The Visualase MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064mm lasers.

Device Description

The Visualase MRI-Guided Laser Ablation System comprises hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of: a diode laser (energy source) a coolant pump to circulate saline through the laser application Visualase workstation which interfaces with MRI scanner's host computer Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; two monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections Remote Presence software provides a non-clinical utility application for use by Medtronic only and is not accessible by the user

AI/ML Overview

The provided text describes specific details about the Visualase MRI-Guided Laser Ablation System (SW 3.4) and its comparison to predicate devices, but it does not contain a table of acceptance criteria or a detailed study description with performance metrics in the format requested.

The "Testing Summary" section mentions in vivo testing to demonstrate accuracy and performance of MR Thermometry and Thermal Damage Estimate, as well as software and system verification and validation. However, it does not provide:

Specific acceptance criteria values (e.g., "accuracy must be within X degrees Celsius").
Reported device performance values against these criteria.
Sample sizes for the test set.
Data provenance.
Details about expert involvement or adjudication.
Information on MRMC studies or standalone AI performance.
Details about the training set.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated with numeric values in the document. The general statement is "Testing demonstrated the accuracy and precision of the Visualase MRI-Guided Ablation System's Thermal Damage Estimate and MR Thermometry for its intended use."
Reported Device Performance: Not provided (e.g., no specific accuracy values, precision values, or success rates are given).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: The testing was "In vivo testing conducted 1.5T and 3.0T (in accordance with 21 CFR 58)". 21 CFR Part 58 refers to Good Laboratory Practice for nonclinical laboratory studies, which implies prospective in vivo studies, but does not specify the origin of the data (e.g., country).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document implies the device is a tool used by a neurosurgeon. It does not describe a comparative effectiveness study involving human readers with or without AI assistance, or any effect size for such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document states the system "provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output." It is an MRI-guided system implying human-in-the-loop operation. No standalone algorithm-only performance is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given it's "in vivo testing" for "Thermal Damage Estimate" and "MR Thermometry," the ground truth likely involved a direct measurement method for temperature or thermal damage in the tissue, possibly through implanted probes or post-ablation pathological assessment, but the specific method is not detailed.

8. The sample size for the training set

Not applicable as this document describes performance of a medical device (laser ablation system with software), not a machine learning model explicitly detailing training data. The software components are verified and validated, but no "training set" in the context of AI/ML is mentioned.

9. How the ground truth for the training set was established

Not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 7, 2022

Medtronic Navigation, Inc. Sharon Mcdermott Principal Regulatory Specialist 826 Coal Creek Circle Louisville. Colorado 80027

Re: K211269

Trade/Device Name: Visualase MRI-Guided Laser Ablation System (SW 3.4) 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: ONO Dated: April 26, 2021 Received: April 27, 2021

Dear Sharon Mcdermott:

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.

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

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K211269

Device Name

Visualase MRI-Guided Laser Ablation System (SW 3.4)

Indications for Use (Describe)

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}------------------------------------------------

510(k) Summary

Submitter/Sponsor:	Medtronic Navigation, Inc.826 Coal Creek CircleLouisville, CO 80027
Contact Person:	Sharon McDermott (Primary)Phone:(720) 890-3461 Fax: (720) 890-3500
E-mail :	sharon.mcdermott@medtronic.com
E-mail:	Rishi Sinha (Alternate)Phone: (720) 890-2485 Fax: (720) 890-3500rishi.k.sinha@medtronic.com
Date Summary Prepared:	January 7, 2022
Device Trade Name:	Visualase™ MRI-Guided Laser Ablation System (formerly Visualase Thermal TherapySystem)
Device Common Name:	Neurological Laser with MR Thermometry
Device Classification:	Class II
Product Code:	ONO
Device Regulation:	21CFR 878.4810 – Laser surgical instrument for use in general and plastic surgery and indermatology
Device Description:	The Visualase MRI-Guided Laser Ablation System comprises hardware and softwarecomponents used in combination with three MR-compatible (conditional), sterile,single-use, saline-cooled laser applicators with proprietary diffusing tips that delivercontrolled energy to the tissue of interest. The system consists of:a diode laser (energy source) a coolant pump to circulate saline through the laser application Visualase workstation which interfaces with MRI scanner's host computer Visualase software which provides the system's ability to visualize andmonitor relative changes in tissue temperature during ablation procedures,set temperature limits and control the laser output; two monitors to displayall system imaging and laser ablation via a graphical user interface andperipherals for interconnections Remote Presence software provides a non-clinical utility application for use byMedtronic only and is not accessible by the user

{4}------------------------------------------------

General Information	Primary PredicateNeuroBlate System (K201056)	Secondary PredicateVisualase Thermal Therapy System with 3.2Software (K181859)
FDA Regulation	21 CFR 878.4810	21 CFR 878.4810; 21 CFR 892.5050
FDA Product Code	GEX, HAW	GEX, LLZ
Manufacturer	Monteris Medical	Medtronic Navigation, Inc

Predicate Devices

Indications for Use

The Visualase MRI-guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064nm lasers.

Comparison of Device Characteristics with Predicate Devices

Characteristic	Subject Device	Primary Predicate	Secondary Predicate
	Visualase MRI-guidedLaser Ablation System(v3.4) Software	NeuroBlate System(K201056)	Visualase ThermalTherapy System with 3.2Software (K181859)
Indications for Use	The Visualase™ MRI-guided Laser AblationSystem is a neurosurgicaltool and is indicated foruse to ablate, necrotize,or coagulate intracranialsoft tissue including brainstructures (for example,brain tumor, radiationnecrosis, and epilepticfoci as identified by non-invasive and invasiveneurodiagnostic testing,including imaging)through interstitialirradiation or thermaltherapy in medicine andsurgery in the disciplineof neurosurgerywith 800nm through1064nm lasers.	The Monteris MedicalNeuroBlate® System is aneurosurgical tool and isindicated for use toablate, necrotize, orcoagulate intracranial softtissue, including brainstructures(e.g., brain tumor andepileptic foci as identifiedby non-invasive andinvasiveneurodiagnostic testing,including imaging),through interstitialirradiation or thermaltherapy in medicine andsurgery in the discipline ofneurosurgery with 1064nm lasers.The Monteris MedicalNeuroBlate® System isintended for planning andmonitoring thermaltherapies under MRI	The Visualase™ ThermalTherapy System is indicatedfor use to necrotize orcoagulate soft tissuethrough interstitialirradiation or thermaltherapy under magneticresonance imaging (MRI)guidance in medicine andsurgery incardiovascular thoracicsurgery (excluding the heartand the vessels in thepericardial sac),dermatology, ear-nose-throat, surgery,gastroenterology, generalsurgery, gynecology, headand neck surgery,neurosurgery, plasticsurgery,orthopedics, pulmonology,radiology, and urology, forwavelengths 800nmthrough 1064nm.When therapy is performedunder MRI guidance, andwhen data from compatibleMRI sequences is available,the
	Contraindications	visualization. It providesMRI based trajectoryplanning assistance forthe stereotaxic placementof MRI compatible(conditional) NeuroBlate®Laser Delivery Probes. Italso provides near real-time thermographicanalysis of selected MRIimages.When interpreted by atrained physician, thisSystem providesinformation that may beuseful in thedetermination orassessment of thermaltherapy. Patientmanagement decisionsshould not be made solelyon the basis of theNeuroBlate™ Systemanalysis.	Visualase™ system canprocess images using protonresonance-frequency (PRF)shift analysis and imagesubtraction torelate changes in complexphase angle back to relativechanges in tissuetemperature duringtherapy. The image datamaybe manipulated and viewedin a number of differentways, and the values of dataat certain selected pointsmay bemonitored and/or displayedover time.The Visualase™ ThermalTherapy System iscompatible with GeneralElectric Medical SystemsSigna model MRscanners and with SiemensMedical SolutionsMagnetom Espree systems.When interpreted by atrained physician, thisdevice provides informationthat may be useful in thedetermination orassessment of thermaltherapy. Patientmanagement decisionsshould not be made solelyon the basis of Visualase™analysis.






	The Visualase™ MRI-Guided Laser AblationSystem is contraindicatedfor the followingpatients:• Patients who havemedical conditionsthat arecontraindicated forMRI.• Patients who haveimplanted medicaldevices that arecontraindicated forMRI.• Patients whosephysiciandetermines thatLaser-InducedThermal Therapy(LITT) is not	• The following arecontraindicationsthat apply to theNeuroBlate System:• Patients who arecontraindicated forMRI, includingpatients who mayhavecontraindicationsdue to implantedmedical devices.• Patients who thephysician determinesare not appropriatecandidates for laserinterstitial thermaltherapy (LITT).• Patients who are notcandidates forinvasive surgical	We strongly recommendphysicians weighadvantages anddisadvantages of using adiode laser. Othermodalities or wavelengthsmay be more appropriatedue to any of the following:• Depth of penetration• Volume of necrosis• Propensity for scarringThis product should not beused if thermal therapy orinterstitial laser therapy arecontraindicated. Use thelaser only for the specialtieslisted in the Indications forUse section.
	acceptable.Patients for whichinvasive surgicalprocedures in thebrain is notappropriate.	procedures in thebrain	For those who whom thephysician determines thelaser is not the surgical toolof choice.Do not use the deviceendoscopically in anyprocedure whereendoscopes arecontraindicated.Patients who are unable tobe treated by surgicalmeans or who are intolerantto anesthesia.
	InteractiveGraphical UserInterface (GUI)Interfaces with MRIto acquire imagesand thermometrydataInteractive selectionof points-of-interestInteractivemonitoring ofVisualaseprocedure; displaysrelative changes intissue temperature,calculates estimateof thermal necrosisthroughoutprocedure	M-Vision, M-Vision Pro,M-Vision Fusion, andFusion-S software which includes:user interface forprocedure planning,interactivemonitoring ofNeuroBlateprocedures,interfaces to the MRIand hardwaresubsystems.	Interactive GraphicalUser Interface (GUI)Interface with MRI toacquire images andthermometry dataInteractive selection ofpoints-of-interestInteractive monitoringof Visualase proceduredisplays relativechanges in tissuetemperature,calculates estimate ofthermal necrosisthroughout procedure
Software	Surgeon placed lowtemperature limitmarkers to protectcritical structures	User selected pick pointsfor temperaturemonitoring in regions ofthermometry	Surgeon placed lowtemperature limit markersto protect critical structures
	High-temperature defaultlimit 85°C	Temperature points formonitoring	High-temperature defaultlimit 90°C
	Laser interlock todeactivate laser energywhen low or hightemperature limit targetsreached	No laser interlock featureassociated with pickpoints	Laser interlock to deactivatelaser energy when low orhigh temperature limittargets reached
	Thermal DamageEstimate (TDE):representation ofthermally damagedtissue in two zones:1.Necrotic Zone(complete cellulardeath)	Thermal Dose Threshold(TDT) Lines: depicted as 3contour boundary lines ofthermal isodose region.Yellow: mixture of lethallyand non-lethally injuredcells	Treatment Estimate (TE):representation of thermallydamaged tissue as onezone:1.Necrotic Zone(complete cellulardeath) tissue
	2.Transition Zone(mixture of lethally andnon-lethally injured cells)	Blue: area of complete cellular deathWhite: All tissue experiences cell deathwithin ≤48 hoursThe white TDT line residesinside the blue TDT line.The blue TDT line residesinside the yellow TDT line.
MRI Compatibility	1.5T and 3.0 T	1.5T and 3.0 T	1.5T and 3.0 T

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

Testing Summary

Testing demonstrated the accuracy and precision of the Visualase MRI-Guided Ablation System's Thermal Damage Estimate and MR Thermometry for its intended use. Additionally, software and system verification and validation activities were successfully completed.

Test	Method
Accuracy and performance ofMR Thermometry	In vivo testing conducted 1.5T and 3.0T(in accordance with 21 CFR 58)
Accuracy and performance of ThermalDamage Estimate	In vivo testing conducted in 1.5T and 3.0T(in accordance with 21 CFR 58)
Software verification and validation	Per Medtronic 21 CFR 820.30 compliant DesignControl procedure
System verification	Per Medtronic 21 CFR 820.30 compliant DesignControl procedure

Conclusion

The Visualase™ MRI-Guided Laser Ablation System is substantially equivalent to the primary predicate Monteris NeuroBlate System and the secondary predicate Visualase™ Therapy System. The Visualase Indications for Use have been narrowed and clarified to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) which aligns to the primary predicate's indications for use cleared in K201056. The changes to the Contraindications further align with the predicate NeuroBlate's labeling and removes redundant device description language. The language update in the Contraindications does not change the intended use or risk profile of the device.

The software and corresponding labeling changes included in this submission have been verified and validated demonstrating the changes meet product requirements and user needs. None of the changes affect the intended use or fundamental technology of the Visualase System. Further, none of the changes, including the clarifications of the indications for use, create any new intended use and do not raise any new questions of safety and effectiveness of the Visualase MRI-Guided Laser Ablation System. Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.