(237 days)
The Visualase™ Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064mm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase™ system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
The Visualase™ Thermal Therapy System is compatible with General Electric Medical Systems Signa model MR scanners and with Siemens Medical Solutions Magnetom Espree systems. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase™ analysis.
The Visualase Thermal Therapy System comprises of hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of: a diode laser (energy source); a coolant pump to circulate saline through the laser application; Visualase workstation which interfaces with MRI scanner's host computer Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; two monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections.
Remote Presence software provides a non-clinical utility application for use by Medtronic only and is not accessible by the user.
The provided document is a 510(k) summary for the Medtronic Visualase Thermal Therapy System. It describes labeling changes to the device manual and explicitly states that no new performance testing was required as there are no changes to the device itself. Therefore, the document does not contain information about studies specifically conducted to prove the device meets acceptance criteria for its current performance.
The document indicates that this 510(k) submission is for labeling changes only, primarily adding new warnings and information that were previously distributed via field corrective actions. It confirms that these changes do not affect the intended use or fundamental technology of the Visualase Thermal Therapy System.
Consequently, I cannot provide the requested information regarding acceptance criteria and a study to prove they are met because this 510(k) submission does not include such a study for the current device. The acceptance criteria and performance data would have been established and submitted during earlier 510(k) clearances for the device itself (e.g., K081656), not for this labeling update.
The request for information on multi-reader multi-case (MRMC) studies, effect sizes, standalone performance, training sets, and ground truth establishment are also not applicable to this specific submission, which focuses solely on labeling updates.
§ 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).