(89 days)
Not Found
No
The summary describes image processing for localization and tracking, but does not mention AI, ML, or related concepts like neural networks or deep learning. The performance studies focus on traditional metrics like accuracy and safety, not AI/ML specific evaluations.
No
The device is described as a "navigation surgical software module" intended as an "intraoperative guidance system" to track and display the location of surgical instruments relative to a CT image. Its purpose is to assist the surgeon during procedures, not to directly treat a disease or condition itself.
No
The device is described as an intraoperative guidance system for computer-assisted surgery, tracking surgical instruments relative to a CT image, rather than diagnosing a condition.
No
The device description explicitly lists multiple hardware components beyond just the software, including surgical instruments, registration stickers, a patient tracker, an adaptor cable, and a computer platform (workstation and IO-Tablet).
Based on the provided information, the Stryker PROFESS™ system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is an "intraoperative guidance system" for "intranasal and sinus computer-assisted surgery." It tracks and displays the location of surgical instruments relative to a CT image. This is a surgical navigation system, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The components described are a computer platform, software, surgical instruments, trackers, and cables. These are tools used during surgery for guidance, not for analyzing biological samples.
- Function: The system's function is to provide real-time spatial information during surgery based on pre-operative imaging. It does not perform any tests or analyses on biological specimens.
IVD devices are typically used to test blood, urine, tissue, or other bodily fluids or substances to detect diseases, conditions, or infections. The Stryker PROFESS™ system does not perform any such tests.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
PGW
Device Description
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
- o Stryker Nav3i™ Platform
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
intranasal and sinus, nasal cavities, patient's external soft tissue, tip of nose, top of head, hard palate, skull vertex, patient's skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel such as surgeons and clinic staff.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Accuracy: Verified the accuracy of ± 2 mm according to ASTM F2554:2010 and in phantom and cadaver tests.
Accelerated Ageing Testing: Verified functionality of all single-use, sterile components and integrity of all packaging after accelerated ageing.
Biocompatibility: 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: 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 as well as additional testing to verify compatibility with RFID devices operating in the 125 - 134 kHz frequency band.
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 the EO sterilization process for all single-use, sterile components 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.
Product Validation: Validated the product with users in cadaver labs. Verified compatibility with conventional operative technique and other devices used in intranasal or sinus surgery.
Clinical Testing:
No clinical testing has been conducted.
Conclusion: The results of the nonclinical tests demonstrate that the Stryker PROFESS™ System performs as safely and effectively as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ± 2 mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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'
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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 – Navigation
Boetzinger Str. 41
D-79111 Freiburg, GERMANY
(p) (269) 389-3434
(f) (269) 389-2375 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Becky Ditty
Sr. Staff Regulatory Affairs Specialist
4100 E. Milham Ave
Kalamazoo, MI 49002
becky.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 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 |
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 .
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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 | Clearance
Date | Predicate Substantial
Equivalence Characteristic | Feature | Subject Device | Predicate Devices |
|-----------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stryker Navigation System – ENT
Module | K002732 | 10/01/2000 | Navigated Surgical Instruments | Indications for
Use | 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. | K002732, Stryker Navigation System - ENT Module
The Stryker Navigation System - ENT Module 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 can be identified relative to medical images. The ENT
Module is also indicated for intranasal or sinus use. |
| Stryker Navigation System – Cranial
Module | K062640 | 12/14/2006 | Application Software
Patient Reference Localizer
Registration Accessories | | 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 | K062640, Stryker Navigation System - Cranial Module (iNtellect)
The Stryker Navigation System - Cranial 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 intra-operative guidance where a reference to a rigid
anatomical 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 and
clinic staff. The Cranial Navigation system supports, but is not limited to, the
following 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
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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 for | ||
| Use (continued) | K130874, Stryker NAV3i Platform | |
| The NAV3i platform is a computer workstation that, when used with specific | ||
| Stryker Navigation surgical software, displays patient specific images and/or | ||
| patient specific anatomical landmark information and tracks the position and | ||
| movement of surgical instruments in relation to a target anatomical site on a | ||
| patient. | ||
| The clinical setting and target population for the NAV3i Platform is that of a | ||
| patient 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® Platform | ||
| o Stryker Nav3® Platform | ||
| o 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 - Cart | ||
| K062640, Stryker Navigation System - Cranial Module | ||
| • iNtellect Software | ||
| • Navigated Surgical Instruments | ||
| • Instrument Battery | ||
| • Patient Registration Mask | ||
| • Computer Platform, one of: | ||
| o Stryker Navigation System II - Cart | ||
| o Stryker eNlite | ||
| Equivalent | ||
| Stryker ADAPT® Platform | ||
| Workstation | Stryker PC-3 (SPC-3) | K130874, Stryker NAV3i Platform |
| Stryker PC-3 (SPC-3) | ||
| Equivalent | ||
| Operating | ||
| System | Windows XP | K130874, Stryker NAV3i Platform |
| Windows XP | ||
| Equivalent | ||
| User Interface | • IO-Tablet Touchscreen with virtual keyboard | |
| • Mouse | K130874, Stryker NAV3i Platform | |
| • IO-Tablet Touchscreen with virtual keyboard | ||
| • Mouse | ||
| Equivalent | ||
| Feature | Subject Device | Predicate Devices |
| Main Monitor | 24" | K130874, Stryker NAV3i Platform |
| 32" | ||
| Equivalent | ||
| Main Monitor | ||
| Position | Fixed position facing surgical field | K130874, Stryker NAV3i Platform |
| Mounted on articulated arm for flexible positioning | ||
| Equivalent | ||
| Localizer | N/A | K130874, Stryker NAV3i Platform |
| Infrared optical localizer Navigation System II Camera | ||
| Equivalent | ||
| Interfaces | • USB | |
| • CD/DVD | ||
| • Equipotentially Connector | ||
| Additional interfaces, not used by PROFESS™ System: | ||
| • LAN | ||
| • BNC | ||
| • S-Video | K130874, Stryker NAV3i Platform | |
| • USB | ||
| • CD/DVD | ||
| • Equipotentially Connector | ||
| Additional 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 Platform |
| Deactivated by default, can be activated with an optional RFID Activation Kit | ||
| Equivalent | ||
| WLAN Interface | Deactivated by default, cannot be activated by the user | K130874, Stryker NAV3i Platform |
| Deactivated by default, can be activated with an optional WLAN Activation Kit | ||
| Equivalent | ||
| Uninterruptible | ||
| Power Supply | N/A | K130874, Stryker NAV3i Platform |
| Yes | ||
| Equivalent | ||
| Feature | Subject Device | Predicate Devices |
| Stryker Nav3® Platform | ||
| Workstation | Stryker PC-3 (SPC-3) | K130874, Stryker NAV3i Platform |
| Stryker PC-3 (SPC-3) | ||
| Equivalent | ||
| Operating | ||
| System | Windows XP | K130874, Stryker NAV3i Platform |
| Windows XP | ||
| Equivalent | ||
| User Interface | • IO-Tablet Touchscreen with virtual keyboard | |
| • Mouse | K130874, Stryker NAV3i Platform | |
| • IO-Tablet Touchscreen with virtual keyboard | ||
| • Mouse | ||
| Equivalent | ||
| Main Monitor | 24" | K130874, Stryker NAV3i Platform |
| 32" | ||
| Equivalent | ||
| Main Monitor | ||
| Position | Fixed position facing surgical field | K130874, Stryker NAV3i Platform |
| Mounted on articulated arm for flexible positioning | ||
| Equivalent | ||
| Localizer | Infrared optical localizer Navigation System II Camera | K130874, Stryker NAV3i Platform |
| Infrared optical localizer Navigation System II Camera | ||
| Equivalent | ||
| Interfaces | • USB | |
| • CD/DVD | ||
| • Equipotentially Connector | ||
| Additional interfaces, not used by PROFESS™ System: | ||
| • LAN | ||
| • BNC | ||
| • S-Video | K130874, Stryker NAV3i Platform | |
| • USB | ||
| • CD/DVD | ||
| • Equipotentially Connector | ||
| Additional 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 Platform |
| Deactivated by default, can be activated with an optional RFID Activation Kit | ||
| Equivalent | ||
| WLAN Interface | Deactivated by default, cannot be activated by the user | K130874, Stryker NAV3i Platform |
| Deactivated by default, can be activated with an optional WLAN Activation Kit | ||
| Equivalent | ||
| Uninterruptible | ||
| Power Supply | N/A | K130874, Stryker NAV3i Platform |
| Yes | ||
| Equivalent | ||
| PROFESS™ Software | ||
| Operating | ||
| Principle | The PROFESS™ Software is installed on the computer platform. Images are | |
| imported in DICOM format. The software displays the anatomical images on a | ||
| monitor facing the surgeon and provides the navigational information. | K062640, Stryker Navigation System - Cranial Module | |
| The iNtellect software is installed on the computer platform. Images are | ||
| imported in DICOM format. The software displays the anatomical and functional | ||
| images and planned items on a monitor facing the surgeon and provides the | ||
| navigational information. | ||
| Equivalent | ||
| Modes of | ||
| Operation | • Data Import | |
| • System Setup | ||
| • Registration | ||
| • Navigation | K062640, Stryker Navigation System - Cranial Module | |
| • Data Import | ||
| • Planning | ||
| • System Setup | ||
| • Registration | ||
| • Navigation | ||
| Equivalent | ||
| Control | ||
| Mechanism | The software is controlled using: | |
| • Mouse | ||
| • Touchscreen | ||
| • Keyboard | ||
| • via buttons on the sterile navigated surgical instruments | K062640, Stryker Navigation System - Cranial Module | |
| The software is controlled using: | ||
| • Mouse | ||
| • Keyboard | ||
| • via buttons on the sterile navigated surgical instruments | ||
| Equivalent | ||
| Localization and | ||
| Tracking | ||
| Technology | Video localization and tracking technology: A miniature video camera mounted | |
| on the PROFESS™ Navigated Surgical Instruments captures live video images | ||
| which can be processed by the PROFESS™ Software for localization and | ||
| tracking of the PROFESS™ Navigated Surgical Instrument relative to the | ||
| PROFESS™ Patient Tracker | K062640, Stryker Navigation System - Cranial 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 | ||
| Feature | Subject Device | Predicate Devices |
| System Accuracy | ||
| Statement | Within the nasal cavities the system has a mean accuracy of 2 mm | K062640, Stryker Navigation System - Cranial Module |
| Within the camera working space, the system has a mean accuracy of 2 mm for | ||
| translation and 2° for rotation | ||
| Equivalent | ||
| Supported Image | ||
| Modalities | • CT | K062640, Stryker Navigation System - Cranial Module |
| • CT | ||
| • CTA | ||
| • MR | ||
| • MRA | ||
| • fMRI | ||
| • PET | ||
| • SPECT | ||
| Equivalent | ||
| Scanner | ||
| Interfaces | • CD/DVD | |
| • USB | K062640, Stryker Navigation System - Cranial Module | |
| • CD/DVD | ||
| • USB | ||
| • Network connectivity | ||
| • Magneto Optical Disk | ||
| Equivalent | ||
| Recommended | ||
| CT Imaging | ||
| Protocol | • 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 of | ||
| nose 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™ Registration | |
| Stickers 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 Patient | ||
| Registration 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 matching | ||
| Equivalent | ||
| Feature | Subject Device | Predicate Devices |
| Display of Tip | ||
| Location in | ||
| Navigation Mode | Multiplanar reconstruction with sagittal, coronal and axial views with | |
| superimposed cross-hairs to indicate the intraoperative tip location of the | ||
| PROFESS™ Navigated Surgical Instrument | K062640, Stryker Navigation System - Cranial Module | |
| • Multiplanar reconstruction with sagittal, coronal and axial views with | ||
| superimposed cross-hairs to indicate the intraoperative tip location of the | ||
| navigated surgical instruments. | ||
| • 3D views with superimposed cross-hairs to indicate the intraoperative tip | ||
| location of the navigated surgical instruments and a surface or volumetric | ||
| reconstruction along with a rendered representation of the tools at the | ||
| actual location. | ||
| Equivalent | ||
| Check for | ||
| Sustained | ||
| Accuracy Intra- | ||
| operatively | • Navigated surgical instrument's tip geometry check on initialization of | |
| instrument. | ||
| • Intra-operative interactive landmark test. | K062640, Stryker Navigation System - Cranial Module | |
| • Navigated surgical instrument's tip geometry check on initialization of | ||
| instrument. | ||
| • Intra-operative interactive landmark test. | ||
| Equivalent | ||
| PROFESS™ Navigated Surgical Instruments | ||
| Power Supply | 5V power supply from USB port on computer platform via PROFESS™ Adaptor | |
| Cable | K002732, Stryker Navigation System - ENT Module | |
| 3V power supply from Instrument Battery | ||
| Equivalent | ||
| Communication | ||
| with Computer | ||
| Platform | Via PROFESS™ Adaptor Cable using USB 2.0 protocol | K002732, Stryker Navigation System - ENT Module |
| Wireless infra-red communication using proprietary protocol | ||
| Equivalent | ||
| Number of | ||
| Buttons for | ||
| Control of | ||
| Software from | ||
| the Sterile Field | 1 Button | K002732, Stryker Navigation System - ENT Module |
| 3 Buttons | ||
| Equivalent | ||
| Calibration | Calibrated at the manufacturer's site | K002732, Stryker Navigation System - ENT Module |
| Calibrated at the manufacturer's site | ||
| Equivalent | ||
| Material (for body | ||
| contacting parts) | AISI 301 or AISI 304 Stainless Steel | K002732, Stryker Navigation System - ENT Module |
| AISI 301 or AISI 304 Stainless Steel | ||
| Equivalent | ||
| Sterilization | ||
| Method | Ethylene Oxide (EO) sterilized | K002732, Stryker Navigation System - ENT Module |
| • Navigated Surgical Instruments: Steam Sterilized | ||
| • Instrument Battery: Ethylene Oxide (EO) Sterilized or Gamma Sterilized | ||
| Equivalent | ||
| 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 Only | ||
| Equivalent | ||
| PROFESS™ Patient Tracker | ||
| Patient | ||
| Reference | ||
| Localizer | The PROFESS™ Patient Tracker is the patient reference localizer. The | |
| PROFESS™ Patient Tracker contacts the patient on the bridge of the nose | ||
| (nasion) and the two outer ear canals. The patient tracker is elastic to fit | ||
| different head sizes. Additionally, the position of the ear-pins can be adjusted | ||
| for very small or large head sizes. | K062640, Stryker Navigation System - Cranial Module | |
| The Patient Registration Mask is used as the patient reference localizer. The | ||
| Patient Registration Mask is applied to the patient's skin. | ||
| Equivalent | ||
| Material (for body | ||
| contacting parts) | • ABS Resin | |
| • Thermoplastic Polymer (TPE) | K062640, Stryker Navigation System - Cranial Module | |
| • 3M™ Hypoallergenic pressure sensitive acrylate based adhesive | ||
| Equivalent | ||
| Single-Use vs. | ||
| Re-Usable | Single-use | K062640, Stryker Navigation System - Cranial Module |
| Single-use | ||
| Equivalent | ||
| Sterilization | ||
| Method | Ethylene Oxide (EO) sterilized | K062640, Stryker Navigation System - Cranial Module |
| Ethylene Oxide (EO) sterilized | ||
| Equivalent | ||
| PROFESS™ Registration Stickers | ||
| Registration | ||
| Accessories | The PROFESS™ Registration Stickers are used to define where skin points | |
| are sampled for surface matching | K062640, Stryker Navigation System - Cranial Module | |
| The Patient Registration Mask is used to define where skin points are | ||
| sampled for surface matching | ||
| Equivalent | ||
| Material (for body | ||
| contacting parts) | 3M™ Hypoallergenic pressure sensitive acrylate based adhesive | K062640, Stryker Navigation System - Cranial Module |
| 3M™ Hypoallergenic pressure sensitive acrylate based adhesive | ||
| Equivalent | ||
| Single-Use vs. | ||
| Re-Usable | Single-use | K062640, Stryker Navigation System - Cranial Module |
| Single-use | ||
| Equivalent | ||
| Sterilization | ||
| Method | Ethylene Oxide (EO) sterilized | K062640, Stryker Navigation System - Cranial Module |
| Ethylene Oxide (EO) sterilized | ||
| Equivalent | ||
| TABLE 5-2 COMPARISON TABLE |
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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®
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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".
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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.
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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®
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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".
| Substantial
Equivalence
| (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 to |
| ASTM F2554:2010 and in phantom and | |
| cadaver tests | |
| Accelerated Ageing | |
| Testing | Verified functionality of all single-use, sterile |
| components and integrity of all packaging after | |
| accelerated ageing | |
| Biocompatibility | 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 | 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 | |
| as well as additional testing to verify | |
| compatibility with RFID devices operating in | |
| the 125 - 134 kHz frequency band. | |
| 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 |
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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 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 the EO sterilization process for all |
| single-use, sterile components 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. | |
| Product Validation | Validated the product with users in cadaver |
| labs. Verified compatibility with conventional | |
| operative technique and other devices used in | |
| intranasal 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