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 Description

AlignRT Plus is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is noninvasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.

AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals.

Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances.

Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.

AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position.

Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module".

The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

This Special 510(k) is requested only for software modification for an existing 510(k) cleared product "AlignRT Plus" (K181218). No hardware or material changes have been made since its last 510(k) clearance. The two key changes made in the existing AlignRT v6.0 software which are the subject of this Special 510(k) are listed below;

System Frame Rate improvement
Addition of Video Postural Setup Alignment feature

AI/ML Overview

I am sorry, but I lack the ability to provide a response without the full context of the document. The request references information within the document that is not provided in a conversational format. If you can provide the specific details about the acceptance criteria and study, I would be happy to help describe them.

Summary

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January 3, 2020

Vision RT Ltd. % Arun Mahendran Regulatory Affairs Manager Dove House. Arcadia Avenue London, N3 2JU UNITED KINGDOM

Re: K193431

Trade/Device Name: AlignRT Plus Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: December 9, 2019 Received: December 10, 2019

Dear Arun Mahendran:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193431

Device Name AlignRT Plus

Indications for Use (Describe)

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.

AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.

Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.

AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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visi�nrt

Special 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.2 Tab 6 - 510(k) Summary

The information below is provided for the modifications to AlignRT following the format of 21 CFR 807.92.

Submitter:	Vision RT Ltd.Dove HouseArcadia AvenueLondon, N3 2JUUnited KingdomContact Name: Arun MahendranTel: +44 (0)77 3763 7807Fax: +44 (0)208 436 4634Date Summary was prepared: 09 December 2019
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PREDICATE DEVICE INFORMATION:

Name of the Device:	AlignRT Plus
Premarket Notification:	K181218
Trade/Proprietary Name:	AlignRT Plus (incorporating AlignRT, GateCT, GateRT), may bebranded as OSMS (Optical Surface Monitoring System).
Manufacturer:	Vision RT Limited
Common or Usual Name:	Surface Guided Radio Therapy System (Patient Positioning System -accessory to a linear accelerator)
Device Class:	II
Classification Name:	Medical charged-particle radiation therapy system, IYE, (per 21 CFRsection 892.5050)
Review Panel:	Radiology

SUBJECT (MODIFIED) DEVICE:

Name of the Device:	AlignRT Plus
Device Manufacturer:	Vision RT Limited
Common or Usual Name:	Surface Guided Radio Therapy System (Patient Positioning System accessory to a linear accelerator)

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Image /page/4/Picture/0 description: The image shows the word "visionrt" with a unique design. The letters "v," "i," "s," "i," "o," and "n" are in black, while the letters "r" and "t" are in blue. The "i" in "vision" is dotted with a small black circle, and the "o" in "vision" is replaced with a target symbol, adding a distinctive visual element to the logo.

Special 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.2

Device Class:

Classification Name:

Medical charged-particle radiation therapy system, IYE, (per 21 CFR section 892.5050) Radiology

Review Panel:

Description of Device:

Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.

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".

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Special 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.2

The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

1. System Frame Rate improvement
1. Addition of Video Postural Setup Alignment feature

Indications for Use:

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

No changes are made to the intended use and indications for use.

Summary of the Technological Characteristics:

The Substantial Equivalence Comparison Table shown below provides a comparison of the technological characteristics of AlignRT Plus to those of the predicate device:

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	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
DEVICE NAME	AlignRT Plus (K181218)Incorporating AlignRT, GateCT, GateRT	AlignRT PlusIncorporating AlignRT, GateCT, GateRT	The device name is the same.The AlignRT application has beenup-issued from V6.0 to V6.2.
MANUFACTURER	Vision RT Ltd	Vision RT Ltd	The manufacturer has notchanged.
Indications forUse	The AlignRT Plus system is indicated for useto position and monitor patients relative tothe prescribed treatment isocenter, and towithhold the beam automatically duringradiation delivery. For cranial treatments, amanual head adjuster is included which canbe used in concert with AlignRT Plus toprovide fine corrections for pitch, roll andyaw rotations. AlignRT Plus is also used totrack the patient's respiratory pattern forrespiratory synchronized image acquisition,and radiation therapy treatment. Patientcontour data can be extracted and exportedfrom the data acquired for the purpose oftreatment planning. AlignRT Plus can becalibrated directly to the treatment beamisocenter and in turn assists in performingquality assurance on MV, kV imagers, roomlasers and the treatment couch. AlignRT Plusmay be used during simulation, setup and	The AlignRT Plus system is indicated for useto position and monitor patients relative tothe prescribed treatment isocenter, and towithhold the beam automatically duringradiation delivery. For cranial treatments, amanual head adjuster is included which canbe used in concert with AlignRT Plus toprovide fine corrections for pitch, roll andyaw rotations. AlignRT Plus is also used totrack the patient's respiratory pattern forrespiratory synchronized image acquisition,and radiation therapy treatment. Patientcontour data can be extracted and exportedfrom the data acquired for the purpose oftreatment planning. AlignRT Plus can becalibrated directly to the treatment beamisocenter and in turn assists in performingquality assurance on MV, kV imagers, roomlasers and the treatment couch. AlignRT Plusmay be used during simulation, setup and	The indications for use areexactly the same and have notchanged since previousclearances.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
	stereotactic radiosurgery and precisionradiotherapy for lesions, tumors andconditions anywhere in the body whereradiation is indicated.	stereotactic radiosurgery and precisionradiotherapy for lesions, tumors andconditions anywhere in the body whereradiation is indicated.
Principles ofoperation	Video based imaging of 3D skin surface datausing surface matching software.	Video based imaging of 3D skin surface datausing surface matching software.	The principles of operation areexactly the same and have notchanged since previousclearances.
TargetPopulation	Any individual (adult or child) undergoingradiotherapy.	Any individual (adult or child) undergoingradiotherapy.	The target population is exactlythe same and have not changedsince previous clearances.
Materials	PC workstation, cables, video cameras. BlockPolystyrene (calibration phantom), carbonfibre laminate material (head adjuster).	PC workstation, cables, video cameras. BlockPolystyrene (calibration phantom), carbonfibre laminate material (head adjuster).	The materials used tomanufacture the device areexactly the same and have notchanged since previousclearances.
SystemPerformance andAccuracy	Positioning accuracy: Target registrationerrors (as measured using calibrationphantom) < 1mm (0.5mm) for all couchangles.Respiratory tracking: Tracks respiratorysignal from imaged surface data and sendsto CT (4D CT) or to Linac or imaging device(gating).	Positioning accuracy: Target registrationerrors (as measured using calibrationphantom) < 1mm (0.5mm) for all couchangles.Respiratory tracking: Tracks respiratorysignal from imaged surface data and sendsto CT (4D CT) or to Linac or imaging device(gating).	These system performances havenot changed since previousclearances.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
	Surface displacements can be tracked withRMS errors $ < 0.5mm $ over 10 or morebreathing cycles.	Surface displacements can be tracked withRMS errors $ < 0.5mm $ over 10 or morebreathing cycles.
Biocompatibility	The AlignRT Plus product requires no directcontact with the patient.The only interactions between the user andthe system are with:the PC (in the control room) orremote workstation (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 thevault)	The AlignRT Plus product requires no directcontact with the patient.The only interactions between the user andthe system are with:the PC (in the control room) orremote workstation (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 thevault)	The materials used tomanufacture the device areexactly the same and have notchanged since the previousclearances.
PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
The materials of the devices (which arecommonly used in light-industrial,commercial and home use) and that theapplication only involves intermittentexternal contact with intact skin.	The materials of the devices (which arecommonly 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.Head adjuster is clamped to the treatmentcouch through universal base plate.	Cameras are ceiling mounted and do notcontact patient or user.Head adjuster is clamped to the treatmentcouch through universal base plate.	The mechanical safety of thedevice is exactly the same andhas not changed since theprevious clearances.
Anatomicaltreatment sites	Entire body surface.	Entire body surface.	The anatomical treatment sitesof the device are exactly thesame and have not changed sincethe previous clearances.
Human factors	Imaging process is fully automatic as isestimation of new couch position; 3D visualdisplay provided to show any discrepancy inpatient position.For respiratory tracking, user selects regionof interest or tracking point(s) during firstsession. These are detected automaticallyduring subsequent sessions.For cranial treatments, a manual headadjuster may be used by turning designateddials to provide fine corrections for pitch,yaw and roll rotations in concert with real	Imaging process is fully automatic as isestimation of new couch position; 3D visualdisplay provided to show any discrepancy inpatient position.For respiratory tracking, user selects regionof interest or tracking point(s) during firstsession. These are detected automaticallyduring subsequent sessions.For cranial treatments, a manual headadjuster may be used by turning designateddials to provide fine corrections for pitch,yaw and roll rotations in concert with real	Minor changes made to the UIwithout functional change. Thesechanges do not raise differentquestions of safety andeffectiveness because the resultsof usability study are same as theprevious study cleared underK181218. The modified device issubstantially equivalent to itspredicate device.The modified device continues tomeet FDA guidance on "Applying
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
	time visual feedback provided to the user byAlignRT Plus.	time visual feedback provided to the user byAlignRT Plus.	Human Factors and UsabilityEngineering to Medical Devices"and IEC 62366-1: 2015 MedicalDevices-Part 1: Application ofUsability Engineering to MedicalDevices.
Optical pattern	Optical (near infra-red) pattern is projectedto patient.	Optical (near infra-red) pattern is projectedto patient.	The optical pattern of the deviceis exactly the same and has notchanged since the previousclearances.
Compatibilitywith theenvironment andother devices	For use in hospital and clinic environments.	For use in hospital and clinic environments.	The compatibility with theenvironment is exactly the sameas those of the previousclearances.
General Electricalsafety standards	IEC60601-1 compliant.	IEC60601-1 compliant.	The hardware remains same.No changes were made to thehardware in AlignRT v6.2
EMC standards	IEC60601-1-2 compliant.	IEC60601-1-2 compliant.	The hardware remains same.No changes were made to thehardware in AlignRT v6.2Device complies with the currentFDA recognised standard IEC60601-1-2: 2014 (4th Ed.).Supporting information wasprovided during the last 510(k)
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
Size	The camera (key part of the system) has thefollowing dimensions:Cameras (each) – 470 x 220 x 70 – 4.5kg	The camera (key part of the system) has thefollowing dimensions:Cameras (each) – 470 x 220 x 70 – 4.5kg	The size and weight of the deviceis the same as that of thepreviously cleared device.
Packaging	The system is packaged in a variety of boxesand then packaged within palletised crate.	The system is packaged in a variety of boxesand then packaged within palletised crate.	The packaging of the device is thesame as that of the previouslycleared device.
Environmentalrange	AlignRT Plus is intended for use at altitudesbelow 2000m (6,561ft).The operating temperature is +16°C to +30°C(60.8° to 86° Fahrenheit).	AlignRT Plus is intended for use at altitudesbelow 3000m (9,842ft).The operating temperature is +16°C to +30°C(60.8° to 86° Fahrenheit).	The device is a solid-stateproduct and is not affected bythe altitudes.The modified device issubstantially equivalent to itspredicate device.
	The shipping and storage conditions are -20°C to +50°C (-4° to 122° Fahrenheit).	The shipping and storage conditions are -20°C to +50°C (-4° to 122° Fahrenheit).
WorkstationOperatingSystem	Windows 10	Windows 10	No change to operating system.
Number ofcameras	1-3	1-3	The number of cameras of thedevice is the same as that of thepreviously cleared device.
Powerrequirements	110/230V 50-60Hz	110/230V 50-60Hz	The power requirements of thedevice are the same as that ofthe previously cleared device.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
Network requirements	10BaseT internet connection behind a local firewall.	10BaseT internet connection behind a local firewall.	The network requirements of the device are the same as that of the previously cleared device.
Service provision	All service to be performed by swap-out and return-to-base by Vision RT engineers. Remote support provided by Vision RT engineers through secure remote internet software Axeda (screen-sharing).	All service to be performed by swap-out and return-to-base by Vision RT engineers. Remote support provided by Vision RT engineers through secure remote internet software Axeda (screen-sharing).	The service approach of the device is the same as that of the previously cleared device.

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Special 510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.2

Table 1

Conclusion:

The proposed changes are made and submitted by the legal manufacturer authorized to market the existing device (AlignRT Plus). The changes made in subject device were tested using the same test method and acceptance criteria as the subject device is substantially equivalent to the predicate device. The verification demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device. The conclusion is based upon the devices indications for use, fundamental technological characteristics, principle of operation and performance specifications.

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.