(92 days)
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.
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.
The provided text describes the AlignRT Plus system, a video-based three-dimensional (3D) surface imaging system used for patient positioning and monitoring during radiotherapy.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Objective) | Reported Device Performance (Modified Device) | Comments (from document) |
|---|---|---|
| Positioning Accuracy | Target registration errors < 1mm (0.5mm) for all couch angles. | The modified device has the same performance or better than the predicate. Additional bench testing using improved measurement technique has been performed to substantiate improved claims. These claims and verification data are submitted within the 510k. |
| Respiratory Tracking | Tracks respiratory signal from imaged surface data and sends to CT (4D CT) or to Linac or imaging device (gating). Surface displacements can be tracked with RMS errors < 0.5mm over 10 or more breathing cycles. | Additional bench testing using improved measurement technique has been performed to substantiate improved claims. These claims and verification data are submitted within the 510k. |
2. Sample size used for the test set and the data provenance:
The document mentions "Additional bench testing using improved measurement technique has been performed to substantiate improved claims" for both positioning accuracy and respiratory tracking. However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The testing appears to be conducted on a calibration phantom, not on human subjects.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This information is not provided in the document. The testing appears to be an objective measurement against a known physical standard (calibration phantom), rather than based on expert interpretation of medical images.
4. Adjudication method for the test set:
This information is not applicable/not provided. The performance evaluation is based on direct measurements against physical standards, not on subjective assessment by multiple reviewers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this document. The AlignRT Plus is a patient positioning and monitoring system, not primarily an AI diagnostic tool for image interpretation that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The performance metrics provided for Positioning Accuracy and Respiratory Tracking (target registration errors, RMS errors) likely represent standalone algorithm performance as measured against a physical phantom. The system's function is automated measurement and feedback.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for the performance testing appears to be objective physical measurements from a calibration phantom with known parameters (e.g., precise positions, controlled respiratory movements).
8. The sample size for the training set:
The document does not provide information on the sample size for the training set. As a vision-based system for physical tracking, much of its core functionality would be based on geometric algorithms rather than extensive machine learning training data in the traditional sense of medical image analysis. It's possible internal validation or calibration data was used, but details are not given.
9. How the ground truth for the training set was established:
This information is not provided in the document. Similar to the training set size, details about how any ground truth for potential internal calibration or training was established are not mentioned.
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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
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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
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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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visi�nrt
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 HouseArcadia AvenueLondon, N3 2JUUnited 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 bebranded 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 therapyaccessories, IYE, (per 21 CFR section 892.5050) |
Predicate Device to claim substantial equivalence
Vision RT AlignRT Plus (K123371)
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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:
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.
Indications for Use:
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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:
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| PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |
|---|---|---|---|
| DEVICE NAME | AlignRT Plus K123371Incorporating AlignRT, GateCT, GateRT | AlignRT PlusIncorporating AlignRT, GateCT, GateRT | The device name is the same.The AlignRT application has beenup-issued to V6.0. |
| 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. |
| PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |
| SystemPerformance andAccuracy | Positioning accuracy: Target registrationerrors (as measured using calibrationphantom) < 1mm for all couch angles. | Positioning accuracy: Target registrationerrors (as measured using calibrationphantom) < 1mm (0.5mm) for all couchangles. | The modified device has thesame performance or better thanthe predicate. |
| Respiratory tracking: Tracks respiratorysignal from imaged surface data and sendsto CT (4D CT) or to Linac or imaging device(gating). | Respiratory tracking: Tracks respiratorysignal from imaged surface data and sendsto CT (4D CT) or to Linac or imaging device(gating). | Additional bench testing usingimproved measurementtechnique has been performed tosubstantiate improved claims.These claims and verification | |
| 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. | data are submitted within the510k. | |
| Biocompatibility | The AlignRT Plus product requires no directcontact with the patient. | 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) or | The only interactions between the user andthe system are with:• the PC (in the control room) or | The materials used tomanufacture the device areexactly the same and have notchanged since the previousclearances. | |
| remote 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) | remote 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) | ||
| PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |
| Calibration cube (in the vault) Calibration levelling plate (in the vault) | Calibration cube (in the vault) Calibration levelling plate (in the vault) | ||
| The materials of the devices (which are commonly used in light-industrial, commercial and home use) and that the application only involves intermittent external contact with intact skin. | The materials of the devices (which are commonly used in light-industrial, commercial and home use) and that the application only involves intermittent external contact with intact skin. | ||
| MechanicalSafety | Cameras are ceiling mounted and do not contact patient or user.Head adjuster is clamped to the treatment couch through universal base plate. | Cameras are ceiling mounted and do not contact patient or user.Head adjuster is clamped to the treatment couch through universal base plate. | The mechanical safety of the device is exactly the same and has not changed since the previous clearances. |
| Anatomicaltreatment sites | Entire body surface. | Entire body surface. | The anatomical treatment sites of the device are exactly the same and have not changed since the previous clearances. |
| 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.For respiratory tracking, user selects region of interest or tracking point(s) during first session. These are detected automatically during subsequent sessions | Imaging process is fully automatic as is estimation of new couch position; 3D visual display provided to show any discrepancy in patient position.For respiratory tracking, user selects region of interest or tracking point(s) during first session. These are detected automatically during subsequent sessions | The fundamental usage approach has not changed since the previous clearances, but the detail of the design implementation has changed.Consequently, IEC 62304 has been applied to ensure safety and effectiveness |
| PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |
| 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 realtime visual feedback provided to the user byAlignRT Plus. | 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 realtime visual feedback provided to the user byAlignRT Plus. | ||
| Improvements have been made to thegraphical user interface's layout andpresentation. In addition, workflow has beensimplified where possible in response tocustomer demand. | |||
| 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 | Cleared for use in hospital 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 applied safety standards arethe same as those of the previousclearances. |
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| PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |
|---|---|---|---|
| EMC standards | IEC60601-1-2 compliant. | IEC60601-1-2 compliant. | The applied EMC standards arethe same as those of the previousclearances. |
| 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).The shipping and storage conditions are 20°Cto +50°C (-4° to 122° Fahrenheit). | 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).The shipping and storage conditions are 20°Cto +50°C (-4° to 122° Fahrenheit). | The environmental range of thedevice is the same as that of thepreviously cleared device. |
| WorkstationOperatingSystem | Windows 7 | Windows 10 | The workstation operatingsystem has been changed and sothe software has beenrevalidated in line with IEC62304. |
| Number ofcameras | 1-3 | 1-3 | The number of cameras of thedevice is the same as that of thepreviously cleared device. |
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510(k) Premarket Notification – AlignRT Plus Incorporating AlignRT V6.0
| PREDICATE DEVICE | MODIFIED DEVICE | COMMENTS | |
|---|---|---|---|
| Powerrequirements | 110/230V 50-60Hz | 110/230V 50-60Hz | The power requirements of thedevice is the same as that of thepreviously cleared device. |
| Networkrequirements | 10BaseT internet connection behind a localfirewall. | 10BaseT internet connection behind a localfirewall. | The network requirements of thedevice is the same as that of thepreviously cleared device. |
| Service provision | All service to be performed by swap-out andreturn-to-base by Vision RT engineers.Remote support provided by Vision RTengineers through secure remote internetsoftware Axeda (screen-sharing). | All service to be performed by swap-out andreturn-to-base by Vision RT engineers.Remote support provided by Vision RTengineers through secure remote internetsoftware Axeda (screen-sharing). | The service approach of thedevice is the same as that of thepreviously cleared device. |
AlignRT Plus has the same indications for use and safety characteristics as the comparable predicate devices.
Conclusion:
The proposed device is substantially equivalent to the predicate.
§ 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.