(115 days)
The Visualase V2 ™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.
The Visualase MRI-Guided Laser Ablation System comprises 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; one monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections
The provided FDA 510(k) clearance letter for the Visualase V2 MRI-Guided Laser Ablation System does not contain the detailed information necessary to fully address all aspects of the request. Specifically, the document focuses on regulatory compliance, substantial equivalence to predicate devices, and general testing summaries (software V&V, system V&V, electrical safety). It does not include specific acceptance criteria with performance metrics, details of a clinical study (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies), or direct data proving the device met specific performance criteria.
The letter explicitly states: "A clinical trial was not required to establish substantial equivalence. Clinical evidence provided in a literature summary format supports the safe use of the Visualase V2 System in the intended patient population." This indicates that a prospective clinical performance study, often associated with detailed acceptance criteria and reported performance, was not the primary method for demonstrating substantial equivalence for this particular submission.
Therefore, many sections of your request cannot be fulfilled based on the provided document. I will fill in the information that is present and explicitly state where information is not available.
Acceptance Criteria and Device Performance for Visualase V2 MRI-Guided Laser Ablation System
Based on the provided FDA 510(k) clearance letter (K250307), the device's acceptance criteria and proven performance are primarily demonstrated through verification and validation activities for its software and system, and compliance with electrical safety standards. A formal clinical trial with quantitative performance metrics against specific acceptance criteria (e.g., sensitivity, specificity, accuracy) was not required for this submission to establish substantial equivalence, but rather clinical evidence was provided via a literature summary.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) for the Visualase V2 System as described in the document, performance acceptance criteria are focused on safety, functionality, and equivalence to predicate devices, rather than clinical efficacy metrics typically found in AI/diagnostic device submissions.
| Acceptance Criterion (Inferred/Stated) | Reported Device Performance (as stated in document) |
|---|---|
| Software Verification & Validation (meets product requirements and user needs) | "Software verification and validation Per Medtronic 21 CFR 820.30 compliant Design Control procedure" / "The Platform, software and corresponding labeling changes included in this submission have been verified and validated demonstrating the changes meet product requirements and user needs." |
| System Verification (meets product requirements and user needs) | "System verification Per Medtronic 21 CFR 820.30 compliant Design Control procedure" / "Testing demonstrated the Visualase V2™ MRI-Guided Laser Ablation System meets all design requirements and user needs." |
| Electrical Safety & Applicable Horizontal Standards | "IEC electrical safety and applicable horizontal standards UL certified" |
| Substantial Equivalence to Predicate Devices (for indications, technology, safety) | "The Visualase™ V2 MRI-Guided Laser Ablation System is substantially equivalent to the primary predicate Visualase MRI-Guided Laser Ablation System and the secondary predicate NeuroBlate System (indications only)." |
| Corrected Contraindications and Clarified Indications | "The Visualase Indications for Use have been clarified to define the intended patient population, adults and pediatric patients 2 years and older The changes to the Contraindications removes redundant language and language aligned with medical judgement." |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states: "A clinical trial was not required to establish substantial equivalence. Clinical evidence provided in a literature summary format supports the safe use of the Visualase V2 System in the intended patient population."
Therefore, no specific "test set" sample size for a clinical performance study is reported in this document. The "testing summary" refers to internal verification and validation against design controls and standards, not a clinical data set for performance evaluation of an AI algorithm.
Data Provenance: Not applicable for a clinical test set in this context, as a clinical performance study was not the basis for substantial equivalence for this upgrade. The clinical evidence was a literature summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as a specific clinical test set for performance evaluation (e.g., for an AI algorithm's diagnostic accuracy which would require ground truth labeling) was not conducted as part of this 510(k) as described. The "ground truth" for the device's functionality and safety was established via engineering verification, validation, and regulatory compliance.
4. Adjudication Method for the Test Set
Not applicable, as a clinical test set requiring adjudication was not reported as part of this 510(k) as described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not reported in this 510(k) clearance letter. The submission focused on establishing substantial equivalence through other means (software/system V&V, safety testing, literature review) rather than demonstrating AI assistance performance improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
The Visualase V2 System is a medical device system that includes hardware and software for MRI-guided laser ablation, with software providing monitoring and control capabilities related to temperature and thermal damage estimation. It is not an AI diagnostic algorithm for which a standalone performance evaluation (e.g., AUC, sensitivity/specificity) would typically be required or reported in this format. The software's performance is intrinsically linked to the system's function and user interaction.
Therefore, a "standalone algorithm only" performance study in the sense of a diagnostic AI product is not applicable and not reported.
7. The Type of Ground Truth Used
For the system's functional and safety validation, the "ground truth" would be engineering specifications, design requirements, and established medical and electrical safety standards (e.g., IEC standards, 21 CFR 820.30 Design Controls).
For any inferred clinical claims from the "literature summary," the ground truth would originate from the clinical data reported in the summarized peer-reviewed literature, which could involve histological confirmation, long-term patient outcomes, or expert clinical diagnosis, but these details are not provided in the 510(k) letter itself.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device system update, not an AI algorithm developed using a specific training dataset in the machine learning sense. The "training" for the system's software would derive from its design and programming, verified through the V&V processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI algorithm developed through data-driven training in the machine learning sense. The "ground truth" for the device's design and engineering would be based on scientific and engineering principles, preclinical testing, and existing medical knowledge, as per design control procedures.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.