(266 days)
No
The description mentions image processing and algorithms for temperature mapping and thermal dose calculation, but explicitly states these algorithms are "well established and described in scientific literature," which typically indicates traditional, non-AI/ML methods. There is no mention of AI, ML, or related concepts like neural networks, training data, or performance metrics commonly associated with AI/ML models.
Yes.
The device is indicated for use to "necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy," which is a direct therapeutic action on the body.
No
This device is primarily indicated for necrotizing or coagulating soft tissue using thermal therapy. While it provides information related to tissue temperature changes during therapy that "may be useful in the determination or assessment of thermal therapy," its core function is therapeutic. The text explicitly states that "Patient management decisions should not be made solely on the basis of analysis using the TRANBERG®|Thermoguide Therapy System," further indicating it's not a standalone diagnostic tool.
No
The device is described as a system consisting of three parts: a mobile laser unit (hardware), a laser applicator and introducer (hardware), and a workstation with software. While the workstation component is software, the overall system includes significant hardware components essential to its function (laser generation and delivery).
Based on the provided information, the TRANBERG®|Thermoguide Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential transfusions, or to monitor therapeutic measures.
- TRANBERG®|Thermoguide Therapy System's Intended Use: The primary intended use of the TRANBERG®|Thermoguide Therapy System is to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy. This is a therapeutic intervention performed in vivo (within the living body), not an in vitro examination of specimens.
- Information Provided is for Therapy Guidance: While the system processes MRI images to provide temperature maps and thermal dose information, this information is used to guide and monitor the thermal therapy, not to diagnose a condition or provide information about a physiological or pathological state based on in vitro analysis of specimens. The text explicitly states that "Patient management decisions should not be made solely on the basis of analysis using the TRANBERG®|Thermoguide Therapy System."
In summary, the TRANBERG®|Thermoguide Therapy System is a therapeutic device that uses imaging for guidance and monitoring during a treatment procedure, rather than a device that performs diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The TRANBERG®|Thermoguide 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 neurosurgery, for a wavelength of 1064nm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton resonancefrequency (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 TRANBERG®|Thermoguide Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. 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 analysis using the TRANBERG®|Thermoguide Therapy System.
Product codes
ONO
Device Description
The TRANBERG®|Thermoguide Therapy System is indicated for use in an MRI suite to perform soft tissue ablations under MRI guidance, it consists of three parts:
-
- TRANBERG®|Mobile Laser Unit, cleared by K142216.
-
- TRANBERG®|Laser applicator and introducer, cleared by K201466.
-
- TRANBERG®|Thermoguide Workstation, article no. 1100-01, new in this submission.
The TRANBERG® Mobile Laser Unit includes a laser generator that operates at the wavelength of 1064nm, a continuous wave. The generated laser light is locally applied by means of a single use applicator kit (TRANBERG®)Laser applicator and introducer, cleared by K201466) through a minimally invasive surgical or percutaneous procedure. The energy from the laser generator is transmitted to tissue through the TRANBERG® Laser applicator and absorbed by the tissue surrounding the laser applicator, resulting in increased tissue temperature that necrotizes or coagulates soft tissue. The TRANBERG® Laser applicator is a 12m long optical fiber that allows the laser generator to be placed in the MRI control room. A workstation with software (TRANBERG®)Thermoguide Workstation) is used to extract temperature maps from magnetic resonance (MR) images and to calculate the thermal dose in treated tissue. Algorithms used in the system to calculate temperature maps and thermal dose in tissue are well established and described in scientific literature.
The TRANBERG® Mobile Laser Unit has safety systems to prevent the use of a malfunctioning unit, including self-testing at startup and continuous monitoring of software and components that are critical for the unit and laser emission to function optimally. All laser safety requirements are met according to IEC 60601-2-22:2019.
The TRANBERG® Laser applicator utilizes an RFID tag which limits the maximum power and time (per applicator type) that can be used. It also ensures that an expired fiber, a reused fiber, or a fiber programmed for a different use cannot be used as a treatment fiber.
The TRANBERG®|Thermoguide Workstation has an interface for control of the TRANBERG®|Mobile Laser Unit output through the computer interface port of the laser control). It controls power and time settings on the laser unit, and it can start and stop the laser control and safety as per medical laser equipment requirements are managed by the TRANBERG®|Mobile Laser Unit.
Mandatory conditions must be satisfied to enable the laser unit and run a treatment. When one of more of these conditions are not met, the laser will not allow emitting laser radiation until all conditions are fulfilled:
- Real time images from the scanner are received at least every 5s. If Thermoguide Workstation ● detects update rates longer than 5s the laser emission is automatically interrupted.
- . Laser unit enabled and the connection is verified, any loss of communication within 1.5s between the Laser unit and Thermoquide workstation or data incoherency automatically stops the laser emission.
- . The use of the RFID tag is a mandatory condition to run a treatment and limits the maximum power and time (per applicator type).
- Laser Applicator type confirmed and received by TRANBERG®Thermoguide Workstation, the ● information is read on the RFID tag belonging to the fiber.
- Minimum 1 ROI (monitoring or guard) has been set.
- . Baseline temperature (e.g., core body temperature) is set and confirmed
- . B0 drift compensation: Reference baseline ROI is set and confirmed
- Placement of the High temperature guard ROI.
- . Test dose successful and confirmed
Safety guard functionality: TRANBERG®Thermoguide Workstation can be used to prescribe limits for the temperature at certain points (ROIs) in the image which can, in turn, be used to deactivate the laser if the limits are reached.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
soft tissue, neurosurgery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians, MRI suite
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)
Bench Testing: The laser unit was designed and tested to comply with functional safety, and essential performance as well as laser safety requirements of IEC60601-1-2, IEC60601-2-22. Since the original clearance in K142216, the testing has been repeated due to changes in the hardware as well as to show compliance to updated versions of the IEC standards.
Biocompatibility data for the invasive devices is not included in this submission as it was part of the recent clearance under K201466. Full software V&V data is provided for both the TRANBERG®Mobile Laser Unit and the TRANBERG®|Thermoguide Workstation.
TRANBERG® Thermoguide Workstation used together with TRANBERG® Thermal Therapy System when used for treatments in MR was tested addressing:
- Intraoperability between the different devices of the TRANBERG® Thermoquide Therapy . System, i.e., Mobile laser unit, Thermoguide Workstation, Laser applicator, and MRI scanners.
- . Correct operation of the thermometry algorithm used in the Thermoquide Workstation as determined by correlation to physical measurements.
- . Evaluation of near real time behavior of temperature measurements. When using a commercially available scanner sequence, for the chosen scanner, determine offset from real time and update rate of temperature maps.
- . Verify that the products fulfil product requirement specifications.
Pre-clinical Animal Study: The accuracy and performance of MR Thermometry and Thermal Damage Estimate were evaluated for the TRANBERG®Thermoguide Therapy System in a prospective preclinical animal study under GLP conditions.
No clinical data was provided in support of this submission.
In all instances, the TRANBERG® Thermoguide Therapy System functioned as intended and the performance observed was as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
September 22, 2022
Clinical Laserthermia Systems AB % John Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th Street NW Washington, District of Columbia 20004
Re: K214125
Trade/Device Name: TRANBERG| Thermoguide 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: ONO Dated: December 30, 2021 Received: December 30, 2021
Dear Dr. Smith:
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/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 medical devices and radiation-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
-DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
510(k) Number (if known)
K214125
Device Name
TRANBERG® | Thermoguide Therapy System
Indications for Use (Describe)
The TRANBERG®|Thermoguide 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 neurosurgery, for a wavelength of 1064nm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton resonancefrequency (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 TRANBERG®|Thermoguide Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. 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 analysis using the TRANBERG®|Thermoguide Therapy System.
Type of Use (Select one or both, as applicable)
X 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
Clinical Laserthermia Systems' TRANBERG®|Thermoquide Therapy System
Submitter
Clinical Laserthermia Systems, AB Scheelevagen 2 223 81 Lund, Sweden
Phone: +46-(0)70-590 11 40
Contact Person: Dan Mogren, CEO
Date Prepared: September 22, 2022
Name of Device: TRANBERG®|Thermoguide Therapy System
Common or Usual Name: TRANBERG®|Thermoguide Therapy System
Requlation Name: Laser surqical instrument for use in general and plastic surgery and in dermatology
Regulation: 21 CFR 878.4810
Product Code: ONO
Predicate Device
Medtronic Navigation Inc., Visualase Thermal Therapy System, K181859
Reference Device
Monteris Medical Inc., NeuroBlate System, K201056
Device Description
The TRANBERG®|Thermoguide Therapy System is indicated for use in an MRI suite to perform soft tissue ablations under MRI guidance, it consists of three parts:
-
- TRANBERG®|Mobile Laser Unit, cleared by K142216.
-
- TRANBERG®|Laser applicator and introducer, cleared by K201466.
-
- TRANBERG®|Thermoguide Workstation, article no. 1100-01, new in this submission.
The TRANBERG® Mobile Laser Unit includes a laser generator that operates at the wavelength of 1064nm, a continuous wave. The generated laser light is locally applied by means of a single use applicator kit (TRANBERG®)Laser applicator and introducer, cleared by K201466) through a minimally invasive surgical or percutaneous procedure. The energy from the laser generator is transmitted to tissue through the TRANBERG® Laser applicator and absorbed by the tissue surrounding the laser applicator, resulting in increased tissue temperature that necrotizes or coagulates soft tissue. The TRANBERG® Laser applicator is a 12m long optical fiber that allows the laser generator to be placed in the MRI control room. A workstation with software (TRANBERG®)Thermoguide Workstation) is used to extract temperature maps from magnetic resonance (MR) images and to calculate the thermal dose in treated tissue. Algorithms
4
used in the system to calculate temperature maps and thermal dose in tissue are well established and described in scientific literature.
The TRANBERG® Mobile Laser Unit has safety systems to prevent the use of a malfunctioning unit, including self-testing at startup and continuous monitoring of software and components that are critical for the unit and laser emission to function optimally. All laser safety requirements are met according to IEC 60601-2-22:2019.
The TRANBERG® Laser applicator utilizes an RFID tag which limits the maximum power and time (per applicator type) that can be used. It also ensures that an expired fiber, a reused fiber, or a fiber programmed for a different use cannot be used as a treatment fiber.
The TRANBERG®|Thermoguide Workstation has an interface for control of the TRANBERG®|Mobile Laser Unit output through the computer interface port of the laser control). It controls power and time settings on the laser unit, and it can start and stop the laser control and safety as per medical laser equipment requirements are managed by the TRANBERG®|Mobile Laser Unit.
Mandatory conditions must be satisfied to enable the laser unit and run a treatment. When one of more of these conditions are not met, the laser will not allow emitting laser radiation until all conditions are fulfilled:
- Real time images from the scanner are received at least every 5s. If Thermoguide Workstation ● detects update rates longer than 5s the laser emission is automatically interrupted.
- . Laser unit enabled and the connection is verified, any loss of communication within 1.5s between the Laser unit and Thermoquide workstation or data incoherency automatically stops the laser emission.
- . The use of the RFID tag is a mandatory condition to run a treatment and limits the maximum power and time (per applicator type).
- Laser Applicator type confirmed and received by TRANBERG®Thermoguide Workstation, the ● information is read on the RFID tag belonging to the fiber.
- Minimum 1 ROI (monitoring or guard) has been set.
- . Baseline temperature (e.g., core body temperature) is set and confirmed
- . B0 drift compensation: Reference baseline ROI is set and confirmed
- Placement of the High temperature guard ROI.
- . Test dose successful and confirmed
Safety guard functionality: TRANBERG®Thermoguide Workstation can be used to prescribe limits for the temperature at certain points (ROIs) in the image which can, in turn, be used to deactivate the laser if the limits are reached.
Intended Use / Indications for Use
The TRANBERG® Thermoguide 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 neurosurgery, for a wavelength of 1064nm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®Thermoguide therapy system can process images using proton resonancefrequency (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.
5
The TRANBERG® Thermoguide Therapy System is compatible with 3.0T MR scanner 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 analysis using the TRANBERG®|Thermoguide Therapy System.
The Intended Use/Indications for Use has been limited as compared to the predicate device. Only a fixed wavelength of 1064nm (wavelength of the laser unit, part of TRANBERG®|Thermoguide Therapy System) and only neurosurgical interventions are part of the more limited Intended Use/Indications for Use. Also it is stated that only compatible scanners can be used with the system where the predicate names certain scanner types.
The differences are not critical to the intended therapeutic or surgical use of the device. Bench testing and animal testing according to the Intended Use/Indications for Use have been performed showing that the differences do not affect the safety and effectiveness of the device when used as labeled.
Summary of Technological Characteristics
Soft tissue laser ablation and MRI thermometry is the technological principle for both the subject and predicate devices. The two systems are indicated for precise soft tissue laser ablation by medical professionals only and consist of a medical laser apparatus with single use sterile devices and software for extracting temperature maps from Magnetic Resonance (MR) images and calculation of thermal dose to the tissue. Generated laser light is locally applied within a tissue by means of a single use applicator. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature
At a high level, the subject and predicate devices are based on the following same technological elements:
- . Mobile laser unit using the same energy source.
- . Laser Applicator for transferring energy to tissue.
- . MR thermometry workstation that can calculate and display temperature and thermal damage maps.
- . Thresholds may be defined to deactivate laser power if the temperature in a target point is exceeded.
- . Primary user interface for supporting the workflow and controlling the treatment is performed in the MR thermometry workstation
The following technological differences exist between the subject and predicate devices:
- . The predicate operates in the optical wavelength range 980–1064 nm, whereas the subject device operates only at 1064 nm.
- . The predicate devices use a cooled fiber whereas the subject device uses a non-cooled fiber. However, the subject device fiber is already cleared by K201466.
- . The predicate device includes a cooling pump in its system, whereas no such pump is necessary for the subject device due to the use of a non-cooled fiber.
- . Different operating systems are used: Thermoguide uses Windows 10, Visualase Linux. But the setup of hardware and supporting SOUPs (e.g. drivers) are similar. The combination of hardware and software is supplied pre-installed by each manufacturer.
6
- . The predicate uses the Arrhenius model for calculation of thermal damage or thermal dose whereas the subject device uses the CEM43 algorithm. The CEM43 algorithm is used in the reference device. NeuroBlate System cleared under K201056.
A table comparing the key features of the subject and predicate devices is provided in Table 1 at the end of this 510(k) summary.
Labeling related to safety and mitigating actions of the TRANBERG Thermoguide System was compared to the predicate device, Visualase™ Therapy system and the reference device, NeuroBlate System. The minor differences in technical parameters between the subject device and predicate as well as reference device do not (1) raise different questions of safety and effectiveness; and (2) do not adversely affect the safety and effectiveness of the subject device compared to the predicate.
Performance Data
Bench Testing
The laser unit was designed and tested to comply with functional safety, and essential performance as well as laser safety requirements of IEC60601-1-2, IEC60601-2-22. Since the original clearance in K142216, the testing has been repeated due to changes in the hardware as well as to show compliance to updated versions of the IEC standards.
Biocompatibility data for the invasive devices is not included in this submission as it was part of the recent clearance under K201466. Full software V&V data is provided for both the TRANBERG®Mobile Laser Unit and the TRANBERG®|Thermoguide Workstation.
TRANBERG® Thermoguide Workstation used together with TRANBERG® Thermal Therapy System when used for treatments in MR was tested addressing:
- Intraoperability between the different devices of the TRANBERG® Thermoquide Therapy . System, i.e., Mobile laser unit, Thermoguide Workstation, Laser applicator, and MRI scanners.
- . Correct operation of the thermometry algorithm used in the Thermoquide Workstation as determined by correlation to physical measurements.
- . Evaluation of near real time behavior of temperature measurements. When using a commercially available scanner sequence, for the chosen scanner, determine offset from real time and update rate of temperature maps.
- . Verify that the products fulfil product requirement specifications.
Pre-clinical Animal Study
The accuracy and performance of MR Thermometry and Thermal Damage Estimate were evaluated for the TRANBERG®Thermoguide Therapy System in a prospective preclinical animal study under GLP conditions.
No clinical data was provided in support of this submission.
In all instances, the TRANBERG® Thermoguide Therapy System functioned as intended and the performance observed was as expected.
Conclusions
The TRANBERG®|Thermoguide Therapy System is as safe and effective as the Visualase Thermal Therapy System (K181859). The TRANBERG®)Thermoguide Therapy System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended therapeutic or surgical use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor
7
technological differences between the TRANBERG®|Thermoguide Therapy System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the TRANBERG®Thermoguide Therapy System is as safe and effective as the Visualase Thermal Therapy System (K181859). Thus, the TRANBERG®|Thermoguide Therapy System is substantially equivalent.
8
Table 1. Substantial equivalence of the TRANBERG®|Thermoguide Therapy System is claimed to
the predicate device Visualase® Thermal Therapy system, cleared under K181859.
| Parameter | ||
|---|---|---|
| Image: TRANBERG Thermoguide Workstation | ||
| Image: TRANBERG Mobile Laser K142216, TRANBERG Laser applicator K201466, TRANBERG MR introducer K201466 FDA-cleared | ||
| Product name | TRANBERG® Thermoguide Therapy System | Visualase™ Thermal Therapy system |
| Manufacturer | Clinical Laserthermia Systems CLS, | |
| Sweden | Medtronic Navigation, Inc. | |
| Intended use / | ||
| Indications for use | The TRANBERG® Thermoguide 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 neurosurgery, for a | ||
| wavelength of 1064nm. |
When therapy is performed under MRI
guidance, and when data from compatible
MRI sequences is available, the
TRANBERG® Thermoguide therapy 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 TRANBERG® Thermoguide Therapy
System is compatible with the following 3.0T
MR scanner systems: Siemens MRI
Magnetom and GE MRI Signa. When
interpreted by a trained physician, this | "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 |
| | device provides information that may be
useful in the determination or assessment of | certain selected points may be monitored
and/or displayed over time. |
| | thermal therapy.
Patient management decisions should not be
made solely on the basis of analysis using the
TRANBERG® Thermoguide Therapy System. | 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 Regulatory
Classification | 21 CFR 878.4810 (ΟΝΟ) | CFR892.2050 (LLZ)
CFR878.4810 (GEX)
CFR880.5725 (FRN) |
| Product code | ΟΝΟ (Neurosurgical Laser With MR
Thermography) | LLZ (Image Processing System)
GEX (Surgical Laser, Laser Applicator)
FRN (Infusion Pump) |
| Device class | 2 | 2 |
| 510(k) No | K214125 | K181859 |
| Diode laser generator | Cleared under K142216 | Cleared under K092197
Biotex, Inc.PHOTEX30 DIODE LASER |
| Laser wavelength | 1064 nm | 800 - 1064nm |
| Laser applicator /
handpiece | Cleared under K201466 | Cleared under K053087 |
| Thermometry
software system | New
TRANBERG® Thermoguide Workstation
software | Cleared under K063505
Visualase ENVISION Software system |
| Workstation OS | Windows | Linux |
| Software access | Installation of TRANBERG® Thermoguide
Workstation can only be performed by
qualified personnel authorized by CLS.
Installation controlled by License code.
Log into the system with login prompt and
password. | The Visualase® Thermal Therapy System
should only be assembled and installed by
a Medtronic Service Representative.
Log into the system with login prompt and
password. |
| GUI | Temperature and damage information is
displayed in near real-time during the
treatment
GUI with running Thermoguide software is the
primary user interface and control tool for the
entire TRANBERG® Thermoguide Therapy
System and provides a Workflow guidance for
the user. | Temperature and damage information is
displayed in near real-time during the
treatment
Visualase Console window is the primary
user interface and control tool for the entire
Visualase system. |
| Imaging modality | MR | MR |
| Connectivity | DICOM Import | DICOM Import |
| Image import | Magnitude and phase maps | Magnitude and phase maps |
| Image processing | Proton-Resonance-Frequency (PRF) shift
analysis and image subtraction | Proton-Resonance-Frequency (PRF) shift
analysis and image subtraction |
| | Image processing results in T-maps and
damage prediction maps as overlays on
anatomical MR images. | Image processing results in T-maps and
damage prediction maps as overlays on
anatomical MR images. |
| Thermometry
processing | Relative changes in temperature calculated
from complex phase angle. | Relative changes in temperature calculated
from complex phase angle. |
| Laser control | Using external communication input of laser
generator. | Using external modulation input of laser
generator. |
| Temperature
monitoring | 2D color-coded temperature map. | 2D color-coded temperature map. |
| | Additionally, up to 6 Region of interest (ROIs
as point, line or area) user definable. A single
point ROI is corresponding to a target point.
Temperature values are displayed. | Additionally, up to 6 target points. In defined
target points temperature values are
displayed |
| Temperature threshold | Thresholds may be defined to de-active laser
power if temperature in ROI is exceeded | Thresholds may be defined to de-active
laser power if the temperature in target
point is exceeded |
| Thermal dose | Thermal Dose, expressed as equivalent
minutes of exposure at 43 °C (CEM43)1 | Arrhenius model for calculation of thermal
damage or thermal dose |
| Maximum treatment
time | Laser will automatically revert to STANDBY
mode whenever it is idle for five minutes | Laser will automatically revert to STANDBY
mode whenever it is idle for five minutes |
| High temperature limit | High temperature default limit 85°C | High temperature default limit 85°C |
| Safety features | As safety guard functionality Thermoguide
may be used to prescribe limits for the
temperature at certain points (ROIs) in the
image which can, in turn, be used to
deactivate the laser if the limits are reached.
Additional safety features are provided.
Mandatory conditions to enable the laser unit
and run a treatment:
-
Real time images from scanner are
received at least every 5s. -
Real time images from the scanner are
received at least every 5s. If Thermoguide
Workstation detects update rates longer
than 5s the laser emission is automatically
interrupted. -
Laser unit enabled and the connection is
verified, any loss of communication within
1.5s between the Laser unit and
Thermoguide workstation or data
incoherency automatically stops the laser
emission. -
The use of the RFID tag is a mandatory
condition to run a treatment and limits the
maximum power and time (per applicator
type). -
Laser Applicator type confirmed and
received by TRANBERG®Thermoguide | Real-time thermal analysis of specified
targets can be used as an optional safety
interlock feature to deactivate the laser -
At least one target point has to be
selected. -
Set the Tbody value to the patient's core
temperature value. |
| Workstation, the information is read on the RFID tag belonging to the fiber. -
Minimum 1 ROI (monitoring or guard) has been set.
-
Baseline temperature (e.g., core body temperature) is set and confirmed
-
B0 drift compensation: Reference baseline ROI is set and confirmed
-
Placement of the High temperature guard ROI.
-
Test dose successful and confirmed
Laser safety is handled entirely by the laser unit that has been tested according to IEC60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | | |
| Maintenance | requires authorized personal for maintenance | requires authorized personal for maintenance |
| Biocompatibility | See Laser applicator / handpiece | See Laser applicator / handpiece |
| Sterilization | See Laser applicator / handpiece | See Laser applicator / handpiece |
| User Population | trained medical professionals | trained medical professionals |
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1: A reference device, NeuroBlate System cleared under K201056, was used for equivalence to thermal dose. The reference device utilized the same CEM43 algorithm for calculation of the thermal does as the TRANBERG®|Thermoguide Therapy System.