(21 days)
Not Found
No
The description focuses on hardware components, software for planning and monitoring, and real-time thermographic analysis, without mentioning AI or ML algorithms.
Yes
The device is used to ablate, necrotize, or coagulate soft tissue, which directly treats a medical condition.
No
The NeuroBlate System is described as a device for ablation, necrotizing, or coagulating soft tissue using laser thermal therapy, 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 primary function is therapeutic intervention and monitoring of that intervention, not diagnosis of a disease or condition. It assists in treatment delivery and assessment of that treatment's effect, rather than identifying a medical condition.
No
The device description explicitly lists multiple hardware components (Laser Delivery Probes, Probe Driver, System Electronics Rack and Components) in addition to the software (Control Workstation including the 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: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- 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, its core purpose is to deliver a physical treatment (thermal therapy) directly to the patient's tissue, not to analyze a sample taken from the patient.
- Intended Use: The intended use clearly states its purpose is for "ablating, necrotizing, or coagulating soft tissue" and for "planning and monitoring thermal therapies." This is a therapeutic application, not a diagnostic one.
- Device Description: The components described (laser delivery probes, probe driver, electronics, control workstation) are all consistent with a system designed for delivering energy and controlling a physical intervention within the body.
While the system provides "information that may be useful in the determination or assessment of thermal therapy," this information is derived from monitoring the effect of the therapy on the tissue in real-time using MRI, not from analyzing a biological sample for diagnostic purposes.
Therefore, the NeuroBlate System falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
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 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 Medical 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:
- . Gas-cooled Laser Delivery Probes (Probes) 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 Philips Magnetic Resonance Imaging Systems.
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
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 Philips MRI's as it does with the Siemens, IMRIS, and GE MRI's.
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2014
Monteris Medical Corporation % Mr. Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, California 94501
Re: K141983
Trade/Device Name: Monteris Medical NeuroBlate System Regulation Number: 21 CFR 878.4810, 882.4560 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, Stereotaxic instrument Regulatory Class: Class II Product Code: GEX, HAW Dated: July 18, 2014 Received: July 21, 2014
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
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141983
Device Name Monteris Medical NeuroBlate System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.08.11 10:48:05 -04'00
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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 graphic of several green circles arranged in a pattern.
Section 5: 510(k) Summary
a. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Monteris Medical Corp. |
| 16305 36th Ave. North, Suite 200 | |
| Plymouth, MN 55446 |
Brooke Ren, Ph.D.
Senior Vice President of Operations
Tel: 763-253-4716; Fax: 763-746-0084
www.monteris.com |
| Correspondent Contact
Information: | Craig Coombs
Coombs Medical Device Consulting
1193 Sherman Street
Alameda, CA 94501
Tel: 510-337-0140; Fax: 510-337-0416 |
| Device Proprietary Name: | Monteris Medical NeuroBlate™ System |
| 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 |
Predicate Device Information:
| Predicate Device: | NeuroBlate™ System |
|---|---|
| Predicate Device Manufacturer: | Monteris Medical |
| Predicate Device Common Name: | Monteris NeuroBlate™ System |
| Predicate Device Premarket Notification # | K120561, K131278, K131955 |
| 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 18 July 2014
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c. Description of Device
The Monteris Medical 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:
- . Gas-cooled Laser Delivery Probes (Probes) 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 Philips 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 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 application Monteris Medical NeuroBlate System, which is compatible with Siemens, IMRIS, GE and Philips MRI's, is substantially equivalent in intended use, technology, design, and physician use to the predicate Monteris NeuroBlate System (K131955), which is compatible with only Siemens, IMRIS, and GE MRI's.
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 as the predicate devices.
5
The application System is compatible with the listed Philips 1.5 and 3.0T MRI systems, along with the predicate Systems compatibility with listed Siemens, IMRIS and GE 1.5 and 3.0T MRI Systems.
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 (Siemens, IMRIS, GE and Philips MRI compatible) is substantially equivalent to the predicate NeuroBlate System (Siemens, IMRIS, and GE 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 Philips MRI's as it does with the Siemens, IMRIS, and GE MRI's.