(30 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 intracranial delivery of precision thermal therapy in the practice of neurosurgery.
As previously described in K172881, the NeuroBlate™ System is typically used for the minimally invasive ablation of 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 Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module):
- A System Electronics Rack and Components, which includes the laser and 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, fiducial markers, bone screws, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools).
Thus, there is no change to entire system, with the exception of an additional (alternative) NeuroBlate M-Vision/ M-Vision Pro Software Package (V3.13). While the modified software package includes several modifications which do not meet the FDA's "significant change" submission criteria, there is at least one proposed change which modifies an existing risk control measure for a hazardous situation and thus, per FDA 510(k) guidance, requires a new 510(k) submission.
The provided text describes the Monteris Medical NeuroBlate™ System (K173305), which is a modification of a previously cleared device (K172881). The submission is for an updated M-Vision/M-Vision Pro Software Package (V3.13). The document primarily focuses on demonstrating substantial equivalence to the predicate device due to a software update that modifies an existing risk control measure.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "Each verification test protocol incorporated clearly defined acceptance criteria" and "Each validation protocol described the objective, test method and acceptance criteria." However, it does not provide the specific acceptance criteria or the reported performance data for these tests. It only states that the tests "confirmed (and documented) the design output met the design input for the requirements" and that the "modified NeuroBlate™ System met the user needs and intended use."
To fill the table below, I must infer the general nature of the criteria based on the device and its intended use, as specific details are not provided. The device performs planning and real-time thermographic analysis for thermal therapy. Therefore, acceptance criteria would likely relate to the accuracy, precision, and reliability of these functions.
| Metric (Inferred) | Acceptance Criteria (Not explicitly stated, inferred) | Reported Device Performance (Not explicitly stated, inferred) |
|---|---|---|
| Design Verification: | ||
| Accuracy of trajectory planning assistance | Trajectory planning assistance provided by the M-Vision/M-Vision Pro software should meet predefined accuracy specifications to ensure precise placement of probes. | The design verification process utilized protocols and corresponding test reports confirmed that the design output met the design input for the requirements, implying that the trajectory planning assistance performs as specified. |
| Accuracy of real-time thermographic analysis | Real-time thermographic analysis provided by the M-Vision/M-Vision Pro software should accurately reflect thermal changes in tissue within specified tolerances. | The design verification process confirmed that the design output met the design input for the requirements, meaning the thermographic analysis functions within its specified accuracy. |
| Software functionality and reliability | All functions of the M-Vision/M-Vision Pro V3.13 software should perform as intended without errors or crashes, adhering to documented specifications. | The design verification process confirmed that the design output met the design input for the requirements, implying that the software is functional and reliable as per its specifications. |
| Risk control measure effectiveness (modified) | The modified risk control measure in V3.13 software should effectively mitigate the identified hazardous situation to an acceptable level, as per risk assessment. | The submission for K173305 was specifically triggered because the updated software modifies an existing risk control measure for a hazardous situation. The design verification and validation process documented the meeting of these requirements, implying the modified risk control measure is effective. |
| Design Validation (User Needs & Intended Use): | ||
| System performance in intended use | The NeuroBlate™ System with V3.13 software should effectively ablate, necrotize, or coagulate intracranial soft tissue when used by a trained physician, and information provided should be useful for thermal therapy assessment. | The design validation process utilized protocols and corresponding test reports confirmed that the modified NeuroBlate™ System met the user needs and intended use. This implies the system functions as intended and provides useful information for patient management when interpreted by a trained physician, although specific outcomes are not quantified. |
| MRI compatibility and visualization | The system's MRI compatibility and ability to provide MRI-based trajectory planning and real-time thermographic analysis should perform reliably in an MRI environment. | The design validation process confirmed the system met user needs and intended use, which would encompass the proper functioning of MRI compatibility and visualization features. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in the design verification or design validation. It only mentions that "The Design Verification process utilized protocols to detail the associated tests. The corresponding test reports which confirmed (and documented) the design output met the design input for the requirements." Similarly, for validation, "The Design Validation process utilized protocols to detail the associated tests. The corresponding test reports which confirmed (and documented) the modified NeuroBlate™ System met the user needs and intended use."
The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. The indications for use state "When interpreted by a trained physician," implying that qualified medical professionals are involved in the use and interpretation of the system, but this doesn't directly address the establishment of ground truth for testing purposes.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The submission is for a software update to an existing device, focusing on maintaining substantial equivalence rather than a new clinical effectiveness claim through an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document describes software (M-Vision/M-Vision Pro) that provides "trajectory planning assistance" and "real-time thermographic analysis." It explicitly states, "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis," indicating that a human (trained physician) is always intended to be in the loop.
Therefore, it is highly likely that standalone algorithm-only performance was evaluated as part of the design verification (e.g., measuring the inherent accuracy of planning algorithms or thermographic calculations), but not as a replacement for human-in-the-loop performance in the clinical application. The document indicates that the software provides "information that may be useful" and requires interpretation by a trained physician.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for either verification or validation. Given the nature of a laser thermal therapy system, potential ground truths could include:
- Physical measurements/phantoms: For accuracy of laser delivery and thermal profile generation during verification.
- Pathology/histology: To confirm ablation zones in preclinical or bench testing.
- Expert consensus/clinical outcomes: To evaluate the system's utility and accuracy in real or simulated clinical scenarios during validation, although this is inferred.
The document states the purpose of the software update was for a "risk control measure for a hazardous situation," suggesting that the ground truth for evaluating this might involve risk analyses, simulated failure modes, and verification of corrective actions.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is because the submission concerns a software update (V3.13) for an existing system, and the description focuses on verification and validation of changes rather than the development of a new AI/ML model that typically involves distinct training sets.
9. How the Ground Truth for the Training Set Was Established
As no training set is discussed or implied for a new AI/ML model, the establishment of ground truth for a training set is not applicable in this context. The V3.13 software is likely a deterministic software update rather than an adaptive AI system requiring a 'training set' in the machine learning sense.
§ 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.