
- . Skull reconstruction procedures
- Orbital cavity reconstruction procedures .
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6. Substantial Equivalence Comparison
In summary, the indications for use of the modified Stryker CranialMap Neuro Module are identical to the predicate device Cranial Module. Furthermore, the technological characteristics of the modified CranialMap Neuro Application Software are substantially equivalent to the original Cranial Application Software. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the CranialMap Neuro Module is substantially equivalent to the predicate device.
The following table gives an overview of the substantial equivalence reflecting all modifications being made between the predicate device and the subject device.
| Topic | Predicate DeviceiNtellect CranialSoftware | Subject DeviceCranialMap NeuroSoftware | Equivalence assessment |
|---|---|---|---|
| Indicationsfor Use | Refer to chapter 5"Indications for use" | Refer to chapter 5"Indications for use" | IdenticalIdentical, except for themodule name, titles andthe order of listedindications for use. |
| Look of theSoftwareUserInterface | Grey-style graphicaluser interface on 4:3screen ratio, one tabper task concept fromleft to right on top ofscreen, image box withimage tools and taskpanel on the right | Black-style graphicaluser interface on 16:9screen ratio, one tabper task concept fromleft to right on top ofscreen, image box withimage tools and tasktablet on the right | EquivalentRefreshed and touch-enabled graphical userinterface on HD screen.Changes are minor and donot alter the way thesoftware performs noraffect safety andeffectiveness of device. |
| Modes ofOperation | Software workflowcontrolled by tabs fromleft to right, registrationplanning tab afterplanning tab. | Software workflowcontrolled by tabs fromleft to right, registrationplanning tab movedbefore planning tab. | EquivalentModification improves theease of use of thesoftware and does notnegatively affect the safetyand effectiveness of theproposed device. |
| Topic | Predicate DeviceiNtellect CranialSoftware | Subject DeviceCranialMap NeuroSoftware | Equivalence assessment |
| ControlMechanism | Mouse Keyboard Buttons onnavigated sterilesmart tools. | Mouse Virtual Keyboard Buttons onnavigated sterilesmart tools. IO-Tablet with touchscreen | EquivalentThe control mechanismduring surgery is identical.The control mechanismbefore surgery isequivalent: mouse,keyboard and touchscreen. |
| OperatingPrinciple | The iNtellect Cranialsoftware is installed onthe computer that ispart of the Navigationsystem platform.Images are imported inDICOM format. | The CranialMapsoftware is installed onthe computer that ispart of the Navigationsystem platform.Images are imported inDICOM format. | IdenticalThe operating principle onthe Stryker Platform isunchanged. |
| AccuracyStatement | Within the cameraworking space, thesystem has a meanaccuracy of 2 mm fortranslation and 2° forrotation. | Within the cameraworking space, thesystem has a meanaccuracy of 2 mm fortranslation and 2° forrotation. | Identical |
| RegistrationAccuracy | The root mean squarevalue is displayed asmean error of theregistration. | The root mean squarevalue is displayed asmean error of theregistration. | Identical |
| Check forSustainedAccuracyIntra-operatively | Navigation instrument'stip geometry check oninitialization ofinstrument.Intra-operativeinteractive landmarkchecks demanded bythe software, e.g.during mandatoryregistrationconfirmation step. | Navigation instrument'stip geometry check oninitialization ofinstrument.Intra-operativeinteractive landmarkchecks demanded bythe software, e.g.during mandatoryregistrationconfirmation step. | IdenticalAn additional videoguidance how to check theinstrument's tip geometrymakes the device moreusers friendly and doesnot negatively affect thesafety and effectiveness ofthe proposed device. |
| Topic | Predicate DeviceiNtellect CranialSoftware | Subject DeviceCranialMap NeuroSoftware | Equivalence assessment |
| System Components | |||
| LocalizationTechnologyand WorkingSphere | Infrared optical activesensing technology:Infrared light emitted bydiodes placed in aknown fashion oninstruments (trackers)is sensed by a cameraarray thus allowing forcomputation of thespatial information. | Infrared optical activesensing technology:Infrared light emitted bydiodes placed in aknown fashion oninstruments (trackers)is sensed by a cameraarray thus allowing forcomputation of thespatial information. | IdenticalThe Navigation Camera isthe same camera as usedfor the predicate device. |
| NavigationSystemPlatform | Stryker NavigationSystem II - Cart,Stryker eNlite:• StrykerNavigationCamera• Mouse,Keyboard• Stryker PCComputer | Stryker NavigationPlatform:• StrykerNavigationCamera• IO-Tablet• Stryker PC-3Computer | EquivalentThe same navigationcamera and equivalent PCbased components areused. The IO-tabletinterface to control theapplication is a state-of-the-art alternative to usinga mouse and keyboard foruser's convenience. |
| OR Display | Display properties:• 4:3 LCD monitor• 1280 x 1024 pixelresolution• 19" screen | Display properties:• 16:9 LCD monitor• 1980 x 1080 pixelresolution• 32" screen | EquivalentThe larger high resolutiondisplay does notnegatively affect the safetyand effectiveness of thesubject device. |
| SmartInstrumentTechnology(Trackers) | Active, batterypowered, wirelessinstrumentation with bi-directional IR-communication and IR-LEDs for tracking | Active, batterypowered, wirelessinstrumentation with bi-directional IR-communication and IR-LEDs for tracking | IdenticalAll smart instrumentssupported by the predicatedevice are supported bythe subject device as well. |
| Topic | Predicate DeviceiNtellect CranialSoftware | Subject DeviceCranialMap NeuroSoftware | Equivalence assessment |
| Calibration ofInstrumentDimensions | Workflow to calibrateand validate thenavigated instrumentsduring the operation. | Workflow to calibrateand validate thenavigated instrumentsduring the operation. | Identical |
| DisposableParts | Batteries for trackers,registration markers,Frameless Guide,Patient Registrationand tracking mask. | Batteries for trackers,registration markers,Frameless Guide,Patient Registrationand tracking mask. | Identical |
| ScannerInterfaceTechnology(to imagingdevices) | Magneto Optical DiskCD, DVD, USBNetwork connectivityDICOM storage client | CD, DVD, USBNetwork connectivityDICOM storage clientDICOM query/retrieve | EquivalentModification to supportstate-of-the-art scannerinterfaces. |
| Supportedimagingmodalities | CT, CTAMR, MRA, fMRIPET, SPECT | CT, CTAMR, MRA, fMRIPET. SPECT | EquivalentMore convenient imagemodality correlation basedon DICOM frame-of-reference ID supported. |
| Microscopeinterfaces | Zeiss NC4,Zeiss Pentero,Leica M5xx,Leica M720microscope models | Zeiss NC4, ZeissPentero, ZeissPentero 900, LeicaM5xxLeica M720microscope models | EquivalentThe additional support ofthe Zeiss Pentero 900microscope is identical tothe Pentero microscopeexcept for a newmicroscope ID. |
| Topic | Predicate DeviceiNtellect CranialSoftware | Subject DeviceCranialMap NeuroSoftware | Equivalence assessment |
| Operating System and Implementation Technology | |||
| PlatformOperatingSystem | Windows 2000Windows XP | Windows XP | EquivalentHigher version of Windowsoperating system used. |
| SoftwareImplemen-tation | C and C++programming applyingobject oriented analysisand design methods,Qt GUI design and up-to-date continuousintegration and testingtools in a Microsoftdevelopmentenvironment. | C and C++programming applyingobject oriented analysisand design methods,Qt GUI design and up-to-date continuousintegration and testingtools in a Microsoftdevelopmentenvironment. | EquivalentAdditional methods havebeen applied to thesoftware development ofthe subject device forstate-of-the-art softwarequality, e.g. codecoverage measurementsand 100% code reviews. |
| Use of Off-the-Shelf(OTS)Software | OTS software forlogging, visualization,algorithms, 3Dgraphics, multi-threading, GUIcomponents, volumerendering, multi-modality matching,backup on CD and cpp-templates. | OTS software forlogging, visualization,algorithms, 3Dgraphics, multi-threading, GUIcomponents, volumerendering, multi-modality matching,backup on CD and cpp-templates.DICOM Tool Kit | EquivalentFor the CranialMap NeuroSoftware the same Off-the-Shelf softwarecomponents that havealready been used for thepredicate device are usedwith updated versionswhere appropriate.The new DICOMQuery/Retrieve extensionis based on the DICOMTool Kit. |
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| Topic | Predicate DeviceiNtellect CranialSoftware | Subject DeviceCranialMap NeuroSoftware | Equivalence assessment |
|---|---|---|---|
| CranialMap Neuro Modifications | |||
| TouchScreenFunctionality | No touch screen GUI operated viaMouse input | Touch on IO-tabletcan be usedalternatively tomouse control | EquivalentAdditional touch screenfunctionality does notnegatively affect the safetyand effectiveness |
| LiveCamSystemSetup | System setup usingside and top view ofworking sphere. | System setup usingside and top view ofworking sphere. Additionally a"localizer's eye" livevideo view option. | EquivalentThe additional option usingthe LiveCam does notaffect the performance orthe indications for useof the subject device. |
| CollisionZones | Segments andannotations can bedefined | Segments andannotations can bedefined Collision checkoption forsegments,annotations andfunctional overlaysduring navigation | EquivalentAn additional option foraudible and visualfeedback duringnavigation is provided.This modification does notnegatively affect safetyand effectiveness orchange the indications foruse of the subject device. |
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| Topic | Predicate DeviceiNtellect CranialSoftware | Subject DeviceCranialMap NeuroSoftware | Equivalence assessment |
|---|---|---|---|
| Image seriesimport andhandling | Anatomical and functional MRI data is imported as separate image series. The "identity correlation" feature is used to correlate functional data to the appropriate anatomical MRI series. The correctness of the image correlation must be confirmed during image import. | Functional MRI images are detected during image import as overlays of a related anatomical MRI image series automatically. System applies an "identity correlation" based on DICOM reference frame ID. The correctness of the image correlation must be confirmed during image import. Deletion of imported image series. | EquivalentSimplification by reducing number of steps needed to correlate image modalities. Like in the predicate device the user must confirm the result.For convenience an unintentionally imported image series can be removed.The modification does not negatively affect the safety and effectiveness of the subject device. |
| 3D modelvisualization | Advanced virtual surgical planning based on 3D DICOM data, e.g. a CT scanned implant possible. | Planning based on 3D model data, e.g. STL models is possible. The 3D models can be loaded and aligned with anatomical image data. | EquivalentAdvanced virtual planning is enhanced but no change of indications for use. Change does not negatively affect safety and effectiveness. |
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| Topic | Predicate DeviceiNtellect CranialSoftware | Subject DeviceCranialMap NeuroSoftware | Equivalence assessment |
|---|---|---|---|
| Automaticintra-operativemask (AIM)registration | • Automatic maskregistration andtracking based onskin surfaceextraction. | • Automatic maskregistration andtracking based onskin surfaceextraction.• The mask isattached on thepatient during theCT scan and AIMregistration is ableto detect the LEDpositions of themask in the scan. | EquivalentAdditional maskregistration method usinga CT scan while the maskis attached to the patient.The established point-to-point registrationalgorithms are used. Nochange of the indicationsfor use. Change does notnegatively affect safetyand effectiveness. |
7. Non-clinical Testing
Validation activities, including human factors validation testing, have been conducted to provide assurance that the device meets the performance requirements under its indications for use conditions. In addition, system software validation acc, to IEC 62304 "Medical device software -Software life cycle processes", have been performed to show that the device is safe and effective.
8. Clinical Testing
No clinical testing has been conducted.
9. Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the Stryker Navigation Application Software CranialMap Neuro performs as safely and effectively as the legally marketed device identified in chapter 3. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the Stryker Navigation System - CranialMap Neuro Module is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.
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Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2013
Stryker Corporate Ms. Lilian Eckert Boetzinger Str. 41 Freiburg, Baden-Wuerttemberg, GM 79111
Re: K131214
Trade/Device Name: Cranial Map Neuro Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: September 12, 2013 Received: September 16, 2013
Dear Ms. Eckert:
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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Page 2 - Ms. Lilian Eckert
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting 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):
Device Name:
Stryker CranialMap Neuro Module
Indications For Use:
The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Styker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The system should be operated only by trained personnel such as surgeons and clinic staff.
The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures:
- Cranial biopsies ●
- Puncture of abscesses .
- Craniotomies .
- Craniectomies .
- Resection of tumors and other lesions .
- Removal of foreign objects .
- Skull base procedures �
- Transnasal neurosurgical procedures �
- . Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement .
- Placement of electrodes for recording, stimulation and lesion generation �
- Endoscopic Sinus Surgery (ESS) �
- Intranasal procedures .
- Ear implant procedures .
- Craniofacial procedures .
- Skull reconstruction procedures .
- Orbital cavity reconstruction procedures .
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Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ・
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 2 of _ _ 2__
§ 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).