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.

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:

1. TRANBERG®|Mobile Laser Unit, cleared by K142216.
1. TRANBERG®|Laser applicator and introducer, cleared by K201466.
1. 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.

AI/ML Overview

The given text is a 510(k) summary for the TRANBERG®|Thermoguide Therapy System. It describes the device, its intended use, and lays out the argument for its substantial equivalence to a predicate device (Visualase™ Thermal Therapy system, K181859). The document focuses on technological comparisons and performance data obtained through bench testing and a pre-clinical animal study. However, it explicitly states: "No clinical data was provided in support of this submission."

Therefore, based on the provided document, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria using clinical data or human evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the performance data submitted for FDA clearance, which here consists of bench testing and preclinical animal studies.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is explicitly stated as not present:

Acceptance Criteria and Device Performance (Based on available data)

Since no clinical study involving acceptance criteria for diagnostic performance (like sensitivity, specificity, accuracy) is mentioned for human use, the "acceptance criteria" discussed here are related to the successful operation and performance of the device's thermometry algorithm and safety features during non-human testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from testing)	Reported Device Performance
Functional Safety & Performance	Compliance with IEC60601-1-2 and IEC60601-2-22 (General and Laser Safety Standards)	"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."
Software V&V	Full software Verification & Validation	"Full software V&V data is provided for both the TRANBERG®Mobile Laser Unit and the TRANBERG®
Interoperability	Correct operation and communication between all system components (Mobile laser unit, Thermoguide Workstation, Laser applicator, and MRI scanners).	"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® Thermoguide Therapy System, i.e., Mobile laser unit, Thermoguide Workstation, Laser applicator, and MRI scanners."
Thermometry Algorithm Accuracy	Correct operation of the thermometry algorithm as determined by correlation to physical measurements.	"Correct operation of the thermometry algorithm used in the Thermoguide Workstation as determined by correlation to physical measurements." This was further evaluated in the pre-clinical animal study.
Near Real-time Performance	Evaluation of near real-time behavior of temperature measurements; determine offset from real time and update rate of temperature maps for chosen scanner sequences.	"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."
Product Requirement Specification	Fulfillment of product requirement specifications.	"Verify that the products fulfil product requirement specifications."
Overall Performance	Function as intended; performance as expected.	"In all instances, the TRANBERG® Thermoguide Therapy System functioned as intended and the performance observed was as expected."
Biocompatibility & Sterilization	Compliance with relevant standards for invasive devices.	"Biocompatibility data for the invasive devices is not included in this submission as it was part of the recent clearance under K201466." "Sterilization: See Laser applicator / handpiece." (Referencing K201466 clearance).

Given the explicit statement "No clinical data was provided in support of this submission," the following sections cannot be fully answered or are marked as not applicable based on the provided document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size:
- Bench Testing: Not specified in terms of numerical "sample size" for data points, but described in terms of tests performed to verify compliance and functionality.
- Pre-clinical Animal Study: The document mentions "a prospective preclinical animal study under GLP conditions." The exact number of animals or data points from this study is not specified.
Data Provenance:
- Country of Origin: Not explicitly stated, but the manufacturer is "Clinical Laserthermia Systems AB, Lund, Sweden."
- Retrospective or Prospective: The animal study was "prospective." Bench testing is inherently prospective in nature (tests are performed on the device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable for the reported performance studies. The "ground truth" for technical performance was established through physical measurements (for thermometry algorithm accuracy) and defined specifications (for functional tests). For the animal study, the ground truth would be based on direct measurements and pathological assessment of ablated tissue, not human expert consensus on images.
The device's Indications for Use state, "When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy." However, no study involving human interpretation of the device's output for establishing clinical ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This typically refers to the process of resolving discrepancies among multiple human readers in a diagnostic study. Since no human reader studies are described, no adjudication method was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data was provided in support of this submission."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence, the "Thermometry Algorithm Accuracy" and "Near Real-time Performance" evaluations described under bench testing are standalone performance assessments. These tests evaluated the algorithm's ability to accurately calculate and display temperature maps and thermal dose independent of a human operator making clinical decisions based on the output. The pre-clinical animal study also assessed the device's performance in generating accurate thermal data without human intervention in the data generation process itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Physical Measurements: For the accuracy of the thermometry algorithm, the ground truth was based on physical measurements of temperature.
Defined Specifications: For functional testing and compliance, the ground truth was the satisfaction of predefined engineering and safety specifications (e.g., proper communication, correct power output, safety interlocks).
Pathology/Tissue Assessment: For the pre-clinical animal study, the ground truth for thermal damage would typically be established through histological examination of the ablated tissue, comparing the predicted thermal damage to the actual tissue necrosis.

8. The sample size for the training set

Not applicable / Not specified. This submission is for a medical device that includes software for processing MR images to display temperature and thermal dose. The document describes the algorithms used as "well established and described in scientific literature," implying that they are based on known physical principles (Proton Resonance-Frequency shift analysis, CEM43 algorithm) rather than being a deep learning or AI model trained on a large dataset in the conventional sense. Therefore, there's no "training set" in the context of machine learning model development specified here.

9. How the ground truth for the training set was established

Not applicable / Not specified. As noted above, the device seems to rely on established physics-based algorithms rather than a trained AI/ML model that would require a ground-truth-labeled training set. If the algorithms involved any parameter tuning or classical machine learning components, that data and its ground truth are not detailed in this summary.

Summary

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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

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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

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-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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

1. TRANBERG®|Mobile Laser Unit, cleared by K142216.
1. TRANBERG®|Laser applicator and introducer, cleared by K201466.
1. TRANBERG®|Thermoguide Workstation, article no. 1100-01, new in this submission.

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used in the system to calculate temperature maps and thermal dose in tissue are well established and described in scientific literature.

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

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.

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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.

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. 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

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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.

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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 TherapySystem is indicated for use to necrotize orcoagulate soft tissue through interstitialirradiation or thermal therapy under magneticresonance imaging (MRI) guidance inmedicine and surgery in neurosurgery, for awavelength of 1064nm.When therapy is performed under MRIguidance, and when data from compatibleMRI sequences is available, theTRANBERG® Thermoguide therapy systemcan process images using proton resonancefrequency (PRF) shift analysis and imagesubtraction to relate changes in complexphase angle back to relative changes intissue temperature during therapy. The imagedata may be manipulated and viewed in anumber of different ways, and the values ofdata at certain selected points may bemonitored and/or displayed over time.The TRANBERG® Thermoguide TherapySystem is compatible with the following 3.0TMR scanner systems: Siemens MRIMagnetom and GE MRI Signa. Wheninterpreted by a trained physician, this	"The Visualase® Thermal Therapy Systemis indicated for use to necrotize or coagulatesoft tissue through interstitial irradiation orthermal therapy under magnetic resonanceimaging (MRI) guidance in medicine andsurgery in cardiovascular thoracic surgery(excluding the heart and the vessels in thepericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, generalsurgery, gynecology, head and necksurgery, neurosurgery, plastic surgery,orthopedics, pulmonology, radiology, andurology, for wavelengths 800nm through1064nm.When therapy is performed under MRIguidance, and when data from compatibleMRI sequences is available, the Visualase®system can process images using protonresonance-frequency (PRF) shift analysisand image subtraction to relate changes incomplex phase angle back to relativechanges in tissue temperature duringtherapy. The image data may bemanipulated and viewed in a number ofdifferent ways, and the values of data at
	device provides information that may beuseful in the determination or assessment of	certain selected points may be monitoredand/or displayed over time.
	thermal therapy.Patient management decisions should not bemade solely on the basis of analysis using theTRANBERG® Thermoguide Therapy System.	The Visualase® Thermal Therapy System iscompatible with General Electric MedicalSystems Signa model MR scanners andwith Siemens Medical Solutions MagnetomEspree systems. When interpreted by atrained physician, this device providesinformation that may be useful in thedetermination or assessment of thermaltherapy. Patient management decisionsshould not be made solely on the basis ofVisualase® analysis."
Device RegulatoryClassification	21 CFR 878.4810 (ΟΝΟ)	CFR892.2050 (LLZ)CFR878.4810 (GEX)CFR880.5725 (FRN)
Product code	ΟΝΟ (Neurosurgical Laser With MRThermography)	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 K092197Biotex, Inc.PHOTEX30 DIODE LASER
Laser wavelength	1064 nm	800 - 1064nm
Laser applicator /handpiece	Cleared under K201466	Cleared under K053087
Thermometrysoftware system	NewTRANBERG® Thermoguide Workstationsoftware	Cleared under K063505Visualase ENVISION Software system
Workstation OS	Windows	Linux
Software access	Installation of TRANBERG® ThermoguideWorkstation can only be performed byqualified personnel authorized by CLS.Installation controlled by License code.Log into the system with login prompt andpassword.	The Visualase® Thermal Therapy Systemshould only be assembled and installed bya Medtronic Service Representative.Log into the system with login prompt andpassword.
GUI	Temperature and damage information isdisplayed in near real-time during thetreatmentGUI with running Thermoguide software is theprimary user interface and control tool for theentire TRANBERG® Thermoguide TherapySystem and provides a Workflow guidance forthe user.	Temperature and damage information isdisplayed in near real-time during thetreatmentVisualase Console window is the primaryuser interface and control tool for the entireVisualase 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) shiftanalysis and image subtraction	Proton-Resonance-Frequency (PRF) shiftanalysis and image subtraction
	Image processing results in T-maps anddamage prediction maps as overlays onanatomical MR images.	Image processing results in T-maps anddamage prediction maps as overlays onanatomical MR images.
Thermometryprocessing	Relative changes in temperature calculatedfrom complex phase angle.	Relative changes in temperature calculatedfrom complex phase angle.
Laser control	Using external communication input of lasergenerator.	Using external modulation input of lasergenerator.
Temperaturemonitoring	2D color-coded temperature map.	2D color-coded temperature map.
	Additionally, up to 6 Region of interest (ROIsas point, line or area) user definable. A singlepoint ROI is corresponding to a target point.Temperature values are displayed.	Additionally, up to 6 target points. In definedtarget points temperature values aredisplayed
Temperature threshold	Thresholds may be defined to de-active laserpower if temperature in ROI is exceeded	Thresholds may be defined to de-activelaser power if the temperature in targetpoint is exceeded
Thermal dose	Thermal Dose, expressed as equivalentminutes of exposure at 43 °C (CEM43)1	Arrhenius model for calculation of thermaldamage or thermal dose
Maximum treatmenttime	Laser will automatically revert to STANDBYmode whenever it is idle for five minutes	Laser will automatically revert to STANDBYmode 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 Thermoguidemay be used to prescribe limits for thetemperature at certain points (ROIs) in theimage which can, in turn, be used todeactivate the laser if the limits are reached.Additional safety features are provided.Mandatory conditions to enable the laser unitand run a treatment:- Real time images from scanner arereceived at least every 5s.- Real time images from the scanner arereceived at least every 5s. If ThermoguideWorkstation detects update rates longerthan 5s the laser emission is automaticallyinterrupted.- Laser unit enabled and the connection isverified, any loss of communication within1.5s between the Laser unit andThermoguide workstation or dataincoherency automatically stops the laseremission.- The use of the RFID tag is a mandatorycondition to run a treatment and limits themaximum power and time (per applicatortype).- Laser Applicator type confirmed andreceived by TRANBERG®Thermoguide	Real-time thermal analysis of specifiedtargets can be used as an optional safetyinterlock feature to deactivate the laser- At least one target point has to beselected.- Set the Tbody value to the patient's coretemperature 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 confirmedLaser 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.

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.