(24 days)
Not Found
No
The description focuses on 3D surface imaging, real-time tracking, and image processing for positioning and monitoring, without mentioning AI or ML algorithms. The software changes are related to frame rate and a "Video Postural Setup Alignment feature," which doesn't inherently imply AI/ML.
No.
The device is used to position and monitor patients during radiation therapy and assists in quality assurance; it does not directly treat or diagnose a disease or condition.
No
The AlignRT Plus system is primarily used for patient positioning, monitoring, and beam control during radiation therapy, as well as for quality assurance of radiotherapy equipment. It does not diagnose diseases or conditions; rather, it assists in the delivery of a prescribed treatment.
No
The device description explicitly states that the system consists of advanced software, a computer workstation, and one, two or three 3D camera units. While this 510(k) is for a software modification, the underlying device includes hardware components (computer workstation and camera units).
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 non-invasive, video-based surface imaging system used to position and monitor patients during radiation therapy. It works by imaging the external surface of the patient's skin.
- No Specimen Analysis: The system does not analyze any biological specimens taken from the patient. Its function is entirely based on external surface imaging and tracking.
Therefore, the AlignRT Plus system falls under the category of medical devices used for patient positioning and monitoring during radiation therapy, not 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, 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
IYE
Device Description
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 noninvasive, 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".
Mentions image processing
Yes
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) undergoing radiotherapy.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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January 3, 2020
Vision RT Ltd. % Arun Mahendran Regulatory Affairs Manager Dove House. Arcadia Avenue London, N3 2JU UNITED KINGDOM
Re: K193431
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: December 9, 2019 Received: December 10, 2019
Dear Arun Mahendran:
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 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,
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) K193431
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
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Special 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.2 Tab 6 - 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: Arun Mahendran
Tel: +44 (0)77 3763 7807
Fax: +44 (0)208 436 4634
Date Summary was prepared: 09 December 2019 |
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
PREDICATE DEVICE INFORMATION:
| Name of the Device: | AlignRT Plus |
|---|---|
| Premarket Notification: | K181218 |
| 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: | Medical charged-particle radiation therapy system, IYE, (per 21 CFR |
| section 892.5050) | |
| Review Panel: | Radiology |
SUBJECT (MODIFIED) DEVICE:
| Name of the Device: | AlignRT Plus |
|---|---|
| Device Manufacturer: | Vision RT Limited |
| Common or Usual Name: | Surface Guided Radio Therapy System (Patient Positioning System accessory to a linear accelerator) |
4
Image /page/4/Picture/0 description: The image shows the word "visionrt" with a unique design. The letters "v," "i," "s," "i," "o," and "n" are in black, while the letters "r" and "t" are in blue. The "i" in "vision" is dotted with a small black circle, and the "o" in "vision" is replaced with a target symbol, adding a distinctive visual element to the logo.
Special 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.2
ll
Device Class:
Classification Name:
Medical charged-particle radiation therapy system, IYE, (per 21 CFR section 892.5050) Radiology
Review Panel:
Description of Device:
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 noninvasive, 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".
5
Special 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.2
The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.
This Special 510(k) is requested only for software modification for an existing 510(k) cleared product "AlignRT Plus" (K181218). No hardware or material changes have been made since its last 510(k) clearance. The two key changes made in the existing AlignRT v6.0 software which are the subject of this Special 510(k) are listed below;
-
- System Frame Rate improvement
-
- Addition of Video Postural Setup Alignment feature
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.
No changes are made to the intended use and indications for use.
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:
6
| PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |
|---|---|---|---|
| DEVICE NAME | AlignRT Plus (K181218) | ||
| Incorporating AlignRT, GateCT, GateRT | AlignRT Plus | ||
| Incorporating AlignRT, GateCT, GateRT | The device name is the same. | ||
| The AlignRT application has been | |||
| up-issued from V6.0 to V6.2. | |||
| MANUFACTURER | Vision RT Ltd | Vision RT Ltd | The manufacturer has not |
| changed. | |||
| Indications for | |||
| Use | The AlignRT Plus system is indicated for use | ||
| to position and monitor patients relative to | |||
| the prescribed treatment isocenter, 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 | |||
| isocenter and in turn assists in performing | |||
| quality assurance on MV, kV imagers, room | |||
| lasers and the treatment couch. AlignRT Plus | |||
| may be used during simulation, setup and | The AlignRT Plus system is indicated for use | ||
| to position and monitor patients relative to | |||
| the prescribed treatment isocenter, 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 | |||
| isocenter and in turn assists in performing | |||
| quality assurance on MV, kV imagers, room | |||
| lasers and the treatment couch. AlignRT Plus | |||
| may be used during simulation, setup and | The indications for use are | ||
| exactly the same and have not | |||
| changed since previous | |||
| clearances. | |||
| PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |
| stereotactic radiosurgery and precision | |||
| radiotherapy for lesions, tumors and | |||
| conditions anywhere in the body where | |||
| radiation is indicated. | stereotactic radiosurgery and precision | ||
| radiotherapy for lesions, tumors and | |||
| conditions anywhere in the body where | |||
| radiation is indicated. | |||
| Principles of | |||
| operation | Video based imaging of 3D skin surface data | ||
| using surface matching software. | Video based imaging of 3D skin surface data | ||
| using surface matching software. | The principles of operation are | ||
| exactly the same and have not | |||
| changed since previous | |||
| clearances. | |||
| Target | |||
| Population | Any individual (adult or child) undergoing | ||
| radiotherapy. | Any individual (adult or child) undergoing | ||
| radiotherapy. | The target population is exactly | ||
| the same and have not changed | |||
| since previous clearances. | |||
| Materials | PC workstation, cables, video cameras. Block | ||
| Polystyrene (calibration phantom), carbon | |||
| fibre laminate material (head adjuster). | PC workstation, cables, video cameras. Block | ||
| Polystyrene (calibration phantom), carbon | |||
| fibre laminate material (head adjuster). | The materials used to | ||
| manufacture the device are | |||
| exactly the same and have not | |||
| changed since previous | |||
| clearances. | |||
| System | |||
| Performance and | |||
| Accuracy | Positioning accuracy: Target registration | ||
| errors (as measured using calibration | |||
| phantom) |