(239 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 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 K182036 and K222983, the NeuroBlate System is typically used for the ablation of target tissue (tumors, radiation necrosis, epileptic foci) in the brain.
The NeuroBlate System components consist of:
- Families of gas-cooled Laser Delivery 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™. M-Vision Pro™. M-Vision Fusion™ , or Fusion-STM 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, MRI head coils, and other optional accessories, . including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, fiducial markers, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.
There is no change to entire system, with the exception of an additional NB3 (1.6mm) Laser Probe and the corresponding labeling updates.
The provided text refers to the FDA's 510(k) premarket notification for the Monteris Medical NeuroBlate System, specifically concerning the addition of a new NB3 (1.6mm) Laser Probe. The document focuses on demonstrating substantial equivalence to existing predicate devices rather than detailing a study that proves the device meets specific acceptance criteria in the context of clinical performance or AI algorithm validation.
Therefore, many of the requested sections related to acceptance criteria, device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets do not apply to the information provided in this regulatory submission.
The document primarily describes:
- Device Description: The NeuroBlate System and the new NB3 probe.
- Intended Use/Indications for Use: What the device is intended to do (ablate, necrotize, or coagulate intracranial soft tissue) and its role in planning and monitoring thermal therapies under MRI visualization.
- Comparison to Predicate Devices: How the new NB3 probe is similar to previously cleared NeuroBlate probes and other competitive laser probes.
- Summary of Supporting Data: A high-level overview of the design verification and validation process, stating that acceptance criteria were defined and met.
Since this is a 510(k) submission for a modification (adding a new probe size) and relies on substantial equivalence, it does not present a clinical study with detailed performance metrics against specific acceptance criteria in the way an AI/ML device submission would.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Each verification test protocol incorporated clearly defined acceptance criteria. The corresponding test reports confirmed (and documented) the design output met the design input for the requirements." And "Each validation protocol described the objective, test method and acceptance criteria. The corresponding test reports confirmed (and documented) the modified NeuroBlate System met the user needs and intended use."
However, the specific quantitative acceptance criteria and the reported numerical device performance results are NOT explicitly provided in the given text. The comparison table (Table 1: Substantial Equivalence; Technical Comparison) focuses on technical characteristics for demonstrating substantial equivalence, not performance against clinical acceptance criteria.
Based on the provided text, a table cannot be constructed with specific numerical acceptance criteria and reported device performance. The document only states that such criteria were met during design verification and validation.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The document describes design verification and validation activities, but does not detail a specific "test set" in the context of a clinical performance study with patient data, nor does it mention sample sizes for such tests or data provenance. The focus is on technical equivalence and design control compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. This information would typically be relevant for studies evaluating human interpretation or AI algorithm performance. The document focuses on the technical aspects of a medical device (laser probe) and its regulatory clearance based on substantial equivalence.
4. Adjudication Method for the Test Set
Not applicable/Not provided. Similar to the above, adjudication methods are associated with studies involving human interpretation or AI performance assessment, which is not the focus of this regulatory submission as presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not provided. This device is a surgical tool (laser probe) for thermal therapy, not an AI-assisted diagnostic or interpretative system that would typically be evaluated in an MRMC study concerning human reader improvement. While the NeuroBlate System "provides MRI-based trajectory planning assistance" and "near real-time thermographic analysis," it explicitly states, "Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis." The submission focuses on the new probe's physical properties and safety, not on the comparative effectiveness of an AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. The NeuroBlate System's software (M-Vision, M-Vision Pro, M-Vision Fusion, Fusion-STM) is described as providing "near real-time thermographic analysis," but the submission does not detail a standalone performance evaluation of this analytic component. The overall regulatory focus is on the substantial equivalence of the physical laser probe and system.
7. The Type of Ground Truth Used
Not explicitly provided in detail. The document mentions that the design verification and validation process confirmed the device met "design input for the requirements" and "user needs and intended use." This implies a ground truth defined by engineering specifications and intended clinical outcomes, but the specific methodologies for establishing this ground truth (e.g., in vivo pathology, clinical outcomes as defined for a clinical trial) are not described in the given text.
8. The Sample Size for the Training Set
Not applicable/Not provided in the context of an AI/ML training set. The document describes the development and testing of a physical medical device (laser probe), not the training of an AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable/Not provided. As there is no mention of a training set for an AI/ML algorithm in the provided text, this question is not addressed.
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December 8, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Monteris Medical David Mueller Senior Principal Regulatory Affairs Specialist 131 Cheshire Lane, Suite 100 Minnetonka, Minnesota 55305
Re: K231061
Trade/Device Name: NeuroBlate System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, HAW, ONO Dated: November 8, 2023 Received: November 8, 2023
Dear David Mueller:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Adam D. Pierce -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Adam D. Pierce -S" and "Date: 2023.12.08 15:27:42-05'00'". The image appears to be a digital signature.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231061
Device Name Monteris Medical NeuroBlate System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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Section 5: 510(k) Summary
| Category | Comments |
|---|---|
| Sponsor: | Monteris Medical131 Cheshire Lane, suite 100Minnetonka, MN 55305866-799-7655www.monteris.com |
| Correspondent ContactInformation: | David H. MuellerSenior Principal Regulatory Affairs SpecialistMonteris Medical,TEL: 763-333-1614Email: DMueller@Monteris.com |
| Device Common Name: | Magnetic Resonance Image Guided Laser ThermalTherapy System |
| Device Classification Number: | 21 CFR 878.4810• Laser surgical instrument for use in general andplastic surgery and in dermatology• Neurosurgical Laser With MR Thermography21 CFR 882.4560Stereotaxic instrument |
| Device Classification &Product Code: | Class II, GEXClass II, HAWClass II, ONO |
| Device Proprietary Name: | Monteris Medical NeuroBlate® System |
5.1. Device Information:
Predicate Device Information:
| Predicate Device: | NeuroBlate System |
|---|---|
| Predicate Device Manufacturer: | Monteris Medical |
| Predicate Device Common Name: | Monteris NeuroBlate System |
| Primary Predicate Device | K222983 |
| Additional Predicate Monteris | K182036 |
| Additional Predicate Non-Monteris | |
| • Clinical Laserthermia Systems AB | K214125 |
| • Medtronic | K211269 |
| Predicate Device Regulations: | 21 CFR 878.4810• Laser surgical instrument for use ingeneral and plastic surgery and indermatology• Neurosurgical Laser With MRThermography21 CFR 882.4560 |
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| Stereotaxic instrument | |
|---|---|
| Predicate Device Classifications &Product Codes: | Class II, GEXClass II, HAWClass II, ONO |
5.2. Date Summary Prepared
December 8, 2023
5.3. Description of Device
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 K182036 and K222983, the NeuroBlate System is typically used for the ablation of target tissue (tumors, radiation necrosis, epileptic foci) in the brain.
The NeuroBlate System components consist of:
- Families of gas-cooled Laser Delivery 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™. M-Vision Pro™. M-Vision ● Fusion™ , or Fusion-STM 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, MRI head coils, and other optional accessories, . including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, fiducial markers, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.
There is no change to entire system, with the exception of an additional NB3 (1.6mm) Laser Probe and the corresponding labeling updates.
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5.4. Indications for Use
There is no change to the indications for use, i.e., they remain:
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 mav 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.
5.5. Comparison to Predicate Device
The NB3 probe does not include changes to the entire existing NeuroBlate System, Software, and Indications for Use (as described in K222983). The NB3 is simply the addition of a smaller diameter probe (1.6mm) to the existing probe family, i.e., the NeuroBlate 2.2mm and 3.3mm laser probes (as described in K182036). The NB3 probe has the same function and Indications for Use as existing laser probes. The smaller diameter NB3 probe uses the same probe cooling range, and delivers the same maximum power as the NeuroBlate FullFire probe types currently used in clinical practice.
Monteris' NB3 probe is substantially equivalent to Monteris' 2.2mm and 3.3mm diameter NeuroBlate Optic Laser Probe (Secondary Predicate K182036) in design, technology, and function. Use of the NB3 probe requires no changes to the overall NeuroBlate System and Software (Primary Predicate K222983). Additionally, the NB3 1.6 diameter probe is substantially equivalent to Medtronic Visualase probes (K211269) and CLS Tranberg and Prism laser probes (K214125).. Reference Table 1: Substantial Equivalence; Technical Comparison.
As the modifications presented in the current device do not change the intended use, operating principles, or raise any unaddressed safety concerns, it can be concluded the NeuroBlate System with the alternative NB3 Probe is substantially equivalent to the predicate NeuroBlate System with existing NeuroBlate probes and to probes used with competitive systems.
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| Characteristic | NB3 ProbeK231061 | PRIMARY PREDICATE: K222983Monteris NeuroBlate System Laser ProbesSECONDARY PREDICATE: K182036NeuroBlate System DTP Fiber Design LaserProbes |
|---|---|---|
| Fiber | ||
| Fiber Core Material | No change from current NBS probes | Fused Silica |
| Fiber Size | 400um core,440um clad, 470um hard clad, 600umjacket (5) | 600um core,660um clad, 710um jacket |
| Emitting Length | 4mm(6) | 6mm |
| Connector | No change from current NBS probes | E2000 |
| Lens | ||
| Lens material | Borosilicate Glass | Sapphire-synthetic |
| Wavelength | ||
| Probe's Laser wavelengthcapability | No change from current NBS probes | Fiber optic can transmit visible and invisible laserwavelengths |
| Power | ||
| Maximum Power | No change from current NBS probes | Diffuse Tip Probe 12W max power settings |
| Energy Delivery | No change from current NBS probes | 600 J/min |
| Probe Cooling Control | No change from current NBS probes | Closed Loop control using fiber optic temp sensor |
| Coolant | No change from current NBS probes | Carbon dioxide |
| Operating Time of Laser forClinical Use | No change from current NBS probes | No limits |
| ISO 60825-1 compliant | No change from current NBS probes | ISO 60825-1 compliant |
| Probe Characteristics | ||
| Probe Outer Diameter (OD) (7) | 1.6 mm(7) | 2.2 mm and 3.3mm |
| Probe Fiber Insertable Length | 275mm(8) | 135-280 mm |
| Diffuse Tip | Diffuse Tip | Diffuse Tip(2.2mm and 3.3mm) |
| Overall Probe + Umbilical length | 1380mm(9) | Multiple lengths: 1190mm – 1320mm |
| MRI Compatible | No change from current NBS probes | MRI Conditional |
| Incorporated ruler(s) | Probe Holder Ruler (No Change);Visible gradations on inner Probe shaftFlexible plastic ruler(10) | Probe Holder Ruler incorporated |
| Depth Stop | Modified design that locks onto ProbeShaft | Depth Stop incorporated |
| Sterilization | No change from current NBS probes | Ethylene oxide |
| Single Use | No change from current NBS probes | Yes |
| Shelf-Life | No change from current NBS probes | 2 year |
Table 1: Substantial Equivalence; Technical Comparison
Table 1 footnotes
(1) Pharmaceutical packaging glass as an outer cladding, which includes glass filaments made of a Pe-contaning white glass.
(3) Plastic tube filled with transparent matrix with light dispersing particles
(4) Distal end sealed with higher concentration of scattering particles in a conical structure to prevent forward energy transmission
(5) Substantially Equivalent to PREDICATE Medtronic K211269: Fiber size; 400, 600, 800, 1000 um.
(6) Substantially Equivalent to PREDICATE CLS K214125: Fiber emitting length is within this probes 1mm to 25 mm range
(7) Substantially Equivalent to PREDICATE CLS K214125; Probe 1.55mm diameter; NB3 is within the range of 1.55mm to 2.2mm.
(8) Substantially Equivalent to PREDICATE Medronic K211269; Probe length 355 mm; NB3 is within the range of 135mm to 355mm.
(9) Substantially Equivalent to PREDICATE CLS K214125; Overall Probe + Umbilical length maximum is 12,000mm; NB3 is within the range of 1190mm and 12,000mm
(10) Substantially Equivalent to PREDICATE Medtronic K211269; which also includes plastic ruler for initial depth setting.
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5.6. Summary of Supporting Data
The updated NeuroBlate NB3 Probe development process followed Monteris' documented Quality System and incorporated a design verification and design validation process. This process included an overarching Design Verification and Design Validation Master Plan. This plan describes the design verification and the design validation of the user needs for the NB3 Probe when used within the NeuroBlate System.
The Design Verification process utilized protocols to detail the associated tests. Each verification test protocol incorporated clearly defined acceptance criteria. The corresponding test reports confirmed (and documented) the design output met the design input for the requirements.
The Design Validation process utilized protocols to detail the associated tests. Each validation protocol described the objective, test method and acceptance criteria. The corresponding test reports confirmed (and documented) the modified NeuroBlate System met the user needs and intended use.
The application for the Monteris Medical NeuroBlate System with the NB3 Laser Probe is substantially equivalent to the predicate Monteris NeuroBlate System 2.2mm and 3.3mm laser probes (K182036, K222983) and to the non-Monteris laser probe devices (K214125, K211269) in intended use, technology, design and physician use.
§ 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.