(70 days)
Not Found
No
The document mentions image processing and proposes a correction shift based on image analysis, but it does not explicitly mention AI, ML, or any related terms like deep learning or neural networks. The description of performance studies and key metrics focuses on accuracy and traditional testing methods, not on AI/ML specific evaluation metrics or training/test set details typically associated with such technologies.
No
The device is used for localizing patient position and providing correction feedback to a radiation therapy device. It aids in the therapy but does not therapeutically treat the patient itself.
No
The device is used for patient localization and providing correction feedback in radiation therapy, not for diagnosing a disease or condition. Its purpose is to ensure the correct positioning of the patient during treatment.
No
The device description explicitly states that I2C "must be integrated into a radiation therapy system" and "will interact with components of the radiation therapy center." It also mentions "acquisition of 2D, 2D stereoscopic and 3D images using 2D detectors," implying interaction with hardware for image acquisition. Furthermore, performance studies were conducted in a "simulated clinical environment with actual hardware." These points indicate the device is not solely software but is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device, I2C, is used for patient positioning and localization within a radiation therapy system. It uses imaging data (X-ray, CT, CBCT) to verify the patient's position relative to the treatment equipment and provide feedback for correction.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely focused on spatial positioning and image-based verification.
Therefore, the device's intended use and functionality clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.
Product codes (comma separated list FDA assigned to the subject device)
LHN
Device Description
For clinical use, I2C must be integrated into a radiation therapy system. I2C will interact with components of the radiation therapy center.
I2C supports the acquisition of 2D, 2D stereoscopic and 3D images using 2D detectors.
I2C will be used by the clinical therapist to verify by imaging that the treatment target position received from the treatment control applicative layer is 'valid', i.e. that it brings the center of the treatment target volume at the isocenter of the therapy equipment with required accuracy. If it is not, I2C will propose a correction shift - or correction vector - that will be exported to the radiation therapy system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (2D, 2D stereoscopic, 3D CBCT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical therapist / Radiation therapy center
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
A second test environment was used to verify communication with different 30 party software configurations (Elekta Mosaiq, Varian Aria) installed on their dedicated workstations.
Third, additional performance tests were done on a stand-alone system with appropriate datasets collected from simulated treatments and radiographs of phantom acquired in IBA treatment centres, from test bench data acquired with phantoms, and from anonymised patient data provided by IBA treatment centers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests for determination of substantial equivalence:
When verifying the effectiveness and safety of the design and its implementation, part of the activities was done in a simulated clinical environment with the actual hardware and 30 party software applications. The X-Ray imaging equipment was installed on a test bench in a vault appropriate for radiologic operation. The geometry of the system was adapted to represent different configuration setups. The rotation of the gantry was simulated by a rotation of the phantom on a turn table driven by a real gantry controller. A configuration of 30 party software applications was setup in order to test the whole treatment workflow scenarios, including exception cases.
A second test environment was used to verify communication with different 30 party software configurations (Elekta Mosaiq, Varian Aria) installed on their dedicated workstations.
Third, additional performance tests were done on a stand-alone system with appropriate datasets collected from simulated treatments and radiographs of phantom acquired in IBA treatment centres, from test bench data acquired with phantoms, and from anonymised patient data provided by IBA treatment centers.
As a fourth verification and validation strategy axis, a process of evaluation by a group of a-users has been put in place to assess the usability of the software. Throughout the development, intermediate releases are distributed to a group of reference users in proton therapy. A process has been put in place to collect a user evaluation of the system, especially regarding usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Achievable matching accuracy:
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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M-Id 39876 Rev. B Page 2
510(k) Summary 12C
510(k) SUMMARY lon Beam Applications S.A.
06 November 2013
Submitter
lon Beam Applications S.A. Chemin du Cyclotron, 3 B-1348 Louvain-la-Neuve Belgium Contact person : Mr Baelen Michel 32-10-47-58-45 Phone : 32-10-47-58-10 Facsimile: E-mail: Michel Baelen@iba-group.com
Contact and Agent for lon Beam Applications S.A. in the US
Bruce D. Armon Saul, Ewing, Remick & Saul Centre Square West 38th Floor Philadelphia, PA 19102-2186 Phone: (215) 972-7124 Facsimile: (215) 972-1906 E-mail: barmon@saul.com
ಗಿ
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Name of the Device
I₂C (IBA Image Guided Therapy Consol) (brand name: adapt Insight)
Classification Name
Medical charged-particle radiation therapy systems. (21 C.F.R. §892.5050)
Predicate Devices
I2C is claimed to be equivalent to the predicate devices listed in table 1 below, based on the fact that they have the same intended use and principles of operation, and are substantially equivalent in terms of performance and technological characteristics.
| Device | Indication for use |
|---|---|
| Verisuite | |
| (K080742, Medcom) | The VeriSuite patient position verification system is used for |
| verification and correction of the patient's position during a | |
| radiotherapy treatment with external beams or charged particles. It is | |
| based on stereoscopic X-ray images and DRRs calculated from a CT | |
| image series of the treatment region of the patient and information | |
| from the treatment planning. | |
| ExacTrac 3rd Party | |
| (K072046, Brainlab) | The ExacTrac 3rd Party system is intended to be used in conjunction |
| with the MHI-TM2000 radiation therapy linear accelerator system | |
| manufactured by Mitsubishi Heavy Industries, Ltd. | |
| ExacTrac 3rd Party uses the images received from the MH1-TM2000 | |
| linear accelerator for analyzing the current patient position and | |
| calculating - when applicable - a necessary correction shift. The | |
| correction shift is then exported to the MHI-TM2000 linear | |
| accelerator. | |
| The ExacTrac 3rd Party system uses stereoscopic x-ray or cone | |
| beam CT registration and optical tracking of infrared reflective | |
| markers in order to localize and correct the patient position before | |
| and during treatment. | |
| OBI | |
| (K040192 & | |
| K042720, Varian) | The On-Board Imager device is used for verification of correct patient |
| position in relation to isocenter and verification of the treatment fields | |
| in relation to anatomical and/or fiducial landmarks |
Table 1: List of the identified predicate devices and their indication for use
Indication for Use of the device
IzC is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.
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Description of the device
For clinical use, l2C must be integrated into a radiation therapy system. I2C will interact with components of the radiation therapy center.
I2C supports the acquisition of 2D, 2D stereoscopic and 3D images using 2D detectors.
I2C will be used by the clinical therapist to verify by imaging that the treatment target position received from the treatment control applicative laver is 'valid', i.e. that it brings the center of the treatment target volume at the isocenter of the therapy equipment with required accuracy. If it is not, InC will propose a correction shift - or correction vector - that will be exported to the radiation therapy system.
Technological Characteristics of the device
1. Image acquisition
The I2C software supports the acquisition of 2D, 2D stereoscopic and 3D images using 2D detectors.
The 2D and 2D stereoscopic images can be acquired using one or multiple imaqing devices arranqed in various geometrical configurations.
The 3D images are created using a single 2D imaging device which rotates around the volume to be imaged: The 3D images are then reconstructed using the acquired 2D images and the associated spatial information (angle of acquisition).
The image acquisition supports a range of OEM devices1, such as the following X-ray tubes, generators and detectors:
| 2D | 2D/3D | |
|---|---|---|
| X-ray tube | Varian B130H | Varian GS2075 |
| Generator | Sedecal SHF835 | Sedecal SHF845RF |
| Detector | Varian Paxscan 4030E | Thales Pixium RF4343 |
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1 The conformity of these devices and their proper integration into the I-C system were ensured by the verification and validation activities followed during the development of the system and described in 12C VnV plan - MID 37685.
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2. Image registration
Image registration is used to verify, based on the reference and acquired images. that the position of the patient in regard to the equipment matches the treatment plan geometry and eventually compute a correction vector that can be applied to ensure correct patient positioning. It has been designed such that a submillimeter matching accuracy can be reached.
The registration provides a correction vector of up to 6 degrees of freedom that can be sent to third party systems.
2D image registration
The 2D or 2D stereoscopic image registration uses either:
- Intensity based information between the acquired X-ray planar images and the Digital Reconstructed Radiograph (DRR) (generated from the treatment planning reference CT) data or provided by Treatment Planning System - TPS -, ... ), this is done automatically, or
- Markers that have been identified on the acquired X-ray planar images and the DRR generated from the CT data, or
- Manual registration of the images by drag and drop of one image to the other one.
3D image registration
The 3D image reqistration uses either
- Intensity based information between the acquired 3D data set and the a CT data, or
- Manual registration of the images by drag and drop of one image to the other one.
- ・ The registration provides a correction vector of 6 degrees of freedom that can be sent to third party system.
3. Connectivity to third party systems
The device exchanges data with 30 party systems such as an Oncology Information System using either a push or a pull method, or any third party system supporting DICOM standards.
4
Comparison to the predicate devices
Like the predicate devices in Table 1, 12C is designed to be used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device-
The predicate devices also provide the same or substantially equivalent functions, characteristics, and accessories.
Based on the purpose of the 12C system, its environment of use, its main components and features, the following elements have been used for comparison:
- . Intended use
- Radiation type: clinical relevance, patient safety, known technology .
- . Acquisition geometry
- Detector type .
- Image used as reference for matching .
- o Data compared during matching
- . Type of matching approach
- Communication to 3rd party software .
Table 2: Comparison table of I2C with identified predicate devices
| Characteristics | I₂C | Verisuite
(K080742,
Medcom) | ExacTrac
3rd Party
(K072046,
Brainlab) | OBI
(K040192 &
K042720,
Varian) |
|----------------------------------------------------------------|-----|-----------------------------------|-------------------------------------------------|------------------------------------------|
| Indication for use: | | | | |
| • Verification of patient
setup position | ✓ | ✓ | ✓ | ✓ |
| • Used with a charge
particle radiation therapy
system | ✓ | ✓ | | |
| • Used with a photon
radiation therapy system | ✓ | ✓ | ✓ | ✓ |
| Image acquisition: | | | | |
| • High accuracy kV X-Ray
imaging with digital flat
panel | ✓ | ✓ | ✓ | ✓ |
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| Characteristics | I₂C | Verisuite
(K080742,
Medcom) | ExacTrac
3rd Party
(K072046,
Brainlab) | OBI
(K040192 &
K042720,
Varian) |
|---------------------------------------------------------------------------------------|-----|-----------------------------------|-------------------------------------------------|------------------------------------------|
| • Stereoscopic acquisition | ✓ | ✓ | ✓ | ✓ |
| • Flexible X-Ray setup:
various arrangements of
panels, generators and
tubes | ✓ | ✓ | | |
| Image matching: | | | | |
| • Registration using
anatomical landmarks | ✓ | ✓ | ✓ | ✓ |
| • Registration using fiducial
landmarks | ✓ | ✓ | ✓ | ✓ |
| • Registration using CBCT
with planning CT | ✓ | | | ✓ |
| • Registration of
radiographs with DRR
generated from planning
CT | ✓ | ✓ | ✓ | ✓ |
| o 2D/2D (5 DOF
registration) | ✓ | ✓ | ✓ | ✓ |
| o 2D/3D (6 DOF
registration) | ✓ | ✓ | ✓ | - |
| Interface to 3rd party applications: | | | | |
| • Transfer of correction shift
(correction vector) | ✓ | ✓ | ✓ | - |
| • DICOM exchange of
clinical data | ✓ | ✓ | ✓ | ✓ |
Table 3 provides a comparison of 12C with predicate devices for some of characteristic specification.
Table 3: Indication of performance and technological specification of I-C and its predicate devices
| Performance / technological
specification | I2C | Verisuite
(K080742,
Medcom) | ExacTrac
3rd Party
(K072046,
Brainlab) | OBI
(K040192 &
K042720,
Varian) |
| ---------------------------------------------- | ----- | ----------------------------------- | ------------------------------------------------- | ------------------------------------------ |
|---|
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| Performance / technological
specification | I2C | Verisuite
(K080742,
Medcom) | ExacTrac
3rd Party
(K072046,
Brainlab) | OBI
(K040192 &
K042720,
Varian) |
|----------------------------------------------|-----------------------|-----------------------------------|-------------------------------------------------|------------------------------------------|
| Generator operating range
(radiographic) | 40-150 kVp | 40-150 kVp | - | 40-150 kVp |
| Generator operating range
(CBCT) | 40-125 kVp | N/A | N/A | 60-140 kVp |
| Flat panel pixel size | 148 µm | 127 µm | - | 194 µm |
| Flat panel pixel matrix | > 2880x2880
pixels | 3200x3200
pixels | - | 3200x2304
pixels |
| CBCT scale & distance
accuracy | 1% | N/A | N/A | 1% |
| CBCT spatial resolution | At least 5
lp/cm | N/A | N/A | 4-7 lp/cm |
| CBCT low contrast resolution | 15mm@1% | N/A | N/A | 15mm@1% |
| CBCT numbers accuracy | +/- 40 HU | N/A | N/A | +/- 40 HU |
| CBCT Uniformity | +/- 40 HU | N/A | N/A | +/- 40 HU |
| Achievable matching accuracy |