(122 days)
No
The document describes a system for MRI-guided thermal ablation with planning and monitoring software, but there is no mention of AI or ML in the device description, intended use, or performance studies. The software functions described are related to trajectory planning and thermographic analysis, which are not inherently AI/ML capabilities.
Yes
The intended use explicitly states its purpose is "to ablate, necrotize, or coagulate intracranial soft tissue" using thermal therapy, which describes a direct therapeutic intervention.
No
Explanation: The device is described as a "neurosurgical tool" and is indicated for use to "ablate, necrotize, or coagulate intracranial soft tissue." While it provides "information that may be useful in the determination or assessment of thermal therapy," its primary function is therapeutic (ablation), not diagnostic. It assists in planning and monitoring therapy, not in diagnosing conditions.
No
The device description explicitly lists multiple hardware components, including laser delivery probes, probe drivers, an interface platform, and a system electronics rack, in addition to the software.
Based on the provided text, the Monteris Medical NeuroBlate System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- NeuroBlate System's Function: The NeuroBlate System is a surgical tool used to directly ablate, necrotize, or coagulate intracranial soft tissue using lasers. It is used during a surgical procedure to treat identified targets within the brain.
- Intended Use: The intended use clearly states it is a "neurosurgical tool" for "ablating, necrotizing, or coagulating intracranial soft tissue." While it uses imaging for planning and monitoring, its primary function is a therapeutic intervention, not the analysis of biological specimens for diagnostic purposes.
- Device Description: The description details laser delivery probes, drivers, and software for planning and monitoring the thermal therapy. These are components of a surgical system, not an IVD system.
Therefore, the NeuroBlate System falls under the category of a therapeutic surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 and epileptic 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, HAW
Device Description
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 K171255, K182036, K193375, 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 (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, M-Vision Fusion, and Fusion-S 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI visualization
Anatomical Site
intracranial soft tissue, including brain structures (e.g., brain tumor and epileptic foci)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical tool, neurosurgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Considering the intended labeling clarifications include no physical, material, or software related device design changes, the NeuroBlate System predicates' previously provided in-vitro (bench) and in-vivo (animal) data remains applicable and are incorporated by reference.
As these modifications to the Indications For Use do not create a new intended use or raise new or different questions of safety or efficacy and incorporates previously provided clinical data, additional clinical data are not necessary to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains 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.
August 21, 2020
Monteris Medical David H. Mueller Senior Principal Regulatory Affairs Specialist 14755 27th Avenue North, Suite C Plymouth, Minnesota 55447
Re: K201056
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 Dated: July 20, 2020 Received: July 22, 2020
Dear Mr. 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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices 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) K201056
Device Name 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 and epileptic 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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Image /page/3/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the word "MONTERIS" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" is a series of teal-colored circles arranged in an arc shape. The circles vary in size, with the largest circles in the center and the smallest circles on the edges.
510(k) Summary
a. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Monteris Medical |
| 14755 27th Avenue North | |
| Suite C | |
| Plymouth, MN 55447 | |
| 763-253-4710 | |
| Fax: 763-746-0084 | |
| www.monteris.com | |
| Correspondent Contact | |
| Information: | David H. Mueller |
| Senior Principal Regulatory Affairs Specialist | |
| Monteris Medical | |
| TEL: 763-253-2732 | |
| FAX: 763-746-0084 | |
| Email: DMueller@Monteris.com | |
| Device Common Name: | Magnetic Resonance Image Guided Laser Thermal |
| Therapy System | |
| Device Classification Number: | 21 CFR 878.4810 |
| Laser surgical instrument for use in general and plastic | |
| surgery and in dermatology | |
| Device Classification & | |
| Product Code: | 21 CFR 882.4560 |
| Stereotaxic instrument | |
| Class II, GEX | |
| Class II, HAW | |
| Device Proprietary Name: | NeuroBlate® System |
| Predicate Devices | Monteris Medical NeuroBlate® System (K171255, |
| K182036, K193375) | |
| FDA Guidance Reference | |
| Predicate Devices(¹) | K163244, truFreeze System |
| K171626, truFreeze System |
b. Date Summary Prepared
August 17, 2020
c. Description of Device
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.
1 Food and Drug Administration. The Least Burdensome Provisions: Guidance for Industry and Food and Drug Administration Staff. Draft Guidance. February 5th ed. Washington, D.C., U.S. Department of Health and Human Services. Food and Drug Administration, Center for Devices and Radiological Health, US Printing Office, 2019
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Image /page/4/Picture/0 description: The image shows the logo for Monteris Medical. The logo has the word "MONTERIS" in blue, all-caps, bold letters. Below that is the word "MEDICAL" in smaller, blue, all-caps letters. Above the word "MONTERIS" are 9 teal-colored circles of varying sizes.
As previously described in K171255, K182036, K193375, 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 (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, M-Vision Fusion, and Fusion-S 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.
Change Description
Considering the Laser Interstitial Therapy (LITT) related Real World Evidence(') from Monteris' on-going post-market registry, the available scientific clinical literature peer reviewed published data, and the corresponding FDA publications, Monteris' minor (non-significant) modifications to the Indications For Use(3) statement duplicate existing information in order to improve clarity and ease of understanding for the NeuroBlate System's (a) "tool" indication and (b) existing intended patient populations. These updates are in alignment with the current intended use. The modified text (underlined) will read:
2 United States Food and Drug Administration. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Guidance for Clinical Investigators, Industry, and FDA Staff. August 31st ed. Washington, D.C .: FDA, 2017.
3 United States Food and Drug Administration, the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (510(k)), Guidance for Industry and Food and Drug Administration Staff. Washington, D.C.: FDA, 2014.
http://www.fda.gov/downloads/MedicalDevices/..../UCM284443.pdf
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Image /page/5/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, blue, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are several blue-green circles of varying sizes, arranged in an arc.
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 and epileptic 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 traiectory 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 therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™™ System analysis.
The clarified and duplicated indications were determined to not create a new intended use or raise different questions of safety and effectiveness, and were also determined to not introduce any new or different technical characteristics which could raise different questions of safety and effectiveness, i.e., the clarified indications are consistent with the existing intended use as well as the existing Indications For Use.
d. Indications For Use
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 and epileptic 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.
e. Comparison to Predicate Devices
The application for the Monteris Medical NeuroBlate System with the modified labeling is substantially equivalent (and/ or identical) to the predicate Monteris NeuroBlate System (K171255, K182036, K193375) in intended use, Indications For Use, technology, design and physician use.
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Image /page/6/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are several teal-colored circles of varying sizes, arranged in an arc shape.
f. Summary of Supporting Data
Considering the intended labeling clarifications include no physical, material, or software related device design changes, the NeuroBlate System predicates' previously provided in-vitro (bench) and in-vivo (animal) data remains applicable and are incorporated by reference.
As these modifications to the Indications For Use do not create a new intended use or raise new or different questions of safety or efficacy and incorporates previously provided clinical data(4), additional clinical data are not necessary to demonstrate substantial equivalence.