MapRT

K231185 · Vision Rt, Ltd. · IYE · Jun 23, 2023 · Radiology

Device Facts

• Record ID: K231185
• Device Name: MapRT
• Applicant: Vision Rt, Ltd.
• Product Code: IYE · Radiology
• Decision Date: Jun 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MapRT is indicated for assisting with planning of radiation therapy by: - Assessing which combinations of ganty/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and - Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.

Device Story

MapRT is a software-based system with adhesive couch markers used by radiotherapy professionals during CT simulation and treatment planning. It imports treatment plan parameters to generate a 3D model of the patient and accessories. The system calculates a clearance map for various gantry and couch angles by modeling equipment geometry (using LiDAR or 3D CAD) and patient surfaces. It outputs an interactive clearance map, allowing clinicians to visualize collision-free angles and optimize dose distribution. By predicting potential collisions between the treatment machine, patient, and support structures, the device helps ensure safe and efficient treatment delivery.

Clinical Evidence

No clinical investigations were performed. Evidence consists of bench-level verification testing and summative validation testing per IEC 62366-1:2015. All test cases passed.

Technological Characteristics

Software-based system with 5x adhesive couch markers. Uses 3D modeling of patient/accessory surfaces and pre-loaded gantry/couch models (LiDAR/CAD). Clearance calculated with ±2cm accuracy. Operates on Windows. Biocompatibility assessed for markers. No energy delivered to patients.

Indications for Use

Indicated for radiotherapy professionals to assist in radiation therapy planning by assessing gantry/couch/isocentre collision risks and identifying angles to enhance dose distribution.

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

• ClearCheck Model RADCC V2 (K220583)

Submission Summary (Full Text)

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June 23, 2023

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

Re: K231185

Trade/Device Name: MapRT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: April 12, 2023 Received: April 26, 2023

Dear Jade Dunphy:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about 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.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The date of the signature is 2023.06.23 at 13:17:25 -04'00'.

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

Enclosure

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#### Indications for Use

510(k) Number (if known) K231185

Device Name MapRT

Indications for Use (Describe)

MapRT is indicated for assisting with planning of radiation therapy by:

- Assessing which combinations of ganty/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and

- Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.

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

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## visionrt

## 510(k) Premarket Notification – MapRT

#### 510(k) Summary

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

#### 1. Submitter's information

| Submitter's name: | Jade Dunphy |
|----------------------------|------------------------------------------------------------------|
| Company: | Vision RT Ltd. |
| Address: | Dove House<br>Arcadia Avenue<br>London, N3 2JU<br>United Kingdom |
| Contact person: | Jade Dunphy<br>Regulatory Affairs Manager |
| Phone: | [phone] |
| Fax: | N/A |
| Email: | [e-mail] |
| Date summary was prepared: | 12-Apr-2023 |

#### Device information 2.

| Trade name: | MapRT |
|----------------------|-------------------------------------------------------------------|
| Common name: | Surface-guided clearance mapping system |
| Classification: | Class II |
| Classification name: | Accessory to Medical charged-particle radiation<br>therapy system |
| Regulation number: | 892.5050 |
| Product code: | IYE |

Radiology

Classification panel:

#### 3. Predicate device information

#### Predicate device

Device name: Premarket notification: Manufacturer:

#### 4. Subject device

Name of the device: Device manufacturer: Common name:

ClearCheck Model RADCC V2 K220583 Radformation, Inc.

MapRT Vision RT Ltd. Surface-quided clearance mapping system

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# visionrt

### 510(k) Premarket Notification – MapRT

Device classification: Classification name:

Product code: Classification panel: Class II, 21 CFR 892.5050 Medical charged-particle radiation therapy system IYE Radiology

#### 5. Device description

The MapRT module is intended for use by radiotherapy professionals during the CT simulation and treatment planning stages of radiotherapy for collision avoidance and facilitating dose optimisation.

MapRT is a system which uses advanced software and couch markers to deliver a full 3D model of the patient and accessories. This model is used to calculate a clearance map for all couch and gantry angles. Plans can be imported to check beams, arcs and transition clearance.

#### 6. Indications for use

MapRT is indicated for assisting with planning of radiation therapy by:

- -Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and
- -Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.

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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 circle with a crosshair inside. The letters "rt" are in blue. The text is simple and modern.

#### 7. Technological characteristics

The substantial equivalence comparison table below provison of the technological characteristics of MapRT to those of the predicate device, ClearCheck Model RADCC V2.

| | Predicate device<br>(ClearCheck Model RADCC V2) | Subject device<br>(MapRT) | Comments |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | ClearCheck Model RADCC V2 | MapRT | Different name to the<br>predicate device. |
| Manufacturer | Radformation, Inc. | Vision RT Ltd. | Different manufacturer to the<br>predicate device. |
| Indications for use | ClearCheck is intended to assist<br>radiation therapy professionals in<br>generating and assessing the<br>quality of radiotherapy treatment<br>plans. ClearCheck is also intended<br>to assist radiation treatment<br>planners in predicting when a<br>treatment plan might result in a<br>collision between the treatment<br>machine and the patient or support<br>structures. | MapRT is indicated for assisting with<br>planning of radiation therapy by:<br>- Assessing which<br>combinations of gantry/couch<br>angle and isocentre may<br>result in a collision and which<br>are available to potentially<br>enhance the dose<br>distribution; and<br>- Predicting when a treatment<br>plan might result in a<br>collision between the<br>treatment machine and the<br>patient or support structures. | Minor differences to the<br>predicate device. MapRT is<br>indicated for a subset of the<br>predicate indication. It is not<br>indicated for generating<br>radiotherapy treatment plans.<br>In terms of assessing the<br>quality of radiotherapy<br>treatment plans and<br>predicting potential collisions,<br>the indications are equivalent<br>to the predicate device.<br>This minor difference does<br>not affect the safety or<br>effectiveness of the device.<br>MapRT works as intended.<br>Sufficient performance data<br>has been collated and shows<br>the software functions<br>effectively to achieve its<br>intended use. |
| Energy used and/or delivered | None - software-only application.<br>The software application does not<br>deliver or depend on energy<br>delivered to or from patients. | None - the software application and<br>couch markers do not deliver or<br>depend on energy delivered to or<br>from patients. | Equivalent to the predicate<br>device. |
| | Predicate device<br>(ClearCheck Model RADCC V2) | Subject device<br>(MapRT) | Comments |
| Intended users | Trained clinically qualified radiation<br>oncology personnel. | MapRT is intended to be used by<br>radiotherapy professionals. | Equivalent to the predicate<br>device. |
| OTC/Rx | Rx | Rx | Equivalent to the predicate<br>device. |
| Functionality | Performs dosimetric and plan<br>evaluation for Radiation Treatment<br>Plans. Also simulates the plan and<br>predicts whether gantry collisions<br>occur with patient or support<br>structures. | Simulates Radiation Treatment Plans<br>to check static and arc beams, and<br>transition clearance in between<br>fields, predict collisions between the<br>gantry and patient, couch and<br>accessories and facilitate dose<br>optimisation.<br><br>reconstruction of patient and<br>treatment accessory<br>surfaces acquired during<br>simulation;<br>modelling the geometry and<br>movement of equipment<br>within the radiotherapy<br>environment to check for<br>collisions in the designed<br>plan; and<br>facilitating treatment plan<br>optimisation. | Minor differences with the<br>predicate device. Dosimetric<br>evaluation is not a function of<br>MapRT. Otherwise, features<br>are equivalent to the<br>predicate device.<br>This minor difference does<br>not affect the safety or<br>effectiveness of the device.<br>MapRT works as intended.<br>Sufficient performance data<br>has been collated and shows<br>the software functions<br>effectively to achieve its<br>intended use. |
| Design: Graphical User Interface | Contains a Data Visualisation /<br>Graphical User Interface | Contains a Data Visualisation /<br>Graphical User Interface | Equivalent to the predicate<br>device. |
| Design: supported files | Files/Treatment Planning System<br>API-provided data containing CT,<br>Structure Set, and Treatment Plan<br>(including treatment field)<br>parameters. | Files exported from the Treatment<br>Planning System containing<br>Treatment Plan (including treatment<br>field) parameters. | Equivalent to the predicate<br>device. |
| Design: calculation requirements | Uses local hardware | Uses local hardware and couch<br>markers. | Minor differences with the<br>predicate device. MapRT |
| | Predicate device<br>(ClearCheck Model RADCC V2) | Subject device<br>(MapRT) | Comments |
| | | | uses couch markers as a<br>hardware accessory to assist<br>with calibration.<br>These markers are not<br>intended for contact with the<br>patient or user, except<br>incidental contact. The<br>materials have been<br>assessed for biocompatibility<br>and do not introduce any<br>new safety and effectiveness<br>concerns. Verification and<br>validation testing has been<br>conducted with the couch<br>markers and shows that the<br>addition of these couch<br>markers doesn't pose any<br>safety or effectiveness<br>concerns. |
| Design: reporting | Reporting built-in and user has<br>ability to customise | Reporting built-in and user has ability<br>to customise | Equivalent to the predicate<br>device. |
| Pure software | Yes | Uses both software and hardware (5x<br>adhesive couch markers) | Minor differences with the<br>predicate device.<br>MapRT is primarily software,<br>however it also uses couch<br>markers as a hardware accessory to<br>assist with calibration.<br>These markers are not<br>intended for contact with the<br>patient or user, except<br>incidental contact. The<br>materials have been |
| | Predicate device<br>(ClearCheck Model RADCC V2) | Subject device<br>(MapRT) | Comments |
| Operating system | Windows | Windows | Equivalent to the predicate<br>device. |
| Input | Treatment data, image data and<br>structure set data obtained from<br>supporting Treatment Planning<br>System and Application<br>Programming Interfaces. | Treatment data obtained from<br>supporting Treatment Planning<br>System. | Minor differences with the<br>predicate device. MapRT<br>does not import data from<br>the APIs. There are no safety<br>or effectiveness concerns as<br>there are no risks associated<br>with the APIs. |
| Simulation details | Simulates the plan and predicts<br>whether any gantry collisions occur<br>with patient or support structures. | Simulates the plan and predicts<br>whether any gantry collisions occur<br>with patient or support structures.<br>Calculates gantry clearance by<br>modelling the patient and accessory<br>surfaces acquired during CT<br>simulation, along with pre-loaded<br>models of the couch and gantry<br>created from LiDAR scans or 3D<br>CAD models. Clearance is calculated<br>with an accuracy of $\pm$ 2cm. | Minor differences with the<br>predicate device. Gantry<br>clearance is displayed to the<br>user, who can view treatment<br>deliverability at any given<br>combination of couch /<br>gantry angle and isocentre.<br>Clearance is calculated with<br>an accuracy of $\pm$ 2cm.<br>This minor difference does<br>not affect the safety or<br>effectiveness of the device.<br>MapRT works as intended. |
| | | | assessed for biocompatibility<br>and do not introduce any<br>new safety and effectiveness<br>concerns. Verification and<br>validation testing has been<br>conducted with the couch<br>markers and shows that the<br>addition of these couch<br>markers doesn't pose any<br>safety or effectiveness<br>concerns. |
| | Predicate device<br>(ClearCheck Model RADCC V2) | Subject device<br>(MapRT) | Comments |
| | Calculates gantry clearance by<br>modelling the linac as a cylinder<br>with a user-configured value for<br>distance between isocentre and the<br>face of the gantry. Collision Check<br>also supports additional applicators:<br>Stereotactic radiosurgery cones<br>(also modelled as a cylinder) and<br>Electron Applicators (modelled as a<br>rectangular prism). ClearCheck<br>also simulates the on-board<br>imaging (OBI) arms as a<br>rectangular prism. User can define<br>a warning distance that adds a<br>margin to the shapes in the<br>simulation. | | Sufficient performance data<br>has been collated and shows<br>the software functions<br>effectively to achieve its<br>intended use. |
| Collision check output | Collisions Check tests thousands of<br>sample points against CT data and<br>patient and couch structures and<br>reports the number of sample<br>points that resulted in a collision.<br>Collision Check also displays these<br>sample point test results with a 3D<br>display and an axial 2D image plan<br>viewer for the user to inspect the<br>results. | MapRT presents a Clearance Map to<br>the user using the couch (x axis) and<br>gantry (y axis) to show collision-free<br>angles and angles resulting in a<br>collision at any given isocentre.<br>MapRT also displays these angles<br>visually using the acquired patient<br>and accessory surfaces and pre-<br>loaded models of the couch and<br>gantry. The user can interact with the<br>Clearance Map to inspect clearance<br>at any couch / gantry angle and<br>isocentre. | Minor differences with the<br>predicate device. The<br>Clearance Map generated by<br>MapRT is interactive,<br>allowing the user to inspect<br>the results at any angle or<br>isocentre.<br>This minor difference does<br>not affect the safety or<br>effectiveness of the device.<br>MapRT works as intended.<br>Sufficient performance data<br>has been collated and shows<br>the software functions<br>effectively to achieve its<br>intended use. |
| | Predicate device<br>(ClearCheck Model RADCC V2) | Subject device<br>(MapRT) | Comments |
| Dose optimisation | Collisions Check tests thousands of<br>sample points against CT data and<br>patient and couch structures and<br>reports the number of sample<br>points that resulted in a collision.<br>Collision Check also displays these<br>sample point test results with a 3D<br>display and an axial 2D image plan<br>viewer for the user to inspect the<br>results. | MapRT presents a Clearance Map to<br>the user This map displays which<br>couch / gantry angles and isocentres<br>would result in a collision during<br>treatment, and which are available to<br>enhance the dose distribution. | Minor differences with the<br>predicate device. The<br>predicate checks a single<br>plan for collisions and<br>provides binary data on<br>whether or not a collision is<br>predicted. Whereas, the<br>Clearance Map generated by<br>MapRT allows the user to<br>identify all combinations of<br>couch / gantry and isocentre<br>available to enhance the<br>dose distribution.<br>This minor difference does<br>not affect the safety or<br>effectiveness of the device.<br>MapRT works as intended.<br>Sufficient performance data<br>has been collated and shows<br>the software functions<br>effectively to achieve its<br>intended use. |

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Image /page/6/Picture/0 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, consisting of a circle with a crosshair through it.

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Image /page/7/Picture/0 description: The image shows the word "visionrt" with a unique design. The letters "visi" are in black, followed by a black circle with a crosshair in the middle, replacing the letter "o". The letters "rt" are in blue, creating a contrast with the rest of the word.

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Image /page/8/Picture/0 description: The image shows the word "visionrt" with a unique design. The letters "visi" are in black, followed by a black circle with a crosshair in the middle, replacing the letter "o". The letters "rt" are in blue, creating a contrast with the rest of the word.

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Image /page/9/Picture/0 description: The image shows the word "visionrt" with a unique design. The letters "visi" are in black, followed by a black circle with a crosshair in the middle, replacing the letter "o". The letters "rt" are in blue, creating a contrast with the rest of the word.

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Image /page/10/Picture/0 description: The image shows the word "visionrt" with a stylized "o". The letters "visi" are in black, the "o" is a black circle with a crosshair through it, and the "rt" is in blue. The font is sans-serif and the letters are close together. The image is simple and modern.

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## visionrt 510(k) Premarket Notification – MapRT

#### Performance data 8.

As with the predicate device, no clinical investigations were performed for MapRT. Verification tests were performed to ensure that the module works as intended and pass/fail criteria were used to verify requirements. Validation testing was performed using summative evaluation techniques per IEC 62366-1:2015. Verification and validation testing passed in all test cases.

#### 9. Conclusion

MapRT is substantially equivalent to the predicate device. The technological differences between MapRT and the predicate device does not raise any questions on the safety and effectiveness of MapRT. Verification and validation testing demonstrate that MapRT is safe and effective and performs as well as or better than the predicate device.