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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.

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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.

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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 to determine 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.

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.

The four components have themselves been previously cleared for marketing via 510(k) notifications with the new device bringing these four components into a single portable cart for use in MR-guided laser thermal therapy procedures. In practice, all of the devices are used according to their approved indications for use. That is, the laser applicator is introduced into the tissue to be destroyed and connected to both the laser energy source and the cooling pump. The cooling pump and laser are operated as normal to deliver energy and cause tissue ablation. Since the laser applicator is MR-compatible, the laser ablation procedure may be carried out inside of an MRI magnet. In this case, appropriate MR imaging can be performed during the treatment, and the MR analysis software can be used to evaluate the thermal changes in the target tissue.

The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or the methodology typically associated with evaluating AI/software performance as requested in the prompt.

The document K071328 is a 510(k) summary for the Visualase® Thermal Therapy System, describing it as a combination of four previously cleared devices: a laser energy source, a cooled laser applicator, a pump, and MRI analysis software. The summary focuses on the substantial equivalence of this combined system to its predicate devices, emphasizing that the individual components' functions and performance remain unchanged.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics. It rather states that "Performance and technical data for each of the components of the Visualase Thermal Therapy System are unchanged from those listed in the original submissions." This implies that the individual components met their respective acceptance criteria in prior 510(k) clearances, and the combination as a system is not introducing new performance parameters that require a new set of criteria.

2. Sample size used for the test set and the data provenance:

Not applicable. The submission is a 510(k) for a system combination, not a new device requiring a performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set or ground truth establishment is described for this 510(k).

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device predates the common application of AI in this context and is a combination of existing cleared components. The MR analysis software provides "passive monitoring" and "information that may be useful," but explicitly states "Patient management decisions should not be made solely on the basis of Visualase analysis," indicating it's not designed for standalone diagnostic or decision-making. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document indicates the Visualase MRI analysis software is for "passive monitoring" and processing "images to determine relative changes in tissue temperature during therapy." It provides "information that may be useful in the determination or assessment of thermal therapy" but explicitly states "Patient management decisions should not be made solely on the basis of Visualase analysis." This suggests it is not intended for standalone decision-making, and no standalone performance study is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. There is no new performance study described in this 510(k) that would require establishing a ground truth for a test set. The individual components would have had their own validation data during their initial clearances.

8. The sample size for the training set:

Not applicable. The document describes a combination of existing cleared devices. There is no mention of a new "training set" for the MRI analysis software in this context. The software processes images based on physical principles (proton resonance-frequency shift analysis), not machine learning requiring a training set in the modern sense.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

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