(58 days)
The Motion Tracking and Compensation Feature is an option within the indications for use of the Radixact Treatment Delivery System. The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
The Motion Tracking and Compensation Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The Motion Tracking and Compensation Feature measures tumor location and motion using images provided by a kV imaging subsystem and predicts tumor location based upon a respiration amplitude measurement device. The Radixact Treatment Delivery System then compensates for tumor motion by making real-time adjustments.
The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.
The provided text describes a 510(k) premarket notification for a new feature (Motion Tracking and Compensation Feature) for an existing device (Radixact Treatment Delivery System). The core of the submission is to demonstrate substantial equivalence to the predicate device, not necessarily to provide specific performance metrics against pre-defined acceptance criteria in the way one might for a diagnostic AI device.
Therefore, the response below will focus on what is available in the text regarding "acceptance criteria" (more accurately, the claims of substantial equivalence) and the "study" (the verification and validation testing) that supports these claims, rather than a typical AI performance table.
1. A table of acceptance criteria and the reported device performance
For a substantial equivalence submission, the "acceptance criteria" are typically demonstrating that the new device feature does not raise new questions of safety or effectiveness compared to a predicate device, and performs as well as the predicate for its intended use. The table below summarizes the claims of substantial equivalence for various characteristics.
| Device Characteristic | Predicate Device Performance (Radixact K161146) | Reported Device Performance (Radixact with Motion Tracking and Compensation) | Acceptance Criteria Met? (Analysis) |
|---|---|---|---|
| Intended Use | Delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues. | Option within the intended use of the Radixact Treatment Delivery System. Intended for delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues. | Identical: The device's intended use fits within and is identical to the predicate's. |
| Indications for Use | Delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. | Option within the indications for use of the Radixact Treatment Delivery System. Indicated for delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. | Identical: The device's indications for use fit within and are identical to the predicate's, with the addition of an introductory sentence for the feature. |
| System Configuration | Stand-alone radiation delivery system. | Stand-alone radiation delivery system with kV imaging and motion tracking and compensation added. | Substantially Equivalent: Introduction of Motion Tracking and Compensation Feature does not raise different issues of safety or effectiveness. |
| Physical Dimensions | Minimum Room Dimensions: 274 x 462 x 602 cm; Device Dimensions: 255 x 280 x 473 cm; Device Mass: 6580 kg. | Minimum Room Dimensions: 274.3 x 463 x 602 cm; Device Dimensions: 255 x 280 x 470.5 cm; Device Mass: 6580 kg plus 235 kg for kV subsystem components. | Substantially Equivalent: Minor differences are negligible or the added weight/components do not result in different questions of safety or effectiveness. |
| Basic Operation Parameters (Electrical, Environmental, Gantry) | Line Voltage: 380-480 V ac; Ambient Temp: 20-24 °C; Humidity: 30-60%; Bore Diameter: 85 cm; Gantry Rotation Continuous (1-5 RPM treatment, 10 RPM imaging); Couch Support in Bore: Provided. | Same as predicate. | Identical. |
| Radiation Delivery Modes | Helical, Direct. | Same as predicate. | Identical. |
| Photon Beam (Accelerator Type, RF Source, Energy, Field Size, Dose Rate) | Standing wave, Magnetron, 6 MV, Fixed/Dynamic Field Sizes, Dose Rate: 850 cGy/min standard, 1000 cGy/min optional. | Same as predicate. | Identical. |
| Collimation | Primary collimation, jaws and multi-leaf collimator. | Primary collimation, jaws and multi-leaf collimator. | Substantially Equivalent: Jaws have a new dynamic behavior for motion managed plans, continually adjusted to repoint the beam at the moving target while maintaining the same field size. This difference does not raise different questions of safety or effectiveness. |
| MVCT Imaging | Source: MVCT; FOV: 39 cm diameter; Dose: 0.5-3.0 cGy; Slice Spacing: 1, 2, 3, 4, 6 mm; Spatial Resolution: 1.6 mm. | Same as predicate. | Identical. |
| kV Imaging | Feature not present. | 50-150 kV Radiography Class I (60601-2-28) X-ray tube assembly; FOV: 20 cm x 20 cm; Spatial Resolution: |
§ 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.