AlignRT Plus

K203387 · Vision Rt, Ltd. · IYE · Mar 4, 2021 · Radiology

Device Facts

• Record ID: K203387
• Device Name: AlignRT Plus
• Applicant: Vision Rt, Ltd.
• Product Code: IYE · Radiology
• Decision Date: Mar 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 stereo camera pairs to capture patient skin surface data without ionizing radiation or markers. The system performs real-time surface matching to monitor patient position relative to the treatment isocenter. If movement exceeds user-defined tolerances, it automatically withholds the radiation beam. It also tracks respiratory patterns for gated imaging and treatment. The system includes an optional InBore camera for bore-based linear accelerators and a manual head adjuster for cranial SRS. Used in clinical settings by radiotherapy professionals, the system provides visual feedback for setup and monitors for intrafraction motion. It also supports quality assurance for MV/kV imagers, lasers, and treatment couches. Data can be exported for treatment planning. The system runs on a Windows 10 PC workstation.

Clinical Evidence

Bench testing only. Performance verified through target registration error (TRE) measurements < 1mm (0.5mm) for all couch angles and RMS errors < 0.5mm for respiratory tracking over 10+ breathing cycles. Mechanical safety verified per ISO 14971:2019. Electrical safety and EMC compliance verified per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Video-based 3D surface imaging; near-infrared pattern projection. Components: PC workstation, stereo camera units (ceiling or InBore mounted), calibration phantom (block polystyrene), head adjuster (carbon fiber laminate). Connectivity: 10BaseT network. Software: Windows 10, 64-bit architecture. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62366-1.

Indications for Use

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

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

• AlignRT Plus (K193431)

Submission Summary (Full Text)

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March 4, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Vision RT Ltd % Jade Dunphy Regulatory Affairs Manager Dove House, Arcadia Avenue London, N3 2JU UNITED KINGDOM

Re: K203387

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 28, 2020 Received: December 28, 2020

Dear Jade Dunphy:

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

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devices or postmarketing safety reporting (21 CFR 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 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

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) K203387

Device Name AlignRT Plus

Indications for Use (Describe)

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

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

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

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

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

AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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## visienrt

## 510(k) Premarket Notification – AlignRT v.6.4

### 510(k) Summary

K203387

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: Jade Dunphy Tel: [phone] Fax: [phone]

Date Summary was prepared: 17 December 2020

#### PREDICATE DEVICE INFORMATION:

| Name of the Device: | AlignRT Plus |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|
| Premarket Notification: | K193431 |
| Trade/Proprietary Name: | AlignRT Plus (incorporating AlignRT, GateCT, GateRT), may be<br>branded as OSMS (Optical Surface Monitoring System). |
| Manufacturer: | Vision RT Limited |
| Common or Usual Name: | Surface Guided Radio Therapy System (Patient Positioning System<br>- accessory to a linear accelerator) |
| Device Class: | II |
| Classification Name: | Accessory to Medical charged-particle radiation therapy accessories,<br>IYE, (per 21 CFR section 892.5050) |
| Review Panel: | Radiology |

### SUBJECT (MODIFIED) DEVICE:

| Name of the Device: | AlignRT Plus |
|-----------------------|------------------------------------------------------------------------------------------------------------|
| Device Manufacturer: | Vision RT Limited |
| Common or Usual Name: | Surface Guided Radio Therapy System (Patient Positioning System<br>accessory to a linear accelerator) |
| Device Class: | II |
| Classification Name: | Accessory to Medical charged-particle radiation therapy accessories,<br>IYE, (per 21 CFR section 892.5050) |
| Review Panel: | Radiology |

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## 510(k) Premarket Notification - AlignRT v.6.4

#### Description of Device:

The AlignRT Plus system (K193431) is a combination of the devices AlignRT, GateCT and GateRT. A special 510(K) K193431 was submitted by Vision RT Ltd. in December 2019 and this was cleared by FDA in January 2020 for the changes and improvements made in AlignRT.

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 non-invasive, 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 510(k) is requested for a new optional InBore camera and a change in memory size for an existing FDA 510(k) cleared product "AlignRT Plus" (K193431).

The InBore camera is optional hardware for use with bore-based linear accelerators.

The increase in memory size from 32 to 64bit increases the system's processing speed, enabling a frame rate improvement.

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## 510(k) Premarket Notification – AlignRT v.6.4

In line with the FDA's guidance on full disclosure, there are also minor software changes which we have evaluated as not meeting the threshold for clearance under the 510(k) programme, but which are nonetheless described in this application:

- Thermal check .
- ROI Metrics feature ●
- Hitachi, IBA and C-Series interfaces
- OPASCA lighting control system ●
- Protocol Navigator ●
- Treatment report improvement
- Surface Deformation
- QA Workflows ●

#### 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 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 (K193431)<br>Incorporating AlignRT, GateCT, GateRT | AlignRT Plus<br>Incorporating AlignRT, GateCT, GateRT | The device name is the same.<br>The AlignRT software application<br>has been up issued from v.6.2 to<br>v.6.4. |
| Manufacturer | Vision RT Ltd | Vision RT Ltd | The manufacturer has not<br>changed. |
| Indications for<br>Use | The AlignRT Plus system is indicated for use<br>to position and monitor patients relative to the<br>prescribed treatment isocenter, and to<br>withhold the beam automatically during<br>radiation delivery.<br><br>For cranial treatments, a manual head<br>adjuster is included which can be used in<br>concert with AlignRT Plus to provide fine<br>corrections for pitch, roll and yaw rotations.<br><br>AlignRT Plus is also used to track the<br>patient's respiratory pattern for respiratory<br>synchronized image acquisition, and<br>radiation therapy treatment. Patient contour<br>data can be extracted and exported from the<br>data acquired for the purpose of treatment<br>planning.<br><br>AlignRT Plus can be calibrated directly to the<br>treatment beam isocenter and in turn assists<br>in performing quality assurance on MV, kV<br>imagers, room lasers and the treatment<br>couch. | The AlignRT Plus system is indicated for use<br>to position and monitor patients relative to the<br>prescribed treatment isocenter, and to<br>withhold the beam automatically during<br>radiation delivery.<br><br>For cranial treatments, a manual head<br>adjuster is included which can be used in<br>concert with AlignRT Plus to provide fine<br>corrections for pitch, roll and yaw rotations.<br><br>AlignRT Plus is also used to track the<br>patient's respiratory pattern for respiratory<br>synchronized image acquisition, and<br>radiation therapy treatment. Patient contour<br>data can be extracted and exported from the<br>data acquired for the purpose of treatment<br>planning.<br><br>AlignRT Plus can be calibrated directly to the<br>treatment beam isocenter and in turn assists<br>in performing quality assurance on MV, kV<br>imagers, room lasers and the treatment<br>couch. | The indications for use are the<br>same as those of the previously<br>cleared device. |
| | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS |
| | AlignRT Plus may be used during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. | AlignRT Plus may be used during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. | |
| 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 the same as those of the previously cleared device. |
| Target Population | Any individual (adult or child) undergoing radiotherapy. | Any individual (adult or child) undergoing radiotherapy. | The target population is the same as that of the previously cleared device. |
| Materials | PC workstation, cables, video cameras.<br>Block Polystyrene (calibration phantom), carbon fibre laminate material (head adjuster). | PC workstation, cables, video cameras.<br>Block Polystyrene (calibration phantom), carbon fibre laminate material (head adjuster). | The materials used are the same as those of the previously cleared device. |
| System Performance and Accuracy | Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.<br>Respiratory tracking: Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating).<br>Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles. | Positioning accuracy: Target registration errors (as measured using calibration phantom) < 1mm (0.5mm) for all couch angles.<br>Respiratory tracking: Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating).<br>Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles. | The system performance and accuracy have not changed since previous clearances, including with the additional optional hardware (InBore camera). |
| | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS |
| Biocompatibility | The AlignRT Plus product requires no direct<br>contact with the patient.<br><br>The only interactions between the user and<br>the system are with:<br>the PC (in the control room) or 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) Calibration cube (in the vault) Calibration levelling plate (in the vault) | The AlignRT Plus product requires no direct<br>contact with the patient.<br><br>The only interactions between the user and<br>the system are with:<br>the PC (in the control room) or 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) Calibration cube (in the vault) Calibration levelling plate (in the vault) | The materials used to<br>manufacture the device are the<br>same as those of the previously<br>cleared device. |
| | The materials of the devices (which are<br>commonly used in light-industrial, commercial<br>and home use) and that the application only<br>involves intermittent external contact with<br>intact skin. | The materials of the devices (which are<br>commonly used in light-industrial, commercial<br>and home use) and that the application only<br>involves intermittent external contact with<br>intact skin. | |
| Mechanical<br>Safety | Cameras are ceiling mounted and do not<br>contact patient or user.<br><br>Head adjuster is clamped to the treatment<br>couch through universal base plate. | Cameras are ceiling mounted and do not<br>contact patient or user.<br><br>The InBore camera solution is fixed to the<br>inside of the bore-based linac.<br>Head adjuster is clamped to the treatment<br>couch through universal base plate. | The location of the InBore camera<br>is inside of the bore-based linac;<br>as with the ceiling-mounted<br>cameras the mechanical safety<br>has been verified through risk<br>management processes to ISO<br>14971:2019. |
| | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS |
| Anatomical<br>treatment sites | Entire body surface. | Entire body surface. | The anatomical treatment sites of<br>the device are the same as those<br>of the previously cleared device. |
| Human factors | lmaging process is fully automatic as is<br>estimation of new couch position; 3D visual<br>display provided to show any discrepancy in<br>patient position.<br>For respiratory tracking, user selects region<br>of interest or tracking point(s) during first<br>session. These are detected automatically<br>during subsequent sessions.<br>For cranial treatments, a manual head<br>adjuster may be used by turning designated<br>dials to provide fine corrections for pitch, yaw<br>and roll rotations in concert with real time<br>visual feedback provided to the user by<br>AlignRT Plus. | There is an extra non-clinical workflow for the<br>InBore camera. A customer must remove the<br>camera in order to service the bore-based<br>linear accelerator.<br>Imaging process is fully automatic as is<br>estimation of new couch position: 3D visual<br>display provided to show any discrepancy in<br>patient position.<br>For respiratory tracking, user selects region<br>of interest or tracking point(s) during first<br>session. These are detected automatically<br>during subsequent sessions.<br>For cranial treatments, a manual head<br>adjuster may be used by turning designated<br>dials to provide fine corrections for pitch, yaw<br>and roll rotations in concert with real time<br>visual feedback provided to the user by<br>AlignRT Plus. | The modified device continues to<br>meet FDA guidance on "Applying<br>Human Factors and Usability<br>Engineering to Medical Devices"<br>and IEC 62366-1: 2015 Medical<br>Devices-Part 1: Application of<br>Usability Engineering to Medical<br>Devices. |
| Optical pattern | Optical (near infra-red) pattern is projected to<br>patient. | Optical (near infra-red) pattern is projected to<br>patient. | The optical pattern of the device<br>is the same as that of the<br>previously cleared device. |
| Compatibility<br>with the<br>environment and<br>other devices | For use in hospital and clinic environments. | For use in hospital and clinic environments. | The compatibility with the<br>environment is the same as that<br>of the previously cleared device. |
| | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS |
| General<br>Electrical safety<br>standards | IEC 60601-1 compliant. | IEC 60601-1 compliant. | The modified device has been<br>tested and continues to comply to<br>IEC 60601-1. |
| EMC standards | IEC 60601-1-2 compliant. | IEC 60601-1-2 compliant. | The modified device has been<br>tested and continues to comply to<br>IEC 60601-1-2: 2014 (4th Ed.). |
| Size | The camera (key part of the system) has the<br>following dimensions:<br>Cameras (each) – 470 x 220 x 70 – 4.5kg | The camera (key part of the system) has the<br>following dimensions:<br>Cameras (each) – 470 x 220 x 70 – 4.5kg<br>InBore optional camera accessory - Ring<br>499mm diameter (plus 1mm protrusions) x<br>177mm wide (max) - 3.2kg | The camera (key part of the<br>system) has not changed in size.<br>The InBore camera is new to this<br>application. |
| Packaging | The system is packaged in a variety of boxes<br>and then packaged within palletised crate. | The system is packaged in a variety of boxes<br>and then packaged within palletised crate. | The packaging of the device is<br>the same as that of the previously<br>cleared device. |
| Environmental<br>range | AlignRT Plus is intended for use at altitudes<br>below 2000m (6,561ft).<br>The operating temperature is +16°C to +30°C<br>(60.8° to 86° Fahrenheit).<br>The shipping and storage conditions are -<br>20°C to +50°C (-4° to 122° Fahrenheit). | AlignRT Plus is intended for use at altitudes<br>below 3000m (9,842ft).<br>The operating temperature is +16°C to +30°C<br>(60.8° to 86° Fahrenheit).<br>The shipping and storage conditions are -<br>20°C to +50°C (-4° to 122° Fahrenheit). | The device is a solid-state<br>product and is not affected by<br>altitude.<br>The modified device is<br>substantially equivalent to its<br>predicate device. |
| Workstation<br>Operating<br>System | Windows 10 | Windows 10 | No change to operating system. |

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## visionrt

### 510(k) Premarket Notification - AlignRT v.6.4

| | PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of<br>cameras | 1-3 | 1-3<br>Optional InBore camera | An additional camera has been<br>included in this submission, which<br>is exclusively for bore-based linac<br>accelerators, which uses the<br>same technology as the other 1-3<br>cameras. |
| Power<br>requirements | 110-230V 50/60Hz | 110-230V 50/60Hz | The power requirements of the<br>device are the same as those of<br>the previously cleared device. |
| Network<br>requirements | 10BaseT internet connection behind a local<br>firewall. | 10BaseT internet connection behind a local<br>firewall. | The network requirements of the<br>device are the same as those of<br>the previously cleared device. |
| Service<br>provision | All service to be performed by swap-out and<br>return-to-base by Vision RT engineers.<br>Remote support provided by Vision RT<br>engineers through secure remote internet<br>software. | All service to be performed by swap-out and<br>return-to-base by Vision RT engineers.<br>Remote support provided by Vision RT<br>engineers through secure remote internet<br>software. | The service approach of the<br>device is the same as that of the<br>previously cleared device. |

#### Conclusion

The proposed changes are made by the legal manufacturer and submitted to market the existing device (AlignRT Plus). The changes made in subject device were test method and acceptance criteria as the predicate device and the subject device is substantially equivalent to the predication and/or validation demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device. The condusion is devices intended use, indications for use, fundamental technological characteristiss, principle of operation and performance specifications.