(106 days)
The Stryker SpineMap® 3D Navigation System, when used with a 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 rigid anatomical structure can be identified.
The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including:
· Pedicle screw placement
The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine.
- · In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.
- · When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.
The Stryker SpineMap® 3D Navigation System is an image guided surgery system to enable open or percutaneous computer-assisted spinal surgery.
The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a CT image.
The system consists of a software application, smart instruments (e.g. patient/instrument trackers, pointers, navigated surgical instruments), and several accessories to enable the tracking of surgical instruments. The system also includes the SpineMask™ Tracker, a new patient tracking device.
The software application runs on a Stryker computer platform, consisting of a Stryker computer, a navigation camera and an IO-Tablet.
The provided document is a 510(k) summary for the Stryker SpineMap® 3D Navigation System and the Stryker SpineMask™ Tracker. It focuses on demonstrating substantial equivalence to predicate devices and outlines non-clinical testing. Crucially, the document explicitly states "No clinical testing has been conducted." Therefore, there is no study described that proves the device meets acceptance criteria through clinical performance.
However, the document details non-clinical acceptance criteria and the performance related to those:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Test | Acceptance Criteria (Description) | Reported Device Performance (Description from "Non-Clinical Testing" section) |
|---|---|---|
| SpineMask Tracker Patient Tracking | Equivalence of SpineMask Tracker and the Spine Clamp / Spine Tracker combination for minimally invasive procedures. | Validated the equivalence of SpineMask Tracker and the Spine Clamp / Spine Tracker combination for minimally invasive procedures. |
| User Needs | Validation of the product with users in cadaver labs or simulated use tests. Verified compatibility with conventional operative technique and other devices used in spinal surgery. | Validated the product with users in cadaver labs or simulated use tests. Verified compatibility with conventional operative technique and other devices used in spinal surgery. |
| Accuracy | Mean navigation accuracy of ± 2mm point displacement and ± 2° angular axis displacement according to ASTM F2554:2010 and in phantom tests. Equivalent system accuracy compared to predicate in cadaver tests. | Verified the mean navigation accuracy of ± 2mm point displacement and ± 2° angular axis displacement according to ASTM F2554:2010 and in phantom tests. Verified equivalent system accuracy compared to predicate in cadaver tests. |
| Safety | Effectiveness of all risk controls determined in the device risk analysis. | Verified the effectiveness of all risk controls determined in the device risk analysis. |
| General Requirements and Performance | All components against their design specifications. | Verified all components against their design specifications. |
| Software | Verification and validation according to IEC 62304:2006 and FDA guidance on general principles of software validation, June 9, 1997. | Verification and validation according to IEC 62304:2006 and FDA guidance on general principles of software validation, June 9, 1997. |
| Shelf Life Testing | Functionality of the single-use, sterile device and integrity of the packaging after aging. | Verified functionality of the single-use, sterile device and integrity of the packaging after aging. |
| Biocompatibility | Biocompatibility of all patient contact materials according to ISO 10993-1:2009 and FDA draft guidance on the use of ISO 10993-1, April 23, 2013. | Verified the biocompatibility of all patient contact materials according to ISO 10993-1:2009 and FDA draft guidance on the use of ISO 10993-1, April 23, 2013. |
| Electrical Safety | Conformance to ANSI/AAMI ES 60601-1:2006-02. | Verified conformance to ANSI/AAMI ES 60601-1:2006-02. |
| Electromagnetic Compatibility | Conformance to IEC 60601-1-2: 2007-03, CISPR 11 Group 1, Class B requirements as well as additional testing to verify compatibility with RFID devices operating in the 125 - 134 kHz frequency band. | Verified conformance to IEC 60601-1-2: 2007-03, CISPR 11 Group 1, Class B requirements as well as additional testing to verify compatibility with RFID devices operating in the 125 - 134 kHz frequency band. |
| Shipping | Functionality of the device after simulated shipping conditions. | Verified functionality of the device after simulated shipping conditions. |
| Sterilization | EO sterilization process for the single-use, sterile device according to ISO 11135-1:2007 to a sterility assurance level (SAL) of 10-6 and verified EO and ECH residuals are within the limits defined in ISO 10993-7:2008. | Validated the EO sterilization process for the single-use, sterile device according to ISO 11135-1:2007 to a sterility assurance level (SAL) of 10-6 and verified that the EO and ECH residuals are within the limits defined in ISO 10993-7:2008. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for the "test set" in the context of clinical data because no clinical testing was performed. For non-clinical testing:
- Accuracy: Tested in phantom tests and cadaver tests. No specific sample size (number of phantoms or cadavers) is mentioned.
- User Needs: Validated in cadaver labs or simulated use tests. No specific sample size is mentioned.
- Data provenance: Not specified for non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as no clinical testing was performed. For User Needs validation (cadaver labs/simulated use), it mentions "users," but does not specify their number or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical testing was performed.
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
Not applicable as no clinical testing was performed and the device is a navigation system, not an AI diagnostic/reader tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the navigation system components (software and hardware) independently, which is covered by the non-clinical tests for accuracy, software validation, electrical safety, etc. The "Accuracy" test specifically reports on the system's inherent navigation precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Accuracy: "Ground truth" would be established by precise measurement tools in phantom and cadaver settings, comparing the system's output to the known position/orientation.
- Other tests (Software, Electrical Safety, EMC, Sterilization, Biocompatibility): Ground truth is compliance with relevant industry standards (e.g., ISO, IEC, ASTM, ANSI/AAMI) and internal design specifications.
8. The sample size for the training set
Not applicable in the context of machine learning model training. The device is a navigation system, not an AI model that learns from training data in the traditional sense of AI diagnostics. Its software is validated against established specifications and standards.
9. How the ground truth for the training set was established
Not applicable as there is no "training set" for an AI model. "Ground truth" for system design and verification is based on engineering specifications and adherence to international standards.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.
October 31, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Leibinger GmbH & Company. KG Ms. Becky Ditty Senior Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K141941
Trade/Device Name: Stryker SpineMap® 3D Navigation System, Stryker SpineMask™ Tracker Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 16, 2014 Received: October 17, 2014
Dear Ms. Ditty:
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
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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.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141941
Device Name Stryker SpineMap® 3D Navigation System
Indications for Use (Describe)
The Stryker SpineMap® 3D Navigation System, when used with a 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 rigid anatomical structure can be identified.
The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including:
· Pedicle screw placement
Type of Use (Select one or both, as applicable)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."
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Indications for Use
510(k) Number (if known) K141941
Device Name Stryker SpineMask™ Tracker
Indications for Use (Describe)
Indications for Use
The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine.
- · In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.
- · When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.
Contraindication
The SpineMask™ Tracker is not intended for use in a MR Environment. The SpineMask™ Tracker is MR unsafe.
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) | ||
|---|---|---|---|
| X | X | ||
| 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."
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Image /page/4/Picture/0 description: The image shows the Stryker logo. The word "stryker" is in bold, black letters. Below the word "stryker" is the word "navigation" in a smaller, non-bolded font.
510(k) Summary റ
This chapter provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
5.1 Contact Details
| Applicant Name: | Stryker Leibinger GmbH & Co. KGBoetzinger Strasse 41D-79111 Freiburg, GermanyPhone number: +49-761-4512117Fax number: +49-761-451249117 |
|---|---|
| Registration No.: | 8010177 |
| Name of Contact Person: | Becky DittySr. Staff Regulatory Affairs Specialist4100 E. Milham AveKalamazoo, MI 49001becky.ditty@stryker.com(269) 389-3434 |
| Date Prepared: | October 16, 2014 |
Table 5-1: Contact Details
5.2 Device Name
| Trade Name: | Stryker SpineMap® 3D Navigation System | ||||
|---|---|---|---|---|---|
| Common Name: | Spine Navigation System | ||||
| ClassificationName: | ProductCode | Device | RegulationNumber | Class | ReviewPanel |
| PrimaryCodeOLO | OrthopedicStereotaxicInstrument | 21 CFR§882.4560 | II | Orthopedic |
Table 5-2: Device Name
5.3 Device Description
The Stryker SpineMap® 3D Navigation System is an image guided surgery system to enable open or percutaneous computer-assisted spinal surgery.
The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a CT image.
The system consists of a software application, smart instruments (e.g. patient/instrument trackers, pointers, navigated surgical instruments), and several accessories to enable the tracking of surgical instruments. The system also includes the SpineMask™ Tracker, a new patient tracking device.
The software application runs on a Stryker computer platform, consisting of a Stryker computer, a navigation camera and an IO-Tablet.
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Image /page/5/Picture/0 description: The image shows the Stryker logo. The word "stryker" is in bold, black letters. Below the word "stryker" is the word "navigation" in smaller, black letters.
5.4 Intended Use / Indications for Use
Stryker SpineMap® 3D Navigation System Indications for Use
The Stryker SpineMap® 3D Navigation System, when used with a 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 Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including:
- . Pedicle screw placement
Stryker SpineMask™ Tracker Indications for Use
The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine.
- . In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.
- . When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.
Contraindication
The SpineMask™ Tracker is not intended for use in a MR Environment. The SpineMask™ Tracker is MR unsafe.
5.5 Predicate Devices
The Stryker SpineMap 3D Navigation System, including the SpineMask™ Tracker, has the same intended use and substantially equivalent technological characteristics as the predicate devices shown in the following table:
| 510(k) Number | K012380 | K131214 | K022579 |
|---|---|---|---|
| Product Code | HAW | HAW | HAW |
| Trade Name | Stryker NavigationSystem - Spine &Fluoroscopy Module | Stryker NavigationSystem - CranialMapNeuro Module | Stryker NavigationSystem – KneeModule |
| Manufacturer | Stryker LeibingerGmbH & Co. KG | Stryker LeibingerGmbH & Co. KG | Stryker LeibingerGmbH & Co. KG |
| SubstantialEquivalenceCharacteristic | Intended UseTechnologicalFeatures | Intended UseTechnologicalFeatures | Intended Use |
Table 5-3: Legally Marketed Predicate Devices
5.6 Substantial Equivalence Comparison
Table 5-4 provides an overview of the substantial equivalence between the predicate devices and the subject devices.
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| Topic | Subject Device | Predicate Devices | EquivalenceAssessment |
|---|---|---|---|
| Intended Use | |||
| Indications for use | Stryker SpineMap® 3D Navigation System Indications for Use The Stryker SpineMap® 3D Navigation System, when used with a 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 Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including: Pedicle screw placement Stryker SpineMask™ Tracker Indications for Use The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine. In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery. When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine. Stryker SpineMask™ Tracker Contraindication The SpineMask™ Tracker is not intended for use in a MR | K012380, Stryker Navigation System - Spine & Fluoroscopy Module The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images. The Stryker Navigation System – Spine & Fluoroscopy Module supports, but is not limited to, the following surgical procedures: Pedicle screw placement Navigation Precisely positioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones. The system is not intended for total joint replacement procedures. | Equivalent |
| Topic | Subject Device | Predicate Devices | EquivalenceAssessment |
| Indications for use(continued) | See above | K131214, Stryker Navigation System - CranialMap NeuroModule | Equivalent |
| The Stryker Navigation System - Cranial Module is intendedas a planning and intraoperative guidance system to enableopen or percutaneous computer assisted surgery. | |||
| The system is indicated for any medical condition in which theuse of computer assisted planning and surgery may beappropriate. The system can be used for intra-operativeguidance where a reference to a rigid anatomical structure canbe identified. | |||
| The system should be operated only by trained personnel suchas surgeons and clinic staff. | |||
| The Cranial Navigation system supports, but is not limited to,the following surgical procedures: | |||
| ENT Procedures Endoscopic Sinus Surgery (ESS) Intranasal procedures Ear implant procedures | |||
| Neuro 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 Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures | |||
| Contraindications Surgical situation where increasing surgical time may bedetrimental to the patient | |||
| Topic | Subject Device | Predicate Devices | EquivalenceAssessment |
| Indications for use(continued) | See above | K022579, Stryker Navigation System - Knee ModuleThe Stryker Navigation System - Knee Module is intended asa planning and intraoperative guidance system to enable openor percutaneous computer assisted surgery.The system is indicated for conditions of the knee joint in whichthe use of computer assisted surgery may be appropriate.The surgeon has to determine whether the patient's conditionsare appropriate for this kind of procedure or not. A pathologicalcondition against the use of this system could be in somecases advanced osteoporosis or a displastic hip. | Equivalent |
| Main systemcomponents | Computer Platform SpineMap 3D Software Application Smart Instruments Patient Tracker Fixation Navigated Manual Instruments Instrument Battery, Trays | K012380, Stryker Navigation System – Spine &Fluoroscopy Module Computer Platform Spine Software Application Smart Instruments Patient Tracker Fixation Navigated Manual Instruments Instrument Battery, Trays K131214, Stryker Navigation System - CranialMap NeuroModule Computer Platform CranialMap Neuro Software Application Smart Instruments Patient Tracker Fixation Navigated Manual Instruments | Equivalent |
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| Topic | Subject Device | Predicate Devices | EquivalenceAssessment |
|---|---|---|---|
| Main systemcomponents (continued) | See above | K022579, Stryker Navigation System - Knee Module Computer Platform Knee Software Application Smart Instruments Patient Tracker Fixation Navigated Manual Instruments Instrument Battery, Trays | Equivalent |
| Modes of operation | Patient Preparation System Setup Image Import Planning Patient Registration Navigation | K012380, Stryker Navigation System - Spine &Fluoroscopy ModuleK131214, Stryker Navigation System - CranialMap NeuroModule Patient Preparation System Setup Image Import Planning Patient Registration Navigation K022579, Stryker Navigation System - Knee Module Patient Preparation System Setup Patient Registration | Equivalent |
| Topic | Subject Device | Predicate Devices | EquivalenceAssessment |
| Localization and trackingtechnology | Infrared optical active sensing technology: Infrared light emitted by diodes placed in a known fashion on navigated surgical instruments is sensed by a camera array (navigation camera) on the computer platform, thus allowing for computation of the spatial information | K012380, Stryker Navigation System – Spine &Fluoroscopy ModuleK131214, Stryker Navigation System – CranialMap NeuroModuleK022579, Stryker Navigation System – Knee Module Infrared optical active sensing technology: Infrared light emitted by diodes placed in a known fashion on navigated surgical instruments is sensed by a camera array (navigation camera) on the computer platform, thus allowing for computation of the spatial information | Equivalent |
| Operating principle | The software is installed on the computer that is part of the computer platform Images are imported in DICOM format The software displays the images and planned items with navigational information on a monitor | K012380, Stryker Navigation System – Spine &Fluoroscopy ModuleK131214, Stryker Navigation System – CranialMap NeuroModule The software is installed on the computer that is part of the computer platform Images are imported in DICOM format The software displays the images and planned items with navigational information on a monitor K022579, Stryker Navigation System – Knee Module The software is installed on the computer that is part of the computer platform The software displays the images and planned items with navigational information on a monitor | Equivalent |
| Topic | Subject Device | Predicate Devices | EquivalenceAssessment |
| Technological Characteristics - SpineMap 3D 3.0 Software | |||
| System accuracystatement | Mean navigation accuracy of $\pm$ 2mm point (tip) displacement and $\pm$ 2° angular axis displacement | K012380, Stryker Navigation System - Spine &Fluoroscopy ModuleK131214, Stryker Navigation System - CranialMap NeuroModule Mean navigation accuracy of $\pm$ 2mm point (tip) displacement and $\pm$ 2° angular axis displacement | Equivalent |
| Supported imagemodalities | CT MRI PET 3D C-Arm | K012380, Stryker Navigation System - Spine &Fluoroscopy Module CT MRI PET 3D C-Arm K131214, Stryker Navigation System - CranialMap NeuroModule CT MRI PET | Equivalent |
| Topic | Subject Device | Predicate Devices | EquivalenceAssessment |
| Planning features | Screws Measurements Planes Annotation Points Trajectories Segmentations Anatomical Systems Correlation 3D Models Compositions | K012380, Stryker Navigation System - Spine &Fluoroscopy Module Screws Measurements K131214, Stryker Navigation System - CranialMap NeuroModule Measurements Annotation Points Trajectories Segmentations Anatomical Systems Correlation 3D Models Compositions | Equivalent |
| Registration features | Anatomical Registration 3D C-arm Registration Automatic Intraoperative Mask (AIM) Registration | K012380, Stryker Navigation System – Spine &Fluoroscopy Module Anatomical Registration 3D C-arm Registration K131214, Stryker Navigation System - CranialMap NeuroModule Anatomical Registration Automatic Intraoperative Mask (AIM) Registration | Equivalent |
| Topic | Subject Device | Predicate Devices | EquivalenceAssessment |
| Technological Characteristics - SpineMask Tracker | |||
| Patient attachment | • Adhesive tape applied to patient's skin | K012380, Stryker Navigation System - Spine &Fluoroscopy Module Spine Clamp is attached to patient's spinous process K131214, Stryker Navigation System - CranialMap NeuroModule Adhesive tape applied to patient's skin | Equivalent |
| Patient tracking | • SpineMask Tracker applied to the dorsal surface of the patient. | K012380, Stryker Navigation System - Spine &Fluoroscopy Module Spine Tracker together with Spine Clamp, with the clamp attached to the spinous process K131214, Stryker Navigation System - CranialMap NeuroModule Patient Tracker together with Mayfield Clamp, with the clamp attached to the patient's skull Patient Registration Mask Tracker that is applied to the patient's face | Equivalent |
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Table 5-4: Substantial Equivalence Comparison
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The conclusions drawn from the nonclinical tests demonstrate that the Stryker SpineMap® 3D Navigation System performs substantially equivalent to the predicate devices. The differences in the indications for use, technological characteristics and performance characteristics do not raise new questions of safety and effectiveness. Consequently, the Stryker SpineMap® 3D Navigation System is substantially equivalent to the predicate device. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the Stryker SpineMap® 3D Navigation System is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.
5.7 Non-Clinical Testing
Validation activities have been conducted to provide assurance that the device meets the performance requirements under its indications for use conditions.
| Test | Description |
|---|---|
| SpineMaskTracker PatientTracking | Validated the equivalence of SpineMask Tracker and the Spine Clamp /Spine Tracker combination for minimally invasive procedures. |
| User Needs | Validated the product with users in cadaver labs or simulated use tests.Verified compatibility with conventional operative technique and otherdevices used in spinal surgery. |
| Accuracy | Verified the mean navigation accuracy of $\pm$ 2mm point displacement and $\pm$ 2°angular axis displacement according to ASTM F2554:2010 and in phantomtests.Verified equivalent system accuracy compared to predicate in cadaver tests. |
| Safety | Verified the effectiveness of all risk controls determined in the device riskanalysis. |
| GeneralRequirementsand Performance | Verified all components against their design specifications. |
| Software | Verification and validation according to IEC 62304:2006 and FDA guidanceon general principles of software validation, June 9, 1997. |
| Shelf Life Testing | Verified functionality of the single-use, sterile device and integrity of thepackaging after aging. |
| Biocompatibility | Verified the biocompatibility of all patient contact materials according to ISO10993-1:2009 and FDA draft guidance on the use of ISO 10993-1, April 23,2013. |
| Electrical Safety | Verified conformance to ANSI/AAMI ES 60601-1:2006-02. |
| ElectromagneticCompatibility | Verified conformance to IEC 60601-1-2: 2007-03, CISPR 11 Group 1, ClassB requirements as well as additional testing to verify compatibility with RFIDdevices operating in the 125 - 134 kHz frequency band. |
| Shipping | Verified functionality of the device after simulated shipping conditions. |
| Sterilization | Validated the EO sterilization process for the single-use, sterile deviceaccording to ISO 11135-1:2007 to a sterility assurance level (SAL) of 10-6and verified that the EO and ECH residuals are within the limits defined inISO 10993-7:2008. |
Table 5-5: Non-clinical Testing
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Image /page/15/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. Below the word "stryker" is a horizontal line. Below the line is the word "navigation" in a smaller, sans-serif font. The logo is black and white.
5.8 Clinical Testing
No clinical testing has been conducted.
5.9 Conclusion
The results of the non-clinical tests demonstrate that the Stryker SpineMap® 3D Navigation System performs as safely and effectively as the legally marketed predicate device. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the Stryker SpineMap® 3D Navigation System is substantially equivalent to the predicate devices with respect to its intended use, technological characteristics and performance characteristics.
§ 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).