K Number
K143457
Device Name
NeuroBlate System
Date Cleared
2015-02-19

(78 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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. The NeuroBlate System components consist of: - . Families of gas-cooled Laser Delivery Probes (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone. This application includes the smaller diameter SideFire Select and FullFire Select families of Probes; - 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; - 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 NeuroBlateTM procedures, and interfaces to the MRI and hardware subsystems. This submission adds a line of 2.2mm Reduced Diameter Probes to the existing 3.3mm diameter probes. They will be known as the SideFire Select™ and FullFire Select™ Probes.
More Information

Not Found

No
The summary describes a system for thermal therapy guided by MRI, focusing on hardware components, software for planning and monitoring, and real-time thermographic analysis. There is no mention of AI or ML in the intended use, device description, or performance studies. The software functions described are typical for image-guided procedures and do not indicate the use of AI/ML algorithms for analysis or decision support beyond basic thermographic interpretation.

Yes
The device is used to ablate, necrotize, or coagulate soft tissue, which directly treats a condition and therefore falls under the definition of a therapeutic device.

No

The device is primarily a therapeutic system for ablating, necrotizing, or coagulating soft tissue using lasers, with capabilities for planning and monitoring thermal therapies under MRI visualization. While it provides "information that may be useful in the determination or assessment of thermal therapy," this information is for monitoring and assessing the therapy being delivered by the device itself, rather than for diagnosing a condition or disease. The text explicitly states that "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis," indicating its role is supportive to a physician's overall assessment, not primary diagnosis.

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 (M-Vision™).

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 taken 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 ablating, necrotizing, or coagulating soft tissue directly within the body using lasers. It is a therapeutic device that performs a physical intervention.
  • Intended Use: The intended use clearly states its purpose is for "ablating, necrotizing, or coagulating soft tissue" and "planning and monitoring thermal therapies under MRI visualization." This is a treatment and monitoring system, not a diagnostic test performed on a sample outside the body.
  • Device Description: The components described (laser delivery probes, probe drivers, interface platform, etc.) are all designed for delivering and controlling energy within the body for therapeutic purposes.

While the system provides "information that may be useful in the determination or assessment of thermal therapy" through real-time thermographic analysis, this information is derived from monitoring the therapeutic process itself, not from analyzing a biological specimen 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 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.

The NeuroBlate System components consist of:

  • . Families of gas-cooled Laser Delivery Probes (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone. This application includes the smaller diameter SideFire Select and FullFire Select families of Probes;
  • 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;
  • 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 NeuroBlateTM procedures, and interfaces to the MRI and hardware subsystems.

This submission adds a line of 2.2mm Reduced Diameter Probes to the existing 3.3mm diameter probes. They will be known as the SideFire Select™ and FullFire Select™ Probes.

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, 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)

Bench verification testing has demonstrated that the NeuroBlate System in general, and the new sizes of Laser Delivery Probes in particular, are in compliance with the medical community's expectations and the product labeling and product specifications.

In particular, the bench testing demonstrated that the new sizes of the Laser Delivery Probes exhibited compliance to the same electrical requirements, mechanical integrity and operation (e.g., cooling) requirements, and laser emission requirements as the predicate sizes; that they interfaced with the NeuroBlate System in an identical manner; and that adequate labeling information was provided to ensure that they could be accurately placed within the target tissue.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141983

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2015

Monteris Medical. Inc. % Mr. Craig Coombs President Coombs Medical Device Consulting 1193 Sherman Street Alameda, California 94501

Re: K143457

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: January 19, 2015 Received: January 21, 2015

Dear Mr. Craig 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

1

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 devicerelated 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.

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 yours.

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) K143457

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 )
----------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows two identical arrangements of teal-colored circles of varying sizes. Each arrangement consists of seven circles, with one larger circle at the top and smaller circles arranged around it. The circles have shadows, giving them a three-dimensional appearance. The background is plain white.

Section 5: 510(k) Summary K143457

CategoryComments
Sponsor:Monteris Medical Corp.
16305 36th Ave. North, Suite 200
Plymouth, MN 55446
763-253-4710
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 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 |

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 #:K141983
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

19 February 2015

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Image /page/4/Figure/0 description: The image shows two identical arrangements of five turquoise circles each, positioned against a white background. Each arrangement consists of one larger circle at the top, two medium-sized circles in the middle, and two smaller circles at the bottom. Each circle has a shadow effect, giving them a three-dimensional appearance.

c. 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.

The NeuroBlate System components consist of:

  • . Families of gas-cooled Laser Delivery Probes (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone. This application includes the smaller diameter SideFire Select and FullFire Select families of Probes;
  • 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;
  • 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 NeuroBlateTM procedures, and interfaces to the MRI and hardware subsystems.

This submission adds a line of 2.2mm Reduced Diameter Probes to the existing 3.3mm diameter probes. They will be known as the SideFire Select™ and FullFire Select™ Probes.

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.

5

Image /page/5/Figure/0 description: The image shows a pattern of teal-colored circles arranged in two similar clusters. Each cluster consists of a larger circle at the top and several smaller circles below, creating a triangular shape. The circles have soft shadows, giving them a slightly raised or three-dimensional appearance. The background is plain white, which makes the teal circles stand out.

e. Comparison to Predicate Device

The application Monteris Medical NeuroBlate™ System with the Reduced Diameter Laser Delivery Probes is substantially equivalent to the predicate Monteris NeuroBlate™ System (K141983) in intended use, technology, design and physician use.

The Indications for Use for the modified NeuroBlate System are unchanged from the predicate NeuroBlate System. The fundamental technology is also unchanged.

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.

The application System with the Reduced Diameter Laser Delivery Probes has similar laser emission patterns and laser ablation effect as the predicate Laser Delivery Probes. The expected use of the Reduced Diameter Probe for either its SideFire or FullFire is no different than the expected use of the predicate laser delivery probes.

Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling and specifications. It demonstrates that NeuroBlate system works as well with the Reduced Diameter Probe as it does with the larger diameter versions.

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 added Reduced Diameter Laser Delivery Probes is substantially equivalent to the predicate NeuroBlate™ System.

f. Summary of Supporting Data

Bench verification testing has demonstrated that the NeuroBlate System in general, and the new sizes of Laser Delivery Probes in particular, are in compliance with the medical community's expectations and the product labeling and product specifications.

In particular, the bench testing demonstrated that the new sizes of the Laser Delivery Probes exhibited compliance to the same electrical requirements, mechanical integrity and operation (e.g., cooling) requirements, and laser emission requirements as the predicate sizes; that they interfaced with the NeuroBlate System in an identical manner; and that adequate labeling information was provided to ensure that they could be accurately placed within the target tissue.