(121 days)
MKM system, Stealth Station sold by Sofamor Danek
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No
The description focuses on image processing, registration, and interactive display based on infrared tracking, with no mention of AI or ML algorithms for analysis or decision support.
No.
The system provides navigational support during surgery by displaying the position and trajectory of surgical tools, but it does not directly treat or diagnose a disease or condition itself.
No
The device provides "navigational support during surgery" by displaying the position and trajectory of a surgical tool relative to pre-loaded radiological images. It does not perform a diagnosis or provide diagnostic information about the patient's medical condition.
No
The device description explicitly states that the system localizes tools in space via an "industry standard infra-red LED based camera system," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "navigational support during surgery" and displays the position and trajectory of surgical tools relative to radiological images. This is a surgical guidance system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces the navigational aspect, explaining how it localizes surgical tools in space using an infra-red camera system and displays their position on imaging data.
- No mention of in vitro testing: There is no indication that this device interacts with or analyzes biological samples (blood, tissue, urine, etc.) outside of the body.
IVD devices are specifically designed for testing samples taken from the human body to provide diagnostic or other health information. This device's function is entirely focused on providing real-time spatial information during a surgical procedure.
N/A
Intended Use / Indications for Use
The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery They permit the surgical team to load radiological imaging studies onto a workstation equipped with image processing and visualization software. After correlation of the patient position with the images, (the registration procedure) the system displays the position, trajectory and other localization information of the current "tool" interactively throughout the surgical procedure. These devices are used to aid the surgeon in visualizing the surgical site and guiding the surgeon through the surgical course.
Product codes
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Device Description
The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group. The SMN's primary "tool" is a surgical microscope that, through features such as an autofocus and heads-up display, permit the high accuracy localization of the critical focus and hence an area of interest in the patients anatomy. The STN by contrast uses a variety of "Pointers" and instruments as tools. Here the surgeon touches the area of interest with the pointer or instrument instead of virtually probing it with the microscope autofocus. The functionality of the SMN can be added to the STN as an upgrade and conversely the microscope functionality (i.e. SMN) can be added to an STN. Furthermore a system having both "modules" can easily be used in either configuration in a given surgical procedure. Both systems localize the tools in space, to a high degree of accuracy, via an industry standard infra-red LED based camera system. The LED's coordinates are then transferred to the workstation which in turn converts them to the coordinate system of the imaging data and interactively displays them.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiological imaging studies
Anatomical Site
any location of the body (for stereotactically guided surgical procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, surgical team
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
MKM system, Stealth Station sold by Sofamor Danek
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
510-k Summary
APR 23 1997
Pursuant to 21 CFR 807.92 the following summary is submitted.
- Submitter's name-
Carl Zeiss, Inc. 1 Zeiss Drive Thornwood, NY 10594 (914) 681-7761 Contact Person-Kenneth M. Nicoll December 19, 1996
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SMN System with STN system and permit individual sale of STN Surgical Microscope/ Image Guided System and Instrument Based Image Guided System
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We are claiming an exemption as a Surgical Microscope due to the exemption set forth in the Federal Register Notice dated December 7, 1994 which exempted surgical microscopes. Or in the alternative we are also claiming substantial equivalence to our MKM system which is used in a similar manner as our SMN system. Finally, we are claiming substantial equivalence to the Stealth Station sold by Sofamor Danek which is very similar to our STN system.
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- The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery They permit the surgical team to load radiological imaging studies onto a workstation equipped with image processing and visualization software. After correlation of the patient position with the images, (the registration procedure) the system displays the position, trajectory and other localization information of the current "tool" interactively throughout the surgical procedure.
The SMN's primary "tool" is a surgical microscope that, through features such as an autofocus and heads-up display, permit the high accuracy localization of the critical focus and hence an area of interest in the patients anatomy. The STN by contrast uses a variety of "Pointers" and instruments as tools. Here the surgeon touches the area of interest with the pointer or instrument instead of virtually probing it with the microscope autofocus. The functionality of the SMN can be added to the STN as an upgrade and conversely the microscope functionality (i.e. SMN) can be added to an STN. Furthermore a system having both "modules" can easily be used in either configuration in a given surgical procedure.
- The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery They permit the surgical team to load radiological imaging studies onto a workstation equipped with image processing and visualization software. After correlation of the patient position with the images, (the registration procedure) the system displays the position, trajectory and other localization information of the current "tool" interactively throughout the surgical procedure.
Both systems localize the tools in space, to a high degree of accuracy, via an industry standard infra-red LED based camera system. The LED's coordinates are then transferred to the workstation which in turn converts them to the coordinate system of the imaging data and interactively displays them.
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510-k Summary Page 2
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These devices will be used in the same manner as all Surgical Microscope/ Image Guided Systems are used and as all Instrument Based Image Guided Systems are used. These devices are used to aid the surgeon in visualizing the surgical site and guiding the surgeon through the surgical course. The systems do not take the place of the surgeon they are only a tool used to assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure still rest firmly with the surgeon. These systems incorporate the original intended uses of our MKM system and now the STN system can be used as a stand alone navigational tool.
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The SMN is substantially equivalent to our MKM system ( Multiple Coordinate Manipulator) which is already cleared. Both of these systems are used in surgical procedures where magnification and illumination of the site is required. They are both ideally suited for stereotactically guided surgical procedures in any location of the body. Both systems utilize either identical or very similar microscopes. They both operate on the same stereotactic surgical planning system, which has been specially adapted for use with these systems and can be used to plan stereotactic-guided procedures.
The primary differences between the variations of the SMN and the MKM are that the MKM is capable of moving and tracking its position with internal servo-motors. While all versions of the SMN are passive and require manual positioning of the microscope, relying on an external light based localization system.
The STN system is virtually identical to the medical device known as the StealthStation® sold by Sofamor Danek. The primary difference is in the image processing software that runs on the workstation. Otherwise the localization system of both instruments are manufactured and supplied by the same company.