(30 days)
Not Found
No
The document describes software for planning and monitoring thermal therapies and real-time thermographic analysis, but there is no mention of AI or ML algorithms being used for these functions. The focus is on image processing and analysis for visualization and planning, not on learning or predictive capabilities.
Yes
The device is indicated for "ablate, necrotize, or coagulate intracranial soft tissue," which directly treats a condition, making it a therapeutic device.
No
The device is primarily intended for thermal therapy (ablation, necrotization, coagulation) of intracranial soft tissue. While it includes features for planning and monitoring therapies under MRI visualization and real-time thermographic analysis, this information is explicitly stated to "not be made solely on the basis of the NeuroBlate™ System analysis" for patient management decisions, indicating its role is supportive to a physician's overall assessment rather than providing a standalone diagnosis of a medical condition.
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:
- Intended Use: The intended use is to "ablate, necrotize, or coagulate intracranial soft tissue... through internal therapy." This describes a therapeutic intervention performed directly on the patient's body, not a test performed on samples taken from the body.
- Device Description: The device components are described as laser delivery probes, probe drivers, an interface platform, electronics rack, and control workstation. These are all components used for delivering energy and guiding a surgical procedure within the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body. The system uses MRI for planning and monitoring, which is an imaging modality used in vivo.
Therefore, the NeuroBlate™ System is a therapeutic device used for surgical intervention, not an IVD device used for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
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.
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 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.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, 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)
The updated M-Vision/ M-Vision Pro (V3.13) Software 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 M-Vision Pro (V3.13) Software when used within the NeuroBlate System.
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. Each verification test protocol incorporated clearly defined acceptance criteria.
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. Each validation protocol described the objective, test method and acceptance criteria.
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 17, 2017
Monteris Medical David Mueller Senior Regulatory Affairs Specialist 14755 27th Avenue North Suite C Plymouth, Minnesota 55447
Re: K173305
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: October 17, 2017 Received: October 18, 2017
Dear Mr. 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Michael J. Hoffmann -S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173305
Device Name Monteris Medical 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 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.
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Image /page/3/Picture/1 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 directly underneath. Above the word "MONTERIS" is a series of teal-colored circles arranged in an arc shape, with larger circles in the center and smaller circles on the sides.
Section 1: 510(k) Summary
5a. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Monteris Medical Corp. |
| 14755 27th Avenue North | |
| Suite C | |
| Plymouth, MN 55446 | |
| 763-253-4710 | |
| Fax: 763-746-0084 | |
| www.monteris.com | |
| Correspondent Contact | |
| Information: | David H. Mueller |
| Senior Principal Regulatory Affairs Specialist | |
| Monteris Medical, | |
| TEL: 763-253-4710 x2732 | |
| 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 |
21 CFR 882.4560
Stereotaxic instrument |
| Device Classification &
Product Code: | Class II, GEX
Class II, HAW |
| Device Proprietary Name: | Monteris Medical 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 #: | K172881 |
| Predicate Device Regulation: | 21 CFR 878.4810 |
| Laser surgical instrument for use in general | |
| and plastic surgery and in dermatology |
21 CFR 882.4560
Stereotaxic instrument |
| Predicate Device Classification &
Product Code: | Class II, GEX
Class II, HAW |
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K173305 - Page 2 of 4
Image /page/4/Picture/1 description: The image shows the logo for Monteris Medical, followed by the text "5b. Date Summary Prepared" and the date "30 October 2017". The Monteris Medical logo consists of the word "MONTERIS" in bold, uppercase letters, with the word "MEDICAL" in smaller letters underneath. Above the word "MONTERIS" are several small, teal-colored circles arranged in a pattern.
5c. 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 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.
5
Image /page/5/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, dark blue letters, with the word "MEDICAL" in smaller, lighter blue letters underneath. Above the word "MONTERIS" are seven light blue circles arranged in an arc. The circles are of equal size and are evenly spaced.
5d. 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 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.
5e. Comparison to Predicate Device
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 application for the Monteris Medical NeuroBlate™ System with the M-Vision/ M-Vision Pro is substantially equivalent to the predicate Monteris NeuroBlate™ System (K172881) 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 M-Vision Pro (V3.13) Software is substantially equivalent to the predicate NeuroBlate™ System.
5f. Summary of Supporting Data
The updated M-Vision/ M-Vision Pro (V3.13) Software 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 M-Vision Pro (V3.13) Software when used within the NeuroBlate System.
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
6
Image /page/6/Picture/1 description: The image shows the logo for Monteris Medical. The logo features a series of teal-colored circles arranged in an arc above the company name. The company name, "MONTERIS," is written in a bold, sans-serif font, with the word "MEDICAL" appearing in a smaller font size directly below it.
input for the requirements. Each verification test protocol incorporated clearly defined acceptance criteria.
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. Each validation protocol described the objective, test method and acceptance criteria.
Thus, the application for the Monteris Medical NeuroBlate™ System with the M-Vision Pro (V3.13) is substantially equivalent to the predicate Monteris NeuroBlate™ System (K172881) in intended use, technology, design and physician use.