(98 days)
No
The description focuses on real-time tracking and display based on pre-operative imaging and a position-sensing probe, without mentioning any AI/ML techniques for image analysis, prediction, or decision support.
No
The device is described as a medical imaging workstation integrated with a position-sensing probe that correlates pre-operative imaging data with the intra-operative situation to display the orientation and position of the probe. Its function is to provide guidance and navigation during surgery by displaying anatomical information, not to directly treat a medical condition.
No
The device correlates pre-operative imaging data with the intra-operative situation to display the position and orientation of a surgical probe, which is a navigational aid rather than a diagnostic tool used for identifying diseases or conditions.
No
The device description explicitly states it is comprised of a medical imaging workstation integrated with a position-sensing user directed probe, indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "medical imaging workstation that is integrated with a position-sensing user directed probe" used for "surgical navigation" by correlating pre-operative imaging data with the intra-operative situation. This is a description of a surgical guidance system, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on real-time tracking of a probe's position relative to anatomical structures based on imaging data. This is characteristic of surgical navigation systems.
- Mentions image processing: While it mentions image processing, this is in the context of "Image Processing/Surgical Navigation System," further reinforcing its role in surgical guidance.
- Input Imaging Modality: It uses CT and/or MR imaging data, which are used for visualizing anatomy, not for analyzing biological specimens.
IVD devices are typically used to perform tests on samples like blood, urine, tissue, etc., to provide diagnostic information. This device's function is to assist a physician during surgery by providing real-time positional information relative to pre-operative images.
N/A
Intended Use / Indications for Use
Not Found
Product codes
092.1750
Device Description
The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intra-operative situation. Once a patient's CT or MR images have been transferred to the workstation, the patient is correlated to that image dataset. The system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved. The Family of Viewing Wands is designed to: - Process and display pre-operative radiographic images on a monitor. . - Provide intra-operative image control based upon the position and orientation of a user directed ● probe - Allow for the optional integration and usage of different position sensing technologies . (articulated arm, infrared freehand) and surgical probes (hand-held pointers, surgical microscope). - Store/retrieve image data on computer access media i.e. hard disks, archive media. . - Transmit data over local and wide area networks .
The components of the Family of Viewing Wands along with their intended functionality are listed as follows:
- Workstation - The workstation is designed to store, process and display radiographic image data such that a physician can view and interact with this data electronically in order to derive corroborative information related to the specific anatomy of the patient.
- Localizing device - The localizing device is designed to provide spatial localization information related to both the orientation of a probe and the probe tip. This information is used by the workstation to control the display of the diagnostic image data, such that a physician can intra-operatively view that data in relation to the patient.
- Communications Device - The communications device is designed to transmit image data from one workstation to another using the industry standard TCP/IP protocol over industry standard networks and transmission lines: Ethernet, Token ring, T1, ISDN, FDDI, ATM, POTS, etc. For transmission over local area networks (LAN) the communication device is industry standard interface hardware built into the workstation itself e.g. an ethernet card.
- Archive Storage/Retrieval Device - The archive storage/retrieval device is designed to assume responsibility for ensuring access to a reusable copy of image data. The Family of Viewing Wands does not perform any direct image scanning operations. Image data can be imported from a wide variety of scanners, either through a direct interface or through data transfer using an industry standard storage medium. Examples include floppy disks, hard disks, magnetic tape, optical disks, WORM media (Write Once Read Many), etc. The Family of Viewing Wands supports most industry standard storage devices. Device selection is not inherently restricted by the Family of Viewing Wands, but is associated with the workstation configuration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and/or MR imaging data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
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
Image /page/0/Picture/1 description: The image shows a logo with the letters "ISC" in a stylized font. The letters are white and are set against a black rectangular background. To the right of the rectangle, the word "PROCESSING" is written vertically along a curved line, suggesting a circular or semi-circular design element. The overall design is simple and bold, with a focus on the acronym "ISC".
510(k) SUMMARY
Contact Information
| Name and Address of Manufacturer: | ISG Technologies, Incorporated
6509 Airport Road
Mississauga
Ontario
Canada |
|-----------------------------------|-----------------------------------------------------------------------------------------------------|
| | L4V 1S7 |
| Telephone numbers: | (905) 672 2100 ext. 360
1 800 724 5970 ext.360 |
| Facsimile number: | (905) 672 2307 |
| Name of Contact Person: | Robin A. Owen, Ph.D.
Medical Scientist
Department of Clinical Development
ISG Technologies |
| Date: | 16th February, 1996 |
Image /page/0/Picture/5 description: The image shows a handwritten text that appears to be the letters "uiu". The letters are written in a cursive style with varying stroke thicknesses. Above the letters, there is a thick black bar that obscures any potential text or details that might have been present in that area.
1
General Information
Classification:
The ISG family of viewing wands are substantially equivalent to other devices within the classification of diagnostic devices (21 CFR 092.1750) that have been reviewed under the previsions of the Medical Device Amendments and are being marketed in interstate commerce. Such devices have been classified as Class II devices.
Classification Name:
Diagnostic Device - Computer Tomography X-ray System (Accessory)
Common/Usual Name:
Image Processing/Surgical Navigation System
Proprietary Name:
ISG Family of Viewing Wands
Predicate Devices:
The Family of Viewing Wands as described in this submission is substantially equivalent to the Allegro Viewing Wand by ISG Technologies Inc. which was the subject matter of 510(k) file #K911783 and which is currently being marketed by ISG Technologies, Incorporated. The Family of Viewing Wands also incorporates some of the features that were previously provided by the CAMRA Allegro workstation (#K901679).
The Family of Viewing Wands incorporates components that are substantially equivalent to other legally marketed devices, including the Zeiss MKM (Multiple Coordinate Manipulator ) system (#K942233); the Radionics OAS (Operating Arm System) neurosurgery planning and guidance system (#K951262); and the Codman Acustar I Advanced Surgical Navigation System (#K944612).
Performance Standards:
There are currently no Section 514 performance standards applicable to systems of this type. Standards are defined and tested under the specifications included in this submittal.
Description of the Device:
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intra-operative situation. Once a patient's CT or MR images have been transferred to the workstation, the patient is correlated to that image dataset. The system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved. The Family of Viewing Wands is designed to:
- Process and display pre-operative radiographic images on a monitor. .
- Provide intra-operative image control based upon the position and orientation of a user directed ● probe
- Allow for the optional integration and usage of different position sensing technologies . (articulated arm, infrared freehand) and surgical probes (hand-held pointers, surgical microscope).
- Store/retrieve image data on computer access media i.e. hard disks, archive media. .
- Transmit data over local and wide area networks .
2
The components of the Family of Viewing Wands along with their intended functionality are listed as follows:
Workstation - The workstation is designed to store, process and display radiographic image data 1. such that a physician can view and interact with this data electronically in order to derive corroborative information related to the specific anatomy of the patient.
Localizing device - The localizing device is designed to provide spatial localization information 2. related to both the orientation of a probe and the probe tip. This information is used by the workstation to control the display of the diagnostic image data, such that a physician can intra-operatively view that data in relation to the patient.
-
Communications Device - The communications device is designed to transmit image data from one workstation to another using the industry standard TCP/IP protocol over industry standard networks and transmission lines: Ethernet, Token ring, T1, ISDN, FDDI, ATM, POTS, etc. For transmission over local area networks (LAN) the communication device is industry standard interface hardware built into the workstation itself e.g. an ethernet card.
-
Archive Storage/Retrieval Device - The archive storage/retrieval device is designed to assume responsibility for ensuring access to a reusable copy of image data. The Family of Viewing Wands does not perform any direct image scanning operations. Image data can be imported from a wide variety of scanners, either through a direct interface or through data transfer using an industry standard storage medium. Examples include floppy disks, hard disks, magnetic tape, optical disks, WORM media (Write Once Read Many), etc. The Family of Viewing Wands supports most industry standard storage devices. Device selection is not inherently restricted by the Family of Viewing Wands, but is associated with the workstation configuration.