(86 days)
Not Found
No
The summary describes a video-based 3D surface imaging system for patient positioning and monitoring in radiotherapy. While it uses image processing and real-time tracking, there is no mention of AI or ML algorithms being used for these functions or any other part of the system. The focus is on geometric surface matching and tracking.
No.
The device is used to position and monitor patients during radiation therapy and assists in quality assurance, but it does not directly treat or diagnose a disease or condition.
No
The device is used to position and monitor patients relative to the prescribed treatment isocentre, withhold the beam during radiation delivery, track respiratory patterns, and assist in quality assurance. It is not used to diagnose a disease or condition.
No
The device description explicitly states that the system consists of "advanced software, a computer workstation, and one, two or three 3D camera units". It also mentions the introduction of "new camera pods (hardware)" as part of the modifications. This indicates the device includes significant hardware components beyond just a computer workstation.
Based on the provided information, the AlignRT Plus system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- AlignRT Plus Function: The AlignRT Plus system is a surface imaging system used to position and monitor patients during radiation therapy. It works by imaging the external surface of the patient's skin in 3D.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient. Its function is entirely based on external imaging and tracking of the patient's surface.
Therefore, the AlignRT Plus system falls under the category of a medical device used for patient positioning and monitoring during radiation therapy, not an In Vitro Diagnostic device.
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The AlignRT Plus system (K203387) is a combination of the devices AlignRT, GateCT and GateRT.
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 matchinq 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 modifications to FDA 510(k) cleared product "AlignRT Plus" (K203387).
This 510(k) is to obtain clearance for the following changes to the cleared device:
- 一 Introduction of new software, SimRT 7.2. This is an updated version of the cleared software, GateCT, with a new user interface similar to the cleared AlignRT 6.2/6.3/6.4 software;
-
- Introduction of new camera pods (hardware). These function in the same way as the currently cleared hardware but are aesthetically different and have upgraded capabilities to support future product development;
-
- Improve the product's accuracy claim for Source-Surface Distancing (SSD) from 2.0mm to 0.2mm.
Mentions image processing
AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video-based three-dimensional (3D) surface imaging
Anatomical Site
Entire body surface.
Indicated Patient Age Range
Any individual (adult or child)
Intended User / Care Setting
For use in hospital and clinic environments.
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)
The system performance and accuracy have not changed since previous clearances.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vision RT Ltd. % Jade Dunphy Regulatory Affairs Manager Dove House Arcadia Avenue London, N3 2JU United Kingdom
Re: K212583
Trade/Device Name: AlignRT Plus Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: August 13, 2021 Received: August 16, 2021
Dear Jade Dunphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Thalia T. Mills, Ph.D Director. Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212583
Device Name AlignRT Plus
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
visionrt
510(k) Premarket Notification – AlignRT Plus
510(k) Summary
The information below is provided for the modifications to AlignRT following the format of 21 CFR 807.92.
Submitter:
Vision RT Ltd. Dove House Arcadia Avenue London, N3 2JU United Kingdom Contact Name: Jade Dunphy Tel: +44 (0)20 8346 4300 Fax: +44 (0)20 8346 4634
Date Summary was prepared: 17 December 2020
PREDICATE DEVICE INFORMATION:
| Name of the Device: | AlignRT Plus |
|---|---|
| Premarket Notification: | K203387 |
| Trade/Proprietary Name: | AlignRT Plus (incorporating AlignRT, GateCT, GateRT), may be |
| branded as OSMS (Optical Surface Monitoring System). | |
| Manufacturer: | Vision RT Limited |
| Common or Usual Name: | Surface Guided Radio Therapy System (Patient Positioning System |
- accessory to a linear accelerator) |
| Device Class: | II |
| Classification Name: | Accessory to Medical charged-particle radiation therapy accessories,
IYE, (per 21 CFR section 892.5050) |
| Review Panel: | Radiology |
SUBJECT (MODIFIED) DEVICE:
| Name of the Device: | AlignRT Plus (incorporating AlignRT, GateCT, SimRT, GateRT), may
be branded as OSMS (Optical Surface Monitoring System) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Device Manufacturer: | Vision RT Limited |
| Common or Usual Name: | Surface Guided Radio Therapy System (Patient Positioning System
accessory to a linear accelerator) |
| Device Class: | II |
| Classification Name: | Accessory to Medical charged-particle radiation therapy accessories,
IYE, (per 21 CFR section 892.5050) |
| Review Panel: | Radiology |
4
510(k) Premarket Notification - AlignRT Plus
Description of Device:
The AlignRT Plus system (K203387) is a combination of the devices AlignRT, GateCT and GateRT.
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 matchinq 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 modifications to FDA 510(k) cleared product "AlignRT Plus" (K203387).
This 510(k) is to obtain clearance for the following changes to the cleared device:
- 一 Introduction of new software, SimRT 7.2. This is an updated version of the cleared software, GateCT, with a new user interface similar to the cleared AlignRT 6.2/6.3/6.4 software;
-
- Introduction of new camera pods (hardware). These function in the same way as the currently cleared hardware but are aesthetically different and have upgraded capabilities to support future product development;
-
- Improve the product's accuracy claim for Source-Surface Distancing (SSD) from