(237 days)
Not Found
No
The document describes image processing techniques (PRF shift analysis, image subtraction) for temperature monitoring, but does not mention AI or ML.
Yes
The device is indicated for "necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy," which describes a direct therapeutic action on the body.
No
The device is primarily a therapeutic system for necrotizing or coagulating soft tissue using thermal therapy. While it uses MRI guidance and processes images to monitor temperature changes, its core function is intervention (therapy), not diagnosis. The text states it "provides information that may be useful in the determination or assessment of thermal therapy," but explicitly states "Patient management decisions should not be made solely on the basis of Visualase™ analysis," implying it's a tool to aid therapy rather than a standalone diagnostic device.
No
The device description explicitly states that the Visualase Thermal Therapy System comprises both hardware and software components, including a diode laser, coolant pump, workstation, monitors, and peripherals, in addition to the software.
Based on the provided information, the Visualase™ Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic or monitoring purposes.
- Visualase™ Function: The Visualase™ system is a therapeutic device that uses laser energy to necrotize or coagulate soft tissue in vivo (within the living body) under MRI guidance. It monitors temperature changes during this therapeutic process.
- Lack of Specimen Analysis: The system does not analyze specimens taken from the body. Its function is to deliver energy directly to tissue within the patient.
While the system uses imaging data and provides information that a physician can use in conjunction with other clinical information, its primary function is therapeutic intervention, not the diagnostic analysis of in vitro specimens.
N/A
Intended Use / Indications for Use
The Visualase™ 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 vericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064mm.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, LLZ, FRN
Device Description
The Visualase Thermal Therapy System comprises of 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI)
Anatomical Site
soft tissue in cardiovascular thoracic surgery (excluding the heart and the vericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new performance testing was required for this change as there are no changes to the Visualase™ Thermal Therapy System as a result of this labeling change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & 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 includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
March 6, 2019
Medtronic Navigation Inc. c/o Sharon McDermott Principal Regulatory Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K181859
Trade/Device Name: Visualase Thermal Therapy System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 11, 2018 Received: July 12, 2018
Dear Ms. 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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Matthew C. Krueger -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181859
Device Name Visualase Thermal Therapy System
Indications for Use (Describe)
The Visualase™ 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 vericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064mm.
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.
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.
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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510(k) Summary 5
| Submitter/Sponsor: | Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, CO 80027 |
|--------------------|-----------------------------------------------------------------------------|
| Contact Person: | Sharon McDermott
Phone: (720) 890-3461 Fax: (720) 890-3500 |
| E-mail: | sharon.l.mcdermott@medtronic.com |
| | Rishi Sinha (Alternate) |
| E-mail: | Phone: (720) 890-2485 Fax: (720) 890-3500
rishi.k.sinha@medtronic.com |
This 510(k) submission notifies FDA of labeling changes to the Visualase Thermal Therapy System Manual to add new warnings and information. No design changes are the subject of this submission.
Date Summary Prepared: March 5, 2019
| Device Trade Name: | Visualase™ Thermal Therapy System |
|---|---|
| Device Common Name: | Magnetic Resonance Image-guided Laser Thermal Therapy System |
| Device Classification: | Class II |
| Product Code: | GEX (Surgical Laser, Laser Applicator) |
| LLZ (Image Processing System) | |
| FRN (Infusion Pump) | |
| Device Regulation: | 21CFR 878.4810 - Surgical Laser Instrument/Applicator |
| 21CFR 892.2050 – Picture Archiving and Communications System | |
| 21CFR 880.5725 – Infusion Pump | |
| Predicate Device: | Visualase™ Thermal Therapy System |
| Predicate Manufacturer: | Medtronic Navigation, Inc. |
| Predicate 510(k): | K081656 (Biotex, Inc) |
| Predicate Product Code: | GEX (Surgical Laser, Laser Applicator) |
| LLZ (Image Processing System) | |
| FRN (Infusion Pump) | |
| Predicate Regulation: | 21CFR 878.4810 – Surgical Laser Instrument/Applicator |
| 21CFR 892.2050 - Picture Archiving & Communications System | |
| 21CFR 880.5725 – Infusion Pump |
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| Indications for Use: | 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 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. |
| Device Description: | The Visualase Thermal Therapy System comprises of 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.
Comparison of Technological Characteristics with Predicate Device
The changes that are the subject of this 510(k) submission are labeling updates that do not change the indications for use or impact the device's technology. Along with grammatical corrections, the labeling changes encompass the addition of warnings and notes that were provided via a Field Corrective Action distributed to current users on June 1, 2018 and August 21, 2018.
Performance Characteristics
No new performance testing was required for this change as there are no changes to the Visualase™ Thermal Therapy System as a result of this labeling change.
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Conclusion
The Visualase™ Thermal Therapy System is substantially equivalent to the predicate Visualase™ Therapy System. The labeling changes do not affect the intended use or fundamental technology. Further, the labeling modifications do not raise any new questions of safety and effectiveness of the Visualase Thermal Therapy System.