· 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.

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:

1. 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.
1. Introduction of new hardware:
- a. DoseRT camera to enable Cherenkov imaging.
1. Update to indications for use to include the new Cherenkov imaging feature and clarify existing indications.

AI/ML Overview

The provided document describes the AlignRT Plus 7.3 system, a surface-guided radiation therapy system. However, it does not contain detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (AlignRT Plus K212583) and a reference device (BeamSite K212606) for new features, primarily Cherenkov imaging and an updated respiratory module. It mentions "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. Verification and validation testing passed in all test cases." but does not provide details of these tests, specific acceptance criteria, or the results.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a summary of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria (from document)	Reported Device Performance (from document)
Positioning Accuracy	Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.	Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.
Respiratory Tracking Accuracy (relative respiratory position)	≤0.5mm with a confidence level of ≥95%.	Calculated to an accuracy of ≤0.5mm with a confidence level of ≥95%.
Cherenkov Signal Visualization	Visible for treatment beam energies of ≥6MV and ≤18MV and at treatment beam delivery rates between ≥100MU/Min and ≤2400MU/Min.	The location of the radiation dose on the patient surface during treatment can be visualized using the Cherenkov Effect for treatment at treatment beam energies of ≥6MV and ≤18MV and at treatment beam delivery rates of between ≥100MU/Min and ≤2400MU/Min.
Surface Displacement Tracking (RMS errors)	< 0.5mm over 10 or more breathing cycles.	< 0.5mm over 10 or more breathing cycles.
IEC 62366-1:2015 (Usability/Human Factors)	Device continues to meet FDA guidance on "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366-1: 2015.	Validation testing was performed using summative evaluation techniques per IEC 62366-1:2015. Verification and validation testing passed in all test cases.
General Electrical Safety Standards	IEC 60601-1 compliant.	IEC 60601-1 compliant.
EMC Standards	IEC 60601-1-2 compliant.	IEC 60601-1-2 compliant.
Verification and Validation Tests	All tests passed specified pass/fail criteria.	Verification and validation testing passed in all test cases.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the performance claims. The document states "no clinical investigations were performed."
Data Provenance: Not specified. It's likely internal testing data given the lack of clinical studies. Retrospective or prospective nature is not mentioned, nor is country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not describe the use of experts to establish ground truth for testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The device is a patient positioning and monitoring system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The document implies that the device's technical performance characteristics (e.g., positioning accuracy, respiratory tracking) were evaluated as a standalone system against predefined specifications, as it mentions "Verification tests were performed to ensure that the module works as intended and pass/fail criteria were used to verify requirements." However, no specific details like algorithms, metrics, or detailed results are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the positioning accuracy, the ground truth appears to be based on measurements using a "calibration phantom."
For respiratory tracking, the ground truth for "relative respiratory position" is implied to be a measured value for comparison.
For Cherenkov visualization, the ground truth is the actual presence and characteristics of the radiation beam.
No expert consensus, pathology, or outcomes data is explicitly mentioned as ground truth for these technical performance tests.

8. The sample size for the training set:

Not applicable/Not specified. The document describes a medical device system, not an AI model requiring a distinct training set in the typical sense of machine learning. The "advanced software" may incorporate algorithms, but details about training data, if any, are not present.

9. How the ground truth for the training set was established:

Not applicable/Not specified (refer to point 8).

Summary

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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

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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

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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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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 HouseArcadia AvenueLondon, N3 2JUUnited Kingdom
Contact person:	Chelsey LudlowRegulatory 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

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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, AlignRTInBore, DoseRT, GateCT, GateRT, SimRT)
Common name:	Surface Guided Radio Therapy System (PatientPositioning System - accessory to a linearaccelerator)
Classification:	Class II
Classification name:	Accessory to Medical charged-particle radiationtherapy 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.

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.

This 510(k) notification is to obtain clearance for the following changes to the cleared device:

1. 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.

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visionrt

510(k) Premarket Notification – AlignRT Plus 7.3

1. Introduction of new hardware:
- a. DoseRT camera to enable Cherenkov imaging.
1. 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.

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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:

Technologicalcharacteristics	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 thatof the predicate device.
Indications forUse	The AlignRT Plus system is indicated foruse to position and monitor patientsrelative to the prescribed treatmentisocenter, and to withhold the beamautomatically during radiation delivery.For cranial treatments, a manual headadjuster is included which can be used inconcert with AlignRT Plus to provide finecorrections for pitch, roll and yawrotations.AlignRT Plus is also used to track thepatient's respiratory pattern for respiratorysynchronized image acquisition, andradiation therapy treatment. Patientcontour data can be extracted andexported from the data acquired for thepurpose of treatment planning.AlignRT Plus can be calibrated directly tothe treatment beam isocenter and in turnassists in performing quality assurance onMV, kV imagers, room lasers and thetreatment couch.	The AlignRT Plus system is indicated for:Tracking respiratory motionthroughout the simulation processto facilitate subsequent 4DCTreconstruction and coaching thepatient in breathing techniquesrequired for Deep-InspirationBreath Hold (DIBH). Verification of patient identity fortheir radiation treatment session. Positioning and monitoring ofpatients during radiation delivery,relative to the setup isocenterand/or the prescribed treatmentisocenter. Withholding the beamautomatically during radiationdelivery, as well as gating thebeam based on the patient'srespiratory motion. Performing quality assurance onMV, kV imagers, room lasers, andthe treatment couch. Visualizing the Cherenkov signal	The subject device indications for use havebeen updated to include visualization of theCherenkov signal, verification of thepatient's identity prior to radiation treatmentand to clarify the existing indications.The addition of Cherenkov imaging andverification of the patient's identity and theclarification of the cleared indications doesnot affect the safety or effectiveness of thedevice. AlignRT Plus works as intended.Sufficient performance data has beencollated and shows the device functionseffectively to achieve its intended use.
Technologicalcharacteristics	Primary Predicate device(AlignRT Plus, K212583)	Subject device	Comments
	AlignRT Plus may be used duringsimulation, setup and stereotacticradiosurgery and precision radiotherapyfor lesions, tumors and conditionsanywhere in the body where radiation isindicated.	(AlignRT Plus 7.3)on entry and exit from the patient.Passing and receiving informationto/from other systems associatedwith the radiotherapy treatment.
Product code	IYE	IYE	Equivalent to the predicate device.
DeviceClassification	Class II	Class II	Equivalent to the predicate device.
ClassificationName	Accessory to Medical charged-particleradiation therapy accessories	Accessory to Medical charged-particleradiation therapy accessories	Equivalent to the predicate device.
RequlationNumber	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 radiationoncology personnel.	Trained clinically qualified radiationoncology personnel.	Equivalent to the predicate device.
OTC/Rx	Rx (Prescription)	Rx (Prescription)	Equivalent to the predicate device.
Principles ofoperation	Video based imaging of 3D skin surfacedata using surface matching software.	Video based imaging of 3D skin surfacedata using surface matching software.	Equivalent to the predicate device.
TargetPopulation	Any individual (adult or child) undergoingradiotherapy.	Any individual (adult or child undergoingradiotherapy).	Equivalent to the predicate device.
Technologicalcharacteristics	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 (headadjuster).	PC workstation, cables, video cameras.Block Polystyrene (calibration phantom),carbon fibre laminate material (headadjuster).Anodised aluminium and polyesterpowder coating (DoseRT camera casing).ABS plastic (DoseRT reference board).	The component materials in the subjectdevice are identical to the primarypredicate.The introduction of the new components(DoseRT camera casing and DoseRTreference board) and materials have notbeen evaluated for biocompatibility as theydo not come in contact with the patient, noreffect patient safety.
SystemPerformanceand Accuracy	Positioning accuracy: Target registrationerrors (as measured using calibrationphantom) < 1mm (0.5mm) for all couchangles.Respiratory tracking: Tracks respiratorysignal from imaged surface data andsends to CT (4D CT) or to Linac orimaging device (gating).Surface displacements can be trackedwith RMS errors < 0.5mm over 10 or morebreathing cycles.	Positioning accuracy: Target registrationerrors (as measured using calibrationphantom) < 1mm (0.5mm) for all couchangles.Respiratory tracking: Tracks respiratorysignal from imaged surface data andsends to CT (4D CT) or to Linac orimaging device (gating).The relative respiratory position withinrespiratory cycles is calculated to anaccuracy of ≤0.5mm with a confidencelevel of ≥95%.The location of the radiation dose on thepatient surface during treatment can bevisualized using the Cherenkov Effect fortreatment at treatment beam energies of≥6MV and ≤18MV and at treatment beamdelivery rates of between ≥100MU/Minand ≤2400MU/Min.	As a result of the updated features, such asthe visualization of the Cherenkov signaland respiratory tracking associated with theRespiratory Module software module, thesubject's performance, and accuracy differslightly from the predicate device.In support of the substantial equivalencedetermination, the validation met thepredetermined specifications andacceptance criteria.The performance data demonstrate that thedevice is as safe and effective as thepredicate devices
Technologicalcharacteristics	Primary Predicate device(AlignRT Plus, K212583)	Subject device(AlignRT Plus 7.3)	Comments
Biocompatibility	The AlignRT Plus product requires nodirect contact with the patient.The only interactions between the userand the system are with:• the PC (in the control room) or remoteworkstation (in the vault),• the Remote Control (in the vault),• the Real Time Coach (RTC) (in thevault), or• the Head Adjuster (in the vault).• Calibration plate (in the vault)• Calibration cube (in the vault)• Calibration levelling plate (in the vault)The materials of the devices (which arecommonly used in light-industrial,	The AlignRT Plus product requires nodirect contact with the patient.The only interactions between the userand the system are with:• the PC (in the control room) or remoteworkstation (in the vault),• the Remote Control (in the vault),• the Real Time Coach (RTC) (in thevault), or• the Head Adjuster (in the vault).• Calibration plate (in the vault)• Calibration cube (in the vault)• Calibration levelling plate (in the vault)• DoseRT reference board (in the vault)The materials of the devices (which are	Biocompatibility tests conducted on thepredicate device can be applied to AlignRTPlus 7.3 since the surface contactingcomponents and materials are the sameexcept for the reference board.No additional testing was required since thereference board does not contact patients.These differences do not raise new ordifferent concerns of safety andeffectiveness.
	commercial and home use) and that theapplication only involves intermittentexternal contact with intact skin.	commonly used in light-industrial,commercial, and home use) and that theapplication only involves intermittentexternal contact with intact skin.
MechanicalSafety	Cameras are ceiling mounted and do notcontact patient or user.The InBore camera solution is fixed to theinside of the bore-based linac.	Cameras are ceiling mounted and do notcontact patient or user.The InBore camera solution is fixed to theinside of the bore-based linac.	Equivalent to the predicate device.
	Head adjuster is clamped to the treatmentcouch through universal base plate.	Head adjuster is clamped to the treatmentcouch through universal base plate.
Anatomicaltreatment sites	Entire body surface.	Entire body surface.	Equivalent to the predicate device.
Human factors	Imaging process is fully automatic as isestimation of new couch position: 3D	Imaging process is fully automatic as isestimation of new couch position: 3D	The subject device continues to meet FDAguidance on "Applying Human Factors and
Technologicalcharacteristics	Primary Predicate device(AlignRT Plus, K212583)	Subject device(AlignRT Plus 7.3)	Comments
	visual display provided to show anydiscrepancy in patient position.	visual display provided to show anydiscrepancy in patient position.	Usability Engineering to Medical Devices"and IEC 62366-1: 2015 Medical Devices-Part 1: Application of Usability Engineeringto Medical Devices.
	For respiratory tracking, user selectsregion of interest or tracking point(s)during first session. These are detectedautomatically during subsequent sessions.	For respiratory tracking, user selectsregion of interest or tracking point(s)during first session. These are detectedautomatically during subsequent sessions.	This is equivalent to the predicate device.
	For cranial treatments, a manual headadjuster may be used by turningdesignated dials to provide finecorrections for pitch, yaw and roll rotationsin concert with real time visual feedbackprovided to the user by AlignRT Plus.	For cranial treatments, a manual headadjuster may be used by turningdesignated dials to provide finecorrections for pitch, yaw and roll rotationsin concert with real time visual feedbackprovided to the user by AlignRT Plus.
Optical pattern	Optical (near infra-red) pattern isprojected to patient.	Optical (near infra-red) pattern isprojected to patient.	Equivalent to the predicate device.
Compatibilitywith theenvironmentand otherdevices	For use in hospital and clinicenvironments.	For use in hospital and clinicenvironments.	Equivalent to the predicate device.
GeneralElectrical safetystandards	IEC 60601-1 compliant.	IEC 60601-1 compliant.	Equivalent to the predicate device.
EMC standards	IEC 60601-1-2 compliant.	IEC 60601-1-2 compliant.	Equivalent to the predicate device.
Size	The camera (key part of the system) hasthe following dimensions:HD Cameras (each) – 470 x 220 x 70 –4.5kgHorizon cameras (each) – 480 x 140 x127 – 2.75kg	The camera (key part of the system) hasthe following dimensions:HD Cameras (each) – 470 x 220 x 70 –4.5kg	DoseRT cameras are slightly different insize and lighter than the predicate devicecameras.The existing cleared cameras in the primarypredicate device have not changed in thissubmission
Technological	Primary Predicate device	Subject device	Comments
characteristics	(AlignRT Plus, K212583)	(AlignRT Plus 7.3)
	InBore optional camera accessory - Ring499mm diameter (plus 1mm protrusions) x177mm wide (max) – 3.2kg	Horizon cameras (each) – 480 x 140 x127 – 2.75kgInBore optional camera accessory - Ring499mm diameter (plus 1mm protrusions) x177mm wide (max) – 3.2kgDoseRT optional camera has the followingdimensions (including the front lens):Length: 230mm ± 10mm Width: 76 ±10mmHeight: 83mm ± 10mm Weight: 1500	The size of the primary predicate device issubstantially equivalent to that of thesubject device. The difference in size andweight does not affect the safety oreffectiveness of the device.
		grams ± 100 grams (including the frontlens)
WorkstationOperatingSystem	Windows 10	Windows 10	Equivalent to the predicate device.
Number ofcameras	1-3Optional InBore camera	1-3Optional InBore cameraUp to three optional DoseRT cameras.	Up to three DoseRT cameras can be useddepending on the configuration required bythe customer.The existing cleared number of cameras inthe primary predicate device have notchanged in this submission.The number of cameras used aresubstantially equivalent to the predicatedevice. The introduction of DoseRTcameras does not affect the safety oreffectiveness of the device. Sufficientperformance data has been collated and
Technologicalcharacteristics	Primary Predicate device(AlignRT Plus, K212583)	Subject device(AlignRT Plus 7.3)	Comments
			shows the device functions effectively toachieve its intended use.
Powerrequirements	110-230V 50/60Hz	110-230V 50/60Hz	Equivalent to the predicate device.
Networkrequirements	10BaseT internet connection behind alocal firewall.	10BaseT internet connection behind alocal firewall.	Equivalent to the predicate device.
Serviceprovision	All service to be performed by swap-outand return-to-base by Vision RTengineers. Remote support provided byVision RT engineers through secureremote internet software.	All service to be performed by swap-outand return-to-base by Vision RTengineers. Remote support provided byVision RT engineers through secureremote internet software.	Equivalent to the predicate device.

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Image /page/7/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 by a target symbol, with a circle and crosshairs.

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Image /page/8/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 by a target symbol, adding a unique visual element to the logo.

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Image /page/9/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 by a target symbol, adding a unique visual element to the logo.

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Image /page/10/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 by a target symbol, with a circle and crosshairs.

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Image /page/11/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, adding a unique visual element to the logo.

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Image /page/12/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, adding a unique visual element to the logo.

Table 1 – Primary Predicate and subject device comparison

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Image /page/13/Picture/2 description: The image shows the word "visionrt" in a stylized font. The first part of the word, "vision", is written in black, with the "o" replaced by a target symbol. The letters "rt" are in blue.

Reference and subject device technological characteristics

This table details the aspects of the Subject device which cannot be accounted for by the primary predicate device, AlignRT Plus (K212583). The subject device includes amended features such as Dose RT cameras and reference board, and introduction of Cherenkov image visualization. To account for the additional features, Beam Site (K212606) is chosen as the reference device. The table below demonstrates how the DoseRT camera and supporting hardware is exactly the same as the existing cleared reference device.

Technologicalcharacteristics	Reference device(BeamSite, K212606)	Subject device(AlignRT Plus 7.3)
Manufacturer	DoseOptics LLC	Vision RT Ltd
Product code	IYE	IYE
Device	Class II	Class II
ClassificationName	Medical Charged Particle RadiationTherapy System	Accessory to Medical charged-particle radiation therapyaccessories
RegulationNumber	892.5050	892.5050
Type of use	Prescription (Rx)	Rx
Indications forUse	The BeamSite System is intended to beused only with photon external beamradiotherapy during treatment to acquireand visualize the shape of the treatmentradiation beam relative to surfaceanatomical landmarks on the patient,anywhere in the body where radiationtreatment is indicated. BeamSite is usedby radiotherapy professionals inappropriate hospital and freestandingradiation therapy environments.	The AlignRT Plus system is indicated for:Tracking respiratory motion throughout the simulationprocess to facilitate subsequent 4DCT reconstructionand coaching the patient in breathing techniquesrequired for Deep-Inspiration Breath Hold (DIBH). Verification of patient identity for their radiationtreatment session. Positioning and monitoring of patients during radiationdelivery, relative to the setup isocenter and/or theprescribed treatment isocenter. Withholding the beam automatically during radiationdelivery, as well as gating the beam based on thepatient's respiratory motion. Performing quality assurance on MV, kV imagers, room

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Image /page/14/Picture/2 description: The image shows the logo for VisionRT. The logo is composed of the word "visionrt" in a sans-serif font. The letters "v", "i", "s", "i", "o", and "n" are black, while the letters "r" and "t" are blue. The "o" in "vision" is replaced with a target symbol.

Technologicalcharacteristics	Reference device(BeamSite, K212606)	Subject device(AlignRT Plus 7.3)
		lasers, and the treatment couch.• Visualizing the Cherenkov signal associated with theradiation beam on entry and exit from the patient.• Passing and receiving information to/from othersystems associated with the radiotherapy treatment.
Biocompatibility	No contact with patient or clinical staff inthe treatment room.	The AlignRT Plus product requires no direct contact with thepatient.The only interactions between the user and the system arewith:• DoseRT reference board (in the vault)The materials of the devices (which are commonly used inlight-industrial, commercial, and home use) and that theapplication only involves intermittent external contact withintact skin.
Imagingvisualisation	BeamSite captures imagesof Cherenkov light emitted from thepatient's skin during radiotherapyto provide an optical map of the treatmentbeam on the patient.	The AlignRT Plus system can be used to visualize theCherenkov signal associated with the radiation beam on entryand exit from the patient.

Table 2 – Reference and subject device technological characteristics

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visienrt

510(k) Premarket Notification - AlignRT Plus 7.3

Performance data

As with the predicate device, no clinical investigations were performed for AlignRT Plus 7.3. 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. Verification and validation testing passed in all test cases.

Conclusion

AlignRT Plus 7.3 is substantially equivalent to the predicate device. The technological differences between AlignRT Plus 7.3 and the predicate device does not raise any questions on the safety and effectiveness. Verification and validation testing demonstrate that AlignRT Plus 7.3 is as safe and effective and performs as well as or better than the predicate device.

Regulation Number and Section

§ 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.