Who is the manufacturer of AlignRT Plus?

Vision Rt, Ltd. filed the 510(k) submission for AlignRT Plus (K181218).

What is the FDA product code for AlignRT Plus?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for AlignRT Plus?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AlignRT Plus?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AlignRT Plus

Q: What are the predicate devices for AlignRT Plus?

Vision RT AlignRT Plus (K123371).

K181218 · Vision Rt, Ltd. · IYE · Aug 7, 2018 · Radiology

Device Facts

Record ID	K181218
Device Name	AlignRT Plus
Applicant	Vision Rt, Ltd.
Product Code	IYE · Radiology
Decision Date	Aug 7, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

AlignRT Plus is a video-based 3D surface imaging system for radiotherapy. It uses 1-3 ceiling-mounted camera units (each with a stereo pair of sensors) to project a near-infrared pattern onto the patient's skin. The system reconstructs a 3D surface model in real-time without ionizing radiation or body markers. Operated by radiotherapy professionals in a clinic, it tracks patient position and respiratory patterns relative to the treatment isocenter. The system provides visual feedback to clinicians and can automatically withhold the radiation beam if patient movement exceeds user-defined tolerances. It also supports cranial treatments via an optional manual head adjuster and assists in quality assurance for imaging devices and lasers. By ensuring precise patient positioning and motion management, the device aims to improve the accuracy of radiation delivery, potentially benefiting patients through more targeted treatment of lesions and tumors.

Clinical Evidence

Bench testing only. The submission includes verification data for the updated software (V6.0) and operating system. Performance metrics include target registration errors < 1mm (0.5mm) and respiratory tracking RMS errors < 0.5mm over 10 or more breathing cycles. No clinical data was required or provided.

Technological Characteristics

Video-based 3D surface imaging using near-infrared projection. Components: PC workstation, cables, video cameras, calibration phantom (polystyrene), head adjuster (carbon fiber laminate). Connectivity: 10BaseT network. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle).

Indications for Use

Indicated for any individual (adult or child) undergoing radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation is indicated. Used for patient positioning, monitoring, respiratory tracking, and beam gating during simulation, setup, stereotactic radiosurgery, and precision radiotherapy.

Regulatory Classification

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.

Predicate Devices

Vision RT AlignRT Plus (K123371)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. V1s10n KT Ltd % Mr. Chris Hannan VP Ouality and Regulatory Affairs Dove House. Arcadia Avenue London. GB N3 NJU UNITED KINGDOM August 7, 2018 Re: K181218 Trade/Device Name: AlignRT Plus Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 28, 2018 Received: July 2, 2018 Dear Mr. Hannan: 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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Michael D.'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K181218 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) | | |------------------------------------------------------------------------|---------------------------------------------------------------------| | <div>区 Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # visi�nrt ## 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.0 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: Chris Hannan | | | Tel: +44 (0)208 346 4300 | | | Fax: +44 (0)208 436 4634 | | | Date Summary was prepared: 30 April 2018 | | Name of the Device: | AlignRT Plus | | Trade/Proprietary Name: | AlignRT Plus (incorporating AlignRT, GateCT, GateRT), may be branded as OSMS (Optical Surface Monitoring System). | | 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) | Predicate Device to claim substantial equivalence Vision RT AlignRT Plus (K123371) {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "visionrt" in a stylized font. The first six letters, "vision", are in black, while the last two letters, "rt", are in blue. The "i" in "vision" has a dot above it, and the "o" is replaced with a target symbol. ## 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.0 ### Description of Device: The AlignRT Plus system (K123371) is a combination of the devices AlignRT, GateCT and GateRT. It 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". The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT. ### Indications for Use: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "visionrt" in a stylized font. The first part of the word, "vision", is in black, with the "o" replaced by a symbol resembling a target. The letters "rt" are in blue. The font is simple and modern. ## 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.0 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. ### 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 K123371 Incorporating AlignRT, GateCT, GateRT | AlignRT Plus Incorporating AlignRT, GateCT, GateRT | The device name is the same. The AlignRT application has been up-issued to V6.0. | | 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. | | | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | | System Performance and Accuracy | Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm for all couch angles. | Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles. | The modified device has the same performance or better than the predicate. | | | Respiratory tracking: Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating). | Respiratory tracking: Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating). | Additional bench testing using improved measurement technique has been performed to substantiate improved claims. These claims and verification | | | Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles. | Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles. | data are submitted within the 510k. | | Biocompatibility | The AlignRT Plus product requires no direct contact with the patient. | The AlignRT Plus product requires no direct contact with the patient. | | | | The only interactions between the user and the system are with: • the PC (in the control room) or | The only interactions between the user and the system are with: • the PC (in the control room) or | The materials used to manufacture the device are exactly the same and have not changed since the previous clearances. | | | remote workstation (in the vault), • the Remote Control (in the vault), • the Real Time Coach (RTC) (in the vault), or • the Head Adjuster (in the vault). • Calibration plate (in the vault) | remote workstation (in the vault), • the Remote Control (in the vault), • the Real Time Coach (RTC) (in the vault), or • the Head Adjuster (in the vault). • Calibration plate (in the vault) | | | | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | | | Calibration cube (in the vault) Calibration levelling plate (in the vault) | Calibration cube (in the vault) Calibration levelling plate (in the vault) | | | | The materials of the devices (which are commonly used in light-industrial, commercial and home use) and that the application only involves intermittent external contact with intact skin. | The materials of the devices (which are commonly used in light-industrial, commercial and home use) and that the application only involves intermittent external contact with intact skin. | | | Mechanical Safety | Cameras are ceiling mounted and do not contact patient or user. Head adjuster is clamped to the treatment couch through universal base plate. | Cameras are ceiling mounted and do not contact patient or user. Head adjuster is clamped to the treatment couch through universal base plate. | The mechanical safety of the device is exactly the same and has not changed since the previous clearances. | | Anatomical treatment sites | Entire body surface. | Entire body surface. | The anatomical treatment sites of the device are exactly the same and have not changed since the previous clearances. | | Human factors | Imaging process is fully automatic as is estimation of new couch position; 3D visual display provided to show any discrepancy in patient position. For respiratory tracking, user selects region of interest or tracking point(s) during first session. These are detected automatically during subsequent sessions | Imaging process is fully automatic as is estimation of new couch position; 3D visual display provided to show any discrepancy in patient position. For respiratory tracking, user selects region of interest or tracking point(s) during first session. These are detected automatically during subsequent sessions | The fundamental usage approach has not changed since the previous clearances, but the detail of the design implementation has changed. Consequently, IEC 62304 has been applied to ensure safety and effectiveness | | | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | | | For cranial treatments, a manual head adjuster may be used by turning designated dials to provide fine corrections for pitch, yaw and roll rotations in concert with real time visual feedback provided to the user by AlignRT Plus. | For cranial treatments, a manual head adjuster may be used by turning designated dials to provide fine corrections for pitch, yaw and roll rotations in concert with real time visual feedback provided to the user by AlignRT Plus. | | | | | Improvements have been made to the graphical user interface's layout and presentation. In addition, workflow has been simplified where possible in response to customer demand. | | | Optical pattern | Optical (near infra-red) pattern is projected to patient. | Optical (near infra-red) pattern is projected to patient. | The optical pattern of the device is exactly the same and has not changed since the previous clearances. | | Compatibility with the environment and other devices | Cleared for use in hospital environments. | For use in hospital and clinic environments. | The compatibility with the environment is exactly the same as those of the previous clearances. | | General Electrical safety standards | IEC60601-1 compliant. | IEC60601-1 compliant. | The applied safety standards are the same as those of the previous clearances. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ | | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | EMC standards | IEC60601-1-2 compliant. | IEC60601-1-2 compliant. | The applied EMC standards are the same as those of the previous clearances. | | Size | The camera (key part of the system) has the following dimensions: Cameras (each) – 470 x 220 x 70 – 4.5kg | The camera (key part of the system) has the following dimensions: Cameras (each) – 470 x 220 x 70 – 4.5kg | The size and weight of the device is the same as that of the previously cleared device. | | Packaging | The system is packaged in a variety of boxes and then packaged within palletised crate. | The system is packaged in a variety of boxes and then packaged within palletised crate. | The packaging of the device is the same as that of the previously cleared device. | | Environmental range | AlignRT Plus is intended for use at altitudes below 2000m (6,561ft). The operating temperature is +16°C to +30°C (60.8° to 86° Fahrenheit). The shipping and storage conditions are 20°C to +50°C (-4° to 122° Fahrenheit). | AlignRT Plus is intended for use at altitudes below 2000m (6,561ft). The operating temperature is +16°C to +30°C (60.8° to 86° Fahrenheit). The shipping and storage conditions are 20°C to +50°C (-4° to 122° Fahrenheit). | The environmental range of the device is the same as that of the previously cleared device. | | Workstation Operating System | Windows 7 | Windows 10 | The workstation operating system has been changed and so the software has been revalidated in line with IEC62304. | | Number of cameras | 1-3 | 1-3…

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