Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a laser positioning system controlled by an operator or external system, with no mention of AI/ML for positioning or other functions.

Therapeutic

No
The device aids in patient positioning and workflow for radiation therapy planning but does not deliver therapy itself.

Diagnostic

No

The device is described as assisting in reproducible patient positioning during radiation therapy planning and treatment, projecting visual laser beams for positioning. It does not perform any diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it contains "laser devices and a control system," indicating hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the DORADOnova MR3T system is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the system "assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow." This involves positioning the patient's body externally using laser beams.
Device Description: The description details a "moving laser positioning system" that projects visual laser beams onto the patient's body surface.
Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The DORADOnova MR3T system does not interact with or analyze any biological specimens.
Focus on External Positioning: The entire function of the device is to provide external visual guidance for positioning the patient's body for radiation therapy.

Therefore, the DORADOnova MR3T system falls under the category of a medical device used for external patient positioning, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

IYE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Entire body surface

Indicated Patient Age Range

Any individual (adult or child) undergoing radiotherapy.

Intended User / Care Setting

radiotherapy professionals in appropriate hospital environments, professional medical staff, involved in treatment of radiotherapy patients.

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K052682

Reference Device(s)

K152303

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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

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

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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)
☑ 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 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

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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
Alignment System	DORADOnova MR3T
Intended Use	The AlignRT system is
used to position patients at
the isocentre of the linear
accelerator for radiation
therapy procedures. Patient
contour data can be
extracted and exported
from the acquired data for
the purpose of treatment
planning
AlignRT is used by
radiotherapy professionals
in appropriate hospital
environments It can be
used with all types of
radiotherapy patients and
can image any visible
anatomical region. The
system is completely
noninvasive and does not
require the application of
any external markers to the
patient.	The CT Sim Laser
System is used in the
simulation stage of
radiation therapy to
prepare a patient for
treatment. The lasers can
be moved to a
point that defines the
isocenter in the CT suite.
The Gammex CT Sim is
intended to read laser
positioning coordinates in a
Gammex specified software
format from a file in a
shared folder. Typically the
coordinates were calculated
by a Radiation Therapy
Treatment Planning System
(RTPS) using CT images
and sent to the Hospital
Information System (HIS),
Oncology System (OIS) or
other system, by the RTPS.	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.	Similar
The devices are intended
to be used during
treatment planning to
assist in patient
positioning for radiation
therapy procedures. In
addition AlignRT is used to
assure patients
reproducible positioning
during radiation therapy
procedures. The devices
achieve their intended use
completely noninvasive
and are not limited to
certain types of
radiotherapy patients.
Both devices are intended
to be used in a hospital
environment by
professional medical staff,
involved in treatment of
radiotherapy patients.
Patient data can be
received from treatment
planning systems.
Parameter	Predicate device	Reference device	Proposed device	Evaluation
	Vision RT AlignRT	CT Sim Laser
Alignment System	DORADOnova MR3T
Functional
principle	Projection of a visual light
pattern on the patient's skin
surface.
The pattern is detected by
two 3D cameras to
determine the patient's
position relative to a stored
reference image.	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.	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
The devices project visual
light on the patient's skin. Its
reflection is used to determine
the position of the patient
relative to the treatment
device.
Whereas the Predicate device
projects a visual light pattern
that consists of pattern of
points, the proposed device
and the reference device use
laser sources to create 3
specific intersection points,
projected on the patient skin.
Therefore, the functional
principle can be regarded as
equivalent.
Patient
reference
position
information	The patient reference
position information is a
reference surface image. It
is acquired either by the
device or imported from a
treatment planning system.
A surface image consisting
of thousands of points is
acquired at the treatment
device and compared to
the reference image for
reproducible patient
positioning on the
treatment device.	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.
External fiducial markers
are placed on the
surface of the skin at the
3 laser intersection
points for reproducible
patient positioning on
external patient
alignment lasers on the
treatment device.	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.
External fiducial markers
are placed on the
surface of the skin at the
3 laser intersection
points for reproducible
patient positioning on
external patient
alignment lasers on the
treatment device.	Similar
In all devices, patient
reference position information
is either created during the
workflow by the operator or
the device itself or is imported
from the treatment planning
system.
Parameter	Predicate device
Vision RT AlignRT	Reference device
CT Sim Laser
Alignment System	Proposed device
DORADOnova MR3T	Evaluation
Prescription
use only	yes	yes	yes	Identical
Target
population	Any individual (adult or
child) undergoing
radiotherapy.	Any individual (adult or
child) undergoing
radiotherapy.	Any individual (adult or
child) undergoing
radiotherapy.	Identical
User interface	Desktop-PC	Tablet, Desktop-PC	Desktop PC with
Touchscreen	Identical
Projection
sources	2 or 3	3 or 5	3	Similar
Reference device can have
two additional projection
sources
TPS Data
lmport	DICOM	Text & DICOM	Text & DICOM	Similar
While the predicate device is
capable of importing DICOM
data, the reference and the
Proposed device are also
capable of importing data in
text format
Device setup	Projection sources and 3D
cameras rigidly mounted to
the ceiling.	Projection sources rigidly
mounted to the ceiling, wall,
post or bridge setup	Projection sources rigidly
mounted as a bridge setup	Similar
All devices are rigidly
mounted in the diagnostic or
treatment room they are used
in. The devices are mounted
to the ceiling, the walls or the
floor. All devices require an
installation process.
In addition, the reference and
the proposed devices sources
are capable of controlled
movement inside the devices
housing.
Resolution/
line width	2m at 4m (30°)	3m at 3m (53°)	Similar
The wider distribution angle
leads to a longer line length.
This would equal 4m at 4m.
Parameter	Predicate device
Vision RT AlignRT	Reference device
CT Sim Laser
Alignment System	Proposed device
DORADOnova MR3T	Evaluation
				Therefore the safety and
effectiveness is not impaired
in comparison to the predicate
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.