ALIGNRT PLUS

K123371 · Vision RT Limited · IYE · Jan 8, 2013 · Radiology

Device Facts

• Record ID: K123371
• Device Name: ALIGNRT PLUS
• Applicant: Vision RT Limited
• Product Code: IYE · Radiology
• Decision Date: Jan 8, 2013
• 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 3D surface imaging system for radiotherapy. Inputs: near-infrared optical patterns projected onto patient skin; stereo camera pairs capture 3D surface data. Operation: software performs real-time surface matching to track patient position and respiratory patterns. Outputs: 3D surface models, patient position coordinates, respiratory signals for gating, and patient contour data. Used in clinics by radiotherapy professionals. System monitors patient movement; automatically withholds radiation beam if movement exceeds user-defined tolerances. Includes optional manual head adjuster for cranial SRS to correct pitch, roll, and yaw. Also performs QA for MV/kV imagers, room lasers, and treatment couches. Benefits: enables precise patient positioning, respiratory-synchronized treatment, and automated motion management to improve radiotherapy accuracy.

Clinical Evidence

Bench testing only. Performance metrics: target registration errors < 1mm for all couch angles; surface displacement tracking with RMS errors < 0.5mm over 10+ breathing cycles. No clinical data presented.

Technological Characteristics

System components: PC workstation, cables, 3D camera units (stereo sensors). Materials: carbon fibre laminate (head adjuster), polystyrene (calibration phantom). Sensing: near-infrared optical pattern projection. Connectivity: standalone/networked for data export. Software: surface matching and image processing. Sterilization: N/A (non-contact).

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 synchronization, and beam gating.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Vision RT AlignRT (K052682)
• Vision RT GateCT-RT (K072171)

Reference Devices

• Bionix (K100691)

Submission Summary (Full Text)

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K12337

### AlignRT Premarket Notification -

JAN 06 2013

The information below is provided for the modifications to AlignRT following the format of 21 CFR 907.92.

Vision RT Ltd.: Submitter: Dove House Arcadia Avenue London, N3 2JU United Kingdom Contact Name: Dr. Norman Smith [phone] Phone: [phone] Fax: [e-mail] . . . . . . Email:

Date Summary was prepared 25th October 2012

| Name of the Device: | AlignRT Plus |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Trade/Proprietary Name: | AlignRT Plus |
| Common or Usual Name: | Patient Positioning System |
| Classification Name: | Accessory to Medical charged-particle radiation therapy<br>accessories, 90IYE, (per 21 CFR section 892.5050) |

Predicate Device to claim substantial equivalence

Vision RT AlignRT (K052682)

Vision RT GateCT-RT (K072171)

## Description of Device:

AlignRT Plus system is a combination of the predicate devices AlignRT (K052682) and GateCT-RT (K072171). It is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.

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# 510(k) Premarket Notification

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).

### Intended Use Statement:

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

## Summary of the Technological Characteristics:

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

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| | | NEW DEVIC | AlignRT. Plus | Vision RT Ltd | The AlignRT Plus system is indicated for use to<br>position and monitor patients relative to the<br>orescribed treatment isocenter, and | radiation delivery. For cranial treatments, a manual head adjuster is included which ca<br>withhold the beam automatically durin | | | be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus also also rolled to the patient for<br>respiratory synchronized image acquisition | ontour data can be extracted and exporte<br>and radiation therapy treatment. Patient | from the data acquired for the purpose treatment planning. AlignRT Plus can be | calibrated directly to the treatment beam | uality assurance on MV, kV imagers, room<br>socenter and in turn assists in performing | lasers and the treatment couch. AlignRT Plu<br>may be used during simulation, setup and | stereotactic radiosurgery and precisi<br>radiotherapy for lesions, tumors ar | conditions anywhere in the body when<br>radiation is indicated. | | |
| isi�nrt | 510(k) Premarket Notification – AlignRT Plus | PREDICATE DEVICE 2 | .<br>Vision RT's GateCT-RT (K072171 | Vision RT Ltd | :: | . :: | The GateCT-RT system is used to<br>1999 1991 | : | obtain the block of the subscriptions. Statures internet in assemblement of the comment and the comment of the manufacturer in the management of the comments of the comments | | | | automatically. | | · | | | October 201 |
| | | PREDICATE DEVICE | Vision RT's AlignRT (K052682 | /ision RT Ltd | | | | | The AlignRT system is used to positio<br>patients at the isocentre of the linear | accelerator for radiation therapy procedures. Patient contour data car | be extracted and exported from the<br>quired data for the purpose of | treatment planning. | | | | | | |
| | | | DEVICE NAMI | 1ANUFACTURER | | | | | . . | ndications for Use | | | | | | | | 06 Issue 3.0 |
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| | | | | | | | | | | Page 4 of 6 |
|--|----------------------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------|
| | | NEW DEVICE | Video based imaging of 3D skin surface data<br>using surface matching software. Image<br>processing of radiographic image data. | Any individual (adult or child) undergoing<br>radiotherapy | PC workstation, cables, video cameras. Block<br>Polystyrene (calibration phantom), carbon<br>fibre laminate material (head adjuster) which<br>is substantially equivalent to the cleared<br>Bionix (K100691) device. | Positioning accuracy: Target registration<br>errors (as measured using calibration<br>phantom) < 1mm for all couch angles.<br>Respiratory tracking: Tracks respiratory signal<br>from imaged surface data and sends to CT (4D<br>CT) or to Linac or imaging device (gating). | Surface displacements can be tracked with<br>RMS errors < 0.5mm over 10 or more<br>breathing cycles. | No direct contact with patient:<br>Indirect contact with Head adjuster. This is<br>made out of carbon fibre laminate material<br>which is substantially equivalent to the<br>cleared Bionix (K100691) device. | | |
| | visionrt<br>510(k) Premarket Notification – AlignRT Plus | PREDICATE DEVICE 2 | Video based imaging of 3D skin surface<br>data using surface matching software. | Any individual (adult or child)<br>undergoing radiotherapy. | PC workstation, cables, video cameras. | Tracks respiratory signal from imaged<br>surface data and sends to CT (4D CT)<br>or to Linac or imaging device (gating).<br>Surface displacements can be tracked<br>with RMS errors < 0.5mm over 10 or<br>more breathing cycles. | No contact with patient | | 25 October 2012 | |
| | | PREDICATE DEVICE 1 | Video based imaging of 3D skin<br>surface data using surface matching<br>software. | Any individual (adult or child)<br>undergoing radiotherapy. | PC workstation, cables, video<br>cameras. | Sends computed coordinates to<br>treatment couch. | System accuracy: Errors along each of<br>3 axes of treatment: max mean:<br>0.27mm; max std dev: 0.65mm. | No contact with patient | | |
| | | | Principles of operation | Target Population | Materials | System Performance and<br>Accuracy | Biocompatibility | | | 06 Issue 3.0 |
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| | 510(k) Premarket Notification – AlignRT Plus | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PREDICATE DEVICE 1 | PREDICATE DEVICE 2 | NEW DEVICE |
| Mechanical Safety | Cameras are ceiling mounted and do not contact patient or user | Cameras are ceiling mounted and do not contact patient or user | Cameras are ceiling, mounted and do not contact patient or user.<br>Head adjuster is clamped to the treatment couch through universal base plate. |
| Anatomical treatment sites | Entire body surface | Anywhere one encounters the effects of respiratory motion. These areas include, but are not limited to, the lung, breast, liver, pancreas, kidney and organs in the pelvis region, such as the prostate. | Entire body surface. |
| Human factors | Imaging process is fully automatic as is estimation of new couch position; 3D visual display provided to show any discrepancy in patient position | User selects tracking point(s) during first session. This is detected automatically during subsequent sessions. Tracking of the respiratory signal is fully automated. Thresholds for gating are selected manually via software. Motion and irregular breathing are detected automatically. | Imaging process is fully automatic as is estimation of new couch position; 3D visual display provided to show any discrepancy in patient position.<br>For respiratory tracking, user selects region of interest or tracking point(s) during first session. These are detected automatically during subsequent sessions.<br>For cranial treatments, a manual head adjuster may be used by turning designated dials to provide fine corrections for pitch, yaw and roll rotations in concert with real time visual feedback provided to the user by AlignRT Plus. |
| Optical pattern | Optical (near infra-red) pattern is projected to patient. | Optical (near infra-red) pattern is projected to patient. | Optical (near infra-red) pattern is projected to patient. |
| | | | Page 5 of 6 |
| | | | 25 October 2012 |
| | | | 06 Issue 3.0 |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus or a staff with a serpent entwined around it, though it is a more abstract representation.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 8, 2013

Dr. Norman Smith Chief Executive Officer Vision RT Ltd., Dove House Arcadia Avenue LONDON. N3 2JU, UK

Re: K123371

Trade/Device Name: AlignRT Plus Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 26, 2012 Received: November 1, 2012

. Dear Dr. Smith:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael J. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K123371

Device Name: AlignRT Plus

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 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.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael J. D. O'Hara

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)

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