(75 days)
Not Found
None
Unknown
The description mentions a "software feature recognition algorithm" used to automatically locate points on the headset in the CT image data. While this could potentially be implemented using AI/ML techniques, the summary does not explicitly state this or provide details about the algorithm that would confirm it is AI/ML. It could also be a more traditional image processing algorithm.
No
The device aids surgeons in navigating during various nasal and sinus surgical procedures by displaying CT images and tracking instrument position, but it does not directly treat or mitigate disease.
No
The device is described as a surgical navigation system that superimposes an instrument's position onto patient CT image data to guide a surgeon during procedures. While it uses existing diagnostic images, it does not itself generate new diagnostic information or determine the presence or nature of a disease; rather, it aids in surgical execution.
No
The device description explicitly states it includes hardware components such as a wheeled cabinet enclosure, monitor, computer, and a spatial tracking device. Performance studies also involve testing of hardware components like the electromagnetic field distortion mechanism and replaceable instruments.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for surgical navigation during procedures in the intranasal and sinus areas. This involves guiding a surgeon's instrument in real-time based on imaging data.
- Device Description: The device is a surgical navigation system that uses a spatial tracking device and computer to display the position of a surgical instrument on a patient's CT images.
- Anatomical Site: The device is used directly on or within the patient's body (intranasal or sinuses) during surgery.
- IVD Definition: IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
This device clearly operates in vivo (within the body) during a surgical procedure and is used for surgical guidance, not for analyzing biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
Intranasal or sinuses
Product codes
Not Found
Device Description
The device consists of a wheeled cabinet enclosure with a 20-inch color monitor mounted on the top. Mounted within the cabinet is a computer and a spacial tracking device. The electromagnetic, six-degree-of-freedom tracking device is linked to the computer, which provides the monitor with a display of the patient's CT image data and superimposed crosshairs, indicating the position of the tip of the surgical instrument used with the device. The device is controlled via software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT image data
Anatomical Site
Intranasal or sinuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical Testing Summary
Laborarory testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism. Testing was also performed to demonstrate the reproducibility of the location positioning of the replaceable headset and the replaceable pointing instruments.
A mean device accuracy of 0.79 mm was measured which compares to a value of 1.74 mm reported for the predicate device. Results showed that the device detected field distortion under normal use conditions before the induced error became larger than 1.0 mm. The headset was shown to be replaceable such that the overall average effect upon the device accuracy was less than 0.74 mm. The removal and replacement of a pointing instrument result in a change of less than +/-0.914 mm (+/-3 sigma).
Electromagnetic Compatibility testing was conducted and satisfactorily passed. This included emissions in accordance with EN55011(CISPR 11) and RE101 of MIL-STD-461C. and immunity in accordance with IEC 801-2, 801-3, 801-4, 801-5, and RS101 and CS114, of MIL-STD-461C. Because the recommended 10 msec dropout was satisfied, the device has a battery backup.
Clinical Testing Summary
A multicenter study was conducted at four clinical sites. Results of this study indicate the mean accuracy of the device to be 2.28 mm with a 95% confidence interval of the mean of 0.78 mm. This compares to values of 1.8 mm to 4.8 mm for the mean accuracy of the predicate device while using various operating modalities and registration techniques. Under these conditions, the 95% confidence interval of the mean for the predicate device varied from 1.1 mm to 1.6 mm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
The Viewing Wand, manufactured by ISG Technologies, Inc.
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.
Barnes Suction Tube
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K96 033 0
APR - 8 1996
14. Summary of the Safet / and Effectiveness Information
IN PREMARKET NOTIFICATION SUBMISSION
General Information
| Classification: | Class II
21 CFR 892.1750 | Computed Tomography X-ray System |
|---------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | | Interactive CT Image-Guided Surgical
System |
| Device Trade Name: | | InstaTrak® |
| Intended Uses: | Anatomical Region: | Intranasal or sinuses |
| | Diagnoses: | Acute and chronic sinusitis, endoscopic
dacryocystorhinostomy, optic nerve and
orbital decompression, the removal of
polyps, the biopsy and removal of tumors,
and the repair of CSF leaks, pituitary
disorder, and encephalocele |
| Description: | | The device consists of a wheeled cabinet
enclosure with a 20-inch color monitor
mounted on the top. Mounted within the
cabinet is a computer and a spacial tracking
device. The electromagnetic, six-degree-of-
freedom tracking device is linked to the
computer, which provides the monitor with a
display of the patient's CT image data and
superimposed crosshairs, indicating the
position of the tip of the surgical instrument
used with the device. The device is
controlled via software. |
| Establishment Name
and Address: | | Visualization Technology, Inc.
656 Beacon Street
Boston, MA 02215 |
| Establishment
Registration Number: | | (Planned) |
| Performance Standard: | | None established under Section 514 |
1
Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Safety Parameter Summary
Risk Current:
Enclosure