(19 days)
PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Rotational Fluoroscopy, Endoscopy and other imaging systems. CT, Ultrasound, PET, MR, and Rotational Fluoroscopy may be fused in various combinations, such as CT with MR, MR with ultrasound, etc. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument taking into account patient movement. This is intended for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The device is intended to be used in interventional and diagnostic procedures in a clinical setting. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another.
Example procedures include, but are not limited to:
- Image fusion for diagnostic clinical examinations and procedures
- Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, etc.)
- Soft tissue ablation (liver, kidney, breast, pancreas lung, etc.)
- Bone ablations
- Bone biopsies
- Nerve Blocks & Pain Management
- Drainage placements
- Hydrodissections
- Bladder Stimulation
- Fiducial placements
- Tumor resections
- Sinus procedures
- Intranasal procedures
- Transphenoidal procedures
The PercuNav system 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 different modalities. Different imaging modalities such as CT, Ultrasound, PET, MR, and Rotational Fluoroscopy may be fused in various combinations, for example CT with MR, CT with Ultrasound, PET/CT with ultrasound, MR with ultrasound, etc.
The Philips PercuNav Ultrasound Tracker is designed to be used with the PercuNav image-guided intervention system for diagnostic or interventional procedures using ultrasound. The Ultrasound Tracker consists of a connector, a cable, and trackedsensor housing with a release tab that attaches to the needle-guidance system.
The Philips PercuNav system provides image guided intervention and diagnostic information. This 510(k) summary focuses on modifications to the Ultrasound Tracker accessory, specifically related to its reprocessing for reuse.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements | "functional requirements have been met, and that core functions execute as expected." |
| Safety and Effectiveness | "Safety and Effectiveness has been established through bench testing and non-clinical performance testing inducing Surgical Simulation and the Clinical Accuracy simulation tests." |
| "The completed tests were conducted to ensure that the changes to the proposed device did not introduce any new issues of safety or effectiveness from our legally marketed device - K121498." | |
| Surgical Simulation Accuracy | The system must demonstrate accuracy comparable to the "Euclidian System Error" (Target Registration Error - TRE) commonly used in image-guided surgery. |
| Image Registration Accuracy | Verify image registration. |
| Image Fusion Accuracy | Qualify each registration method available to the operator. |
| Reprocessing Durability | Withstand cleaning and disinfection associated with reuse, in accordance with AAMI TIR12:2010, AAMI TIR30:2011, ISO 17664:2004, and ANSI ST81:2004/(R) 2010. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set used in the "Surgical Simulation" or "Non Clinical Accuracy" tests. It mentions "a phantom based simulation" for surgical simulation and tests for "Image Registration" and "Image Fusion Accuracy."
The data provenance is non-clinical bench testing and simulation. No country of origin is specified beyond Philips Healthcare being located in Toronto, Ontario, Canada, and the FDA submission being in the USA. The nature of the studies implies prospective testing of the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies described are bench and simulation tests, which typically rely on pre-defined phantoms or analytical models rather than expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
Given that the testing involved "bench testing and non-clinical performance testing inducing Surgical Simulation and the Clinical Accuracy simulation tests" using phantoms and controlled setups, there would typically be no human adjudication in the traditional sense. The ground truth accuracy would be established by the known characteristics of the phantom and the measurement methods.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. The studies described are focused on the device's standalone performance and its ability to withstand reprocessing, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The document describes "bench testing and non-clinical performance testing inducing Surgical Simulation and the Clinical Accuracy simulation tests" which focused on the device's performance, including "Euclidian System Error," "Image Registration," and "Image Fusion Accuracy." These tests are designed to evaluate the system's inherent performance.
7. The type of ground truth used
The ground truth used was based on known characteristics of phantoms or pre-defined analytical models for the "Surgical Simulation" and "Non Clinical Accuracy" tests. For the reprocessing durability, the ground truth would be the ability to meet the specified performance after being subjected to the defined cleaning and disinfection protocols.
8. The sample size for the training set
This device is not an AI/ML algorithm that requires a training set in the typical sense. It is an image-guided intervention system accessory. Therefore, there is no mention of a training set sample size.
9. How the ground truth for the training set was established
As there is no training set in the context of an AI/ML algorithm, this question is not applicable.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.