(29 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 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 K173305, 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:
- 0 Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone.
- 0 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™, or M-Vision ● Fusion™ software, which includes a user interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsvstems.
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.
There is no change to entire system, with the exception of an additional NeuroBlate Fusion-STM Software Package (V3.15).
This FDA 510(k) summary for the Monteris Medical NeuroBlate™ System with the Fusion-S Software (V3.15) focuses on demonstrating substantial equivalence to a predicate device, primarily due to software modifications. It does not present a detailed study on device performance against specific acceptance criteria in the manner requested for an AI/ML device.
The document describes software development processes (design verification and validation) and states that these processes confirmed the device met user needs and intended use, but it does not provide specific performance metrics, sample sizes, or ground truth details common in AI/ML performance studies.
Therefore, I cannot extract the detailed information requested in the prompt based on the provided text, as the application's focus is on substantial equivalence rather than a new performance study with specific acceptance criteria for a novel AI/ML component.
Here's a breakdown of why the requested information cannot be provided from this document:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states that "Each verification test protocol incorporated clearly defined acceptance criteria" and "Each validation protocol described the objective, test method and acceptance criteria," but it does not list these criteria or the numerical results of meeting them.
- Sample sizes used for the test set and the data provenance: This information is not provided. The document mentions "design verification and design validation process" but doesn't specify test set sizes or data origins.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Ground truth establishment is not discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned as a separate performance study. The device is described as assisting a "trained physician," indicating a human-in-the-loop context for its intended use, but no specific AI performance study is detailed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: This refers to an AI/ML training set, which is not applicable or discussed here as this is a software modification rather than an AI/ML training process for a new algorithm.
- How the ground truth for the training set was established: Not applicable, as detailed AI/ML training is not the subject of this 510(k).
In summary: The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of an updated version of an existing device (NeuroBlate System with Fusion-S software) to its predicates, rather than presenting a performance study for a novel AI/ML component against specific acceptance criteria. The modifications are described as "not change the intended use, operating principles, or raise any unaddressed safety concerns." The verification and validation processes mentioned are general quality system activities to ensure the software functions as intended and meets user needs, not a specific clinical performance study with the metrics and details requested for an AI/ML evaluation.
{0}------------------------------------------------
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.
January 3, 2020
Monteris Medical David Mueller Senior Principal Regulatory Affairs Specialist 14755 27th Avenue North; Suite C Plymouth, Minnesota 55447
Re: K193375
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: December 4, 2019 Received: December 5, 2019
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 (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
{1}------------------------------------------------
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 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 (QS) 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 medical devices and radiation-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., M.S. 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K193375
Device Name NeuroBlate™ System
Indications for Use (Describe)
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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in a bold, dark blue 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.
510(k) Summary
1a. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Monteris Medical Corp.14755 27th Avenue NorthSuite CPlymouth, MN 55446763-253-4710Fax: 763-746-0084www.monteris.com |
| Correspondent ContactInformation: | David H. MuellerSenior Principal Regulatory Affairs SpecialistMonteris Medical,TEL: 763-253-4710 x2732FAX: 763-746-0084Email: DMueller@Monteris.com |
| Device Common Name: | Magnetic Resonance Image Guided LaserThermal Therapy System |
| Device Classification Number: | 21 CFR 878.4810Laser surgical instrument for use in general andplastic surgery and in dermatology |
| 21 CFR 882.4560Stereotaxic instrument | |
| Device Classification &Product Code: | Class II, GEXClass II, HAW |
| Device Proprietary Name: | NeuroBlate™ System |
Predicate Device Information:
| Predicate Device: | NeuroBlate™ System |
|---|---|
| Predicate Device Manufacturer: | Monteris Medical |
| Predicate Device Common Name: | Monteris NeuroBlate System |
| Predicate Device Premarket Notification #: | K173305, K182036 |
| Predicate Device Regulation: | 21 CFR 878.4810Laser surgical instrument for use in generaland plastic surgery and in dermatology21 CFR 882.4560Stereotaxic instrument |
| Predicate Device Classification &Product Code: | Class II, GEXClass II, HAW |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in a bold, dark blue font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are seven teal-colored circles arranged in an arc shape. The logo is simple and modern, and the colors are calming and professional.
1b. Date Summary Prepared
December 4, 2019
1c. 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 K173305, 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:
- 0 Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone.
- 0 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™, or M-Vision ● Fusion™ software, which includes a user interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsvstems.
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.
There is no change to entire system, with the exception of an additional NeuroBlate Fusion-STM Software Package (V3.15). While the modified software package includes several modifications
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in a bold, dark blue font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are nine teal-colored circles arranged in a curved line.
which do not meet the FDA's "significant change" submission criteria, there is at least one intended 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.
1d. Indications for Use
There is no change to the indications for use, i.e., they remain:
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, 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.
1e. Comparison to Predicate Device
There is no change to entire system, with the exception of an additional (alternative) NeuroBlate Fusion-S Software Package (V3.15). While the modified software package includes several modifications which do not meet the FDA's "sigmificant change" submission criteria, there is at least one intended 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 application for the Monteris Medical NeuroBlate™ System with the Fusion-S Software is substantially equivalent to the predicate Monteris NeuroBlate™ System (K182036 and K173305) in intended use, technology, design and physician use.
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 application NeuroBlate™ System with the alternative Fusion-S (V3.15) Software is substantially equivalent to the predicate NeuroBlate™ System.
1f. Summary of Supporting Data
The updated Fusion-S (V3.15) Software development process followed Monteris' documented Ouality System and incorporated a design verification and design validation process. This process included an overarching Design Verification and Design Validation Master Plan. This
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the company name in a dark blue, sans-serif font, with the word "MONTERIS" in a larger font size than the word "MEDICAL" below it. Above the company name is a series of teal-colored circles arranged in an arc shape, with the largest circle in the center and smaller circles on either side.
plan describes the design verification and the design validation of the user needs for the Fusion-S (V3.15) Software 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.
Thus, the application for the Monteris Medical NeuroBlate™ System with the Fusion-S software (V3.15) is substantially equivalent to the predicate Monteris NeuroBlate™ System (K182036 and K173305) 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.