(33 days)
Not Found
No
The summary describes a system for laser ablation guided by MRI, with software for planning and monitoring. There is no mention of AI or ML in the device description, intended use, or performance studies. The software functions described (trajectory planning assistance, real-time thermographic analysis) are typical of image-guided surgery systems and do not inherently require AI/ML.
Yes
The device is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy, which constitutes a therapeutic intervention.
No
The device is indicated for ablating, necrotizing, or coagulating soft tissue through interstitial irradiation or thermal therapy, and for planning and monitoring thermal therapies. While it provides "information that may be useful in the determination or assessment of therapy," it explicitly states that "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis," which indicates it is not a primary diagnostic tool.
No
The device description explicitly lists multiple hardware components (Laser Delivery Probe, Probe Driver, System Electronics Rack and Components) in addition to the software (M Vision™ Software).
Based on the provided information, the Monteris Medical NeuroBlate™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- NeuroBlate System Function: The NeuroBlate System is a surgical device used for ablating, necrotizing, or coagulating soft tissue within the body using a laser. It is used in vivo (within a living organism), not in vitro (in a test tube or lab setting).
- Intended Use: The intended use clearly states its purpose is for "ablating, necrotizing, or coagulating soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery." This is a therapeutic procedure, not a diagnostic test performed on a sample.
- Device Description: The components described (laser delivery probe, probe driver, electronics rack, control workstation) are all consistent with a surgical system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, the NeuroBlate System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
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 Probes. It also provides real-time thermographic analysis of selected MR1 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
This submission clears the use of the NeuroBlate System with specific 1.5 & 3.0T General Electric Magnetic Resonance Imaging Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
soft tissue, neurosurgery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Software and bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling. It demonstrates that the NeuroBlate System works as well with the GE MRI's as it does with the Siemens and IMRIS MRI's.
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
K131955
NeuroBlate™ System – GE MRI Compatibility Special Premarket Notification
Section 5: 510(k) Šummary
| Category | Comments |
|---|---|
| Sponsor: | Monteris Medical Corp. |
| 16305 36th Ave. North, Suite 200 | |
| Plymouth, MN 55446 | |
| 763-253-4710 | |
| Fax: 763-746-0084 | |
| www.monteris.com | |
| JUL 30 2013 | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| 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 |
a. Device Information:
Predicate Device Information:
| Predicate Device: | NeuroBlate™ System |
|---|---|
| Predicate Device Manufacturer: | Monteris Medical |
| Predicate Device Common Name: | Monteris NeuroBlate™ System |
| Predicate Device Premarket Notification # | K120561 |
| 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 |
b. Date Summary Prepared 25 June 2013
1
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.
This submission clears the use of the NeuroBlate System with specific 1.5 & 3.0T General Electric Magnetic Resonance Imaging Systems.
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 Probes. It also provides real-time thermographic analysis of selected MR1 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.
e. Comparison to Predicate Device
The application Monteris Medical NeuroBlate™ System (GE, Siemens, and IMRIS MRI compatible) is substantially equivalent to the predicate Monteris NeuroBlate™ System (Siemens, and IMRIS MRI compatible) 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.
2
The application System is compatible with listed GE 1.5 and 3.0T MRI systems, along with the predicate Systems compatibility with listed Siemens and IMRIS 1.5 and 3.0 MRI Systems
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 application NeuroBlate™ System (GE, Siemens, and IMRIS MRI compatible) is substantially equivalent to the predicate NeuroBlate™ System (Siemens, and IMRIS MRI compatible).
f. Summary of Supporting Data
Software and bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling. It demonstrates that the NeuroBlate System works as well with the GE MRI's as it does with the Siemens and IMRIS MRI's.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2013
Monteris Medical, Incorporated % Mr. Craig Coombs Coombs Medical Device Consulting, Incorporated 1193 Sherman Street, Alameda, California 94501
Re: K131955
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: June 26, 2013 Received: July 01, 2013
Dear Mr. Coombs:
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 (reporting of medical
4
Page 2 - Mr. Coombs
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
5
Section 4: Indications for Use
510(k) Number (if known): K131955
Device Name: Monteris Medical NeuroBlate™ System
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 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.
Prescription Use × AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR 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)
Page 1 of 1
Neil R Ogden 2013.07.29 09:27:30 -04'00' (Division Sign-off) for MxM Division of Surgical Devices 510(k) Number