(106 days)
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.
The AlignRT Plus system (K193431) is a combination of the devices AlignRT, GateCT and GateRT. A special 510(K) K193431 was submitted by Vision RT Ltd. in December 2019 and this was cleared by FDA in January 2020 for the changes and improvements made in AlignRT.
AlignRT Plus 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). This is provided with the brand name "AlignRT SRS module".
The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.
This 510(k) is requested for a new optional InBore camera and a change in memory size for an existing FDA 510(k) cleared product "AlignRT Plus" (K193431).
The InBore camera is optional hardware for use with bore-based linear accelerators.
The increase in memory size from 32 to 64bit increases the system's processing speed, enabling a frame rate improvement.
The provided text is a 510(k) Premarket Notification for the AlignRT Plus device K203387, which describes modifications to an existing cleared device K193431. The document does not contain a detailed study that proves the device meets specific acceptance criteria with supporting data, an approach often seen for substantial equivalence claims where modifications are minor and performance remains unchanged from a previously cleared predicate. Instead, it relies on demonstrating that the modified device's performance and characteristics are the same as its predicate device.
Therefore, the following information is based on what is stated and what can be inferred from the provided text, primarily focusing on the comparison to the predicate device.
Acceptance Criteria and Reported Device Performance
The "Acceptance Criteria" for this submission are fundamentally defined by the performance of the predicate device (K193431). The "Reported Device Performance" for the modified device (K203387) is stated to be unchanged from that of the predicate.
| Acceptance Criteria (Based on Predicate Device Performance) | Reported Device Performance (Modified Device K203387) |
|---|---|
| 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.