(402 days)
Not Found
No
The summary describes a system for MRI-guided thermal therapy 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 focuses on trajectory planning assistance and real-time thermographic analysis, which are standard image processing and analysis techniques, not necessarily AI/ML.
Yes
The device is indicated for ablating, necrotizing, or coagulating soft tissue through interstitial irradiation or thermal therapy, which are direct therapeutic actions.
No
Explanation: The device is primarily described as a system for ablating, necrotizing, or coagulating soft tissue using lasers and for planning and monitoring these thermal therapies under MRI visualization. While it provides "information that may be useful in the determination or assessment of thermal therapy," its core function is therapeutic intervention and monitoring thereof, not diagnosis. The text explicitly states that "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis," further indicating it's not a standalone diagnostic tool.
No
The device description explicitly lists multiple hardware components including a Laser Delivery Probe, Probe Driver, and System Electronics Rack, in addition to the software component (Control Workstation including M Vision™ Software).
Based on the provided information, 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 examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- NeuroBlate System Function: The NeuroBlate System is a therapeutic device. Its primary function is to ablate, necrotize, or coagulate soft tissue using a laser. While it uses MRI for planning and monitoring, it is directly interacting with and treating tissue within the body, not analyzing specimens outside the body.
- Intended Use: The intended use clearly states "to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy". This is a therapeutic action, not a diagnostic one based on analyzing specimens.
- Device Description: The components described (laser delivery probe, probe driver, electronics, control workstation) are consistent with a system designed for delivering energy and manipulating a probe within the body for treatment.
While the system provides "information that may be useful in the determination or assessment of thermal therapy," this information is derived from monitoring the in vivo treatment process using MRI, not from analyzing in vitro specimens. The system is a tool for performing a therapeutic procedure, not for diagnosing a condition by analyzing bodily fluids or tissues.
N/A
Intended Use / Indications for Use
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue 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 Probe. 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
GEX, HAW
Device Description
The Monteris NeuroBlate™ System is a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy. The NeuroBlate System components consist of:
- A gas-cooled Laser Delivery Probe (Probe) to deliver controlled energy to a target . zone:
- . A Probe Driver which allows the surgeon to precisely position, stabilize and manipulate a laser probe within the target zone;
- A System Electronics Rack and Components, which includes necessary . umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation; and
- A Control Workstation including the M Vision™ Software, which includes a user ● interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsystems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Soft tissue (in the discipline of neurosurgery)
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)
Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling.
In particular the following testing was conducted to demonstrate electromagnetic and MRI compatibility:
- . EMC/EMI testing in accordance with IEC 60601-1-2.
- Verification of probe placement accuracy within MR environment. .
- Testing for RF Induced heating during MR Imaging. ●
- MR compatibility for 1.5T and 3T per ASTM standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K12056/
ﺑ
NeuroBlate™ System Traditional Premarket Notification
Section 5: 510(k) Summary
1 2013 APR
| a. Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Monteris Medical, Inc. |
| 100 - 78 Innovation Drive | |
| Winnipeg, Manitoba | |
| CANADA R3T 6C2 | |
| Tel: 204-272-2220 | |
| Fax: 204-272-2219 | |
| www.monteris.com | |
| Correspondent Contact | |
| Information: | John Schellhorn |
| President & C.E.O. | |
| Monteris Medical Corp. | |
| 16305 36th Ave. North, Suite 200 | |
| Plymouth, MN 55446 | |
| 763-253-4712 office | |
| 617-230-1252 mobile | |
| jschellhorn@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 NeuroBlateTM System |
Predicate Device Information:
| Predicate Device: | AutoLITT® System |
|---|---|
| Predicate Device Manufacturer: | Monteris Medical |
| Predicate Device Common Name: | Monteris AutoLITT® System |
| Predicate Device Premarket Notification # | K081509 |
| 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 |
1
b. Date Summary Prepared . 28 March 2013
c. Description of Device
The Monteris NeuroBlate™ System is a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy. The NeuroBlate System components consist of:
- A gas-cooled Laser Delivery Probe (Probe) to deliver controlled energy to a target . zone:
- . A Probe Driver which allows the surgeon to precisely position, stabilize and manipulate a laser probe within the target zone;
- A System Electronics Rack and Components, which includes necessary . umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation; and
- A Control Workstation including the M Vision™ Software, which includes a user ● interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsystems.
d. Indications for Use
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue 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 Probe. 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.
e. Comparison to Predicate Device
The Monteris Medical NeuroBlate™ System is substantially equivalent to the predicate Monteris AutoLITT® device in intended use, technology, design and physician use.
All patient contacting materials are identical in composition, source, and use with respect to the predicate device.
The technical modes of action and technical principles are materially the same the predicate devices.
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Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling.
As the modifications presented in the current device do not change the intended use, operating principles, or raise any unaddressed safety concerns, with respect to the predicate device, it can be concluded the NeuroBlate™ System is substantially equivalent to the AutoLITT® System.
f. Summary of Supporting Data
Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling.
In particular the following testing was conducted to demonstrate electromagnetic and MRI compatibility:
- . EMC/EMI testing in accordance with IEC 60601-1-2.
- Verification of probe placement accuracy within MR environment. .
- Testing for RF Induced heating during MR Imaging. ●
- MR compatibility for 1.5T and 3T per ASTM standards.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 1, 2013
Monteris Medical, Incorporated % Mr. John Schellhorn Chief Executive Officer 16305 36th Ave. North, Suite 200 Plymouth, MN 55446
Re: K120561
Trade/Device Name: Monteris Medical 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: February 22, 2012 Received: February 24, 2012
Dear Mr. Schellhorn:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 – Mr. John Schellhorn
forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N.Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use
510(k) Number (if known): K120561
Monteris Medical NeuroBlate™ System Device Name:
Indications for Use:
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue 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 Probe. 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.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogdens 2013.03.29 08:48:43 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K120561
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Section 4, Page 1