(68 days)
No
The document describes a video-based 3D surface imaging system for patient positioning and monitoring in radiotherapy, but it does not mention the use of AI or ML technologies in its description, intended use, or performance studies.
No
The device is used for positioning and monitoring patients during radiation therapy, not for delivering therapeutic treatment itself. It's a tool to assist in the precise delivery of another therapy.
No
The device is primarily used for patient positioning, monitoring, and beam withholding during radiation delivery, and for quality assurance of other radiation therapy equipment. While it collects patient contour data that "can be extracted and exported for the purpose of treatment planning," its main function is not to diagnose conditions or diseases.
No
The device description explicitly states that the system consists of "advanced software, a computer workstation, and one, two or three 3D camera units". This indicates the presence of significant hardware components beyond just a computer to run the software.
Based on the provided information, the AlignRT Plus system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The AlignRT Plus system images the surface of the patient's body and processes radiographic image data acquired by other devices. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for positioning, monitoring, and tracking patients during radiation therapy. This is a clinical application directly involving the patient's physical position and movement, not the analysis of biological specimens for diagnostic purposes.
- The device description focuses on surface imaging and its components (cameras, software, workstation). This aligns with a medical imaging and positioning system, not an IVD.
- The performance studies evaluate positioning accuracy and respiratory tracking. These are metrics relevant to patient setup and motion management during treatment, not diagnostic accuracy based on biological markers.
In summary, the AlignRT Plus system is a medical device used for patient positioning and monitoring during radiation therapy, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
AlignRT Plus system is a combination of the predicate devices AlignRT (K052682) and GateCT-RT (K072171). It is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process. AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals. Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances. Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals. AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position. Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video-based 3D surface imaging
Anatomical Site
Entire body surface
Indicated Patient Age Range
Any individual (adult or child) undergoing radiotherapy
Intended User / Care Setting
Not Found
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)
Positioning accuracy: Target registration errors (as measured using calibration phantom)
§ 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.
0
K12337
AlignRT Premarket Notification -
JAN 06 2013
The information below is provided for the modifications to AlignRT following the format of 21 CFR 907.92.
Vision RT Ltd.: Submitter: Dove House Arcadia Avenue London, N3 2JU United Kingdom Contact Name: Dr. Norman Smith +44(0)20 8346 4300 Phone: +44(0)20 8346 4634 Fax: nsmith@visionrt.com . . . . . . Email:
Date Summary was prepared 25th October 2012
| Name of the Device: | AlignRT Plus |
|---|---|
| Trade/Proprietary Name: | AlignRT Plus |
| Common or Usual Name: | Patient Positioning System |
| Classification Name: | Accessory to Medical charged-particle radiation therapy |
| accessories, 90IYE, (per 21 CFR section 892.5050) |
Predicate Device to claim substantial equivalence
Vision RT AlignRT (K052682)
Vision RT GateCT-RT (K072171)
Description of Device:
AlignRT Plus system is a combination of the predicate devices AlignRT (K052682) and GateCT-RT (K072171). It is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.
1
510(k) Premarket Notification
AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both . instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals.
Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances.
Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.
AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.
The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position.
Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS).
Intended Use Statement:
The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Summary of the Technological Characteristics:
The Substantial Equivalence Comparison Table shown below provides a comparison of the technological characteristics of AlignRT Plus to those of the predicate device:
2
| 9 | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Page 3 of | ||||||||||||||||||
| NEW DEVIC | AlignRT. Plus | Vision RT Ltd | The AlignRT Plus system is indicated for use to | |||||||||||||||
| position and monitor patients relative to the | ||||||||||||||||||
| orescribed treatment isocenter, and | radiation delivery. For cranial treatments, a manual head adjuster is included which ca | |||||||||||||||||
| withhold the beam automatically durin | be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus also also rolled to the patient for | |||||||||||||||||
| respiratory synchronized image acquisition | ontour data can be extracted and exporte | |||||||||||||||||
| and radiation therapy treatment. Patient | from the data acquired for the purpose treatment planning. AlignRT Plus can be | calibrated directly to the treatment beam | uality assurance on MV, kV imagers, room | |||||||||||||||
| socenter and in turn assists in performing | lasers and the treatment couch. AlignRT Plu | |||||||||||||||||
| may be used during simulation, setup and | stereotactic radiosurgery and precisi | |||||||||||||||||
| radiotherapy for lesions, tumors ar | conditions anywhere in the body when | |||||||||||||||||
| radiation is indicated. | ||||||||||||||||||
| isi�nrt | 510(k) Premarket Notification – AlignRT Plus | PREDICATE DEVICE 2 | . | |||||||||||||||
| Vision RT's GateCT-RT (K072171 | Vision RT Ltd | :: | . :: | The GateCT-RT system is used to | ||||||||||||||
| 1999 1991 | : | obtain the block of the subscriptions. Statures internet in assemblement of the comment and the comment of the manufacturer in the management of the comments of the comments | automatically. | · | October 201 | |||||||||||||
| PREDICATE DEVICE | Vision RT's AlignRT (K052682 | /ision RT Ltd | The AlignRT system is used to positio | |||||||||||||||
| patients at the isocentre of the linear | accelerator for radiation therapy procedures. Patient contour data car | be extracted and exported from the | ||||||||||||||||
| quired data for the purpose of | treatment planning. | |||||||||||||||||
| DEVICE NAMI | 1ANUFACTURER | . . | ndications for Use | 06 Issue 3.0 | ||||||||||||||
3
| Page 4 of 6 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| NEW DEVICE | Video based imaging of 3D skin surface data | |||||||||
| using surface matching software. Image | ||||||||||
| processing of radiographic image data. | Any individual (adult or child) undergoing | |||||||||
| radiotherapy | PC workstation, cables, video cameras. Block | |||||||||
| Polystyrene (calibration phantom), carbon | ||||||||||
| fibre laminate material (head adjuster) which | ||||||||||
| is substantially equivalent to the cleared | ||||||||||
| Bionix (K100691) device. | Positioning accuracy: Target registration | |||||||||
| errors (as measured using calibration | ||||||||||
| phantom) |