K Number

Device Name

AlignRT Plus

Manufacturer

Vision RT Ltd

Date Cleared

2018-08-07

(92 days)

Product Code

IYE

Regulation Number

892.5050

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 Description

The AlignRT Plus system (K123371) is a combination of the devices AlignRT, GateCT and GateRT. It is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is noninvasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process. AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals. Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances. Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals. AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position. Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module". The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K123371

Reference Devices

K123371

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on 3D surface imaging, real-time tracking, and image processing, but does not mention AI or ML.

Therapeutic

No.
The device is used to position and monitor patients during radiation delivery and does not directly provide therapy.

Diagnostic

Explanation: The device is described as a system for positioning and monitoring patients during radiation therapy, tracking respiratory patterns, and assisting in quality assurance of other equipment. While it collects data and performs surface matching, its primary functions are related to guiding and ensuring the accuracy of radiation treatment and supporting workflow, not diagnosing medical conditions or diseases.

SaMD (Software as a Medical Device)

The device description explicitly states that the system consists of "advanced software, a computer workstation, and one, two or three 3D camera units". This indicates the presence of significant hardware components beyond just a standard computer.

IVD (In Vitro Diagnostic)

Based on the provided information, the AlignRT Plus system is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
AlignRT Plus Function: The AlignRT Plus system is a surface imaging system used to position and monitor patients during radiation therapy. It works by imaging the external surface of the patient's body.
No Specimen Analysis: The system does not collect, prepare, or analyze any specimens taken from the human body. Its function is entirely external and focused on patient positioning and monitoring based on surface data.

Therefore, the AlignRT Plus system falls under the category of a medical device used for treatment delivery and quality assurance in radiation therapy, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

IYE

Device Description

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Video-based 3D surface imaging

Anatomical Site

anywhere in the body where radiation is indicated.

Indicated Patient Age Range

Any individual (adult or child)

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Positioning accuracy: Target registration errors (as measured using calibration phantom)

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.

Summary

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

V1s10n KT Ltd % Mr. Chris Hannan VP Ouality and Regulatory Affairs Dove House. Arcadia Avenue London. GB N3 NJU UNITED KINGDOM

August 7, 2018

Re: K181218

Trade/Device Name: AlignRT Plus Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 28, 2018 Received: July 2, 2018

Dear Mr. Hannan:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good

manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D.'Hara
For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K181218

Device Name AlignRT Plus

Indications for Use (Describe)

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

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

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

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

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

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

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

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510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.0 Tab 6 - 510(k) Summary

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

| Submitter: | Vision RT Ltd.
Dove House
Arcadia Avenue
London, N3 2JU
United Kingdom |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Chris Hannan |
| | Tel: +44 (0)208 346 4300 |
| | Fax: +44 (0)208 436 4634 |
| | Date Summary was prepared: 30 April 2018 |
| Name of the Device: | AlignRT Plus |
| Trade/Proprietary Name: | AlignRT Plus (incorporating AlignRT, GateCT, GateRT), may be
branded as OSMS (Optical Surface Monitoring System). |
| Common or Usual Name: | Surface Guided Radio Therapy System (Patient Positioning System –
accessory to a linear accelerator) |
| Device Class: | II |
| Classification Name: | Accessory to Medical charged-particle radiation therapy
accessories, IYE, (per 21 CFR section 892.5050) |

Predicate Device to claim substantial equivalence

Vision RT AlignRT Plus (K123371)

Image /page/4/Picture/0 description: The image shows the word "visionrt" in a stylized font. The first six letters, "vision", are in black, while the last two letters, "rt", are in blue. The "i" in "vision" has a dot above it, and the "o" is replaced with a target symbol.

510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.0

Description of Device:

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".

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

Indications for Use:

Image /page/5/Picture/0 description: The image shows the word "visionrt" in a stylized font. The first part of the word, "vision", is in black, with the "o" replaced by a symbol resembling a target. The letters "rt" are in blue. The font is simple and modern.

510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.0

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

Summary of the Technological Characteristics:

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

	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
DEVICE NAME	AlignRT Plus K123371
Incorporating AlignRT, GateCT, GateRT	AlignRT Plus
Incorporating AlignRT, GateCT, GateRT	The device name is the same.
The AlignRT application has been
up-issued to V6.0.
MANUFACTURER	Vision RT Ltd	Vision RT Ltd	The manufacturer has not
changed.
Indications for
Use	The AlignRT Plus system is indicated for use
to position and monitor patients relative to
the prescribed treatment isocenter, and to
withhold the beam automatically during
radiation delivery. For cranial treatments, a
manual head adjuster is included which can
be used in concert with AlignRT Plus to
provide fine corrections for pitch, roll and
yaw rotations. AlignRT Plus is also used to
track the patient's respiratory pattern for
respiratory synchronized image acquisition,
and radiation therapy treatment. Patient
contour data can be extracted and exported
from the data acquired for the purpose of
treatment planning. AlignRT Plus can be
calibrated directly to the treatment beam
isocenter and in turn assists in performing
quality assurance on MV, kV imagers, room
lasers and the treatment couch. AlignRT Plus
may be used during simulation, setup and	The AlignRT Plus system is indicated for use
to position and monitor patients relative to
the prescribed treatment isocenter, and to
withhold the beam automatically during
radiation delivery. For cranial treatments, a
manual head adjuster is included which can
be used in concert with AlignRT Plus to
provide fine corrections for pitch, roll and
yaw rotations. AlignRT Plus is also used to
track the patient's respiratory pattern for
respiratory synchronized image acquisition,
and radiation therapy treatment. Patient
contour data can be extracted and exported
from the data acquired for the purpose of
treatment planning. AlignRT Plus can be
calibrated directly to the treatment beam
isocenter and in turn assists in performing
quality assurance on MV, kV imagers, room
lasers and the treatment couch. AlignRT Plus
may be used during simulation, setup and	The indications for use are
exactly the same and have not
changed since previous
clearances.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
	stereotactic radiosurgery and precision
radiotherapy for lesions, tumors and
conditions anywhere in the body where
radiation is indicated.	stereotactic radiosurgery and precision
radiotherapy for lesions, tumors and
conditions anywhere in the body where
radiation is indicated.
Principles of
operation	Video based imaging of 3D skin surface data
using surface matching software.	Video based imaging of 3D skin surface data
using surface matching software.	The principles of operation are
exactly the same and have not
changed since previous
clearances.
Target
Population	Any individual (adult or child) undergoing
radiotherapy.	Any individual (adult or child) undergoing
radiotherapy.	The target population is exactly
the same and have not changed
since previous clearances.
Materials	PC workstation, cables, video cameras. Block
Polystyrene (calibration phantom), carbon
fibre laminate material (head adjuster).	PC workstation, cables, video cameras. Block
Polystyrene (calibration phantom), carbon
fibre laminate material (head adjuster).	The materials used to
manufacture the device are
exactly the same and have not
changed since previous
clearances.
	PREDICATE DEVICE	MODIFIED DEVICE	COMMENTS
System
Performance and
Accuracy	Positioning accuracy: Target registration
errors (as measured using calibration
phantom)