(31 days)
UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and register these images with those from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the ability to display a simulated insertion tool such as a biopsy needle, guidewire, gridplate or probe on a computer monitor screen that shows images of the target organ and the projected future path of the interventional instrument taking into account patient movement. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 2D/3D image registration.
UroNav is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diaical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers.
UroNav 3 is a medical image processing system that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. The target can be indicated either pre-procedurally or intra-procedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intra-procedural imaging to assist in locating areas of interest detected on one set of images on the other. The system provides fusion between Ultrasound (US) and different imaging modalities such as Magnetic Resonance Imaging (MR), Computed Tomography (CT), etc. When used as a navigation aid, it also transforms two and three-dimensional patient images (scan sets) into dynamic representations on which a medical instrument can be navigated. The system performs spatial mapping from one image space to another image space or from image space to physical space ("registration") allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive interventional procedures. Images used by UroNav can include archived image data from a CD, PACS, etc., and live images from an ultrasound system.
The UroNav system consists of an Electromagnetic Measurement System (EMMS) (including a Field Generator, System Control Unit and System Interface Unit(s)), a System Unit (including a CPU/monitor, medical-grade power supply and mobile cart), Field Generator stand, UroNav software and various instrumentation devices. The UroNav System Unit and the UroNav software utilize the keyboard, mouse and visual display to interact with the image data from a connected Ultrasound System. This interaction includes the selection of targets and associated navigation on the UroNav monitor. Targeted use areas for UroNav include hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms.
UroNav 3 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, transrectal ultrasound (TRUS) probe, commercially available needle guides and needle gun combinations. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3D image registration. UroNav utilizes an electromagnetic measurement system (EMMS) for identifying and tracking the location of the TRUS probe (and associated needle quides, instruments, etc.) relative to the 2D and 3D images. The EMMS Field Generator is positioned near the patient and provides an electromagnetic (EM) field for detection by a proprietary electromagnetic (EM) Sensor, which is attached to the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The Field Generator and EM Sensor are connected to the UroNav System Control Unit and the PC running the UroNav software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of UroNav 3. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, UroNav is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate.
The reconstructed 3D image can be further processed to perform various measurements including volume estimation and can be examined for abnormalities by the physician. Patient information, notes and images may be stored for future retrieval.
Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3D image and 3D rendered surface model, and stored. Previously created 3D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3D model used for co-reqistration may be based on another series of ultrasound images or DICOM images.
The physician may also attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2D ultrasound image is displayed on the UroNav display during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. UroNav 3 is able to add, display and edit plans for target locations (e.g., biopsy sites) as well as an estimate of the probe position and needle trajectory relative to the 3D image and 3D rendered surface model of the prostate and the planned target locations. UroNav 3 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
In addition to standard transrectal procedures, UroNav 3 also supports transperineal access and commercially available gridplates normally used for performing such procedures. When using transperineal mode, the UroNav EM Sensors are attached to both the TRUS probe and the transperineal gridplate within a mechanical stepper assembly. Procedure planning, segmentation, registration and navigation are performed the same as the standard transrectal procedure except that a computer rendering of the transperineal gridplate is displayed on the UroNav 3 display. UroNav provides an indication of the gridplate coordinates that correspond to the identified target location.
Here's a breakdown of the acceptance criteria and study information for the UroNav 3 device, based on the provided FDA 510(k) summary:
Note: This 510(k) summary does not contain explicit acceptance criteria tables with performance metrics or detailed results of a specific clinical study for the UroNav 3. Instead, it relies on demonstrating substantial equivalence to a predicate device (UroNav Version 2.0 and PercuNav) through comparisons of technological characteristics and confirmation of nonclinical testing.
The document states: "Nonclinical and performance testing has been performed by designated individuals as required by Invivo Corporation's quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by UroNav in each operational mode. UroNav 3 has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met."
However, the specific "predetermined acceptance criteria" themselves and the breakdown of performance against those criteria are not explicitly detailed in the provided text. The safety and effectiveness are established by showing that UroNav 3 has substantially equivalent technological characteristics to the predicate devices and passed internal V&V testing according to applicable standards.
Therefore, the table below reflects what can be inferred rather than explicit numeric acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence and V&V) | Reported Device Performance (Inferred from Substantial Equivalence and V&V) |
|---|---|
| Functional Equivalence: Device performs core intended functions similar to predicate. | UroNav 3 provides image-guided interventional planning and navigation for prostate procedures, views/captures live 2D ultrasound to reconstruct 3D images/models, fuses/registers images from other DICOM modalities, and performs viewing/image-processing functions (segmentation, registration, MPR, measurement, annotation). (Stated as similar to UroNav 2.0 and PercuNav) |
| Safety and Effectiveness: Does not raise new safety or effectiveness concerns. | Demonstrated through: |
- Instructions for use, cautions, warnings, and notes for safe/effective use.
- Risk Management procedure identifying and controlling potential hazards.
- Product (software and hardware) development process, verification, and validation testing.
- Passing all in-house testing criteria, validating design, function, and specifications. (Explicitly stated) |
| Technological Equivalence: Identical or similar technological characteristics. | Nearly identical technological characteristics to predicate devices (UroNav 2.0 and PercuNav) in terms of: PC-based software, Windows OS, multi-modality support, 2D/3D review, live 2D ultrasound, gland segmentation, image registration (rigid/elastic), MPR, DICOM import/export, ultrasound video, standard image viewing/measurement/annotation/segmentation/reporting tools, video capture, image overlays, planning & navigation tools, electromagnetic navigation. (Detailed comparison table provided in K) |
| Compliance to Standards: Adherence to relevant medical device standards. | Complies with IEC 60601-1:2005 Ed 3.1, IEC 60601-1-2:2014 Ed 4, ISO 14971:2007, IEC 62366:2007. (Explicitly stated) |
| Physical Form Factor: Changes do not impact safety or effectiveness. | Differences in physical form factor (smaller enclosure, separate embedded computer vs. integrated computer/display) are stated to not impact device safety or effectiveness. (Explicitly stated) |
| Limited Indications (vs. PercuNav): Scope of use for prostate only (vs. multiple anatomies). | The UroNav system does not include support for all anatomical locations indicated for PercuNav (e.g., liver, lung, pancreas, etc.), but this absence does not significantly affect the use of the device, nor does it raise new or additional safety risks. (Explicitly stated) |
| Minor UI Variations (vs. PercuNav): Cosmetic user interface changes. | Minor user interface variations (GUI icons, screen colors, image viewing layouts) are cosmetic and do not significantly affect the use of the device, nor do they raise new or additional safety risks. (Explicitly stated) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a sample size for a test set in a clinical or performance study of the UroNav 3. The document states that "Nonclinical and performance testing has been performed by designated individuals at the manufacturer's facility." This implies internal testing rather than a formal test set of patient data from external sites.
The data provenance is not explicitly stated beyond internal nonclinical and performance testing done at Invivo Corporation. There is no mention of country of origin, nor whether it was retrospective or prospective in the context of a clinical study for UroNav 3.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The 510(k) summary does not mention a clinical study with a test set requiring expert-established ground truth for UroNav 3. The document focuses on demonstrating substantial equivalence through comparison with predicate devices and internal validation. For the predicate devices or previous versions, this information might exist, but it is not provided for UroNav 3 in this document.
4. Adjudication Method for the Test Set
Since a specific test set requiring expert ground truth and adjudication is not described in the provided document for UroNav 3, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary for UroNav 3. The submission focuses on substantial equivalence based on technological characteristics and nonclinical testing. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The UroNav 3 is described as a "stereotaxic accessory for image-guided interventional and diagnostic procedures" and emphasizes that "A physician, providing ample opportunity for competent human intervention interprets the images and information being displayed and maintains control of the clinical procedure at all times." This indicates that the device is not intended or tested for standalone (algorithm-only) performance without human-in-the-loop. Its functionality is as an aid to a physician.
7. The Type of Ground Truth Used
Given the nature of the submission (substantial equivalence based on technological characteristics and internal V&V testing), the ground truth for any internal performance testing would likely be based on engineering specifications, accuracy targets for tracking systems, and known parameters for image processing algorithms. There is no mention of clinical ground truth types such as expert consensus, pathology, or outcomes data being used in a formal study for UroNav 3 in this document.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. The UroNav 3 is a medical image processing system that integrates various functionalities (image display, registration, segmentation, navigation aid, etc.). While such systems contain algorithms, the submission doesn't describe it as a machine learning/AI device requiring a specific training set in the common sense of statistical or deep learning models needing large datasets for training. Its equivalence is based on established technological characteristics and function.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, no information on how ground truth for a training set was established is provided.
§ 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).