AlignRT Plus

K233622 · Vision Rt, Ltd. · IYE · Mar 29, 2024 · Radiology

Device Facts

• Record ID: K233622
• Device Name: AlignRT Plus
• Applicant: Vision Rt, Ltd.
• Product Code: IYE · Radiology
• Decision Date: Mar 29, 2024
• 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: - Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep-Inspiration Breath Hold (DIBH). - Verification of patient identity for their radiation treatment session. - Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment isocenter. - Withholding the beam automatically during radiation delivery, as well as gating the patient's respiratory motion. - Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch. - Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient. - Passing and receiving information to/from other systems associated with the radiotherapy treatment.

Device Story

Video-based 3D surface imaging system; monitors patient position relative to reference surface; displays offsets to user. Tracks respiratory motion for 4DCT reconstruction and DIBH coaching. Monitors patient during radiation delivery; automatically withholds beam if patient moves out of position. Uses up to 6 cameras to project patterns on patient skin to acquire 3D images. Includes DoseRT feature for visualizing Cherenkov light emitted by radiation beam (6-18MV) on patient skin. Used in hospital/clinic radiotherapy environments by trained radiation oncology personnel. Output visualized by clinician to guide patient positioning and treatment delivery. Benefits include improved positioning accuracy, respiratory gating, and real-time visualization of radiation beam entry/exit.

Clinical Evidence

Bench testing only. No clinical investigations performed. Verification tests confirmed module functionality against pass/fail criteria. Validation testing performed using summative evaluation techniques per IEC 62366-1:2015. All test cases passed.

Technological Characteristics

Video-based 3D surface imaging; near infra-red pattern projection. Components: PC workstation, cables, video cameras, calibration tools, DoseRT camera (anodised aluminium/polyester powder coating), DoseRT reference board (ABS plastic). Positioning accuracy <1mm (0.5mm) target registration error. Respiratory tracking accuracy ≤0.5mm (≥95% confidence). Cherenkov imaging for 6-18MV beams at 100-2400MU/Min. Compliant with IEC 60601-1 and IEC 60601-1-2. Software-based processing.

Indications for Use

Indicated for any individual (adult or child) undergoing radiotherapy. Used for respiratory motion tracking, patient identity verification, patient positioning/monitoring during radiation delivery, beam gating/withholding, quality assurance of imaging/lasers/couches, and visualization of Cherenkov signals during radiation therapy.

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 (K212583)

Reference Devices

• BeamSite (K212606)

Submission Summary (Full Text)

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March 29, 2024

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Vision RT Ltd % Chelsey Ludlow Regulatory Affairs Specialist Dove House. Arcadia Avenue London, N3 2JU UNITED KINGDOM

#### Re: K233622

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: November 10, 2023 Received: November 13, 2023

Dear Chelsey Ludlow:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

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product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

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

Sincerely,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K233622

Device Name AlignRT Plus

#### Indications for Use (Describe)

The AlignRT Plus system is indicated for:

- · Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep-Inspiration Breath Hold (DIBH).
- · Verification of patient identity for their radiation treatment session.
- · Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment isocenter.
- · Withholding the beam automatically during radiation delivery, as well as gating the patient's respiratory motion.
- · Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch.
- · Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient.
- · Passing and receiving information to/from other systems associated with the radiotherapy treatment.

| Type of Use (Select one or both, as applicable) | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|---|--|
| 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | | | . | |

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# visionrt

### 510(k) Premarket Notification - AlignRT Plus 7.3

### 510(k) Summary

The information below is provided for modifications to AlignRT Plus following the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR 807.92.

#### Submitter's information

| Submitter's name: | Chelsey Ludlow |
|----------------------------|------------------------------------------------------------------|
| Company: | Vision RT Ltd. |
| Address: | Dove House<br>Arcadia Avenue<br>London, N3 2JU<br>United Kingdom |
| Contact person: | Chelsey Ludlow<br>Regulatory Affairs Specialist |
| Phone: | [phone] |
| Fax: | N/A |
| Email: | [e-mail] |
| Date summary was prepared: | 10-Nov-2023 |

### Primary Predicate device information

Device name:

Premarket notification: Manufacturer: Common name:

Classification: Classification name:

Regulation number:

#### Reference device information

- Device name: Premarket notification: Manufacturer: Common name: Classification:
AlignRT Plus (incorporating AlignRT, AlignRT InBore, AlignRT Offline, GateCT, SimRT, GateRT) K212583 Vision RT Limited Surface Guided Radio Therapy System (Patient Positioning System - accessory to a linear accelerator) Class II Accessory to Medical charged-particle radiation therapy system 892.5050

BeamSite K212606 DoseOptics LLC Radiotherapy visualization system Class II

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# visionrt

### 510(k) Premarket Notification - AlignRT Plus 7.3

Classification name:

Regulation number:

Medical charged-particle radiation therapy system 892.5050

### Device information

| Trade name: | AlignRT Plus (incorporating AlignRT, AlignRT<br>InBore, DoseRT, GateCT, GateRT, SimRT) |
|-----------------------|------------------------------------------------------------------------------------------------------------|
| Common name: | Surface Guided Radio Therapy System (Patient<br>Positioning System - accessory to a linear<br>accelerator) |
| Classification: | Class II |
| Classification name: | Accessory to Medical charged-particle radiation<br>therapy system |
| Regulation number: | 892.5050 |
| Product code: | IYE |
| Classification panel: | Radiology |

### Device description

The AlignRT Plus system (K212583) is a combination of the devices AlignRT InBore, AlignRT Offline, DoseRT, GateCT, GateRT and SimRT.

AlignRT Plus is a video-based three-dimensional (3D) surface imaging system used to monitor the patient's position in 3D before and during radiotherapy treatment. During each treatment session the patient's position is compared to the reference surface and offsets are displayed to the user. The system can be used to track pation during tumour localization in the CT scanner in order to facilitate subsequent 4D CT reconstruction. The system can be used to track the breath hold level consistency throughout the simulation process. The system can also be used to track patient motion during treatment delivery for radiation therapy procedures and hold the beam when the patient is not in position. Use of optional accessories allows the user to:

- monitor the patient's position inside bore-based linacs; and/or —
- to view the Cherenkov light emitted by the radiation beam as it enters and exits the patient's skin; and/or
- verify the patient's identity.

The system is non-invasive, does not require the use of body markers and produces no irradiation during the imaging process. The system mainly consists of advanced software. 3D cameras (≤6 cameras) and calibration tools. Each camera pod monitoring the pation will, however, project a pattern on the patient to acquire a 3D image of the patient.

This 510(k) notification is to obtain clearance for the following changes to the cleared device:

- 1. Introduction of new software, version 7.3. This is an updated version of the existing cleared software, to support the:
- a. New Cherenkov imaging feature, called DoseRT.
- b. Updated respiratory gating feature, called Respiratory Module.

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# visionrt

### 510(k) Premarket Notification – AlignRT Plus 7.3

- 2. Introduction of new hardware:
- a. DoseRT camera to enable Cherenkov imaging.
- 3. Update to indications for use to include the new Cherenkov imaging feature and clarify existing indications.

Throughout this submission, the device will be referred to as AlignRT Plus as the family name for all configurations. No changes have been made to the currently cleared GateCT, GateRT and SimRT configurations.

### Indications for use

The AlignRT Plus system is indicated for:

- . Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep-Inspiration Breath Hold (DIBH).
- Verification of patient identity for their radiation treatment session.
- Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter • and/or the prescribed treatment isocenter.
- . Withholding the beam automatically during radiation delivery, as well as gating the beam based on the patient's respiratory motion.
- . Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch.
- . Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient.
- . Passing and receiving information to/from other systems associated with the radiotherapy treatment.

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Image /page/6/Picture/2 description: The image shows the word "visionrt" in a stylized font. The first part of the word, "vision", is in black, while the "rt" is in blue. The "o" in "vision" is replaced with a target symbol with a vertical line extending through it.

### Primary Predicate and subject device technological characteristics

The features of AlignRT Plus 7.3 are substantially equivalent to the predicate device, AlignRT Plus (K212583), as discussed in the table below:

| Technological<br>characteristics | Primary Predicate device<br>(AlignRT Plus, K212583) | Subject device<br>(AlignRT Plus 7.3) | Comments |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Vision RT Ltd | Vision RT Ltd | The manufacturer remains the same as that<br>of the predicate device. |
| Indications for<br>Use | The AlignRT Plus system is indicated for<br>use to position and monitor patients<br>relative to the prescribed treatment<br>isocenter, and to withhold the beam<br>automatically during 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<br>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<br>contour data can be extracted and<br>exported from the data acquired for the<br>purpose of treatment planning.<br><br>AlignRT Plus can be calibrated directly to<br>the treatment beam isocenter and in turn<br>assists in performing quality assurance on<br>MV, kV imagers, room lasers and the<br>treatment couch. | The AlignRT Plus system is indicated for:<br>Tracking respiratory motion<br>throughout the simulation process<br>to facilitate subsequent 4DCT<br>reconstruction and coaching the<br>patient in breathing techniques<br>required for Deep-Inspiration<br>Breath Hold (DIBH). Verification of patient identity for<br>their radiation treatment session. Positioning and monitoring of<br>patients during radiation delivery,<br>relative to the setup isocenter<br>and/or the prescribed treatment<br>isocenter. Withholding the beam<br>automatically during radiation<br>delivery, as well as gating the<br>beam based on the patient's<br>respiratory motion. Performing quality assurance on<br>MV, kV imagers, room lasers, and<br>the treatment couch. Visualizing the Cherenkov signal | The subject device indications for use have<br>been updated to include visualization of the<br>Cherenkov signal, verification of the<br>patient's identity prior to radiation treatment<br>and to clarify the existing indications.<br><br>The addition of Cherenkov imaging and<br>verification of the patient's identity and the<br>clarification of the cleared indications does<br>not affect the safety or effectiveness of the<br>device. AlignRT Plus works as intended.<br>Sufficient performance data has been<br>collated and shows the device functions<br>effectively to achieve its intended use. |
| Technological<br>characteristics | Primary Predicate device<br>(AlignRT Plus, K212583) | Subject device | Comments |
| | AlignRT Plus may be used during<br>simulation, setup and stereotactic<br>radiosurgery and precision radiotherapy<br>for lesions, tumors and conditions<br>anywhere in the body where radiation is<br>indicated. | (AlignRT Plus 7.3)<br>on entry and exit from the patient.<br>Passing and receiving information<br>to/from other systems associated<br>with the radiotherapy treatment. | |
| Product code | IYE | IYE | Equivalent to the predicate device. |
| Device<br>Classification | Class II | Class II | Equivalent to the predicate device. |
| Classification<br>Name | Accessory to Medical charged-particle<br>radiation therapy accessories | Accessory to Medical charged-particle<br>radiation therapy accessories | Equivalent to the predicate device. |
| Requlation<br>Number | 21 CFR 892.5050 | 21 CFR 892.5050 | Equivalent to the predicate device. |
| Contra-<br>indications | None known. | None known. | Equivalent to the predicate device. |
| Intended users | Trained clinically qualified radiation<br>oncology personnel. | Trained clinically qualified radiation<br>oncology personnel. | Equivalent to the predicate device. |
| OTC/Rx | Rx (Prescription) | Rx (Prescription) | Equivalent to the predicate device. |
| Principles of<br>operation | Video based imaging of 3D skin surface<br>data using surface matching software. | Video based imaging of 3D skin surface<br>data using surface matching software. | Equivalent to the predicate device. |
| Target<br>Population | Any individual (adult or child) undergoing<br>radiotherapy. | Any individual (adult or child undergoing<br>radiotherapy). | Equivalent to the predicate device. |
| Technological<br>characteristics | Primary Predicate device<br>(AlignRT Plus, K212583) | Subject device<br>(AlignRT Plus 7.3) | Comments |
| Materials | PC workstation, cables, video cameras.<br>Block Polystyrene (calibration phantom),<br>carbon fibre laminate material (head<br>adjuster). | PC workstation, cables, video cameras.<br>Block Polystyrene (calibration phantom),<br>carbon fibre laminate material (head<br>adjuster).<br>Anodised aluminium and polyester<br>powder coating (DoseRT camera casing).<br>ABS plastic (DoseRT reference board). | The component materials in the subject<br>device are identical to the primary<br>predicate.<br>The introduction of the new components<br>(DoseRT camera casing and DoseRT<br>reference board) and materials have not<br>been evaluated for biocompatibility as they<br>do not come in contact with the patient, nor<br>effect patient safety. |
| System<br>Performance<br>and Accuracy | Positioning accuracy: Target registration<br>errors (as measured using calibration<br>phantom) < 1mm (0.5mm) for all couch<br>angles.<br>Respiratory tracking: Tracks respiratory<br>signal from imaged surface data and<br>sends to CT (4D CT) or to Linac or<br>imaging device (gating).<br>Surface displacements can be tracked<br>with RMS errors < 0.5mm over 10 or more<br>breathing cycles. | Positioning accuracy: Target registration<br>errors (as measured using calibration<br>phantom) < 1mm (0.5mm) for all couch<br>angles.<br>Respiratory tracking: Tracks respiratory<br>signal from imaged surface data and<br>sends to CT (4D CT) or to Linac or<br>imaging device (gating).<br>The relative respiratory position within<br>respiratory cycles is calculated to an<br>accuracy of ≤0.5mm with a confidence<br>level of ≥95%.<br>The location of the radiation dose on the<br>patient surface during treatment can be<br>visualized using the Cherenkov Effect for<br>treatment at treatment beam energies of<br>≥6MV and ≤18MV and at treatment beam<br>delivery rates of between ≥100MU/Min<br>and ≤2400MU/Min. | As a result of the updated features, such as<br>the visualization of the Cherenkov signal<br>and respiratory tracking associated with the<br>Respiratory Module software module, the<br>subject's performance, and accuracy differ<br>slightly from the predicate device.<br>In support of the substantial equivalence<br>determination, the validation met the<br>predetermined specifications and<br>acceptance criteria.<br>The performance data demonstrate that the<br>device is as safe and effective as the<br>predicate devices |
| Technological<br>characteristics | Primary Predicate device<br>(AlignRT Plus, K212583) | Subject device<br>(AlignRT Plus 7.3) | Comments |
| Biocompatibility | The AlignRT Plus product requires no<br>direct contact with the patient.<br><br>The only interactions between the user<br>and the system are with:<br>• the PC (in the control room) or remote<br>workstation (in the vault),<br>• the Remote Control (in the vault),<br>• the Real Time Coach (RTC) (in the<br>vault), or<br>• the Head Adjuster (in the vault).<br>• Calibration plate (in the vault)<br>• Calibration cube (in the vault)<br>• Calibration levelling plate (in the vault)<br><br>The materials of the devices (which are<br>commonly used in light-industrial, | The AlignRT Plus product requires no<br>direct contact with the patient.<br><br>The only interactions between the user<br>and the system are with:<br>• the PC (in the control room) or remote<br>workstation (in the vault),<br>• the Remote Control (in the vault),<br>• the Real Time Coach (RTC) (in the<br>vault), or<br>• the Head Adjuster (in the vault).<br>• Calibration plate (in the vault)<br>• Calibration cube (in the vault)<br>• Calibration levelling plate (in the vault)<br>• DoseRT reference board (in the vault)<br><br>The materials of the devices (which are | Biocompatibility tests conducted on the<br>predicate device can be applied to AlignRT<br>Plus 7.3 since the surface contacting<br>components and materials are the same<br>except for the reference board.<br><br>No additional testing was required since the<br>reference board does not contact patients.<br>These differences do not raise new or<br>different concerns of safety and<br>effectiveness. |
| | commercial and home use) and that the<br>application only involves intermittent<br>external contact with intact skin. | commonly used in light-industrial,<br>commercial, and home use) and that the<br>application only involves intermittent<br>external contact with intact skin. | |
| Mechanical<br>Safety | 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. | 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. | Equivalent to the predicate device. |
| | Head adjuster is clamped to the treatment<br>couch through universal base plate. | Head adjuster is clamped to the treatment<br>couch through universal base plate. | |
| Anatomical<br>treatment sites | Entire body surface. | Entire body surface. | Equivalent to the predicate device. |
| Human factors | Imaging process is fully automatic as is<br>estimation of new couch position: 3D | Imaging process is fully automatic as is<br>estimation of new couch position: 3D | The subject device continues to meet FDA<br>guidance on "Applying Human Factors and |
| Technological<br>characteristics | Primary Predicate device<br>(AlignRT Plus, K212583) | Subject device<br>(AlignRT Plus 7.3) | Comments |
| | visual display provided to show any<br>discrepancy in patient position. | visual display provided to show any<br>discrepancy in patient position. | Usability Engineering to Medical Devices"<br>and IEC 62366-1: 2015 Medical Devices-<br>Part 1: Application of Usability Engineering<br>to Medical Devices. |
| | For respiratory tracking, user selects<br>region of interest or tracking point(s)<br>during first session. These are detected<br>automatically during subsequent sessions. | For respiratory tracking, user selects<br>region of interest or tracking point(s)<br>during first session. These are detected<br>automatically during subsequent sessions. | This is equivalent to the predicate device.…