(137 days)
No
The summary describes video-based 3D surface imaging and surface matching software for patient positioning and monitoring. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described appears to be based on traditional image processing and surface registration techniques.
No.
The device is used for patient positioning, monitoring, and beam gating during radiation therapy, and quality assurance of equipment. It does not directly treat or cure any medical condition.
No
The device is used for patient positioning, monitoring during radiation therapy, and quality assurance of equipment, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of "advanced software, 3D cameras (≤6 cameras) and calibration tools" and that this 510(k) notification includes the "Introduction of new hardware: DoseRT camera". This indicates the device is a combination of hardware and software, not software-only.
Based on the provided information, the AlignRT Plus system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- AlignRT Plus Function: The AlignRT Plus system is a surface imaging system used to monitor the patient's position during radiotherapy. It uses video-based 3D surface imaging to track the patient's external body surface.
- No Specimen Analysis: The system does not collect or analyze any specimens from the human body. Its function is entirely focused on external patient positioning and motion tracking.
- Intended Use: The intended uses listed are all related to patient positioning, motion tracking, beam gating, and quality assurance within the context of radiation therapy delivery. None of these involve the analysis of biological samples.
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:
- · Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep-Inspiration Breath Hold (DIBH).
- · Verification of patient identity for their radiation treatment session.
- · Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment isocenter.
- · Withholding the beam automatically during radiation delivery, as well as gating the patient's respiratory motion.
- · Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch.
- · Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient.
- · Passing and receiving information to/from other systems associated with the radiotherapy treatment.
Product codes
IYE
Device Description
The AlignRT Plus system (K212583) is a combination of the devices AlignRT InBore, AlignRT Offline, DoseRT, GateCT, GateRT and SimRT.
AlignRT Plus is a video-based three-dimensional (3D) surface imaging system used to monitor the patient's position in 3D before and during radiotherapy treatment. During each treatment session the patient's position is compared to the reference surface and offsets are displayed to the user. The system can be used to track pation during tumour localization in the CT scanner in order to facilitate subsequent 4D CT reconstruction. The system can be used to track the breath hold level consistency throughout the simulation process. The system can also be used to track patient motion during treatment delivery for radiation therapy procedures and hold the beam when the patient is not in position. Use of optional accessories allows the user to:
- monitor the patient's position inside bore-based linacs; and/or —
- to view the Cherenkov light emitted by the radiation beam as it enters and exits the patient's skin; and/or
- verify the patient's identity.
The system is non-invasive, does not require the use of body markers and produces no irradiation during the imaging process. The system mainly consists of advanced software. 3D cameras (≤6 cameras) and calibration tools. Each camera pod monitoring the pation will, however, project a pattern on the patient to acquire a 3D image of the patient.
This 510(k) notification is to obtain clearance for the following changes to the cleared device:
-
- Introduction of new software, version 7.3. This is an updated version of the existing cleared software, to support the:
- a. New Cherenkov imaging feature, called DoseRT.
- b. Updated respiratory gating feature, called Respiratory Module.
-
- Introduction of new hardware:
- a. DoseRT camera to enable Cherenkov imaging.
-
- Update to indications for use to include the new Cherenkov imaging feature and clarify existing indications.
Throughout this submission, the device will be referred to as AlignRT Plus as the family name for all configurations. No changes have been made to the currently cleared GateCT, GateRT and SimRT configurations.
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
Trained clinically qualified radiation oncology personnel. 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
Verification tests were performed to ensure that the module works as intended and pass/fail criteria were used to verify requirements. Validation testing was performed using summative evaluation techniques per IEC 62366-1:2015.
Summary of Performance Studies
Verification and validation testing passed in all test cases.
Key Metrics
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
March 29, 2024
Image /page/0/Picture/1 description: The image contains 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 consists of 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 % Chelsey Ludlow Regulatory Affairs Specialist Dove House. Arcadia Avenue London, N3 2JU UNITED KINGDOM
Re: K233622
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: November 10, 2023 Received: November 13, 2023
Dear Chelsey Ludlow:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
1
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233622
Device Name AlignRT Plus
Indications for Use (Describe)
The AlignRT Plus system is indicated for:
- · Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep-Inspiration Breath Hold (DIBH).
- · Verification of patient identity for their radiation treatment session.
- · Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment isocenter.
- · Withholding the beam automatically during radiation delivery, as well as gating the patient's respiratory motion.
- · Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch.
- · Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient.
- · Passing and receiving information to/from other systems associated with the radiotherapy treatment.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | . |
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 7.3
510(k) Summary
The information below is provided for modifications to AlignRT Plus following the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR 807.92.
Submitter's information
| Submitter's name: | Chelsey Ludlow |
|---|---|
| Company: | Vision RT Ltd. |
| Address: | Dove House |
| Arcadia Avenue | |
| London, N3 2JU | |
| United Kingdom | |
| Contact person: | Chelsey Ludlow |
| Regulatory Affairs Specialist | |
| Phone: | +44 (0)20 8346 4300 |
| Fax: | N/A |
| Email: | regulatory@visionrt.com |
| Date summary was prepared: | 10-Nov-2023 |
Primary Predicate device information
Device name:
Premarket notification: Manufacturer: Common name:
Classification: Classification name:
Regulation number:
Reference device information
- Device name: Premarket notification: Manufacturer: Common name: Classification:
AlignRT Plus (incorporating AlignRT, AlignRT InBore, AlignRT Offline, GateCT, SimRT, GateRT) K212583 Vision RT Limited Surface Guided Radio Therapy System (Patient Positioning System - accessory to a linear accelerator) Class II Accessory to Medical charged-particle radiation therapy system 892.5050
BeamSite K212606 DoseOptics LLC Radiotherapy visualization system Class II
4
visionrt
510(k) Premarket Notification - AlignRT Plus 7.3
Classification name:
Regulation number:
Medical charged-particle radiation therapy system 892.5050
Device information
| Trade name: | AlignRT Plus (incorporating AlignRT, AlignRT
InBore, DoseRT, GateCT, GateRT, SimRT) |
|-----------------------|------------------------------------------------------------------------------------------------------------|
| Common name: | Surface Guided Radio Therapy System (Patient
Positioning System - accessory to a linear
accelerator) |
| Classification: | Class II |
| Classification name: | Accessory to Medical charged-particle radiation
therapy system |
| Regulation number: | 892.5050 |
| Product code: | IYE |
| Classification panel: | Radiology |
Device description
The AlignRT Plus system (K212583) is a combination of the devices AlignRT InBore, AlignRT Offline, DoseRT, GateCT, GateRT and SimRT.
AlignRT Plus is a video-based three-dimensional (3D) surface imaging system used to monitor the patient's position in 3D before and during radiotherapy treatment. During each treatment session the patient's position is compared to the reference surface and offsets are displayed to the user. The system can be used to track pation during tumour localization in the CT scanner in order to facilitate subsequent 4D CT reconstruction. The system can be used to track the breath hold level consistency throughout the simulation process. The system can also be used to track patient motion during treatment delivery for radiation therapy procedures and hold the beam when the patient is not in position. Use of optional accessories allows the user to:
- monitor the patient's position inside bore-based linacs; and/or —
- to view the Cherenkov light emitted by the radiation beam as it enters and exits the patient's skin; and/or
- verify the patient's identity.
The system is non-invasive, does not require the use of body markers and produces no irradiation during the imaging process. The system mainly consists of advanced software. 3D cameras (≤6 cameras) and calibration tools. Each camera pod monitoring the pation will, however, project a pattern on the patient to acquire a 3D image of the patient.
This 510(k) notification is to obtain clearance for the following changes to the cleared device:
-
- Introduction of new software, version 7.3. This is an updated version of the existing cleared software, to support the:
- a. New Cherenkov imaging feature, called DoseRT.
- b. Updated respiratory gating feature, called Respiratory Module.
5
visionrt
510(k) Premarket Notification – AlignRT Plus 7.3
-
- Introduction of new hardware:
- a. DoseRT camera to enable Cherenkov imaging.
-
- Update to indications for use to include the new Cherenkov imaging feature and clarify existing indications.
Throughout this submission, the device will be referred to as AlignRT Plus as the family name for all configurations. No changes have been made to the currently cleared GateCT, GateRT and SimRT configurations.
Indications for use
The AlignRT Plus system is indicated for:
- . Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep-Inspiration Breath Hold (DIBH).
- Verification of patient identity for their radiation treatment session.
- Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter • and/or the prescribed treatment isocenter.
- . Withholding the beam automatically during radiation delivery, as well as gating the beam based on the patient's respiratory motion.
- . Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch.
- . Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient.
- . Passing and receiving information to/from other systems associated with the radiotherapy treatment.
6
Image /page/6/Picture/2 description: The image shows the word "visionrt" in a stylized font. The first part of the word, "vision", is in black, while the "rt" is in blue. The "o" in "vision" is replaced with a target symbol with a vertical line extending through it.
Primary Predicate and subject device technological characteristics
The features of AlignRT Plus 7.3 are substantially equivalent to the predicate device, AlignRT Plus (K212583), as discussed in the table below:
| Technological
characteristics | Primary Predicate device
(AlignRT Plus, K212583) | Subject device
(AlignRT Plus 7.3) | Comments |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Vision RT Ltd | Vision RT Ltd | The manufacturer remains the same as that
of the predicate device. |
| 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. | The AlignRT Plus system is indicated for:
Tracking respiratory motion
throughout the simulation process
to facilitate subsequent 4DCT
reconstruction and coaching the
patient in breathing techniques
required for Deep-Inspiration
Breath Hold (DIBH). Verification of patient identity for
their radiation treatment session. Positioning and monitoring of
patients during radiation delivery,
relative to the setup isocenter
and/or the prescribed treatment
isocenter. Withholding the beam
automatically during radiation
delivery, as well as gating the
beam based on the patient's
respiratory motion. Performing quality assurance on
MV, kV imagers, room lasers, and
the treatment couch. Visualizing the Cherenkov signal | The subject device indications for use have
been updated to include visualization of the
Cherenkov signal, verification of the
patient's identity prior to radiation treatment
and to clarify the existing indications.
The addition of Cherenkov imaging and
verification of the patient's identity and the
clarification of the cleared indications does
not affect the safety or effectiveness of the
device. AlignRT Plus works as intended.
Sufficient performance data has been
collated and shows the device functions
effectively to achieve its intended use. |
| Technological
characteristics | Primary Predicate device
(AlignRT Plus, K212583) | Subject device | Comments |
| | AlignRT Plus may be used during
simulation, setup and stereotactic
radiosurgery and precision radiotherapy
for lesions, tumors and conditions
anywhere in the body where radiation is
indicated. | (AlignRT Plus 7.3)
on entry and exit from the patient.
Passing and receiving information
to/from other systems associated
with the radiotherapy treatment. | |
| Product code | IYE | IYE | Equivalent to the predicate device. |
| Device
Classification | Class II | Class II | Equivalent to the predicate device. |
| Classification
Name | Accessory to Medical charged-particle
radiation therapy accessories | Accessory to Medical charged-particle
radiation therapy accessories | Equivalent to the predicate device. |
| Requlation
Number | 21 CFR 892.5050 | 21 CFR 892.5050 | Equivalent to the predicate device. |
| Contra-
indications | None known. | None known. | Equivalent to the predicate device. |
| Intended users | Trained clinically qualified radiation
oncology personnel. | Trained clinically qualified radiation
oncology personnel. | Equivalent to the predicate device. |
| OTC/Rx | Rx (Prescription) | Rx (Prescription) | Equivalent to the predicate device. |
| 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. | Equivalent to the predicate device. |
| Target
Population | Any individual (adult or child) undergoing
radiotherapy. | Any individual (adult or child undergoing
radiotherapy). | Equivalent to the predicate device. |
| Technological
characteristics | Primary Predicate device
(AlignRT Plus, K212583) | Subject device
(AlignRT Plus 7.3) | Comments |
| 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).
Anodised aluminium and polyester
powder coating (DoseRT camera casing).
ABS plastic (DoseRT reference board). | The component materials in the subject
device are identical to the primary
predicate.
The introduction of the new components
(DoseRT camera casing and DoseRT
reference board) and materials have not
been evaluated for biocompatibility as they
do not come in contact with the patient, nor
effect patient safety. |
| System
Performance
and Accuracy | Positioning accuracy: Target registration
errors (as measured using calibration
phantom)