Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image processing techniques (PRF shift analysis, image subtraction) for temperature monitoring, but does not mention or imply the use of AI or ML algorithms.

Therapeutic

Yes
The device is indicated for ablating, necrotizing, or coagulating intracranial soft tissue, including brain tumors and epileptic foci, through thermal therapy. This process directly treats and alters abnormal tissue, aligning with the definition of a therapeutic device.

Diagnostic

No

The device is described as a neurosurgical tool used to ablate, necrotize, or coagulate intracranial soft tissue, which are therapeutic actions, not diagnostic ones. It monitors temperature changes during ablation, which is part of the treatment delivery and monitoring, not diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Visualase MRI-Guided Laser Ablation System comprises both hardware and software components, including a diode laser, coolant pump, workstation, monitors, and peripherals, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Visualase MRI-Guided Laser Ablation System is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The Visualase system directly interacts with and treats tissue within the body (intracranial soft tissue). It does not analyze samples taken from the patient.
The intended use is for ablation, necrotization, or coagulation of tissue. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The system uses MRI for guidance and monitoring during the procedure. While it processes imaging data, this is to guide and monitor the treatment, not to diagnose a condition based on analysis of a biological specimen.

The Visualase system is a surgical tool used for therapeutic purposes under imaging guidance.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

ONO

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

Mentions image processing

When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase™ system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI

Anatomical Site

intracranial soft tissue including brain structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

neurosurgical tool / Not Found

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

Accuracy and performance of MR Thermometry: In vivo testing conducted 1.5T and 3.0T (in accordance with 21 CFR 58)
Accuracy and performance of Thermal Damage 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 Design Control procedure
System verification: Per Medtronic 21 CFR 820.30 compliant Design Control procedure

Key Metrics

Not Found

Predicate Device(s)

K201056, K181859

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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)

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary

| Submitter/Sponsor: | Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, 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) 890-3500
rishi.k.sinha@medtronic.com |
| Date Summary Prepared: | January 7, 2022 |
| Device Trade Name: | Visualase™ MRI-Guided Laser Ablation System (formerly Visualase Thermal Therapy
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; 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 |

4

| General Information | Primary Predicate
NeuroBlate System (K201056) | Secondary Predicate
Visualase Thermal Therapy System with 3.2
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
Laser Ablation System
(v3.4) Software	NeuroBlate System
(K201056)	Visualase Thermal
Therapy System with 3.2
Software (K181859)
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 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 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 1064
nm lasers.

The Monteris Medical
NeuroBlate® System is
intended for planning and
monitoring thermal
therapies under MRI | The Visualase™ Thermal
Therapy System is indicated
for use to necrotize or
coagulate soft tissue
through interstitial
irradiation or thermal
therapy under magnetic
resonance imaging (MRI)
guidance in medicine and
surgery in
cardiovascular thoracic
surgery (excluding the heart
and the vessels in the
pericardial sac),
dermatology, ear-nose-
throat, surgery,
gastroenterology, general
surgery, gynecology, head
and neck surgery,
neurosurgery, plastic
surgery,
orthopedics, pulmonology,
radiology, and urology, for
wavelengths 800nm
through 1064nm.

When therapy is performed
under MRI guidance, and
when data from compatible
MRI sequences is available,
the |
| | Contraindications | 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. | Visualase™ system can
process images using proton
resonance-frequency (PRF)
shift analysis and image
subtraction to
relate changes in complex
phase angle back to relative
changes in tissue
temperature during
therapy. The image data
may
be manipulated and viewed
in a number of different
ways, and the values of data
at certain selected points
may be
monitored and/or displayed
over time.
The Visualase™ Thermal
Therapy System is
compatible with General
Electric Medical Systems
Signa model MR
scanners and with Siemens
Medical Solutions
Magnetom Espree systems.
When interpreted by a
trained physician, this
device 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 Visualase™
analysis. |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | 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 | • The following are
contraindications
that apply to the
NeuroBlate System:
• Patients who are
contraindicated for
MRI, including
patients who may
have
contraindications
due to implanted
medical devices.
• Patients who the
physician determines
are not appropriate
candidates for laser
interstitial thermal
therapy (LITT).
• Patients who are not
candidates for
invasive surgical | We strongly recommend
physicians weigh
advantages and
disadvantages of using a
diode laser. Other
modalities or wavelengths
may be more appropriate
due to any of the following:
• Depth of penetration
• Volume of necrosis
• Propensity for scarring
This product should not be
used if thermal therapy or
interstitial laser therapy are
contraindicated. Use the
laser only for the specialties
listed in the Indications for
Use section. |
| | acceptable.
Patients for which
invasive surgical
procedures in the
brain is not
appropriate. | procedures in the
brain | For those who whom the
physician determines the
laser is not the surgical tool
of choice.

Do not use the device
endoscopically in any
procedure where
endoscopes are
contraindicated.

Patients who are unable to
be treated by surgical
means or who are intolerant
to anesthesia. |
| | 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 | M-Vision, M-Vision Pro,
M-Vision Fusion, and
Fusion-
S software which includes:
user interface for
procedure planning,
interactive
monitoring of
NeuroBlate
procedures,
interfaces to the MRI
and hardware
subsystems. | Interactive Graphical
User Interface (GUI)
Interface 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 |
| Software | Surgeon placed low
temperature limit
markers to protect
critical structures | User selected pick points
for temperature
monitoring in regions of
thermometry | Surgeon placed low
temperature limit markers
to protect critical structures |
| | High-temperature default
limit 85°C | Temperature points for
monitoring | High-temperature default
limit 90°C |
| | Laser interlock to
deactivate laser energy
when low or high
temperature limit targets
reached | No laser interlock feature
associated with pick
points | Laser interlock to deactivate
laser energy when low or
high temperature limit
targets reached |
| | Thermal Damage
Estimate (TDE):
representation of
thermally damaged
tissue in two zones:
1.
Necrotic Zone
(complete cellular
death) | Thermal Dose Threshold
(TDT) Lines: depicted as 3
contour boundary lines of
thermal isodose region.

Yellow: mixture of lethally
and non-lethally injured
cells | Treatment Estimate (TE):
representation of thermally
damaged tissue as one
zone:
1.
Necrotic Zone
(complete cellular
death) tissue |
| | 2.Transition Zone
(mixture of lethally and
non-lethally injured cells) | Blue: area of complete cellular death
White: All tissue experiences cell death
within ≤48 hours

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