LUNA 3D
Device Facts
| Record ID | K232031 |
|---|---|
| Device Name | LUNA 3D |
| Applicant | Lap GmbH Laser Applikationen |
| Product Code | IYE · Radiology |
| Decision Date | Mar 29, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
Indications for Use
The LAP LUNA 3D system is used to support reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning. LAP LUNA 3D may also be used to guide patients through breath-holds. The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and CT simulation for radiation therapy planning.
Device Story
LUNA 3D is an optical camera system for radiotherapy and CT simulation. It captures 3D patient skin surface data using camera pods that project a visible blue pattern onto the patient. Software compares the live surface to a reference surface (generated by the system or imported via DICOM) using a registration algorithm. The system calculates spatial deviations to assist clinicians in positioning the patient relative to the treatment isocenter and monitors motion during treatment to ensure it remains within predefined tolerances. Used in clinical settings (radiotherapy/radiosurgery suites, CT simulation rooms) by medical staff. Output is displayed to the user to guide patient positioning and monitor stability. Benefits include improved reproducibility of patient positioning and motion monitoring during radiation delivery.
Clinical Evidence
Bench testing only. Testing included electrical/mechanical safety (IEC 60601-1), EMC (IEC 60601-1-2), and photobiological safety (IEC 60601-2-57, IEC 62471). Non-clinical performance testing evaluated warm-up drift, latency, and multi-camera accuracy. Target registration errors were measured using a calibration phantom and found to be < 0.5mm.
Technological Characteristics
Optical camera system with camera pods (video cameras and projector unit). Projects visible blue light pattern. PC workstation, cables, and plastic calibration phantom. Connectivity via 100 Mbit/s local hospital network. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471. Software-based registration algorithm.
Indications for Use
Indicated for all patients undergoing radiotherapy, radiosurgery, and CT simulation for radiation therapy planning. Used for reproducible patient positioning, monitoring patient surface motion, and guiding patients through breath-holds.
Regulatory Classification
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Predicate Devices
- AlignRT Plus (K212583)
Submission Summary (Full Text)
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March 29, 2024
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LAP GmbH Laser Applikationen % Sebastian Boldhaus Regulatory Affairs Manager Zeppelinstraße 23 Lüneburg, 21337 GERMANY
#### Re: K232031
Trade/Device Name: Luna 3D Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: July 6, 2023 Received: July 7, 2023
Dear Sebastian Boldhaus:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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.
Loca Werther
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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## Indications for Use
1 of 1 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
K232031
Device Name
LUNA 3D
Indications for Use (Describe)
The LAP LUNA 3D system is used to support reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning. LAP LUNA 3D may also be used to guide patients through breath-holds. The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and CT simulation for radiation therapy planning.
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)
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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 LUNA 3D meets the requirements of 21 CFR 807.92.
| Submitter information: | LAP GmbH Laser Applikationen<br>Zeppelinstrasse 23<br>21337 Lueneburg<br>Phone: +49 4131 951167<br>Fax: +49 4131 951196 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 9681134<br>Owner/Operator Number: 9019434 |
| Official Correspondent: | Sebastian Boldhaus<br>Zeppelinstrasse 23<br>21337 Lueneburg<br>Germany<br>Phone: +49 4131 9511357<br>Email: s.boldhaus@lap-laser.com |
| US Agent (Contact): | Trent Van Arkel<br>LAP of America Laser Applications, L.C.<br>161 Commerce Rd Ste 3<br>Boynton Beach, FL 33426<br>Phone: 561 4169250<br>Fax: 561 4169263<br>Email: Tava@Lap-Laser.com |
| Date Prepared: | 28th of March 2024 |
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# Device(s) Identification:
| Device trade name: | LUNA 3D |
|--------------------|---------------------------------------------------------------------------------------------------------|
| Common name: | Surface Guided Radio Therapy System (Patient<br>Positioning System – accessory to a linear accelerator) |
#### 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 LUNA 3D optical camera system captures the current 3D patient skin surface with one or multiple camera pods. The software calculates the spacial deviations between the captured live surface and a reference surface within a selected region of interest using a registration algorithm. Reference surfaces may be generated with the optical camera system or may be imported using data received from Treatment Planning Systems (TPS). Based on the registration results the user can adjust the patient position for reproducible patient positioning relative to the treatment isocenter. During the imaging (simulation) and treatment delivery process, the system continuously calculates the deviations between live- and reference surface for patient motion monitoring to ensure that the patient position remains within pre-defined tolerances.
#### Indications for use:
The LAP LUNA 3D system is used to support reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning. LAP LUNA 3D may also be used to guide patients through breath-holds.
The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and CT simulation for radiation therapy planning.
#### Predicate device:
| Device Name: | AlignRT Plus |
|-----------------------------|---------------------------------------------------|
| 510k number: | K212583 |
| Device Classification Name: | Medical charged-particle radiation therapy system |
| Product Code: | IYE |
| C.F.R. Section.: | 892.5050 |
| Classification Panel: | Radiology devices |
| Device Class: | Class II |
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# Comparison to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate device and the proposed device.
| | Vision RT AlignRT<br>Plus | LAP LUNA 3D | Comment |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The AlignRT Plus<br>system is indicated for<br>use to position and<br>monitor patients<br>relative to the<br>prescribed treatment<br>isocenter, and to<br>withhold the beam<br>automatically during<br>radiation delivery. For<br>cranial treatments, a<br>manual head adjuster<br>is included which can<br>be used in concert with<br>AlignRT Plus to<br>provide fine<br>corrections for pitch,<br>roll and yaw rotations.<br>AlignRT Plus is also<br>used to track the<br>patient's respiratory<br>pattern for respiratory<br>synchronized image<br>acquisition, and<br>radiation therapy<br>treatment. Patient<br>contour data can be<br>extracted and exported<br>from the data acquired<br>for the purpose of<br>treatment planning.<br>AlignRT Plus can be<br>calibrated directly to<br>the treatment beam<br>isocenter and in turn<br>assists in performing<br>quality assurance on<br>MV, kV imagers, room<br>lasers and the | The LAP LUNA 3D<br>system is used to<br>support reproducible<br>patient positioning and<br>monitor patient surface<br>motion during<br>radiotherapy and<br>radiosurgery treatments<br>and during CT<br>simulation for radiation<br>therapy planning. LAP<br>LUNA 3D may also be<br>used to guide patients<br>through breath-holds.<br>The LAP LUNA 3D<br>system can be used for<br>all patients, undergoing<br>radiotherapy and<br>radiosurgery treatments<br>and CT simulation for<br>radiation therapy<br>planning. | Similar<br>Even though the<br>Indication for use of the<br>predicate device is more<br>detailed, the core<br>functions remain the<br>same.<br>Both devices are used<br>for positioning the<br>patients and monitoring<br>the patients position<br>during radiotherapy<br>treatment. Both devices<br>can be used to monitor<br>the respiratory pattern of<br>the patients. Both<br>devices can be used to<br>acquire a reference<br>surface or import data to<br>be used as a reference<br>(e.g. DICOM).<br>The LAP LUNA 3D<br>device cannot be used to<br>withhold the beam<br>automatically during<br>radiotherapy.<br>Furthermore, the LAP<br>device comes not with<br>head adjuster for cranial<br>treatment. |
| | Vision RT AlignRT<br>Plus | LAP LUNA 3D | Comment |
| | treatment couch.<br>AlignRT Plus may be<br>used during<br>simulation, setup and<br>stereotactic<br>radiosurgery and<br>precision radiotherapy<br>for lesions, tumors and<br>conditions anywhere in<br>the body where<br>radiation is indicated. | | |
| Principle of<br>operation | Video based imaging<br>of 3D skin surface data<br>using surface<br>matching software. | 3D imaging of the<br>patients surfaces and<br>comparison with<br>reference surfaces. | Identical |
| Target<br>population | Any individual (adult or<br>child) undergoing<br>radiotherapy. | Any individual of any age<br>undergoing radiotherapy. | Identical |
| Components | PC workstation,<br>cables, video cameras.<br>Block Polystyrene<br>(calibration phantom),<br>carbon fibre laminate<br>material (head<br>adjuster). | PC workstation, cables,<br>camera pods (video<br>cameras and a projector<br>unit).<br>Calibration phantom,<br>made of plastic. | Similar<br>The LAP LUNA 3D<br>device does not contain<br>a head adjuster |
| System<br>performance<br>and accuracy | Positioning accuracy:<br>Target registration<br>errors (as measured<br>using calibration<br>phantom) < 1mm<br>(0.5mm) for all couch<br>angles. Respiratory<br>tracking: Tracks<br>respiratory signal from<br>imaged surface data<br>and sends to CT (4D<br>CT) or to Linac or<br>imaging device<br>(gating). Surface<br>displacements can be<br>tracked with RMS<br>errors < 0.5mm over<br>10 or more breathing | Planned Positioning<br>accuracy: Target<br>registration errors (as<br>measured using<br>calibration phantom) <<br>0.5mm for all couch<br>angles. Respiratory<br>tracking: Tracks<br>respiratory signal from<br>imaged surface data.<br>Surface displacements<br>can be tracked with RMS<br>errors < 0.5mm over 10<br>or more breathing<br>cycles. | Similar<br>The LAP LUNA 3D does<br>not have a gating<br>function. |
| | Vision RT AlignRT<br>Plus | LAP LUNA 3D | Comment |
| | cycles. | | |
| omp | The AlignRT Plus<br>product requires no<br>direct contact with the<br>patient. | The LUNA 3D device<br>does not come into<br>contact with patients<br>during its intended use. | Similar<br>The LAP LUNA 3D<br>device does not contain<br>a head adjuster. |
| | The only interactions<br>between the user and<br>the system are with:<br>• the PC (in the control<br>room) or remote<br>workstation (in the<br>vault),<br>• the Remote Control<br>(in the vault),<br>• the Real Time Coach<br>(RTC) (in the vault), or<br>• the Head Adjuster (in<br>the vault).<br>• Calibration plate (in<br>the vault)<br>• Calibration cube (in<br>the vault)<br>• Calibration levelling<br>plate (in the vault)<br>The materials of the<br>devices (which are<br>commonly used in<br>light-industrial,<br>commercial and home<br>use) and that the<br>application only<br>involves intermittent<br>external contact with | The User does come into<br>contact with<br>commercially available<br>user interfaces such as<br>keyboards or<br>touchscreens of mobile<br>devices. Furthermore,<br>during calibration the<br>user does come into<br>contact with the<br>calibration cube. | |
| | Vision RT AlignRT<br>Plus | LAP LUNA 3D | Comment |
| | adjuster is clamped to<br>the treatment couch<br>through universal base<br>plate. | environment. | |
| Optical Pattern | Optical (near infra-red)<br>pattern is projected to<br>patient. | Optical visible blue<br>pattern is projected on<br>the patient's body<br>surface. | Similar<br>Optical pattern is<br>projected on the patient's<br>body surface. |
| Electrical<br>Standard | IEC 60601-1<br>compliant. | IEC 60601-1 compliant. | Identical |
| EMC Standard | IEC 60601-1-2<br>compliant. | IEC 60601-1-2<br>compliant. | Identical |
| Size and<br>Weight | The camera (key part<br>of the system) has the<br>following dimensions:<br>HD Cameras (each) –<br>470 x 220 x 70 – 4.5kg<br>Horizon cameras<br>(each) – 480 x 140 x<br>127 – 2.75kg InBore<br>optional camera<br>accessory - Ring<br>499mm diameter (plus<br>1mm protrusions) x<br>177mm wide (max) –<br>3.2kg | The camera pods have<br>the following dimensions:<br>540mm x 240mm x<br>95mm and a weight of<br>6.4 kg | Similar<br>LAP LUNA 3D system<br>cameras have similar<br>dimensions and weigh<br>as the Align RT horizon<br>camera. |
| Packaging | The system is<br>packaged in a variety<br>of boxes and then<br>packaged within<br>palletised crate. | System components will<br>be packed separately<br>and commissioned<br>based on the customers<br>order. All components<br>could be send separately<br>or shipped together. | Similar<br>Both devices are<br>provided separately<br>packed and<br>commissioned according<br>to request. |
| Environmental<br>range | AlignRT Plus is<br>intended for use at<br>altitudes below 3000m<br>(9,842ft). The<br>operating temperature<br>is +16°C to +30°C<br>(60.8° to 86°<br>Fahrenheit). The<br>shipping and storage<br>conditions are - 20°C | Operating<br>Temp: 15..30°C<br>Humidity: 25-80%<br>Altitude: <= 2000m<br>Storage<br>Temp: -10..+40°C | Similar:<br>Both devices have<br>almost identical<br>operating conditions.<br>However the Align RT<br>Device has a broader<br>storage temperature<br>range. |
| | Vision RT AlignRT<br>Plus | LAP LUNA 3D | Comment |
| | to +50°C (-4° to 122°<br>Fahrenheit). | | |
| Workstation<br>Operating<br>System | Windows 10 | Windows 10 IOT,<br>Windows Server 2022 | Similar:<br>Both devices use<br>Windows OS. |
| Power<br>requirements | 110-230V 50/60Hz | 110-240V 50/60Hz | Similar:<br>The maximum voltage<br>range of the LAP LUNA<br>3D is slightly higher, but<br>not relevant for the US<br>market. |
| Network<br>requirements | 10BaseT internet<br>connection behind a<br>local firewall. | 100 Mbit/s connected to<br>local hospital network | Similar:<br>LAP LUNA 3D device<br>has a secured 100 Mbit/s<br>network connection to<br>the local hospital<br>network. |
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Biocor
Mechanical
safety
Cameras are ceiling
mounted and do not contact patient or user.
The InBore camera
inside of the bore-
based linac. Head
solution is fixed to the
LAP LUNA 3D camera
mounted. Display device
The breath hold device is
clamped to the treatment
is rigidly wall mounted.
pods are ceiling
couch in patient
Similar
couch.
All components are
either rigidly mounted or
clamped to the treatment
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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 photobiological safety according to IEC 60601-2-57 and IEC 62471 respectively. Non-clinical performance testing in terms of warm-up drift, latency, and multi-camera accuracies of the camera pods has been conducted. The conducted tests verify the compliance to the established technical specifications and support the substantial equivalence to the predicate device.
## Conclusion:
LAP GmbH Laser Applikationen believes that the LUNA 3D is substantially equivalent to currently legally marketed devices. The device does not indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
