(133 days)
Not Found
No
The summary describes image processing and navigation features but does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test data sets.
No
The device is a navigation and guidance system used for surgical planning and intraoperative assistance, rather than directly providing therapy.
No
The device is described as a "planning and intraoperative guidance system" for computer-assisted surgery, and its functions are related to surgical planning, navigation, and visualization, not diagnosing medical conditions.
No
The device description explicitly states that the system "comprises software for surgical planning and computer assisted surgery based on a wireless optical tracking localization device". This indicates the system includes hardware (the tracking device) in addition to the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The intended use and device description clearly state that the Stryker Navigation System – OrthoMap® 3D Module is a surgical planning and guidance system that uses image data of anatomical structures (specifically bony structures) to assist in surgical procedures. It does not analyze biological samples like blood, urine, or tissue.
- The focus is on surgical planning and navigation. The listed procedures and functionalities are all related to visualizing, planning, and guiding surgical interventions based on medical imaging. This is distinct from the diagnostic process of analyzing samples to determine a medical condition.
Therefore, the Stryker Navigation System – OrthoMap® 3D Module falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Navigation System - OrthoMap® 3D 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.
The system should be operated only by trained personnel such as surgeons and clinic staff.
The Stryker Navigation System - OrthoMap® 3D Module supports, but is not limited to, the following surgical procedures:
Orthopedic Oncology Procedures
Surgical Planning Procedures
- Segmentation to define volumes of interest using correlated, multi-modality . image data, e.q. to assist outlining and visualizing bony structures such as aberrant pathology
- Image based distance and anqular measurement tools, e.g. to define and maintain safety margins to outlined bony structures
- Image based resection plane planning to define resections relative to identified structures, e.g. to support limb salvage surgery taking safety margins into account
- Virtual screw placement planning in the image data with variable screw length, bead-length and diameter
- Image based annotation point placement and visualization, e.q. to support repositioning of bony anatomic points during surgery
rgical Navigation Procedures
- Intra-operative visualization of volume image data including visualization of pre-planned volumes of interest relative to the tracked instrument, supporting navigated excision of user-defined bony structures
- Intra-operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections
- Intra-operative creation and visualization of annotation points, supporting recording of landmarks on bony anatomy, e.g. to assist oncology replacement prosthesis repositioning, leg length and rotation assessment or navigated implant placement
- Navigated intra-operative screw placement based on pre-planned or intraoperative virtual screw definition
Product codes
OLO
Device Description
The Stryker Navigation System - OrthoMap® 3D Module is part of the product series of the Stryker Navigation System. The system comprises software for surgical planning and computer assisted surgery based on a wireless optical tracking localization device for the use in navigated orthopedic oncology surgery.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality image data, e.q. to assist outlining and visualizing bony structures such as aberrant pathology
Anatomical Site
bony structures
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KOr3009
FEB 1 9 2009
.
| 3.0 510(k) Summary | |
|---|---|
| Device Trade Name: | Stryker Navigation System - OrthoMap® 3D Module |
| Common Name: | Navigation System |
| Product Code: | OLO |
| Classification Name: | Stereotaxic Instruments |
| Title 21 CFR: | §882.4560 |
| Classification | ll |
| 510(k) Contact Person: | Lilian Eckert |
| Stryker Leibinger GmbH & Co. KG | |
| Bötzinger Straße 41 | |
| D-79111 Freiburg | |
| Germany | |
| (+49) 761 45 12 117 | |
| email: lilian.eckert@stryker.com | |
| Date Summary Prepared: | Feburary 9, 2009 |
| Description: | The Stryker Navigation System - OrthoMap® 3D Module is |
| part of the product series of the Stryker Navigation System. | |
| The system comprises software for surgical planning and | |
| computer assisted surgery based on a wireless optical | |
| tracking localization device for the use in navigated | |
| orthopedic oncology surgery. | |
| Intended Use: | The Stryker Navigation System - OrthoMap® 3D 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. | |
| Indications: | The system should be operated only by trained personnel |
| such as surgeons and clinic staff. | |
| The Stryker Navigation System - OrthoMap® 3D Module | |
| supports, but is not limited to, the following surgical | |
| procedures: | |
| Orthopedic Oncology Procedures | |
| Surgical Planning Procedures Segmentation to define volumes of interest using correlated, multi-modality image data, e.g. to assist outlining and visualizing bony structures such as aberrant pathologyImage based distance and angular measurement tools, e.g. to define and maintain safety margins to outlined |
:
1
| | bony structures
Image based resection plane planning to define
resections relative to identified structures, e.g. to support
limb salvage surgery taking safety margins into account
Virtual screw placement planning in the image data with
variable screw length, head-length and diameter
Image based annotation point placement and
visualization, e.g. to support repositioning of bony
anatomic points during surgery |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Surgical Navigation Procedures |
| | Intra-operative visualization of volume image data
including visualization of pre-planned volumes of interest
relative to the tracked instrument, supporting navigated
excision of user-defined bony structures
Intra-operative visualization of resection planes relative
to the tracked instrument on bony structures assisting
bony resections
Intra-operative creation and visualization of annotation
points, supporting recording of landmarks on bony
anatomy, e.q. to assist oncology replacement prosthesis
repositioning, leg length and rotation assessment or
navigated implant placement
Navigated intra-operative screw placement based on
pre-planned or intra-operative virtual screw definition |
| Equivalent to: | K062640 Cranial Module
K012380 Spine & Fluoroscopy Module |
| Substantial Equivalence: | The Stryker Navigation System – OrthoMap® 3D Module
does not raise any new safety and efficacy concerns when
compared to similar devices already legally marketed.
Therefore, the Stryker Navigation System - OrthoMap® 3D
Module is substantially equivalent to these existing devices.
They will be designed and manufactured in accordance with
Stryker Leibinger's Quality Management System covered by
QSR 21CFR 820. |
:
1999 - 1999 - 1999
:
.
and the comments of the comments of
the country of the country of the county of
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Leibinger GmbH & Co.,KG % Ms. Lilian Eckert Regulatory Affairs Specialist Bötzinger Straße 41 D-79111 Freiburg Germany
Re: K083009
Trade/Device Name: Stryker Navigation System - OrthoMap® 3D Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO . Dated: February 10, 2009 Received: February 13, 2009
FEB 1 9 2009
Dear Ms. Eckert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prodibitions againstansing and adulteration. Just
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Lilian Eckert
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Potmarler, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse vents. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Arsistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David Krane
-Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 2.0
510(K) Number (if known): K083009
Device Name: Stryker Navigation System = OrthoMap® 3D Module.
Intended Use
· The Stryker Navigation System – OrthoMap® 3D 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.
Indications for Use
The system should be operated only by trained personnel such as surgeons and clinic staff.
The Stryker Navigation System - OrthoMap® 3D Module supports, but is not limited to, the following surgical procedures:
Orthopedic Oncology Procedures
Surgical Planning Procedures
- Segmentation to define volumes of interest using correlated, multi-modality . image data, e.q. to assist outlining and visualizing bony structures such as aberrant pathology
- Image based distance and anqular measurement tools, e.g. to define and maintain safety margins to outlined bony structures
- Image based resection plane planning to define resections relative to identified structures, e.g. to support limb salvage surgery taking safety margins into account
- Virtual screw placement planning in the image data with variable screw length, bead-length and diameter
- Image based annotation point placement and visualization, e.q. to support repositioning of bony anatomic points during surgery
rgical Navigation Procedures
- Intra-operative visualization of volume image data including visualization of pre-planned volumes of interest relative to the tracked instrument, supporting navigated excision of user-defined bony structures
- Intra-operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections
- Intra-operative creation and visualization of annotation points, supporting recording of landmarks on bony anatomy, e.g. to assist oncology replacement prosthesis repositioning, leg length and rotation assessment or navigated implant placement
- Navigated intra-operative screw placement based on pre-planned or intraoperative virtual screw definition
Page 1 of 2
5
and/or Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
Nil RP Syler
Firman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083009
11:14 ...