(89 days)
The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer-assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available. The Stryker PROFESS™ system supports the following surgical procedures:
• Endoscopic sinus surgery
• Intranasal procedures
The PROFESS™ System, consisting of a computer platform, software and sterile single-use accessories, is designed to enable image guided surgery in intranasal and sinus surgery. Specifically, the system tracks and displays to the surgeon the intraoperative location of navigated surgical instruments, for example suction tools, relative to a CT image. The PROFESS™ System is based on the use of live video images captured by the miniature video camera mounted on the PROFESS™ Navigated Surgical Instruments. The captured images can be processed by the PROFESS™ Software for localization and tracking of the PROFESS™ Navigated Surgical Instrument relative to the PROFESS™ Patient Tracker as long as the PROFESS™ Patient Tracker is partially visible in the video image.
The following are the PROFESS™ System components:
- PROFESS™ Software
- PROFESS™ Navigated Surgical Instruments:
- PROFESS™ Straight Suction
- PROFESS™ Curved 70°Suction
- PROFESS™ Curved 90° Suction
- PROFESS™ Frontal Sinus Seeker
- PROFESS™ Registration Stickers
- PROFESS™ Patient Tracker
- PROFESS™ Adaptor Cable
- Computer platform containing an SPC-3 Workstation and IO-Tablet, one of:
- Stryker ADAPT® Platform
- Stryker Nav3® Platform
- Stryker Nav3i™ Platform
The provided document describes the Stryker PROFESS™ System, a navigation surgical software module intended for intraoperative guidance in intranasal and sinus computer-assisted surgery. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
Accuracy | Verified accuracy of ± 2 mm within nasal cavities (according to ASTM F2554:2010 and in phantom and cadaver tests) |
Accelerated Ageing Testing | Verified functionality of all single-use, sterile components and packaging integrity after accelerated ageing |
Biocompatibility | Verified 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 | Verified conformance to ANSI/AAMI ES 60601-1:2006-02 |
Electromagnetic Compatibility | Verified conformance to IEC 60601-1-2: 2007-03, CISPR 11 Group 1, Class A requirements, and compatibility with RFID devices (125 - 134 kHz) |
General Requirements and Performance | Verified all components against their design specifications |
Safety | Verified the effectiveness of all risk controls determined in the device risk analysis |
Shipping | Verified functionality of all components after simulated shipping conditions |
Software | Verification and validation according to IEC 62304:2006 and FDA guidance on general principles of software validation, June 9, 1997 |
Sterilization | Validated EO sterilization process for single-use, sterile components to a sterility assurance level (SAL) of 10-6 (according to ISO 11135-1:2007) and verified EO and ECH residuals within ISO 10993-7:2008 limits |
Product Validation | Validated product with users in cadaver labs; verified compatibility with conventional operative technique and other devices |
2. Sample size used for the test set and the data provenance
The document states "No clinical testing has been conducted." (Page 15). The non-clinical testing included "phantom and cadaver tests" for accuracy and "users in cadaver labs" for product validation. However, the exact sample sizes (number of phantoms or cadavers) and their provenance (e.g., country of origin, retrospective/prospective) are not specified for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "users in cadaver labs" for product validation, implying medical professionals, but it does not specify the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth in the non-clinical tests.
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 conducted. The document explicitly states, "No clinical testing has been conducted." The device is intended as an intraoperative guidance system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Accuracy" test (± 2 mm) was performed on "phantom and cadaver tests," which appears to be a standalone measurement of the system's ability to localize instruments relative to CT images. This can be considered a standalone performance assessment of the navigation component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the accuracy testing, the ground truth was likely established by precise physical measurements in phantom models and cadaver dissections or using highly accurate measurement systems to determine the true position of instruments relative to the CT images. For product validation, "users in cadaver labs" were involved, suggesting practical effectiveness and usability were assessed. However, specific details about "ground truth" other than physical models are not provided.
8. The sample size for the training set
The document does not mention any training set or details about machine learning model development. This submission is for a surgical navigation system, and the provided information focuses on engineering verification and validation, not on AI model training for diagnostic or predictive tasks.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), this information is not applicable or provided in the document.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2014
Stryker IMT Ms. Becky Ditty Sr. Staff Regulatory Affairs Specialist 4100 E. Milham Ave. Kalamazoo, MI 49001
Re: K141551
Trade/Device Name: Stryker PROFESS System Regulation Number: 21 CFR 882.4560 Regulation Name: Ear, Nose, and Throat Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: June 10, 2014 Received: June 11, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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/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 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,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
Stryker PROFESS™ System
Indications for Use (Describe)
The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intransal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer-assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available. The Stryker PROFESS™ system supports the following surgical procedures:
• Endoscopic sinus surgery
• Intranasal procedures
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Eric A. Mann -S 2014.09.08 17:23:26 -04'00'
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the Stryker Navigation logo. The word "stryker" is in a bold, sans-serif font, with a registered trademark symbol to the right. Below the word "stryker" is the word "Navigation" with a line above it.
Section 5. 510(k) Summary
This section provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 510(k) Owner: | Stryker Leibinger GmbH & Co. KG – NavigationBoetzinger Str. 41D-79111 Freiburg, GERMANY(p) (269) 389-3434(f) (269) 389-2375 |
|---|---|
| Contact Person: | Becky DittySr. Staff Regulatory Affairs Specialist4100 E. Milham AveKalamazoo, MI 49002becky.ditty@stryker.com |
| Registration No.: | 8010177 |
| Trade Name: | Stryker PROFESS™ System |
| Common Name: | Navigation System |
| Classification Name: | Ear, Nose, and Throat Stereotaxic Instrument |
| Regulation Number: | 882.4560 |
| Product Code: | PGW |
| Device Description: | The PROFESS™ System, consisting of a computerplatform, software and sterile single-use accessories, isdesigned to enable image guided surgery in intranasal andsinus surgery. Specifically, the system tracks and displaysto the surgeon the intraoperative location of navigatedsurgical instruments, for example suction tools, relative to aCT image.The PROFESS™ System is based on the use of live videoimages captured by the miniature video camera mountedon the PROFESS™ Navigated Surgical Instruments. The |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all connected, and the word is in black. There is a registered trademark symbol to the right of the word.
captured images can be processed by the PROFESS™ Software for localization and tracking of the PROFESS™ Navigated Surgical Instrument relative to the PROFESS™ Patient Tracker as long as the PROFESS™ Patient Tracker is partially visible in the video image.
The following are the PROFESS™ System components:
- PROFESS™ Software ●
- PROFESS™ Navigated Surgical Instruments: ●
- PROFESS™ Straight Suction
- PROFESS™ Curved 70°Suction
- PROFESS™ Curved 90° Suction
- PROFESS™ Frontal Sinus Seeker
- PROFESS™ Registration Stickers ●
- PROFESS™ Patient Tracker ●
- PROFESS™ Adaptor Cable .
- Computer platform containing an SPC-3 Workstation . and IO-Tablet, one of:
- Stryker ADAPT® Platform
- Stryker Nav3® Platform
- o Stryker Nav3i™ Platform
- The Stryker PROFESS™ system is a navigation surgical Indications for Use: software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative quidance system to enable intranasal and sinus computer assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified.
The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available.
The Stryker PROFESS™ system supports the following surqical procedures:
- Endoscopic sinus surgery .
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "Stryker" in a bold, sans-serif font. The word is in all lowercase letters except for the first letter, which is capitalized. A registered trademark symbol is located to the right of the word. The word is black and the background is white.
- Intranasal procedures
The PROFESS™ System has the same intended use and Predicate Devices: technological characteristics as the predicate devices shown in the following tables:
| Predicate Device | 510(k)Number | ClearanceDate | Predicate SubstantialEquivalence Characteristic | Feature | Subject Device | Predicate Devices |
|---|---|---|---|---|---|---|
| Stryker Navigation System – ENTModule | K002732 | 10/01/2000 | Navigated Surgical Instruments | Indications forUse | The Stryker PROFESS™ system is a navigation surgical software module that,when used with a specific Stryker computer workstation, is intended as anintraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location ofnavigated surgical instruments relative to a CT image. The system can be usedfor intraoperative guidance where a reference to a rigid anatomical structure canbe identified. | K002732, Stryker Navigation System - ENT ModuleThe Stryker Navigation System - ENT Module is intended as a planning andintraoperative guidance system to enable open or percutaneous image guidedsurgery. The system is indicated for any medical condition in which the use ofimage guided surgery may be appropriate, and where a reference to a rigidanatomical structure can be identified relative to medical images. The ENTModule is also indicated for intranasal or sinus use. |
| Stryker Navigation System – CranialModule | K062640 | 12/14/2006 | Application SoftwarePatient Reference LocalizerRegistration Accessories | The Stryker PROFESS™ system is indicated for intranasal and sinus surgery inwhich the use of computer-assisted surgery is appropriate and for which a CTimage of the patient in accordance with the imaging protocol is available.The Stryker PROFESS™ system supports the following surgical procedures:• Endoscopic sinus surgery• Intranasal procedures | K062640, Stryker Navigation System - Cranial Module (iNtellect)The Stryker Navigation System - Cranial Module is intended as a planningand intraoperative guidance system to enable open or percutaneous computerassisted surgery. The system is indicated for any medical condition in whichthe use of computer assisted planning and surgery may be appropriate. Thesystem can be used for intra-operative guidance where a reference to a rigidanatomical structure can be identified. | |
| Stryker NAV3i Platform | K130874 | 09/27/2013 | Computer Platform | The system should be operated only by trained personnel such as surgeons andclinic staff. The Cranial Navigation system supports, but is not limited to, thefollowing surgical procedures: | ||
| ENT/Neuro 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• Placement of patient specific implants |
TABLE 5-1 PREDICATE DEVICES
{6}------------------------------------------------
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol to the right of the word. The word is likely a company logo or brand name.
| Feature | Subject Device | Predicate Devices |
|---|---|---|
| Indications forUse (continued) | K130874, Stryker NAV3i PlatformThe NAV3i platform is a computer workstation that, when used with specificStryker Navigation surgical software, displays patient specific images and/orpatient specific anatomical landmark information and tracks the position andmovement of surgical instruments in relation to a target anatomical site on apatient.The clinical setting and target population for the NAV3i Platform is that of apatient undergoing a surgical procedure using stereotactic techniques.Equivalent | |
| Components | • PROFESS™ Software• PROFESS™ Navigated Surgical Instruments• PROFESS™ Registration • Stickers• PROFESS™ Patient Tracker• PROFESS™ Adaptor Cable• Computer platform, one of:o Stryker ADAPT® Platformo Stryker Nav3® Platformo Stryker Nav3i™ Platform | K002732, Stryker Navigation System - ENT Module• ENT Software• Navigated Surgical Instruments• Instrument Battery• Patient Tracking System• Computer Platform:o Stryker Navigation System I - CartK062640, Stryker Navigation System - Cranial Module• iNtellect Software• Navigated Surgical Instruments• Instrument Battery• Patient Registration Mask• Computer Platform, one of:o Stryker Navigation System II - Carto Stryker eNliteEquivalent |
| Stryker ADAPT® Platform | ||
| Workstation | Stryker PC-3 (SPC-3) | K130874, Stryker NAV3i PlatformStryker PC-3 (SPC-3)Equivalent |
| OperatingSystem | Windows XP | K130874, Stryker NAV3i PlatformWindows XPEquivalent |
| User Interface | • IO-Tablet Touchscreen with virtual keyboard• Mouse | K130874, Stryker NAV3i Platform• IO-Tablet Touchscreen with virtual keyboard• MouseEquivalent |
| Feature | Subject Device | Predicate Devices |
| Main Monitor | 24" | K130874, Stryker NAV3i Platform32"Equivalent |
| Main MonitorPosition | Fixed position facing surgical field | K130874, Stryker NAV3i PlatformMounted on articulated arm for flexible positioningEquivalent |
| Localizer | N/A | K130874, Stryker NAV3i PlatformInfrared optical localizer Navigation System II CameraEquivalent |
| Interfaces | • USB• CD/DVD• Equipotentially ConnectorAdditional interfaces, not used by PROFESS™ System:• LAN• BNC• S-Video | K130874, Stryker NAV3i Platform• USB• CD/DVD• Equipotentially ConnectorAdditional interfaces, not used by PROFESS™ System:• LAN• BNC• S-Video• HDMI• DVI• VGA• FireWire• Microscope (Optional Accessory)Equivalent |
| RFID Reader | Deactivated by default, can be activated with an optional RFID Activation Kit | K130874, Stryker NAV3i PlatformDeactivated by default, can be activated with an optional RFID Activation KitEquivalent |
| WLAN Interface | Deactivated by default, cannot be activated by the user | K130874, Stryker NAV3i PlatformDeactivated by default, can be activated with an optional WLAN Activation KitEquivalent |
| UninterruptiblePower Supply | N/A | K130874, Stryker NAV3i PlatformYesEquivalent |
| Feature | Subject Device | Predicate Devices |
| Stryker Nav3® Platform | ||
| Workstation | Stryker PC-3 (SPC-3) | K130874, Stryker NAV3i PlatformStryker PC-3 (SPC-3)Equivalent |
| OperatingSystem | Windows XP | K130874, Stryker NAV3i PlatformWindows XPEquivalent |
| User Interface | • IO-Tablet Touchscreen with virtual keyboard• Mouse | K130874, Stryker NAV3i Platform• IO-Tablet Touchscreen with virtual keyboard• MouseEquivalent |
| Main Monitor | 24" | K130874, Stryker NAV3i Platform32"Equivalent |
| Main MonitorPosition | Fixed position facing surgical field | K130874, Stryker NAV3i PlatformMounted on articulated arm for flexible positioningEquivalent |
| Localizer | Infrared optical localizer Navigation System II Camera | K130874, Stryker NAV3i PlatformInfrared optical localizer Navigation System II CameraEquivalent |
| Interfaces | • USB• CD/DVD• Equipotentially ConnectorAdditional interfaces, not used by PROFESS™ System:• LAN• BNC• S-Video | K130874, Stryker NAV3i Platform• USB• CD/DVD• Equipotentially ConnectorAdditional interfaces, not used by PROFESS™ System:• LAN• BNC• S-Video• HDMI• DVI• VGA• FireWire• Microscope (Optional Accessory) |
| Feature | Subject Device | Predicate Devices |
| RFID Reader | Deactivated by default, can be activated with an optional RFID Activation Kit | K130874, Stryker NAV3i PlatformDeactivated by default, can be activated with an optional RFID Activation KitEquivalent |
| WLAN Interface | Deactivated by default, cannot be activated by the user | K130874, Stryker NAV3i PlatformDeactivated by default, can be activated with an optional WLAN Activation KitEquivalent |
| UninterruptiblePower Supply | N/A | K130874, Stryker NAV3i PlatformYesEquivalent |
| PROFESS™ Software | ||
| OperatingPrinciple | The PROFESS™ Software is installed on the computer platform. Images areimported in DICOM format. The software displays the anatomical images on amonitor facing the surgeon and provides the navigational information. | K062640, Stryker Navigation System - Cranial ModuleThe iNtellect software is installed on the computer platform. Images areimported in DICOM format. The software displays the anatomical and functionalimages and planned items on a monitor facing the surgeon and provides thenavigational information.Equivalent |
| Modes ofOperation | • Data Import• System Setup• Registration• Navigation | K062640, Stryker Navigation System - Cranial Module• Data Import• Planning• System Setup• Registration• NavigationEquivalent |
| ControlMechanism | The software is controlled using:• Mouse• Touchscreen• Keyboard• via buttons on the sterile navigated surgical instruments | K062640, Stryker Navigation System - Cranial ModuleThe software is controlled using:• Mouse• Keyboard• via buttons on the sterile navigated surgical instrumentsEquivalent |
| Localization andTrackingTechnology | Video localization and tracking technology: A miniature video camera mountedon the PROFESS™ Navigated Surgical Instruments captures live video imageswhich can be processed by the PROFESS™ Software for localization andtracking of the PROFESS™ Navigated Surgical Instrument relative to thePROFESS™ Patient Tracker | K062640, Stryker Navigation System - Cranial ModuleInfrared optical active sensing technology: Infrared light emitted by diodesplaced in a known fashion on navigated surgical instruments is sensed by acamera array (Navigation Camera) on the computer platform, thus allowing forcomputation of the spatial information.Equivalent |
| Feature | Subject Device | Predicate Devices |
| System AccuracyStatement | Within the nasal cavities the system has a mean accuracy of 2 mm | K062640, Stryker Navigation System - Cranial ModuleWithin the camera working space, the system has a mean accuracy of 2 mm fortranslation and 2° for rotationEquivalent |
| Supported ImageModalities | • CT | K062640, Stryker Navigation System - Cranial Module• CT• CTA• MR• MRA• fMRI• PET• SPECTEquivalent |
| ScannerInterfaces | • CD/DVD• USB | K062640, Stryker Navigation System - Cranial Module• CD/DVD• USB• Network connectivity• Magneto Optical DiskEquivalent |
| RecommendedCT ImagingProtocol | • No oblique angle of locator/survey lines• No gantry tilt• Slice thickness - 1 x 1 or 1.25 x 1.25 mm best; 2.0 mm maximum• Scan contiguous, no gap, no overlapping• Pixel/Matrix MUST be square - 256 x 256 minimum; 512 x 512 maximum• FOV- Smallest to include patient's external soft tissue, particularly tip ofnose and top of head• Scan inferior to superior from hard palate to and including top of vertex• Axial, soft tissue algorithm, never bone, helical/spiral acceptable• Patient supine• Patients head in true anatomical position with tip of nose most anterior | K062640, Stryker Navigation System - Cranial Module• Contiguous, non-overlapping slices.• Constant slice thickness. Thinnest possible slice thickness (1-2 mm best, 3 mm maximum acceptable)• Use higher resolution imaging to increase accuracy, e.g., 512 x 512 pixels• Pixels must be square, use the same matrix and pixel size for all images.• No relative shifts or rotations of the images in one set, no gantry tilt.• Use smallest field of view to fully encompass the region of interest with suitable resolution. Include the• For mask registration, the scan has to encompass the entire nose, including the tip of the nose.• Scan from the hard palate to the skull vertex.Equivalent |
| Registration | • Surface matching using video tracking of the PROFESS™ RegistrationStickers to capture the patient's skin surface• Anatomical landmark matching | K062640, Stryker Navigation System - Cranial Module• Surface matching using Infrared optical active sensing of the PatientRegistration Mask to capture the patient's skin surface• Surface matching using pointer to digitize a minimum of 32 distributed arbitrary points on the patient's skin• Anatomical landmark matchingEquivalent |
| Feature | Subject Device | Predicate Devices |
| Display of TipLocation inNavigation Mode | Multiplanar reconstruction with sagittal, coronal and axial views withsuperimposed cross-hairs to indicate the intraoperative tip location of thePROFESS™ Navigated Surgical Instrument | K062640, Stryker Navigation System - Cranial Module• Multiplanar reconstruction with sagittal, coronal and axial views withsuperimposed cross-hairs to indicate the intraoperative tip location of thenavigated surgical instruments.• 3D views with superimposed cross-hairs to indicate the intraoperative tiplocation of the navigated surgical instruments and a surface or volumetricreconstruction along with a rendered representation of the tools at theactual location.Equivalent |
| Check forSustainedAccuracy Intra-operatively | • Navigated surgical instrument's tip geometry check on initialization ofinstrument.• Intra-operative interactive landmark test. | K062640, Stryker Navigation System - Cranial Module• Navigated surgical instrument's tip geometry check on initialization ofinstrument.• Intra-operative interactive landmark test.Equivalent |
| PROFESS™ Navigated Surgical Instruments | ||
| Power Supply | 5V power supply from USB port on computer platform via PROFESS™ AdaptorCable | K002732, Stryker Navigation System - ENT Module3V power supply from Instrument BatteryEquivalent |
| Communicationwith ComputerPlatform | Via PROFESS™ Adaptor Cable using USB 2.0 protocol | K002732, Stryker Navigation System - ENT ModuleWireless infra-red communication using proprietary protocolEquivalent |
| Number ofButtons forControl ofSoftware fromthe Sterile Field | 1 Button | K002732, Stryker Navigation System - ENT Module3 ButtonsEquivalent |
| Calibration | Calibrated at the manufacturer's site | K002732, Stryker Navigation System - ENT ModuleCalibrated at the manufacturer's siteEquivalent |
| Material (for bodycontacting parts) | AISI 301 or AISI 304 Stainless Steel | K002732, Stryker Navigation System - ENT ModuleAISI 301 or AISI 304 Stainless SteelEquivalent |
| SterilizationMethod | Ethylene Oxide (EO) sterilized | K002732, Stryker Navigation System - ENT Module• Navigated Surgical Instruments: Steam Sterilized• Instrument Battery: Ethylene Oxide (EO) Sterilized or Gamma SterilizedEquivalent |
| Feature | Subject Device | Predicate Devices |
| Single Use vs.Re-Usable | Sterile, Single-use Only | K002732, Stryker Navigation System - ENT Module• Navigated Surgical Instruments: Sterile Re-usable• Instrument Battery: Sterile, Single-use OnlyEquivalent |
| PROFESS™ Patient Tracker | ||
| PatientReferenceLocalizer | The PROFESS™ Patient Tracker is the patient reference localizer. ThePROFESS™ Patient Tracker contacts the patient on the bridge of the nose(nasion) and the two outer ear canals. The patient tracker is elastic to fitdifferent head sizes. Additionally, the position of the ear-pins can be adjustedfor very small or large head sizes. | K062640, Stryker Navigation System - Cranial ModuleThe Patient Registration Mask is used as the patient reference localizer. ThePatient Registration Mask is applied to the patient's skin.Equivalent |
| Material (for bodycontacting parts) | • ABS Resin• Thermoplastic Polymer (TPE) | K062640, Stryker Navigation System - Cranial Module• 3M™ Hypoallergenic pressure sensitive acrylate based adhesiveEquivalent |
| Single-Use vs.Re-Usable | Single-use | K062640, Stryker Navigation System - Cranial ModuleSingle-useEquivalent |
| SterilizationMethod | Ethylene Oxide (EO) sterilized | K062640, Stryker Navigation System - Cranial ModuleEthylene Oxide (EO) sterilizedEquivalent |
| PROFESS™ Registration Stickers | ||
| RegistrationAccessories | The PROFESS™ Registration Stickers are used to define where skin pointsare sampled for surface matching | K062640, Stryker Navigation System - Cranial ModuleThe Patient Registration Mask is used to define where skin points aresampled for surface matchingEquivalent |
| Material (for bodycontacting parts) | 3M™ Hypoallergenic pressure sensitive acrylate based adhesive | K062640, Stryker Navigation System - Cranial Module3M™ Hypoallergenic pressure sensitive acrylate based adhesiveEquivalent |
| Single-Use vs.Re-Usable | Single-use | K062640, Stryker Navigation System - Cranial ModuleSingle-useEquivalent |
| SterilizationMethod | Ethylene Oxide (EO) sterilized | K062640, Stryker Navigation System - Cranial ModuleEthylene Oxide (EO) sterilizedEquivalent |
| TABLE 5-2 COMPARISON TABLE |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The letters are closely spaced together, creating a solid block of text.
{9}------------------------------------------------
stryker®
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the Stryker logo in black and white. The logo is a stylized wordmark with a bold, sans-serif font. The registered trademark symbol is located to the right of the word "stryker".
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol to the right of the word. The word is in black and the background is white.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol to the right of the word. The word is likely a company logo or brand name.
{13}------------------------------------------------
stryker®
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all in lowercase, and the word is black. There is a registered trademark symbol to the right of the letter "r".
| SubstantialEquivalence(SE) Rational: | The conclusions drawn from the nonclinical tests demonstrate that the Stryker PROFESS TM 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 PROFESS TM System is substantially equivalent to the predicate devices. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the Stryker PROFESS TM System is substantially equivalent to the predicate devices with respect to its intended use, technological characteristics and performance characteristics. |
|---|---|
| Non-Clinical | Verification and validation activities have been conducted to |
) Testing:
validation activities have been conducted to n ar cation id ) provide assurance that the device meets the performance requirements under its intended use conditions.
| Test | Description |
|---|---|
| Accuracy | Verified the accuracy of ± 2 mm according toASTM F2554:2010 and in phantom andcadaver tests |
| Accelerated AgeingTesting | Verified functionality of all single-use, sterilecomponents and integrity of all packaging afteraccelerated ageing |
| Biocompatibility | Verified the biocompatibility of all patientcontact materials according to ISO 10993-1:2009 and FDA draft guidance on the use ofISO 10993-1, April 23, 2013 |
| Electrical Safety | Verified conformance to ANSI/AAMI ES60601-1:2006-02. |
| ElectromagneticCompatibility | Verified conformance to IEC 60601-1-2: 2007-03, CISPR 11 Group 1, Class A requirementsas well as additional testing to verifycompatibility with RFID devices operating inthe 125 - 134 kHz frequency band. |
| General Requirementsand Performance | Verified all components against their designspecifications |
| Safety | Verified the effectiveness of all risk controlsdetermined in the device risk analysis |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol to the upper right of the word. The word is in black and the background is white.
| Test | Description |
|---|---|
| Shipping | Verified functionality of all components aftersimulated shipping conditions |
| Software | Verification and validation according to IEC62304:2006 and FDA guidance on generalprinciples of software validation, June 9, 1997 |
| Sterilization | Validated the EO sterilization process for allsingle-use, sterile components according toISO 11135-1:2007 to a sterility assurancelevel (SAL) of 10-6 and verified that the EOand ECH residuals are within the limits definedin ISO 10993-7:2008. |
| Product Validation | Validated the product with users in cadaverlabs. Verified compatibility with conventionaloperative technique and other devices used inintranasal or sinus surgery. |
Clinical Testing:
No clinical testing has been conducted.
The results of the nonclinical tests demonstrate that the Conclusion: Stryker PROFESS™ System performs as safely and effectively as the legally marketed predicate devices. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the Stryker PROFESS TM System is substantially equivalent to the predicate devices with respect to its intended use, technological characteristics and performance characteristics
Submitted by:
Sr. Staff Regulatory Affairs Specialist
Signature
Date Submitted:
June 10, 2014
Becky Ditty
§ 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).