(77 days)
No
The summary describes a system for MRI-guided thermal therapy with components for planning, monitoring, and delivering laser energy. It mentions software for planning and monitoring, but there is no indication of AI or ML being used for analysis, decision support, or any other function. The change described is a simple replacement of a temperature sensor.
Yes
The device is indicated for use to "ablate, necrotize, or coagulate intracranial soft tissue," which directly treats a medical condition.
No
The device is primarily an ablative medical device used for thermal therapies, with planning and monitoring capabilities under MRI visualization. While it provides "information that may be useful in the determination or assessment of thermal therapy," this information supports the therapeutic action rather than solely diagnosing a condition or disease. The system's main purpose is to ablate, necrotize, or coagulate tissue.
No
The device is a system that includes multiple hardware components (laser delivery probes, probe drivers, interface platform, system electronics rack) in addition to software. The software is part of a larger hardware-based system for thermal therapy.
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 Diagnostic 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 used for internal therapy (ablation, necrotization, coagulation) of intracranial soft tissue using lasers. It is a surgical tool used directly on the patient's body, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states it's for "internal therapy in medicine and surgery in the discipline of neurosurgery."
- Device Description: The components described are surgical tools and systems for delivering and monitoring thermal therapy within the brain.
Therefore, the NeuroBlate System falls under the category of a therapeutic medical 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 intracranial soft tissue, including brain structures, through internal 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 near 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 (comma separated list FDA assigned to the subject device)
GEX, HAW
Device Description
The Monteris NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided intracranial delivery of precision thermal therapy in the practice of neurosurgery.
As previously described in K170724, K171255, K172881, and K173305, 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 (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 Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
- A System Electronics Rack and Components, which includes the laser and 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™ FUSION™ ● 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, 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).
Monteris' existing NeuroBlate System Laser Delivery Probes ("Probe") include the 3.3mm FullFire and SideFire Probes and the 2.2mm FullFire Probe. In order to ensure that the Probe tip maintains an appropriate temperature while the laser is on, all Monteris Probes incorporate an internal temperature sensor which measures the probe tip's internal temperature. The sensor transmits the temperature reading to the NeuroBlate System and associated M-Vision Software
Note: The only function for the Probe's temperature sensor is to measure the Probe tip's internal temperature, i.e., the sensor is not utilized for determining the patient's brain tissue temperature and is not utilized for the software's thermography visualization.
To perform a NeuroBlate procedure, a NeuroBlate Laser Probe is connected to a Portable Connector Module (PCM). The PCM integrates with the Interface Platform(IP). The IP attaches to the MRI system's patient table or the ATAMA board, and provides supporting electronics for the Probe Drivers and interconnections (including the Portable Connector Module) for the Laser Delivery Probes.
This submission's proposed change simply replaces the Probe's existing internal metallic (wire) thermocouple with a non-metallic fiber optic. temperature sensor. The optical fiber temperature sensor has the identical function as the existing metallic (wire) thermocouple, i.e., to measure the probe tip's internal temperature and to transmit the temperature measurement to the NeuroBlate System and associated M-Vision Software.
Corresponding hardware and software changes are proposed in order to incorporate the new optical fiber component, e.g., (hardware) modified Connector Module, a Signal Conditioner (converts optical fiber signal to electrical temperature signal), and (software) M-Vision Pro Software Package (V3.14), along with associated labeling updates. Additionally, existing Contraindications, Warnings and Cautions are duplicated within the IFU and clarified for ease of reader understanding.
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
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)
The development process for the NeuroBlate™ System Probe with the fiber optic temperature sensor 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 Probe 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): 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.
K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, K131278, K120561, K081509
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and consists of a stylized caduceus symbol. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
October 15, 2018
Monteris Medical David Mueller Senior Principal Regulatory Affairs Specialist 14755 27th Avenue North Suite C Plymouth, Minnesota 55447
Re: K182036
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 Dated: July 27, 2018 Received: July 30, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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).
Sincerely,
Matthew C. Krueger -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182036
Device Name Monteris Medical NeuroBlate™ System
Indications for Use (Describe)
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through internal 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 near 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the company name in a dark blue, sans-serif font, with the word "MONTERIS" in a larger font size than the word "MEDICAL" which is placed directly below it. Above the company name, there is a series of teal-colored circles arranged in an arc shape, with larger circles in the center and smaller circles towards the edges.
510(k) Summary
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 |
| Senior 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:
| Manufacturer | Monteris Medical |
|---|---|
| Commercial | |
| Name | NeuroBlate System |
| Common | |
| Name: | Laser Interstitial Thermal Therapy (LITT) |
| Laser surgical instrument for use in general and plastic surgery and in dermatology | |
| Stereotaxic instrument | |
| Premarket | |
| Notification # | K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, |
| K131278, K120561, K081509 | |
| Regulation | 21 CFR 878.4810 |
| 21 CFR 882.4560 | |
| Class/ Product | |
| Code | Class II |
| GEX, HAW |
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Image /page/4/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the company name in a bold, dark blue font, with the word "MONTERIS" stacked above the word "MEDICAL". Above the company name is a series of teal-colored circles arranged in an arc shape. There are 3 larger circles in the center, with smaller circles on either side.
Date Summary Prepared
27 July 2018
Description of Device
The Monteris NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided intracranial delivery of precision thermal therapy in the practice of neurosurgery.
As previously described in K170724, K171255, K172881, and K173305, 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 (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 Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
- A System Electronics Rack and Components, which includes the laser and 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™ FUSION™ ● 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, 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).
Monteris' existing NeuroBlate System Laser Delivery Probes ("Probe") include the 3.3mm FullFire and SideFire Probes and the 2.2mm FullFire Probe. In order to ensure that the Probe tip maintains an appropriate temperature while the laser is on, all Monteris Probes incorporate an internal temperature sensor which measures the probe tip's internal temperature. The sensor transmits the temperature reading to the NeuroBlate System and associated M-Vision Software
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Image /page/5/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the company name in a dark blue, sans-serif font, with the word "MONTERIS" in a larger font size than "MEDICAL." Above the company name is an arc of seven teal-colored circles, arranged in a semi-circular pattern. The circles vary in size, with the largest circles in the center and smaller circles on the sides.
which regulates the cooling system for the laser probe, e.g., ensures sufficient gas coolant is sent to the Probe tip to maintain an appropriate temperature.
Note: The only function for the Probe's temperature sensor is to measure the Probe tip's internal temperature, i.e., the sensor is not utilized for determining the patient's brain tissue temperature and is not utilized for the software's thermography visualization.
To perform a NeuroBlate procedure, a NeuroBlate Laser Probe is connected to a Portable Connector Module (PCM). The PCM integrates with the Interface Platform(IP). The IP attaches to the MRI system's patient table or the ATAMA board, and provides supporting electronics for the Probe Drivers and interconnections (including the Portable Connector Module) for the Laser Delivery Probes.
This submission's proposed change simply replaces the Probe's existing internal metallic (wire) thermocouple with a non-metallic fiber optic. temperature sensor. The optical fiber temperature sensor has the identical function as the existing metallic (wire) thermocouple, i.e., to measure the probe tip's internal temperature and to transmit the temperature measurement to the NeuroBlate System and associated M-Vision Software.
Corresponding hardware and software changes are proposed in order to incorporate the new optical fiber component, e.g., (hardware) modified Connector Module, a Signal Conditioner (converts optical fiber signal to electrical temperature signal), and (software) M-Vision Pro Software Package (V3.14), along with associated labeling updates. Additionally, existing Contraindications, Warnings and Cautions are duplicated within the IFU and clarified for ease of reader understanding.
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 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 near 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.
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Image /page/6/Picture/0 description: The image shows the logo for Monteris Medical. The logo features a series of teal-colored circles arranged in an arc shape above the company name. The company name, "MONTERIS," is written in a bold, dark blue sans-serif font, with the word "MEDICAL" in a smaller font size directly below it.
Comparison to Predicate Device
In order to ensure that the Probe tip does not over-heat during laser ablation, all Monteris Probes incorporate an internal temperature sensor which measures the probe tip's internal temperature. The sensor transmits the temperature reading to the NeuroBlate System and associated M-Vision Software which regulates the cooling system for the laser probe ensuring sufficient gas coolant is sent to the Probe tip to maintain an appropriate temperature.
This submission's proposed fiber optic temperature sensor (FOTS) has the identical function as the existing (predicate) NeuroBlate Probe's metallic (wire) thermocouple, i.e., to measure the probe tip's internal temperature and to transmit the temperature measurement to the NeuroBlate System and associated M-Vision Software.
These proposed changes are in response to a recall (Z-0194-2018) regarding MRI induced unintentional Probe heating. Replacing the metallic thermocouple with a FOTS prevents the MR energy from coupling to the probe umbilical and thus eliminates the root cause of unintended Probe heating.
In order to incorporate the FOTS component, the current NeuroBlate hardware, software and labeling are also modified.
- Hardware: Portable Connector Module (PCM) The proposed PCM modifies the existing PCM to incorporate a new optical fiber connector port (and a pre-attached fiber optic cable). The modified and existing PCM remain Substantially Equivalent.
- Hardware: Signal Conditioner
The current NeuroBlate Probe's Thermocouple (TC) provides its temperature signal via electrical current while the modified Probe with FOTS utilizes light signals. The provided FOTS signal is "converted" to a temperature signal at the new Optical Signal Conditioner. The Optical Signal Conditioner and the existing Signal Conditioner (WIKA Transmitter Puck) remain Substantially Equivalent.
- Hardware: Associated Fiber Optic Cabling and Accessories ● The current Thermocouple (TC) transmits its electrical temperature signal via electrical cabling and connectors. A fiber optic electrical signal must be transmitted via fiber optic cabling and connectors. These cables and accessories remain Substantially Equivalent.
- Software: M-Vision V3.14 Software ● The existing M-Vision V3.13 Software is slightly modified to form V3.14 such that the system reads probe tip temperature via an optic signal conditioner. Several minor
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Image /page/7/Picture/0 description: The image shows the logo for Monteris Medical. The logo features a series of teal circles arranged in an arc shape above the company name. The company name, "MONTERIS," is written in a bold, dark blue font, with the word "MEDICAL" appearing in a smaller font size directly below it.
software updates were also completed to incorporate FOTS. M-Vision V3.13 and V3.14 remain Substantially Equivalent.
- Labeling: Fiber Optic Labeling Updates and Additional Labeling Clarifications ● Labeling updates include product label branding (i.e., Optic™), corresponding Probe and system component drawings, photographs and instructions related to FOTS incorporation. Additionally, existing Contraindications, Warnings, Cautions, and Instructions are duplicated within the IFU and clarified for ease of reader understanding.
The 510(k) application for the Monteris Medical NeuroBlate™ System with the fiber optic temperature measurement system demonstrates it to be substantially equivalent to the predicate 510(k) submissions for the Monteris NeuroBlate™ System [K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, K131278, K120561, and K081509 in intended use, technology, design and physician use.
As the modifications presented do not change the intended use, operating principles, or raise any unaddressed safety concerns, it can be concluded the application NeuroBlate™ System with the fiber optic temperature (measurement) sensor is substantially equivalent to the predicate NeuroBlate™ System.
Summary of Supporting Data
The development process for the NeuroBlate™ System Probe with the fiber optic temperature sensor 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 Probe 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.
As the proposed modifications do not change the intended use, operating principles or raise any unaddressed safety concerns, the application for the Monteris Medical NeuroBlate™ System Probe with the fiber optic temperature sensor is substantially equivalent to the predicate Monteris NeuroBlate™ System (K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, K131278, K120561, and K081509) in intended use, technology, design and physician use.