(29 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware and software for planning, monitoring, and delivering thermal therapy under MRI guidance.
Yes
The device is used to ablate, necrotize, or coagulate soft tissue, which directly treats a medical condition.
No
The device is indicated for use to ablate, necrotize, or coagulate soft tissue. While it aids in planning and monitoring thermal therapies and provides information for assessment, its primary function is therapeutic (ablation), not solely diagnostic.
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 IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NeuroBlate™ System Function: The NeuroBlate™ System is a surgical system used for ablating, necrotizing, or coagulating soft tissue within the body using lasers under MRI guidance. It is used for planning and monitoring thermal therapies in vivo.
- Lack of Sample Analysis: The description focuses on delivering energy to tissue within the patient and monitoring the effects using imaging. There is no mention of analyzing samples taken from the patient.
Therefore, the NeuroBlate™ System falls under the category of a surgical device used for therapeutic intervention, 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 interstital 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 NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.
As previously described in K143457 and K162762, 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 Advanced, and Robotic, Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
- In consideration that the proposed change is an alternative (portable) Connector o Module (PCM) subcomponent, related Connector Module discussion topics are separated out from the overall Interface Platform (IP) description, discussion and comparison purposes.
- A System Electronics Rack and Components, which includes 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) Portable Connector Module (PCM). The PCM provides the capability to be mounted in various positions on the Interface Platform (IP) Arms, utilizes an externalized laser fiber connector as well as alternative commercially available thermocouple cable connectors (i.e., connectors which utilize wires soldered to connector pins compared to the commercially available connectors which utilize wires crimped to connector pins).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
soft tissue, brain
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
The PCM 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 Portable Connector Module (PCM) when used as an Interface Platform (IP) subcomponent, as part of the NeuroBlate™ system.
The Design Verification process utilized protocols to detail the associated tests which confirmed 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 which confirmed the modified NeuroBlate™ System met the user needs and intended use. Each validation protocol described the objective, test method and acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
K120561, K141983, K14347, K162762
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
Monteris Medical David Mueller Principal Regulatory Affairs Specialist 14755 27th Avenue North Suite C Plymouth, Minnesota 55447
Re: K170724
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: March 8, 2017 Received: March 9, 2017
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. 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
1
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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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.
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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K170724
Device Name Monteris Medical NeuroBlate(TM) System
Indications for Use (Describe)
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstital 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)
☑ 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.
Section 5: 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 |
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 # | K120561, K141983, K14347, K162762 |
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 |
4
Image /page/4/Picture/0 description: The image shows the logo for Monteris Medical, followed by the text "5b. Date Summary Prepared" and the date "08 March 2017". The logo consists of the word "MONTERIS" in bold, blue letters, with the word "MEDICAL" in smaller letters below it. Above the word "MONTERIS" are several small, blue 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 delivery of precision thermal therapy in the practice of neurosurgery.
As previously described in K143457 and K162762, 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 Advanced, and Robotic, Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
- In consideration that the proposed change is an alternative (portable) Connector o Module (PCM) subcomponent, related Connector Module discussion topics are separated out from the overall Interface Platform (IP) description, discussion and comparison purposes.
- A System Electronics Rack and Components, which includes 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).
5
Image /page/5/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" are nine teal-colored circles arranged in an arc shape. The logo is simple and modern, and the teal color gives it a clean and professional look.
Thus, there is no change to entire system, with the exception of an additional (alternative) Portable Connector Module (PCM). The PCM provides the capability to be mounted in various positions on the Interface Platform (IP) Arms, utilizes an externalized laser fiber connector as well as alternative commercially available thermocouple cable connectors (i.e., connectors which utilize wires soldered to connector pins compared to the commercially available connectors which utilize wires crimped to connector pins).
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 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.
5e. Comparison to Predicate Device
Thus, there is no change to entire system, with the exception of an additional (alternative) Portable Connector Module (PCM). The PCM provides the capability to be mounted in various positions on the Interface Platform (IP) Arms, utilizes an externalized laser fiber connector as well as alternative commercially available thermocouple cable connectors (i.e., connectors which utilize wires soldered to connector pins compared to the commercially available connectors which utilize wires crimped to connector pins).
The application for the Monteris Medical NeuroBlate™ System with the PCM is substantially equivalent to the predicate Monteris NeuroBlate™ System (K120561, K141983, K143457 and K162762) 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 PCM is substantially equivalent to the predicate NeuroBlate™ System.
6
Image /page/6/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 directly below it. Above the word "MONTERIS" is a series of teal-colored circles arranged in an arc shape.
5f. Summary of Supporting Data
The PCM 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 Portable Connector Module (PCM) when used as an Interface Platform (IP) subcomponent, as part of the NeuroBlate™ system.
The Design Verification process utilized protocols to detail the associated tests which confirmed 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 which confirmed 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 PCM is substantially equivalent to the predicate Monteris NeuroBlate™ System (K120561, K141983, K143457 and K162762) in intended use, technology, design and physician use.