(88 days)
The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through internal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate Laser Delivery Probes. It also provides real time thermographic analysis of selected MRI images.
When interpreted by a trained physician, this System 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 the NeuroBlate System analysis.
The Monteris NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy that is currently indicated for the practice of neurosurgery.
As previously described in K162762, K170724, the NeuroBlate System is typically used for the minimally invasive ablation of neurosurgeon identified target tissue (tumors, epileptic foci) in the brain.
The NeuroBlate System components consist of:
- Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver . controlled energy to a target zone.
- . Probe Drivers (Advanced Probe Driver, Robotic Probe Driver) which allow the surgeon to precisely position, stabilize and manipulate a probe, endoscope or other device within the target zone.
- . An Interface Platform, which attaches to the MRI system patient table and provides supporting electronics for the Advanced and Robotic Probe Drivers and interconnections for the Laser Delivery Probes;
- . A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation.
- . A Control Workstation including the M-Vision™ and M-Vision Pro™ software, which includes a user interface for procedure planning, interactive monitoring of NeuroBlate procedures, and interfaces to the MRI and hardware subsystems.
The NeuroBlate System is utilized with stereotaxic frames and patient stabilization systems, such as:
- . The AXiiiS stereotaxic mini-frame and the Monteris Cranial Bolt and Mini-Bolt fixation components, and
- The AtamA Stabilization System and MRI receive-only head coil, as well as, other optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, bone screws, fiducial markers, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.
This is a 510(k) premarket notification for Monteris Medical NeuroBlate System, and the submission focuses on clarifying the indications for use statement rather than demonstrating the performance of a new or significantly modified device. Therefore, the typical structure for reporting acceptance criteria and study results for device performance does not apply to this document in the way it would for a new device or a major change.
Here's why and what can be extracted:
- No new device performance data: The document explicitly states: "Given that the modifications to the indications for use do not create a new intended use or raise new or different questions of safety or efficacy, clinical data are not necessary to demonstrate substantial equivalence." and "Considering the proposed changes are labeling clarifications, the previously provided in-vitro (bench), and in-vivo (animal) data remains applicable, and are incorporated by reference." This means no new studies were conducted for this specific submission to demonstrate the device meets acceptance criteria for performance; rather, the existing demonstrated performance of the predicate device is relied upon.
However, I can extract information related to the purpose of this submission and the basis for claiming substantial equivalence given the proposed changes:
1. Table of Acceptance Criteria and Reported Device Performance
As this submission is for a labeling clarification and not a new device or significant performance change, there are no new defined acceptance criteria for device performance presented here, nor new reported device performance metrics. The "acceptance criteria" in this context are regulatory in nature: that the clarified indications do not alter the intended use or raise new safety/effectiveness questions.
| Regulatory Acceptance Criteria for Labeling Clarification | Assessment in Submission |
|---|---|
| No change to intended use | Confirmed: "The proposed labeling modifications... Do not change the intended use, i.e., they only clarify the indications for use within the existing intended use" |
| No new or different questions of safety and effectiveness | Confirmed: "Do not raise new or different questions of safety and effectiveness" and "conclude that the difference in technological characteristics... do not raise new or different questions of safety and effectiveness" |
| No new or different technical characteristics | Confirmed: "Do not introduce any new or different technical characteristics that raise different questions of safety and effectiveness" |
| Consistency with predicate device's intended use and performance | Confirmed: "The application for the Monteris Medical NeuroBlate™ System with the modified labeling is substantially equivalent (and/ or identical) to the predicate Monteris NeuroBlate™ System (K162762, K170724) in intended use, indications for use, technology, design and physician use." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable (no new testing)
- Data Provenance: Not applicable (no new testing). The previous "in-vitro (bench), and in-vivo (animal) data" mentioned are "incorporated by reference" from prior submissions (K162762, K170724), implying no new data was generated for the current filing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission doesn't involve establishing ground truth for a test set of data as it's a labeling clarification.
4. Adjudication method for the test set
- Not applicable. This submission doesn't involve a test set requiring adjudication.
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 is not an AI/CADe system in the context of diagnostic image interpretation, and no MRMC study was conducted or referenced for this submission. The device is a "Magnetic Resonance Image Guided Laser Thermal Therapy System" that provides "real-time thermographic analysis of selected MRI images" primarily for planning and monitoring thermal therapies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device provides "information that may be useful in the determination or assessment of thermal therapy" and explicitly states: "Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis." This indicates it's an assistive tool, not a standalone diagnostic or therapeutic algorithm, and no standalone performance study was done for this particular submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for this submission as no new performance data was generated. For the predicate devices, "in-vitro (bench), and in-vivo (animal) data" were used, which would typically rely on established physical measurements and anatomical/histological verification relevant to laser ablation efficacy and safety.
8. The sample size for the training set
- Not applicable. This submission is not about an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary, this 510(k) notification is a regulatory update to previously cleared devices (K162762, K170724) concerning the clarity of its "indications for use" statement. It asserts that these changes do not impact the device's technical characteristics, intended use, or fundamental safety and effectiveness, thus negating the need for new performance studies or data. The basis for substantial equivalence relies on the existing substantial equivalence determinations for the predicate devices and the argument that the proposed labeling changes are purely clarificatory.
§ 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.