(29 days)
Not Found
No
The summary describes a system for MRI-guided thermal ablation with planning and monitoring software, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is indicated for use to "ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through interstitial irradiation or thermal therapy," which are therapeutic actions.
No
Explanation: The device is indicated for ablating, necrotizing, or coagulating intracranial soft tissue and for planning and monitoring thermal therapies. While it provides information that "may be useful in the determination or assessment of thermal therapy," it explicitly states that "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis." This indicates it's a therapeutic and monitoring tool, not a diagnostic one.
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 component.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- NeuroBlate™ System Function: The NeuroBlate™ System is a surgical system that uses lasers to ablate, necrotize, or coagulate tissue within the body. It is used for treatment (thermal therapy) and provides planning and monitoring tools for this treatment.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient. The system operates directly on the tissue within the brain.
- Intended Use: The intended use clearly states it is for "ablating, necrotizing, or coagulating intracranial soft tissue" and for "planning and monitoring thermal therapies under MRI visualization." This is a therapeutic and procedural system, not a diagnostic one based on specimen analysis.
While the system provides "information that may be useful in the determination or assessment of thermal therapy," this information is derived from real-time imaging and monitoring of the treatment process itself, not from the analysis of a biological specimen for diagnostic purposes.
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 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 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 K170724 and K171255, 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);
- 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) NeuroBlate System modified Laser Probe Umbilicals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
intracranial soft tissue, including brain structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 development process for the NeuroBlate™ System with the (alternative) modified Laser Probe Umbilicals 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 modified Laser Probe Umbilicals when used within 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081509, K120561, K131278, K131955, K141983, K143457, K162762, K170724, K171255
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a circular seal with a symbolic design. To the right of the seal, there is a rectangular block with the letters "FDA" in bold, followed by the words "U.S. FOOD & DRUG" in bold and "ADMINISTRATION" in a smaller font size below it. The logo is in black and white.
February 2, 2018
Monteris Medical David Mueller Principal Regulatory Affairs Specialist 14755 27th Avenue North Suite C Plymouth, Minnesota 55447
Re: K172881
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: September 20, 2017 Received: September 21, 2017
Dear David Mueller:
This letter corrects our substantially equivalent letter of October 20, 2017.
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
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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).
50-2041 or 501-770-7100).
Sincerely,
Jennifer R. Stevenson -S3
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
Image /page/2/Picture/0 description: The image shows the logo for Monteris Medical, which is a medical device company. The logo consists of the word "MONTERIS" in large, bold letters, with the word "MEDICAL" in smaller letters underneath. Above the word "MONTERIS" are several small circles. Below the logo is the text "Section 4: Indications for Use".
510(k) Number (if known): K172881
Device Name: Monteris Medical NeuroBlate™ System
Indications for Use:
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.
× Prescription Use (Part 21 CFR 801 Subpart D) C)
AND/OR Over-The-Counter Use (21 CFR 807 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Evaluation (ODE)
Concurrence of CDRH, Office of Device
Page 1 of __ 1
3
Section 1: 510(k) Summary
| 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 NeuroBlateTM System |
5a. 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 # | K081509, K120561, K131278, K131955, |
| K141983, K143457, K162762, K170724, | |
| K171255 | |
| 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 & | Class II, GEX |
| Product Code: | Class II, HAW |
4
5b. Date Summary Prepared
20 September 2017
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 K170724 and K171255, 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);
- 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) NeuroBlate System modified Laser Probe Umbilicals.
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
5
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 System modified Laser Probe Umbilicals which incorporate a modified Thermocouple assembly manufacturing process and several umbilical related Strain Relief component updates.
The application for the Monteris Medical NeuroBlate™ System with the (alternative) modified Laser Probe Umbilicals is substantially equivalent to the predicate Monteris NeuroBlate™ System (K081509, K120561, K131278, K131955, K141983, K143457, K162762, K170724 and K171255) 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 modified Laser Probe Umbilicals is substantially equivalent to the predicate NeuroBlate™ System.
5f. Summary of Supporting Data
The development process for the NeuroBlate™ System with the (alternative) modified Laser Probe Umbilicals 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 modified Laser Probe Umbilicals when used within 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.
6
Thus, as the modifications presented in the current device do not change the intended use, operating principles or raise any unaddressed safety concerns, the application for the Monteris Medical NeuroBlate™ System with the (alternative) modified Laser Probe Umbilicals NeuroBlate™ System is substantially equivalent to the predicate Monteris NeuroBlate™ System (K081509, K120561, K131278, K131955, K141983, K143457, K162762, K170724 and K171255) in intended use, technology, design and physician use.