(266 days)
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.
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:
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- TRANBERG®|Mobile Laser Unit, cleared by K142216.
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- TRANBERG®|Laser applicator and introducer, cleared by K201466.
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- 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.
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.
§ 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.