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 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.

AI/ML Overview

The provided FDA 510(k) summary for MapRT does not contain acceptance criteria or a detailed study description with the requested information. It only states that "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."

Therefore, I cannot provide the specific tables and details requested based on the input document. The document primarily focuses on establishing substantial equivalence to a predicate device (ClearCheck Model RADCC V2) based on technological characteristics and intended use, rather than presenting a detailed performance study with quantifiable acceptance criteria.

Information Not Found in the Document:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI assistance.
Whether standalone (algorithm only) performance was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Summary

{0}------------------------------------------------

June 23, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 HouseArcadia AvenueLondon, N3 2JUUnited Kingdom
Contact person:	Jade DunphyRegulatory Affairs Manager
Phone:	+44 (0)20 8346 4300
Fax:	N/A
Email:	regulatory@visionrt.com
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 radiationtherapy 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

{4}------------------------------------------------

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.

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.

{5}------------------------------------------------

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(ClearCheck Model RADCC V2)	Subject device(MapRT)	Comments
Device name	ClearCheck Model RADCC V2	MapRT	Different name to thepredicate device.
Manufacturer	Radformation, Inc.	Vision RT Ltd.	Different manufacturer to thepredicate device.
Indications for use	ClearCheck is intended to assistradiation therapy professionals ingenerating and assessing thequality of radiotherapy treatmentplans. ClearCheck is also intendedto assist radiation treatmentplanners in predicting when atreatment plan might result in acollision between the treatmentmachine and the patient or supportstructures.	MapRT is indicated for assisting withplanning of radiation therapy by:- Assessing whichcombinations of gantry/couchangle and isocentre mayresult in a collision and whichare available to potentiallyenhance the dosedistribution; and- Predicting when a treatmentplan might result in acollision between thetreatment machine and thepatient or support structures.	Minor differences to thepredicate device. MapRT isindicated for a subset of thepredicate indication. It is notindicated for generatingradiotherapy treatment plans.In terms of assessing thequality of radiotherapytreatment plans andpredicting potential collisions,the indications are equivalentto the predicate device.This minor difference doesnot affect the safety oreffectiveness of the device.MapRT works as intended.Sufficient performance datahas been collated and showsthe software functionseffectively to achieve itsintended use.
Energy used and/or delivered	None - software-only application.The software application does notdeliver or depend on energydelivered to or from patients.	None - the software application andcouch markers do not deliver ordepend on energy delivered to orfrom patients.	Equivalent to the predicatedevice.
	Predicate device(ClearCheck Model RADCC V2)	Subject device(MapRT)	Comments
Intended users	Trained clinically qualified radiationoncology personnel.	MapRT is intended to be used byradiotherapy professionals.	Equivalent to the predicatedevice.
OTC/Rx	Rx	Rx	Equivalent to the predicatedevice.
Functionality	Performs dosimetric and planevaluation for Radiation TreatmentPlans. Also simulates the plan andpredicts whether gantry collisionsoccur with patient or supportstructures.	Simulates Radiation Treatment Plansto check static and arc beams, andtransition clearance in betweenfields, predict collisions between thegantry and patient, couch andaccessories and facilitate doseoptimisation.reconstruction of patient andtreatment accessorysurfaces acquired duringsimulation;modelling the geometry andmovement of equipmentwithin the radiotherapyenvironment to check forcollisions in the designedplan; andfacilitating treatment planoptimisation.	Minor differences with thepredicate device. Dosimetricevaluation is not a function ofMapRT. Otherwise, featuresare equivalent to thepredicate device.This minor difference doesnot affect the safety oreffectiveness of the device.MapRT works as intended.Sufficient performance datahas been collated and showsthe software functionseffectively to achieve itsintended use.
Design: Graphical User Interface	Contains a Data Visualisation /Graphical User Interface	Contains a Data Visualisation /Graphical User Interface	Equivalent to the predicatedevice.
Design: supported files	Files/Treatment Planning SystemAPI-provided data containing CT,Structure Set, and Treatment Plan(including treatment field)parameters.	Files exported from the TreatmentPlanning System containingTreatment Plan (including treatmentfield) parameters.	Equivalent to the predicatedevice.
Design: calculation requirements	Uses local hardware	Uses local hardware and couchmarkers.	Minor differences with thepredicate device. MapRT
	Predicate device(ClearCheck Model RADCC V2)	Subject device(MapRT)	Comments
			uses couch markers as ahardware accessory to assistwith calibration.These markers are notintended for contact with thepatient or user, exceptincidental contact. Thematerials have beenassessed for biocompatibilityand do not introduce anynew safety and effectivenessconcerns. Verification andvalidation testing has beenconducted with the couchmarkers and shows that theaddition of these couchmarkers doesn't pose anysafety or effectivenessconcerns.
Design: reporting	Reporting built-in and user hasability to customise	Reporting built-in and user has abilityto customise	Equivalent to the predicatedevice.
Pure software	Yes	Uses both software and hardware (5xadhesive couch markers)	Minor differences with thepredicate device.MapRT is primarily software,however it also uses couchmarkers as a hardware accessory toassist with calibration.These markers are notintended for contact with thepatient or user, exceptincidental contact. Thematerials have been
	Predicate device(ClearCheck Model RADCC V2)	Subject device(MapRT)	Comments
Operating system	Windows	Windows	Equivalent to the predicatedevice.
Input	Treatment data, image data andstructure set data obtained fromsupporting Treatment PlanningSystem and ApplicationProgramming Interfaces.	Treatment data obtained fromsupporting Treatment PlanningSystem.	Minor differences with thepredicate device. MapRTdoes not import data fromthe APIs. There are no safetyor effectiveness concerns asthere are no risks associatedwith the APIs.
Simulation details	Simulates the plan and predictswhether any gantry collisions occurwith patient or support structures.	Simulates the plan and predictswhether any gantry collisions occurwith patient or support structures.Calculates gantry clearance bymodelling the patient and accessorysurfaces acquired during CTsimulation, along with pre-loadedmodels of the couch and gantrycreated from LiDAR scans or 3DCAD models. Clearance is calculatedwith an accuracy of $\pm$ 2cm.	Minor differences with thepredicate device. Gantryclearance is displayed to theuser, who can view treatmentdeliverability at any givencombination of couch /gantry angle and isocentre.Clearance is calculated withan accuracy of $\pm$ 2cm.This minor difference doesnot affect the safety oreffectiveness of the device.MapRT works as intended.
			assessed for biocompatibilityand do not introduce anynew safety and effectivenessconcerns. Verification andvalidation testing has beenconducted with the couchmarkers and shows that theaddition of these couchmarkers doesn't pose anysafety or effectivenessconcerns.
	Predicate device(ClearCheck Model RADCC V2)	Subject device(MapRT)	Comments
	Calculates gantry clearance bymodelling the linac as a cylinderwith a user-configured value fordistance between isocentre and theface of the gantry. Collision Checkalso supports additional applicators:Stereotactic radiosurgery cones(also modelled as a cylinder) andElectron Applicators (modelled as arectangular prism). ClearCheckalso simulates the on-boardimaging (OBI) arms as arectangular prism. User can definea warning distance that adds amargin to the shapes in thesimulation.		Sufficient performance datahas been collated and showsthe software functionseffectively to achieve itsintended use.
Collision check output	Collisions Check tests thousands ofsample points against CT data andpatient and couch structures andreports the number of samplepoints that resulted in a collision.Collision Check also displays thesesample point test results with a 3Ddisplay and an axial 2D image planviewer for the user to inspect theresults.	MapRT presents a Clearance Map tothe user using the couch (x axis) andgantry (y axis) to show collision-freeangles and angles resulting in acollision at any given isocentre.MapRT also displays these anglesvisually using the acquired patientand accessory surfaces and pre-loaded models of the couch andgantry. The user can interact with theClearance Map to inspect clearanceat any couch / gantry angle andisocentre.	Minor differences with thepredicate device. TheClearance Map generated byMapRT is interactive,allowing the user to inspectthe results at any angle orisocentre.This minor difference doesnot affect the safety oreffectiveness of the device.MapRT works as intended.Sufficient performance datahas been collated and showsthe software functionseffectively to achieve itsintended use.
	Predicate device(ClearCheck Model RADCC V2)	Subject device(MapRT)	Comments
Dose optimisation	Collisions Check tests thousands ofsample points against CT data andpatient and couch structures andreports the number of samplepoints that resulted in a collision.Collision Check also displays thesesample point test results with a 3Ddisplay and an axial 2D image planviewer for the user to inspect theresults.	MapRT presents a Clearance Map tothe user This map displays whichcouch / gantry angles and isocentreswould result in a collision duringtreatment, and which are available toenhance the dose distribution.	Minor differences with thepredicate device. Thepredicate checks a singleplan for collisions andprovides binary data onwhether or not a collision ispredicted. Whereas, theClearance Map generated byMapRT allows the user toidentify all combinations ofcouch / gantry and isocentreavailable to enhance thedose distribution.This minor difference doesnot affect the safety oreffectiveness of the device.MapRT works as intended.Sufficient performance datahas been collated and showsthe software functionseffectively to achieve itsintended use.

{6}------------------------------------------------

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.

{7}------------------------------------------------

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.

{8}------------------------------------------------

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.

{9}------------------------------------------------

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.

{10}------------------------------------------------

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.

{11}------------------------------------------------

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.

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.