Visualase MRI-Guided Laser Ablation System (SW 3.4)

K211269 · Medtronic Navigation, Inc. · ONO · Jan 7, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K211269
• Device Name: Visualase MRI-Guided Laser Ablation System (SW 3.4)
• Applicant: Medtronic Navigation, Inc.
• Product Code: ONO · General, Plastic Surgery
• Decision Date: Jan 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

System performs MRI-guided laser interstitial thermal therapy (LITT) for intracranial soft tissue ablation. Inputs: MRI scanner data (thermometry/imaging). Processing: Software calculates relative tissue temperature changes and thermal damage estimates (TDE) using MR thermometry; provides GUI for trajectory planning and real-time monitoring; includes laser interlock to deactivate energy when temperature limits are reached. Output: Visual display of thermal damage zones (necrotic/transition) and temperature monitoring. Used in neurosurgery by physicians; operates within MRI suite. Benefits: Enables precise, minimally invasive thermal ablation of brain structures under real-time imaging guidance; assists in protecting critical structures via user-defined temperature limits.

Clinical Evidence

Bench testing only. Evidence includes in vivo testing at 1.5T and 3.0T to validate the accuracy and precision of MR thermometry and Thermal Damage Estimate (TDE) calculations, performed in accordance with 21 CFR 58. Software and system verification and validation were completed per 21 CFR 820.30 design control procedures.

Technological Characteristics

System includes diode laser (800-1064nm), coolant pump, and MR-compatible sterile single-use laser applicators with diffusing tips. Connectivity: Interfaces with MRI scanner host computer. Software: Visualase v3.4 provides real-time MR thermometry and TDE. Features laser interlock, GUI for point-of-interest selection, and temperature limit monitoring. Compatible with 1.5T and 3.0T MRI systems.

Indications for Use

Indicated for patients requiring ablation, necrosis, or coagulation of intracranial soft tissue, including brain tumors, radiation necrosis, and epileptic foci identified via neurodiagnostic testing. Contraindicated for patients with MRI contraindications, those with implanted devices incompatible with MRI, or those for whom LITT or invasive brain surgery is deemed inappropriate by a physician.

Regulatory Classification

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.

Predicate Devices

• NeuroBlate System (K201056)
• Visualase Thermal Therapy System with 3.2 Software (K181859)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K211269

Device Name

Visualase MRI-Guided Laser Ablation System (SW 3.4)

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Submitter/Sponsor: | Medtronic Navigation, Inc.<br>826 Coal Creek Circle<br>Louisville, CO 80027 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sharon McDermott (Primary)<br>Phone:[phone] Fax: [phone] |
| E-mail : | [e-mail] |
| E-mail: | Rishi Sinha (Alternate)<br>Phone: [phone] Fax: [phone]<br>[e-mail] |
| Date Summary Prepared: | January 7, 2022 |
| Device Trade Name: | Visualase™ MRI-Guided Laser Ablation System (formerly Visualase Thermal Therapy<br>System) |
| 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 in<br>dermatology |
| Device Description: | The Visualase MRI-Guided Laser Ablation System comprises hardware and software<br>components used in combination with three MR-compatible (conditional), sterile,<br>single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver<br>controlled energy to the tissue of interest. The system consists of:<br>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<br>monitor relative changes in tissue temperature during ablation procedures,<br>set temperature limits and control the laser output; two monitors to display<br>all system imaging and laser ablation via a graphical user interface and<br>peripherals for interconnections Remote Presence software provides a non-clinical utility application for use by<br>Medtronic only and is not accessible by the user |

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| General Information | Primary Predicate<br>NeuroBlate System (K201056) | Secondary Predicate<br>Visualase Thermal Therapy System with 3.2<br>Software (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-guided<br>Laser Ablation System<br>(v3.4) Software | NeuroBlate System<br>(K201056) | Visualase Thermal<br>Therapy System with 3.2<br>Software (K181859) |
| Indications for Use | The Visualase™ MRI-guided Laser Ablation<br>System is a neurosurgical<br>tool and is indicated for<br>use to ablate, necrotize,<br>or coagulate intracranial<br>soft tissue including brain<br>structures (for example,<br>brain tumor, radiation<br>necrosis, and epileptic<br>foci as identified by non-<br>invasive and invasive<br>neurodiagnostic testing,<br>including imaging)<br>through interstitial<br>irradiation or thermal<br>therapy in medicine and<br>surgery in the discipline<br>of neurosurgery<br>with 800nm through<br>1064nm lasers. | The Monteris Medical<br>NeuroBlate® System is a<br>neurosurgical tool and is<br>indicated for use to<br>ablate, necrotize, or<br>coagulate intracranial soft<br>tissue, including brain<br>structures<br>(e.g., brain tumor and<br>epileptic foci as identified<br>by non-invasive and<br>invasive<br>neurodiagnostic testing,<br>including imaging),<br>through interstitial<br>irradiation or thermal<br>therapy in medicine and<br>surgery in the discipline of<br>neurosurgery with 1064<br>nm lasers.<br><br>The Monteris Medical<br>NeuroBlate® System is<br>intended for planning and<br>monitoring thermal<br>therapies under MRI | The Visualase™ Thermal<br>Therapy System is indicated<br>for use to necrotize or<br>coagulate soft tissue<br>through interstitial<br>irradiation or thermal<br>therapy under magnetic<br>resonance imaging (MRI)<br>guidance in medicine and<br>surgery in<br>cardiovascular thoracic<br>surgery (excluding the heart<br>and the vessels in the<br>pericardial sac),<br>dermatology, ear-nose-<br>throat, surgery,<br>gastroenterology, general<br>surgery, gynecology, head<br>and neck surgery,<br>neurosurgery, plastic<br>surgery,<br>orthopedics, pulmonology,<br>radiology, and urology, for<br>wavelengths 800nm<br>through 1064nm.<br><br>When therapy is performed<br>under MRI guidance, and<br>when data from compatible<br>MRI sequences is available,<br>the |
| | Contraindications | visualization. It provides<br>MRI based trajectory<br>planning assistance for<br>the stereotaxic placement<br>of MRI compatible<br>(conditional) NeuroBlate®<br>Laser Delivery Probes. It<br>also provides near real-<br>time thermographic<br>analysis of selected MRI<br>images.<br>When interpreted by a<br>trained physician, this<br>System provides<br>information that may be<br>useful in the<br>determination or<br>assessment of thermal<br>therapy. Patient<br>management decisions<br>should not be made solely<br>on the basis of the<br>NeuroBlate™ System<br>analysis. | Visualase™ system can<br>process images using proton<br>resonance-frequency (PRF)<br>shift analysis and image<br>subtraction to<br>relate changes in complex<br>phase angle back to relative<br>changes in tissue<br>temperature during<br>therapy. The image data<br>may<br>be manipulated and viewed<br>in a number of different<br>ways, and the values of data<br>at certain selected points<br>may be<br>monitored and/or displayed<br>over time.<br>The Visualase™ Thermal<br>Therapy System is<br>compatible with General<br>Electric Medical Systems<br>Signa model MR<br>scanners and with Siemens<br>Medical Solutions<br>Magnetom Espree systems.<br>When interpreted by a<br>trained physician, this<br>device provides information<br>that may be useful in the<br>determination or<br>assessment of thermal<br>therapy. Patient<br>management decisions<br>should not be made solely<br>on the basis of Visualase™<br>analysis. |
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| | The Visualase™ MRI-<br>Guided Laser Ablation<br>System is contraindicated<br>for the following<br>patients:<br>• Patients who have<br>medical conditions<br>that are<br>contraindicated for<br>MRI.<br>• Patients who have<br>implanted medical<br>devices that are<br>contraindicated for<br>MRI.<br>• Patients whose<br>physician<br>determines that<br>Laser-Induced<br>Thermal Therapy<br>(LITT) is not | • The following are<br>contraindications<br>that apply to the<br>NeuroBlate System:<br>• Patients who are<br>contraindicated for<br>MRI, including<br>patients who may<br>have<br>contraindications<br>due to implanted<br>medical devices.<br>• Patients who the<br>physician determines<br>are not appropriate<br>candidates for laser<br>interstitial thermal<br>therapy (LITT).<br>• Patients who are not<br>candidates for<br>invasive surgical | We strongly recommend<br>physicians weigh<br>advantages and<br>disadvantages of using a<br>diode laser. Other<br>modalities or wavelengths<br>may be more appropriate<br>due to any of the following:<br>• Depth of penetration<br>• Volume of necrosis<br>• Propensity for scarring<br>This product should not be<br>used if thermal therapy or<br>interstitial laser therapy are<br>contraindicated. Use the<br>laser only for the specialties<br>listed in the Indications for<br>Use section. |
| | acceptable.<br>Patients for which<br>invasive surgical<br>procedures in the<br>brain is not<br>appropriate. | procedures in the<br>brain | For those who whom the<br>physician determines the<br>laser is not the surgical tool<br>of choice.<br><br>Do not use the device<br>endoscopically in any<br>procedure where<br>endoscopes are<br>contraindicated.<br><br>Patients who are unable to<br>be treated by surgical<br>means or who are intolerant<br>to anesthesia. |
| | Interactive<br>Graphical User<br>Interface (GUI)<br>Interfaces with MRI<br>to acquire images<br>and thermometry<br>data<br>Interactive selection<br>of points-of-interest<br>Interactive<br>monitoring of<br>Visualase<br>procedure; displays<br>relative changes in<br>tissue temperature,<br>calculates estimate<br>of thermal necrosis<br>throughout<br>procedure | M-Vision, M-Vision Pro,<br>M-Vision Fusion, and<br>Fusion-<br>S software which includes:<br>user interface for<br>procedure planning,<br>interactive<br>monitoring of<br>NeuroBlate<br>procedures,<br>interfaces to the MRI<br>and hardware<br>subsystems. | Interactive Graphical<br>User Interface (GUI)<br>Interface with MRI to<br>acquire images and<br>thermometry data<br>Interactive selection of<br>points-of-interest<br>Interactive monitoring<br>of Visualase procedure<br>displays relative<br>changes in tissue<br>temperature,<br>calculates estimate of<br>thermal necrosis<br>throughout procedure |
| Software | Surgeon placed low<br>temperature limit<br>markers to protect<br>critical structures | User selected pick points<br>for temperature<br>monitoring in regions of<br>thermometry | Surgeon placed low<br>temperature limit markers<br>to protect critical structures |
| | High-temperature default<br>limit 85°C | Temperature points for<br>monitoring | High-temperature default<br>limit 90°C |
| | Laser interlock to<br>deactivate laser energy<br>when low or high<br>temperature limit targets<br>reached | No laser interlock feature<br>associated with pick<br>points | Laser interlock to deactivate<br>laser energy when low or<br>high temperature limit<br>targets reached |
| | Thermal Damage<br>Estimate (TDE):<br>representation of<br>thermally damaged<br>tissue in two zones:<br>1.<br>Necrotic Zone<br>(complete cellular<br>death) | Thermal Dose Threshold<br>(TDT) Lines: depicted as 3<br>contour boundary lines of<br>thermal isodose region.<br><br>Yellow: mixture of lethally<br>and non-lethally injured<br>cells | Treatment Estimate (TE):<br>representation of thermally<br>damaged tissue as one<br>zone:<br>1.<br>Necrotic Zone<br>(complete cellular<br>death) tissue |
| | 2.Transition Zone<br>(mixture of lethally and<br>non-lethally injured cells) | Blue: area of complete cellular death<br>White: All tissue experiences cell death<br>within ≤48 hours<br><br>The white TDT line resides<br>inside the blue TDT line.<br>The blue TDT line resides<br>inside the yellow TDT line. | |
| MRI Compatibility | 1.5T and 3.0 T | 1.5T and 3.0 T | 1.5T and 3.0 T |

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#### 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 of<br>MR Thermometry | In vivo testing conducted 1.5T and 3.0T<br>(in accordance with 21 CFR 58) |
| Accuracy and performance of Thermal<br>Damage Estimate | In vivo testing conducted in 1.5T and 3.0T<br>(in accordance with 21 CFR 58) |
| Software verification and validation | Per Medtronic 21 CFR 820.30 compliant Design<br>Control procedure |
| System verification | Per Medtronic 21 CFR 820.30 compliant Design<br>Control 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.