DORADOnova MR3T

K173926 · Lap GmbH Laser Applikationen · IYE · Sep 14, 2018 · Radiology

Device Facts

• Record ID: K173926
• Device Name: DORADOnova MR3T
• Applicant: Lap GmbH Laser Applikationen
• Product Code: IYE · Radiology
• Decision Date: Sep 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

DORADOnova MR3T is a motorized laser positioning system for radiation therapy planning; projects visual laser beams onto patient skin to define isocenter coordinates. Coordinates are manually input by operator or imported from external treatment planning systems (TPS) via text or DICOM. System consists of motorized and fixed laser devices in a bridge configuration; operated by medical staff in hospital environments, including MRI suites up to 3 Tesla. Provides visual reference for patient alignment; assists in reproducible positioning for radiation therapy. Does not contact patient; non-invasive.

Clinical Evidence

Bench testing only. Testing included electrical and mechanical safety (IEC 60601-1), EMC (IEC 60601-1-2), laser safety (IEC 60825-1), and MRI safety per ASTM standards. Compliance with 21 CFR 1040.10 confirmed.

Technological Characteristics

Motorized laser positioning system; bridge configuration. Projects red, green, or blue laser lines (Class 2). Positioning accuracy +/- 0.1 mm. Connectivity via DICOM/text import from TPS. User interface: Desktop PC with touchscreen. MR compatible up to 3 Tesla. Sterilization: N/A (no patient contact).

Indications for Use

Indicated for any individual (adult or child) undergoing radiation therapy, assisting in reproducible patient positioning during treatment planning workflow.

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

• Vision RT AlignRT (K052682)

Reference Devices

• CT Sim Laser Alignment System (K152303)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| <span> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 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: [phone] |
| | Fax: [phone] |
| | Establishment Registration Number: 9681134 |
| | Owner/Operator Number: 9019434 |
| Official Correspondent: | Martin Pfabel |
| | Zeppelinstrasse 23 |
| | 21337 Lueneburg |
| | Germany |
| | Phone: [phone] |
| | Email: [e-mail] |
| US Agent (Contact): | Trent Van Arkel |
| | LAP of America Laser Applications, L.C. |
| | 161 Commerce Rd Ste 3 |
| | Boynton Beach, FL 33426 |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared: | September 13th, 2018 |

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# 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:

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.

### Indications for use:

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.

# 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

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# 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.

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| Parameter | Predicate device | Reference device | Proposed device | Evaluation |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Vision RT AlignRT | CT Sim Laser<br>Alignment System | DORADOnova MR3T | |
| Intended Use | The AlignRT system is<br>used to position patients at<br>the isocentre of the linear<br>accelerator for radiation<br>therapy procedures. Patient<br>contour data can be<br>extracted and exported<br>from the acquired data for<br>the purpose of treatment<br>planning<br>AlignRT is used by<br>radiotherapy professionals<br>in appropriate hospital<br>environments It can be<br>used with all types of<br>radiotherapy patients and<br>can image any visible<br>anatomical region. The<br>system is completely<br>noninvasive and does not<br>require the application of<br>any external markers to the<br>patient. | The CT Sim Laser<br>System is used in the<br>simulation stage of<br>radiation therapy to<br>prepare a patient for<br>treatment. The lasers can<br>be moved to a<br>point that defines the<br>isocenter in the CT suite.<br>The Gammex CT Sim is<br>intended to read laser<br>positioning coordinates in a<br>Gammex specified software<br>format from a file in a<br>shared folder. Typically the<br>coordinates were calculated<br>by a Radiation Therapy<br>Treatment Planning System<br>(RTPS) using CT images<br>and sent to the Hospital<br>Information System (HIS),<br>Oncology System (OIS) or<br>other system, by the RTPS. | The DORADOnova MR3T<br>system assists in<br>reproducible patient<br>positioning during<br>radiation therapy planning<br>and is utilized during<br>treatment planning<br>workflow. The<br>DORADOnova MR3T<br>system projects visual<br>laser beams which can be<br>positioned at specified<br>coordinates via a control<br>system. The position<br>coordinates are typically<br>chosen by the operator or<br>provided by an external<br>system (e.g. treatment<br>planning system). The<br>DORADOnova MR3T<br>system is allowed to be<br>used in MR environment<br>with a magnetic field, less<br>or equal to 3 Tesla. | Similar<br>The devices are intended<br>to be used during<br>treatment planning to<br>assist in patient<br>positioning for radiation<br>therapy procedures. In<br>addition AlignRT is used to<br>assure patients<br>reproducible positioning<br>during radiation therapy<br>procedures. The devices<br>achieve their intended use<br>completely noninvasive<br>and are not limited to<br>certain types of<br>radiotherapy patients.<br>Both devices are intended<br>to be used in a hospital<br>environment by<br>professional medical staff,<br>involved in treatment of<br>radiotherapy patients.<br>Patient data can be<br>received from treatment<br>planning systems. |
| Parameter | Predicate device | Reference device | Proposed device | Evaluation |
| | Vision RT AlignRT | CT Sim Laser<br>Alignment System | DORADOnova MR3T | |
| Functional<br>principle | Projection of a visual light<br>pattern on the patient's skin<br>surface.<br>The pattern is detected by<br>two 3D cameras to<br>determine the patient's<br>position relative to a stored<br>reference image. | Projection of a visual laser<br>lines on the patient's skin<br>surface.<br>Reflection of the laser lines<br>aide's professional medical<br>staff to determine the<br>patient's position. | Projection of a visual laser<br>lines on the patient's skin<br>surface.<br>Reflection of the laser<br>lines aide's professional<br>medical staff to determine<br>the patient's position. | Similar<br>The devices project visual<br>light on the patient's skin. Its<br>reflection is used to determine<br>the position of the patient<br>relative to the treatment<br>device.<br>Whereas the Predicate device<br>projects a visual light pattern<br>that consists of pattern of<br>points, the proposed device<br>and the reference device use<br>laser sources to create 3<br>specific intersection points,<br>projected on the patient skin.<br>Therefore, the functional<br>principle can be regarded as<br>equivalent. |
| Patient<br>reference<br>position<br>information | The patient reference<br>position information is a<br>reference surface image. It<br>is acquired either by the<br>device or imported from a<br>treatment planning system.<br>A surface image consisting<br>of thousands of points is<br>acquired at the treatment<br>device and compared to<br>the reference image for<br>reproducible patient<br>positioning on the<br>treatment device. | The patient reference<br>position information is the<br>coordinates for 3 laser<br>intersection points. They<br>are either manually input<br>into the device by the<br>operator or imported from<br>the treatment planning<br>system.<br>External fiducial markers<br>are placed on the<br>surface of the skin at the<br>3 laser intersection<br>points for reproducible<br>patient positioning on<br>external patient<br>alignment lasers on the<br>treatment device. | The patient reference<br>position information is<br>the coordinates for 3<br>laser intersection points.<br>They are either manually<br>input into the device by<br>the operator or imported<br>from the treatment<br>planning system.<br>External fiducial markers<br>are placed on the<br>surface of the skin at the<br>3 laser intersection<br>points for reproducible<br>patient positioning on<br>external patient<br>alignment lasers on the<br>treatment device. | Similar<br>In all devices, patient<br>reference position information<br>is either created during the<br>workflow by the operator or<br>the device itself or is imported<br>from the treatment planning<br>system. |
| Parameter | Predicate device<br>Vision RT AlignRT | Reference device<br>CT Sim Laser<br>Alignment System | Proposed device<br>DORADOnova MR3T | Evaluation |
| Prescription<br>use only | yes | yes | yes | Identical |
| Target<br>population | Any individual (adult or<br>child) undergoing<br>radiotherapy. | Any individual (adult or<br>child) undergoing<br>radiotherapy. | Any individual (adult or<br>child) undergoing<br>radiotherapy. | Identical |
| User interface | Desktop-PC | Tablet, Desktop-PC | Desktop PC with<br>Touchscreen | Identical |
| Projection<br>sources | 2 or 3 | 3 or 5 | 3 | Similar<br>Reference device can have<br>two additional projection<br>sources |
| TPS Data<br>lmport | DICOM | Text & DICOM | Text & DICOM | Similar<br>While the predicate device is<br>capable of importing DICOM<br>data, the reference and the<br>Proposed device are also<br>capable of importing data in<br>text format |
| Device setup | Projection sources and 3D<br>cameras rigidly mounted to<br>the ceiling. | Projection sources rigidly<br>mounted to the ceiling, wall,<br>post or bridge setup | Projection sources rigidly<br>mounted as a bridge setup | Similar<br>All devices are rigidly<br>mounted in the diagnostic or<br>treatment room they are used<br>in. The devices are mounted<br>to the ceiling, the walls or the<br>floor. All devices require an<br>installation process.<br>In addition, the reference and<br>the proposed devices sources<br>are capable of controlled<br>movement inside the devices<br>housing. |
| Resolution/<br>line width | <1 mm | <1 mm at 4m distance | 0.5 mm (blue) at 4m<br>distance<br><1 mm (red&green) at 4m<br>distance | Similar |
| Parameter | Predicate device<br>Vision RT AlignRT | Reference device<br>CT Sim Laser<br>Alignment System | Proposed device<br>DORADOnova MR3T | Evaluation |
| Positioning<br>accuracy | System accuracy: Errors<br>along each of 3 axes of<br>treatment: max mean:<br>0.27mm; max std dev:<br>0.65mm. | +/- 0.1 mm | +/- 0.1 mm | Similar |
| Bio-<br>compatibility | No contact with patient | No contact with patient | No contact with patient | Identical |
| Anatomical<br>use sites | Entire body surface | Entire body surface | Entire body surface | Identical |
| Compatibility<br>with the<br>environment<br>and other<br>devices | Cleared for use in hospital<br>environment | Cleared for use in hospital<br>environment | For use in hospital<br>environment, including<br>MRI environment up to<br>and including 3 Tesla. | Similar<br>The proposed device can also<br>be used in MR environment<br>up to and including three<br>Tesla. MRI safety testing and<br>labeling of the proposed<br>device are in accordance with<br>applicable ASTM standards.<br>Bench testing in MR<br>environment up to three Tesla<br>did not show any negative<br>impact on the performance of<br>the proposed device. |
| Laser Class | Laser specific (predicate<br>device does not contain<br>laser) | 2 | 2 | Identical |
| Available laser<br>colors | Laser specific (predicate<br>device does not contain<br>laser) | red, green, blue | red, green, blue | Identical |
| Line length<br>(distribution<br>angle) | Laser specific (predicate<br>device does not contain<br>laser) | >2m at 4m (30°) | 3m at 3m (53°) | Similar<br>The wider distribution angle<br>leads to a longer line length.<br>This would equal 4m at 4m. |
| Parameter | Predicate device<br>Vision RT AlignRT | Reference device<br>CT Sim Laser<br>Alignment System | Proposed device<br>DORADOnova MR3T | Evaluation |
| | | | | Therefore the safety and<br>effectiveness is not impaired<br>in comparison to the predicate<br>device. |

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### 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.