(67 days)
The Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal 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 near 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 intended patients are adults and pediatric from the age of 2 years and older.
The Monteris NeuroBlate System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.
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 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.
The provided text is an FDA 510(k) clearance letter for the Monteris Medical NeuroBlate System (K240877). This document primarily focuses on demonstrating substantial equivalence to a predicate device (K231061) and modifying the pediatric age range in the Indications for Use. It explicitly states that "no additional testing was required" because the changes are labeling-related and "no physical changes, manufacturing changes, process changes, materials changes, or technology changes" were made to the system.
Therefore, the document does not contain details about specific acceptance criteria, a study proving the device met those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies for this specific submission (K240877). The information provided heavily references data from the predicate device (K231061) and general clinical literature reviews.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document as no new acceptance criteria or device performance data were generated for this specific submission (K240877). The submission focuses on a labeling change to an existing device, relying on previous data.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided for this specific submission as no new testing was required. The document mentions that "adult and pediatric data from Monteris' prospective LAANTERN Registry was also reviewed," but it does not specify the sample size from this registry or explicitly define it as a "test set" for this submission. The provenance is from Monteris' prospective registry.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided for this specific submission as no new testing was required.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided for this specific submission as no new testing was required.
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
An MRMC study is not mentioned for this specific submission. The NeuroBlate System is a physical laser thermal therapy system with software for planning and monitoring, not an AI diagnostic tool for interpreting images for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study is not mentioned for this specific submission. The device is intended to be used by a "trained physician" for planning and monitoring, with patient management decisions "not made solely on the basis of the NeuroBlate System analysis," indicating a human-in-the-loop system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated for any data underlying the predicate device, other than general references to "LITT related clinical literature" and "NeuroBlate System commercial clinical experience," and data from the "LAANTERN Registry" (which would likely include outcomes data).
8. The sample size for the training set
This information is not provided for this specific submission as no new technical development or training of algorithms is indicated; the submission relies on previously established performance of the predicate device.
9. How the ground truth for the training set was established
This information is not provided for this specific submission as no new technical development or training of algorithms is indicated.
Summary of Change in K240877 and Rationale:
The core of this 510(k) submission (K240877) is a labeling change to the existing Monteris Medical NeuroBlate System (predicate K231061). The change is to explicitly include "pediatric patients from the age of 2 years and older" in the "Indications for Use" statement, clarifying an existing "adult and pediatric" intended patient population.
The submission asserts that because "no physical changes, manufacturing changes, process changes, materials changes, or technology changes" were made to the device, and the "technical modes of action and technical principles remain the same," no additional testing (in-vitro or in-vivo) was required. The conclusion that the device remains safe and effective for this expanded age range is based on:
- Review of LITT related clinical literature.
- Review of Monteris' own NeuroBlate System commercial clinical experience.
- Review of adult and pediatric data from Monteris' prospective LAANTERN Registry.
The document explicitly states: "Monteris has concluded from these reviews that the NeuroBlate LITT system has been, and remains, an effective and safe tool for use in pediatric patients." This serves as the "study" for this submission, validating the labeling change rather than a new device performance study. However, specific details about the methods or data from these reviews are not included in this FDA letter.
§ 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.