The DORADOnova MR3T system assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system. The position coordinates are typically chosen by the operator or provided by an external system (e.g. treatment planning system). The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla.

Device Description

The LAP moving laser positioning system contains laser devices and a control system. The laser system is provided in a configuration that enables the movement of two projection planes by using an appropriate composition of motorized and fixed laser devices. The installation of the system is realized in a combined bridge solution.

AI/ML Overview

This FDA 510(k) summary (K173926) describes the DORADOnova MR3T system, a medical device used for reproducible patient positioning during radiation therapy planning. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for an AI/algorithm-driven device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those related to AI/algorithm performance, ground truth establishment, expert adjudication, and MRMC studies) are not applicable to this specific device and document, as it is a laser positioning system, not an AI-powered diagnostic or therapeutic device.

However, based on the provided text, I can extract the relevant performance specifications and how they were tested.

Device Name: DORADOnova MR3T (LAP moving laser positioning system)

Device Type: Medical charged-particle radiation therapy system (21 CFR 892.5050, Class II) - Specifically, a laser positioning system.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical positioning device and not an AI/algorithm, "acceptance criteria" are tied to its physical specifications and safety standards, largely demonstrated through bench testing and compliance with recognized standards.

Feature / Criterion	Acceptance Criteria (Stated or Implied)	Reported Device Performance / Characteristics
Intended Use	Must assist in reproducible patient positioning during radiation therapy planning and be utilized during treatment planning workflow, by projecting visual laser beams positionable at specified coordinates. Must be usable in MR environment (≤ 3 Tesla).	The DORADOnova MR3T system "assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system... The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla." (Identical to intended use).
Functional Principle	Must use projection of visual light/laser lines on the patient's skin surface, with reflection aiding medical staff to determine patient's position.	"Projection of a visual laser lines on the patient's skin surface. Reflection of the laser lines aide's professional medical staff to determine the patient's position." (Similar to predicate/reference devices).
Patient Reference Position Information	Must allow coordinates for 3 laser intersection points to be manually input or imported from a treatment planning system for reproducible patient positioning.	"The patient reference position information is the coordinates for 3 laser intersection points. They are either manually input into the device by the operator or imported from the treatment planning system." (Similar to predicate/reference devices).
Positioning Accuracy	Must be comparable to or better than predicate/reference devices. Reference device: +/- 0.1 mm. Predicate device: max mean: 0.27mm; max std dev: 0.65mm.	+/- 0.1 mm (Matches reference device performance, superior to predicate device in terms of stated accuracy).
Resolution / Line Width	Must be comparable to or better than predicate/reference devices. Reference device: <1 mm at 4m distance. Predicate device: <1 mm.	0.5 mm (blue) at 4m distance; <1 mm (red&green) at 4m distance (Meets or exceeds criteria, blues is better than reference).
Compatibility with MR Environment	Must be safe and perform as intended in MR environments up to 3 Tesla.	"For use in hospital environment, including MRI environment up to and including 3 Tesla. MRI safety testing and labeling of the proposed device are in accordance with applicable ASTM standards. Bench testing in MR environment up to three Tesla did not show any negative impact on the performance of the proposed device." (Meets criterion).
Electrical Safety	Must comply with IEC 60601-1.	"The proposed device has been tested in respect to electrical and mechanical safety in accordance with IEC 60601-1..." (Complies).
EMC	Must comply with IEC 60601-1-2.	"...EMC in accordance with IEC 60601-1-2..." (Complies).
Laser Safety	Must comply with IEC 60825-1 and U.S. performance standard 21CFR 1040.10. Laser Class 2.	"...laser safety in accordance with IEC 60825-1. The proposed device complies with U.S. performance standard 21CFR 1040.10." and "Laser Class: 2." (Complies).
Bio-compatibility	Must have no contact with patient.	"No contact with patient." (Identical to predicate/reference devices, indicating compliance with the implicit "no patient contact" requirement for biocompatibility).

Study Details for DORADOnova MR3T Performance:

This device's performance demonstration relies on engineering specifications, adherence to international safety standards, and bench testing, rather than a clinical study in the typical sense for AI/diagnostic devices.

Sample Size Used for the Test Set and Data Provenance:
- Not applicable in the typical AI/diagnostic study sense.
- Performance testing described is focused on physical properties, safety, and compatibility. Tests were likely conducted on a defined number of device units or prototypes. Data provenance is implied to be from internal company testing conducted in Germany (location of LAP GmbH Laser Applikationen).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth for device performance (e.g., accuracy, resolution, safety compliance) is established through standardized engineering measurements and compliance with regulatory standards, not expert clinical interpretation of data.
Adjudication Method for the Test Set:
- Not applicable. This falls under engineering and regulatory compliance testing, not clinical diagnosis where adjudication is needed.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. This is not an AI-assisted diagnostic or CAD device requiring MRMC studies. Its function is to project light for patient positioning.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. This is a physical system with an operator, not an AI algorithm. Its performance directly relates to its ability to project lasers with specified accuracy.
The Type of Ground Truth Used:
- Engineering/Physical Measurement Ground Truth: For parameters like accuracy, resolution, and line width, the ground truth is established by precise metrological measurements using calibrated equipment.
- Standard Compliance Ground Truth: For safety (electrical, laser, EMC, MRI), the "ground truth" is adherence to the specified international and national standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, 21 CFR 1040.10, ASTM standards for MRI safety).
The Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI models that require a "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.

Summary

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

Image /page/0/Picture/0 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.

LAP GmbH Laser Applikationen % Martin Pfabel Director Quality Management & Regulatory Affairs Zeppelinstrasse 23 LUENEBURG, GERMANY 21337

September 14, 2018

Re: K173926

Trade/Device Name: DORADOnova MR3T Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: August 16, 2018 Received: August 20, 2018

Dear Mr. Pfabel:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

Jeff Bolger

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173926

Device Name DORADOnova MR3T

Indications for Use (Describe)

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}------------------------------------------------

510(k) Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act, LAP GmbH Laser Applikationen herewith submits a Summary of Safety and Effectiveness. This 510(k) summary for the LAP moving laser positioning system meets the requirements of 21 CFR 807.92.

Submitter information:	LAP GmbH Laser Applikationen
	Zeppelinstrasse 23
	21337 Lueneburg
	Phone: +49 4131 9511267
	Fax: +49 4131 951196
	Establishment Registration Number: 9681134
	Owner/Operator Number: 9019434
Official Correspondent:	Martin Pfabel
	Zeppelinstrasse 23
	21337 Lueneburg
	Germany
	Phone: +49 4131 9511267
	Email: m.pfabel@lap-laser.com
US Agent (Contact):	Trent Van Arkel
	LAP of America Laser Applications, L.C.
	161 Commerce Rd Ste 3
	Boynton Beach, FL 33426
	Phone: 561 4169250
	Fax: 561 4169263
	Email: Tava@Lap-Laser.com
Date Prepared:	September 13th, 2018

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

Device(s) Identification:

Device trade name:	DORADOnova MR3T
Common name:	Radiotherapy positioning system

Classification of the device:

Device Classification Name:

Product Code: C.F.R. Section .: Classification Panel: Device Class:

Medical charged-particle radiation therapy system IYE 892.5050 Radiology devices Class II

Device Description:

Indications for use:

Predicate device:

Device Name: 510k number: Device Classification Name:

Product Code: C.F.R. Section .: Classification Panel: Device Class:

Reference device:

Device Name: 510k number: Device Classification Name: Product Code: C.F.R. Section .: Classification Panel: Device Class:

AlianRT K052682 System, radiation therapy, chargeparticle IYE 892.5050 Radiology devices Class II

CT Sim Laser Alignment System K152303 Light beam patient position indicator IWE 892.5780 Radiology devices Class I

LAP GmbH Laser Applikationen

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

Comparison to predicate device:

The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate devices and the proposed device.

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

Parameter	Predicate device	Reference device	Proposed device	Evaluation
	Vision RT AlignRT	CT Sim LaserAlignment System	DORADOnova MR3T
Intended Use	The AlignRT system isused to position patients atthe isocentre of the linearaccelerator for radiationtherapy procedures. Patientcontour data can beextracted and exportedfrom the acquired data forthe purpose of treatmentplanningAlignRT is used byradiotherapy professionalsin appropriate hospitalenvironments It can beused with all types ofradiotherapy patients andcan image any visibleanatomical region. Thesystem is completelynoninvasive and does notrequire the application ofany external markers to thepatient.	The CT Sim LaserSystem is used in thesimulation stage ofradiation therapy toprepare a patient fortreatment. The lasers canbe moved to apoint that defines theisocenter in the CT suite.The Gammex CT Sim isintended to read laserpositioning coordinates in aGammex specified softwareformat from a file in ashared folder. Typically thecoordinates were calculatedby a Radiation TherapyTreatment Planning System(RTPS) using CT imagesand sent to the HospitalInformation System (HIS),Oncology System (OIS) orother system, by the RTPS.	The DORADOnova MR3Tsystem assists inreproducible patientpositioning duringradiation therapy planningand is utilized duringtreatment planningworkflow. TheDORADOnova MR3Tsystem projects visuallaser beams which can bepositioned at specifiedcoordinates via a controlsystem. The positioncoordinates are typicallychosen by the operator orprovided by an externalsystem (e.g. treatmentplanning system). TheDORADOnova MR3Tsystem is allowed to beused in MR environmentwith a magnetic field, lessor equal to 3 Tesla.	SimilarThe devices are intendedto be used duringtreatment planning toassist in patientpositioning for radiationtherapy procedures. Inaddition AlignRT is used toassure patientsreproducible positioningduring radiation therapyprocedures. The devicesachieve their intended usecompletely noninvasiveand are not limited tocertain types ofradiotherapy patients.Both devices are intendedto be used in a hospitalenvironment byprofessional medical staff,involved in treatment ofradiotherapy patients.Patient data can bereceived from treatmentplanning systems.
Parameter	Predicate device	Reference device	Proposed device	Evaluation
	Vision RT AlignRT	CT Sim LaserAlignment System	DORADOnova MR3T
Functionalprinciple	Projection of a visual lightpattern on the patient's skinsurface.The pattern is detected bytwo 3D cameras todetermine the patient'sposition relative to a storedreference image.	Projection of a visual laserlines on the patient's skinsurface.Reflection of the laser linesaide's professional medicalstaff to determine thepatient's position.	Projection of a visual laserlines on the patient's skinsurface.Reflection of the laserlines aide's professionalmedical staff to determinethe patient's position.	SimilarThe devices project visuallight on the patient's skin. Itsreflection is used to determinethe position of the patientrelative to the treatmentdevice.Whereas the Predicate deviceprojects a visual light patternthat consists of pattern ofpoints, the proposed deviceand the reference device uselaser sources to create 3specific intersection points,projected on the patient skin.Therefore, the functionalprinciple can be regarded asequivalent.
Patientreferencepositioninformation	The patient referenceposition information is areference surface image. Itis acquired either by thedevice or imported from atreatment planning system.A surface image consistingof thousands of points isacquired at the treatmentdevice and compared tothe reference image forreproducible patientpositioning on thetreatment device.	The patient referenceposition information is thecoordinates for 3 laserintersection points. Theyare either manually inputinto the device by theoperator or imported fromthe treatment planningsystem.External fiducial markersare placed on thesurface of the skin at the3 laser intersectionpoints for reproduciblepatient positioning onexternal patientalignment lasers on thetreatment device.	The patient referenceposition information isthe coordinates for 3laser intersection points.They are either manuallyinput into the device bythe operator or importedfrom the treatmentplanning system.External fiducial markersare placed on thesurface of the skin at the3 laser intersectionpoints for reproduciblepatient positioning onexternal patientalignment lasers on thetreatment device.	SimilarIn all devices, patientreference position informationis either created during theworkflow by the operator orthe device itself or is importedfrom the treatment planningsystem.
Parameter	Predicate deviceVision RT AlignRT	Reference deviceCT Sim LaserAlignment System	Proposed deviceDORADOnova MR3T	Evaluation
Prescriptionuse only	yes	yes	yes	Identical
Targetpopulation	Any individual (adult orchild) undergoingradiotherapy.	Any individual (adult orchild) undergoingradiotherapy.	Any individual (adult orchild) undergoingradiotherapy.	Identical
User interface	Desktop-PC	Tablet, Desktop-PC	Desktop PC withTouchscreen	Identical
Projectionsources	2 or 3	3 or 5	3	SimilarReference device can havetwo additional projectionsources
TPS Datalmport	DICOM	Text & DICOM	Text & DICOM	SimilarWhile the predicate device iscapable of importing DICOMdata, the reference and theProposed device are alsocapable of importing data intext format
Device setup	Projection sources and 3Dcameras rigidly mounted tothe ceiling.	Projection sources rigidlymounted to the ceiling, wall,post or bridge setup	Projection sources rigidlymounted as a bridge setup	SimilarAll devices are rigidlymounted in the diagnostic ortreatment room they are usedin. The devices are mountedto the ceiling, the walls or thefloor. All devices require aninstallation process.In addition, the reference andthe proposed devices sourcesare capable of controlledmovement inside the deviceshousing.
Resolution/line width	<1 mm	<1 mm at 4m distance	0.5 mm (blue) at 4mdistance<1 mm (red&green) at 4mdistance	Similar
Parameter	Predicate deviceVision RT AlignRT	Reference deviceCT Sim LaserAlignment System	Proposed deviceDORADOnova MR3T	Evaluation
Positioningaccuracy	System accuracy: Errorsalong each of 3 axes oftreatment: max mean:0.27mm; max std dev:0.65mm.	+/- 0.1 mm	+/- 0.1 mm	Similar
Bio-compatibility	No contact with patient	No contact with patient	No contact with patient	Identical
Anatomicaluse sites	Entire body surface	Entire body surface	Entire body surface	Identical
Compatibilitywith theenvironmentand otherdevices	Cleared for use in hospitalenvironment	Cleared for use in hospitalenvironment	For use in hospitalenvironment, includingMRI environment up toand including 3 Tesla.	SimilarThe proposed device can alsobe used in MR environmentup to and including threeTesla. MRI safety testing andlabeling of the proposeddevice are in accordance withapplicable ASTM standards.Bench testing in MRenvironment up to three Tesladid not show any negativeimpact on the performance ofthe proposed device.
Laser Class	Laser specific (predicatedevice does not containlaser)	2	2	Identical
Available lasercolors	Laser specific (predicatedevice does not containlaser)	red, green, blue	red, green, blue	Identical
Line length(distributionangle)	Laser specific (predicatedevice does not containlaser)	>2m at 4m (30°)	3m at 3m (53°)	SimilarThe wider distribution angleleads to a longer line length.This would equal 4m at 4m.
Parameter	Predicate deviceVision RT AlignRT	Reference deviceCT Sim LaserAlignment System	Proposed deviceDORADOnova MR3T	Evaluation
				Therefore the safety andeffectiveness is not impairedin comparison to the predicatedevice.

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

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

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

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

Summary of performance testing:

The proposed device has been tested in respect to electrical and mechanical safety in accordance with IEC 60601-1, EMC in accordance with IEC 60601-1-2 and laser safety in accordance with IEC 60825-1. MRI safety has been tested in accordance with applicable ASTM standards. The proposed device complies with U.S. performance standard 21CFR 1040.10.

Conclusion:

LAP GmbH Laser Applikationen believes that the LAP moving laser positioning system is substantially equivalent to currently legally marketed devices. This device does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.

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.