(90 days)
The Visualase Thermal 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 vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.
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 four devices: a laser energy source, a cooled laser applicator, a pump for circulating coolant through the applicator, and a computer workstation with magnetic resonance imaging (MRI) analysis software for determination and visualization of relative changes in tissue temperature during therapy. A software application running on the workstation allows the workstation user to control the laser output and to operate the coolant pump from the workstation interface. Additionally, when appropriate thermal imaging guidance is used, temperature limits may be associated with prescribed image locations and used as an interlock for automatic deactivation of the laser output.
A previous version of the Visualase Thermal Therapy System has been cleared for marketing via 510(k) notification (Visualase Thermal Therapy System, K071328). The instant version of this system extends the functionality of the predicate version by providing a software interface for control of the laser output through the computer interface port of the laser component and on/off operation of the pump through a similar interface. When used with appropriate magnetic resonance thermal imaging guidance, a software tool may be used to prescribe limits for the temperature at certain points in the image which can, in turn, be used to deactivate the laser if the limits are reached. Thus this system provides an additional level of "interlock" security over the previous version which may increase safety and/or precision of the treatment prescription. It is important to note that while temperature image information can be used to automatically deactivate the laser as a safety precaution, the user may, at his discretion, override the interlock and proceed with additional laser energy deposition if warranted. Further, it is important to note that the added security feature is in no way capable of energizing the laser on its own. The laser may ONLY be activated by a deliberate action from the user. Thus the added feature serves only as an additional safety interlock on the laser system similar to many other common safety features.
Computer control of the coolant pump status (ON/OFF) provides an additional convenience to the user and also provides an additional safety feature since, when the laser is operated from the workstation interface, activation of the laser can be made dependent on first activating the coolant pump.
The addition of these features to the Visualase system has no effect on the Indications for Use statement which remains unchanged from the predicate device (except that we have now extended compatibility to Siemens MRI systems).
This 510(k) summary (K081656) describes an updated version of the Visualase Thermal Therapy System. The key purpose of the submission is to demonstrate that the new version, which adds software control for laser output and pump operation, and an additional safety interlock feature, is substantially equivalent to the previously cleared predicate device (K071328).
However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, or MRMC/standalone studies.
The document explicitly states under "Non-clinical Performance Tests":
"Performance, specifications, and technical data for the components of the Visualase component devices are essentially unchanged from the previous version, and are therefore not included here."
This means that the current submission relies on the performance data of the predicate device and asserts that the new features do not alter the core functionality or safety that would necessitate new performance studies against specific acceptance criteria. The enhancements are primarily focused on user convenience and an additional safety interlock, which likely fall under software validation and system integration testing rather than clinical or performance efficacy studies against pre-defined metrics regarding tissue ablation or temperature measurement accuracy.
Therefore, for the information requested in your prompt, I can only state that it is not available in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence based on unchanged indications for use and the nature of the added features.
§ 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).