(115 days)
The Visualase V2 ™ 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 pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.
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; one monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections
The provided FDA 510(k) clearance letter for the Visualase V2 MRI-Guided Laser Ablation System does not contain the detailed information necessary to fully address all aspects of the request. Specifically, the document focuses on regulatory compliance, substantial equivalence to predicate devices, and general testing summaries (software V&V, system V&V, electrical safety). It does not include specific acceptance criteria with performance metrics, details of a clinical study (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies), or direct data proving the device met specific performance criteria.
The letter explicitly states: "A clinical trial was not required to establish substantial equivalence. Clinical evidence provided in a literature summary format supports the safe use of the Visualase V2 System in the intended patient population." This indicates that a prospective clinical performance study, often associated with detailed acceptance criteria and reported performance, was not the primary method for demonstrating substantial equivalence for this particular submission.
Therefore, many sections of your request cannot be fulfilled based on the provided document. I will fill in the information that is present and explicitly state where information is not available.
Acceptance Criteria and Device Performance for Visualase V2 MRI-Guided Laser Ablation System
Based on the provided FDA 510(k) clearance letter (K250307), the device's acceptance criteria and proven performance are primarily demonstrated through verification and validation activities for its software and system, and compliance with electrical safety standards. A formal clinical trial with quantitative performance metrics against specific acceptance criteria (e.g., sensitivity, specificity, accuracy) was not required for this submission to establish substantial equivalence, but rather clinical evidence was provided via a literature summary.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) for the Visualase V2 System as described in the document, performance acceptance criteria are focused on safety, functionality, and equivalence to predicate devices, rather than clinical efficacy metrics typically found in AI/diagnostic device submissions.
| Acceptance Criterion (Inferred/Stated) | Reported Device Performance (as stated in document) |
|---|---|
| Software Verification & Validation (meets product requirements and user needs) | "Software verification and validation Per Medtronic 21 CFR 820.30 compliant Design Control procedure" / "The Platform, software and corresponding labeling changes included in this submission have been verified and validated demonstrating the changes meet product requirements and user needs." |
| System Verification (meets product requirements and user needs) | "System verification Per Medtronic 21 CFR 820.30 compliant Design Control procedure" / "Testing demonstrated the Visualase V2™ MRI-Guided Laser Ablation System meets all design requirements and user needs." |
| Electrical Safety & Applicable Horizontal Standards | "IEC electrical safety and applicable horizontal standards UL certified" |
| Substantial Equivalence to Predicate Devices (for indications, technology, safety) | "The Visualase™ V2 MRI-Guided Laser Ablation System is substantially equivalent to the primary predicate Visualase MRI-Guided Laser Ablation System and the secondary predicate NeuroBlate System (indications only)." |
| Corrected Contraindications and Clarified Indications | "The Visualase Indications for Use have been clarified to define the intended patient population, adults and pediatric patients 2 years and older The changes to the Contraindications removes redundant language and language aligned with medical judgement." |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states: "A clinical trial was not required to establish substantial equivalence. Clinical evidence provided in a literature summary format supports the safe use of the Visualase V2 System in the intended patient population."
Therefore, no specific "test set" sample size for a clinical performance study is reported in this document. The "testing summary" refers to internal verification and validation against design controls and standards, not a clinical data set for performance evaluation of an AI algorithm.
Data Provenance: Not applicable for a clinical test set in this context, as a clinical performance study was not the basis for substantial equivalence for this upgrade. The clinical evidence was a literature summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as a specific clinical test set for performance evaluation (e.g., for an AI algorithm's diagnostic accuracy which would require ground truth labeling) was not conducted as part of this 510(k) as described. The "ground truth" for the device's functionality and safety was established via engineering verification, validation, and regulatory compliance.
4. Adjudication Method for the Test Set
Not applicable, as a clinical test set requiring adjudication was not reported as part of this 510(k) as described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not reported in this 510(k) clearance letter. The submission focused on establishing substantial equivalence through other means (software/system V&V, safety testing, literature review) rather than demonstrating AI assistance performance improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
The Visualase V2 System is a medical device system that includes hardware and software for MRI-guided laser ablation, with software providing monitoring and control capabilities related to temperature and thermal damage estimation. It is not an AI diagnostic algorithm for which a standalone performance evaluation (e.g., AUC, sensitivity/specificity) would typically be required or reported in this format. The software's performance is intrinsically linked to the system's function and user interaction.
Therefore, a "standalone algorithm only" performance study in the sense of a diagnostic AI product is not applicable and not reported.
7. The Type of Ground Truth Used
For the system's functional and safety validation, the "ground truth" would be engineering specifications, design requirements, and established medical and electrical safety standards (e.g., IEC standards, 21 CFR 820.30 Design Controls).
For any inferred clinical claims from the "literature summary," the ground truth would originate from the clinical data reported in the summarized peer-reviewed literature, which could involve histological confirmation, long-term patient outcomes, or expert clinical diagnosis, but these details are not provided in the 510(k) letter itself.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device system update, not an AI algorithm developed using a specific training dataset in the machine learning sense. The "training" for the system's software would derive from its design and programming, verified through the V&V processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI algorithm developed through data-driven training in the machine learning sense. The "ground truth" for the device's design and engineering would be based on scientific and engineering principles, preclinical testing, and existing medical knowledge, as per design control procedures.
FDA 510(k) Clearance Letter - Visualase V2 MRI-Guided Laser Ablation System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 29, 2025
Medtronic Navigation
Sharon McDermott
Sr. Principal Regulatory Affairs Specialist
200 Medtronic Drive
Lafayette, Colorado 80026
Re: K250307
Trade/Device Name: Visualase V2 MRI-guided Laser Ablation System (9736422)
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: May 1, 2025
Received: May 1, 2025
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K250307 - Sharon McDermott
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K250307 - Sharon McDermott
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Sincerely,
Adam D. Pierce -S (Digitally signed by Adam D. Pierce -S Date: 2025.05.29 11:15:08 -04'00')
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250307
Device Name: Visualase V2 MRI-Guided Laser Ablation System
Indications for Use (Describe):
The Visualase V2 ™ 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 pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(k) Summary
K250307
Visualase V2 MRI-Guided Laser Ablation System
Page 1 of 5
Submitter/Sponsor: Medtronic Navigation, Inc.
200 Medtronic Drive
Lafayette, CO 80026
Contact Person: Sharon McDermott (Primary)
Phone: (720) 890-3461 Fax: (720) 890-3500
E-mail: sharon.mcdermott@medtronic.com
Rishi Sinha (Alternate)
Phone: (720) 890-2485 Fax: (720) 890-3500
E-mail: rishi.k.sinha@medtronic.com
Date Summary Prepared: May 29, 2025
Device Trade Name: Visualase™ V2 MRI-Guided Laser Ablation 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 dermatology
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; one monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections
Predicate Devices
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K250307
Visualase V2 MRI-Guided Laser Ablation System
Page 2 of 5
| General Information | Primary Predicate | Secondary Predicate (for indications only) |
|---|---|---|
| Visualase MRI-Guided Laser Ablation System (K211269) | NeuroBlate System (K240877) | |
| FDA Regulation | 21 CFR 878.4810 | 21 CFR 878.4810; 21 CFR 892.5050 |
| FDA Product Code | ONO | ONO,GEX, HAW |
| Manufacturer | Medtronic Navigation, Inc | Monteris Medical |
Indications for Use
The Visualase V2 ™ 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 pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.
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K250307
Visualase V2 MRI-Guided Laser Ablation System
Page 3 of 5
Comparison of Device Indications for Use with Predicate Devices
| Characteristic | Subject Device VisualaseV2 MRI-guided Laser Ablation System | Primary Predicate Visualase Thermal Therapy System with 3.2 Software (K1211269) | Secondary Predicate (Indications ONLY) NeuroBlate System (K240877) |
|---|---|---|---|
| Indications for Use | The Visualase V2 ™ 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 pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older. | 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 1064nm lasers. | The Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic 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 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. The intended patients are adults and pediatric from the age of 2 years and older. |
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K250307
Visualase V2 MRI-Guided Laser Ablation System
Page 4 of 5
Comparison of Device Technical Characteristics with Predicate Device
| Characteristic | Subject Device Visualase V2 MRI-guided Laser Ablation System | Predicate Device Visualase MRI-guided Laser Ablation System (K211269) |
|---|---|---|
| Contraindications | The Visualase™ MRI-Guided Laser Ablation System is contraindicated for patients who have implanted medical devices that are contraindicated for MRI. | The Visualase™ MRI-Guided Laser Ablation System is contraindicated for the following patients: Patients who have medical conditions that are contraindicated for MRI. • Patients who have implanted medical devices that are contraindicated for MRI. • Patients whose physician determines that Laser-Induced Thermal Therapy (LITT) is not acceptable. • Patients for which invasive surgical procedures in the brain is not appropriate. |
| Software | • Interactive Graphical User Interface (GUI) • Interfaces with MRI to acquire images and thermometry data • Interactive selection of points-of-interest • Interactive monitoring of Visualase procedure; displays relative changes in tissue temperature, calculates estimate of thermal necrosis throughout procedure • Automated functionality | • Interactive Graphical User Interface (GUI) • Interfaces with MRI to acquire images and thermometry data • Interactive selection of points-of-interest • Interactive monitoring of Visualase procedure; displays relative changes in tissue temperature, calculates estimate of thermal necrosis throughout procedure |
| Up to 15 temperature targets per MRI slice (up to 15) | Up to 6 temperature | |
| Monitor target type | None | |
| Surgeon placed low and high temperature markers to trigger laser off | Surgeon placed low and high temperature markers to trigger laser off | |
| High-temperature target default limit 85°C | High-temperature target default limit 85°C | |
| Low-temperature target default limit 43°C | Low-temperature target default limit 43°C |
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K250307
Visualase V2 MRI-Guided Laser Ablation System
Page 5 of 5
| Hardware | Thermal Damage Estimate (TDE): representation of thermally damaged tissue in two zones: 1. Necrotic Zone (complete cellular death) 2. Transition Zone (mixture of lethally and non-lethally injured cells) Single touchscreen Light mast with laser mode indicators 980 nm laser (Software limits the 980-nm wavelength to max output power of 14.55 W) Peristaltic pump | Thermal Damage Estimate (TDE): representation of thermally damaged tissue in two zones: 1. Necrotic Zone (complete cellular death) 2. Transition Zone (mixture of lethally and non-lethally injured cells) Dual screen None 980 nm wavelength (Software limited to max output power of 14.55 W) Peristaltic pump |
|---|---|---|
| MRI Compatibility | 1.5T and 3.0 T MRI parameters for thermometry listed in IFU | 1.5T and 3.0 T MRI parameters for thermometry listed in IFU |
Testing Summary
Testing demonstrated the Visualase V2™ MRI-Guided Laser Ablation System meets all design requirements and user needs.
| Test | Method |
|---|---|
| Software verification and validation | Per Medtronic 21 CFR 820.30 compliant Design Control procedure |
| System verification | Per Medtronic 21 CFR 820.30 compliant Design Control procedure |
| IEC electrical safety and applicable horizontal standards | UL certified |
FDA guidances were employed in the development of the clinical evidence to support substantial equivalence for the modification of the indications for use. A clinical trial was not required to establish substantial equivalence. Clinical evidence provided in a literature summary format supports the safe use of the Visualase V2 System in the intended patient population.
Conclusion
The Visualase™ V2 MRI-Guided Laser Ablation System is substantially equivalent to the primary predicate Visualase MRI-Guided Laser Ablation System and the secondary predicate NeuroBlate System (indications only). The Visualase Indications for Use have been clarified to define the intended patient population, adults and pediatric patients 2 years and older The changes to the Contraindications removes redundant language and language aligned with medical judgement. The medication of the Indications for Use statement and the Contraindications does not change the intended use or risk profile of the device.
The Platform, 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.
§ 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.