(266 days)
Not Found
No
The description focuses on standard image processing and registration algorithms, with no mention of AI or ML terms, training/test sets, or performance metrics typically associated with AI/ML devices.
No.
The device is used for patient positioning and motion monitoring during radiotherapy and radiosurgery treatments, which are therapeutic procedures, but the device itself does not deliver therapy or directly treat a disease.
No
The device is used for patient positioning and motion monitoring during radiotherapy and radiosurgery, not for diagnosing medical conditions.
No
The device description explicitly states it is an "optical camera system" that "captures the current 3D patient skin surface with one or multiple camera pods," indicating the presence of hardware components beyond just software.
Based on the provided information, the LAP LUNA 3D system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used for "reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning." This is a function related to patient setup and monitoring during a medical procedure, not for examining specimens from the human body to provide diagnostic information.
- Device Description: The description details an "optical camera system" that captures the "3D patient skin surface" and calculates "spacial deviations." This is a surface imaging and tracking system, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
In summary, the LAP LUNA 3D system is a medical device used for patient positioning and motion monitoring during radiation therapy and simulation, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
IYE
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.
Mentions image processing
Video based imaging of 3D skin surface data using surface matching software.
3D imaging of the patients surfaces and comparison with reference surfaces.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and CT simulation for radiation therapy planning.
Any individual of any age undergoing radiotherapy.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positioning accuracy: Target registration errors (as measured using calibration phantom)
§ 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.
0
March 29, 2024
Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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).
1
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
2
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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 LUNA 3D meets the requirements of 21 CFR 807.92.
| Submitter information: | LAP GmbH Laser Applikationen
Zeppelinstrasse 23
21337 Lueneburg
Phone: +49 4131 951167
Fax: +49 4131 951196 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 9681134
Owner/Operator Number: 9019434 |
| Official Correspondent: | Sebastian Boldhaus
Zeppelinstrasse 23
21337 Lueneburg
Germany
Phone: +49 4131 9511357
Email: s.boldhaus@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: | 28th of March 2024 |
4
Device(s) Identification:
| Device trade name: | LUNA 3D |
|---|---|
| Common name: | Surface Guided Radio Therapy System (Patient |
| 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 |
5
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
Plus | LAP LUNA 3D | Comment |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The AlignRT Plus
system is indicated for
use to position and
monitor patients
relative to the
prescribed treatment
isocenter, and to
withhold the beam
automatically during
radiation delivery. For
cranial treatments, a
manual head adjuster
is included which can
be used in concert with
AlignRT Plus to
provide fine
corrections for pitch,
roll and yaw rotations.
AlignRT Plus is also
used to track the
patient's respiratory
pattern for respiratory
synchronized image
acquisition, and
radiation therapy
treatment. Patient
contour data can be
extracted and exported
from the data acquired
for the purpose of
treatment planning.
AlignRT Plus can be
calibrated directly to
the treatment beam
isocenter and in turn
assists in performing
quality assurance on
MV, kV imagers, room
lasers and the | 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. | Similar
Even though the
Indication for use of the
predicate device is more
detailed, the core
functions remain the
same.
Both devices are used
for positioning the
patients and monitoring
the patients position
during radiotherapy
treatment. Both devices
can be used to monitor
the respiratory pattern of
the patients. Both
devices can be used to
acquire a reference
surface or import data to
be used as a reference
(e.g. DICOM).
The LAP LUNA 3D
device cannot be used to
withhold the beam
automatically during
radiotherapy.
Furthermore, the LAP
device comes not with
head adjuster for cranial
treatment. |
| | Vision RT AlignRT
Plus | LAP LUNA 3D | Comment |
| | treatment couch.
AlignRT Plus may be
used during
simulation, setup and
stereotactic
radiosurgery and
precision radiotherapy
for lesions, tumors and
conditions anywhere in
the body where
radiation is indicated. | | |
| Principle of
operation | Video based imaging
of 3D skin surface data
using surface
matching software. | 3D imaging of the
patients surfaces and
comparison with
reference surfaces. | Identical |
| Target
population | Any individual (adult or
child) undergoing
radiotherapy. | Any individual of any age
undergoing radiotherapy. | Identical |
| Components | PC workstation,
cables, video cameras.
Block Polystyrene
(calibration phantom),
carbon fibre laminate
material (head
adjuster). | PC workstation, cables,
camera pods (video
cameras and a projector
unit).
Calibration phantom,
made of plastic. | Similar
The LAP LUNA 3D
device does not contain
a head adjuster |
| System
performance
and accuracy | Positioning accuracy:
Target registration
errors (as measured
using calibration
phantom)