Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for measuring radiation beams using a water phantom and software for data acquisition, analysis, and export. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.

Therapeutic

No
The device is described as a system for measuring radiation beam characteristics for irradiation units, for use in commissioning treatment planning systems or quality assurance, not for direct therapeutic application to a patient.

Diagnostic

No

The device is designed to measure characteristic radiation beams from irradiation units for quality assurance and commissioning treatment planning systems, not to diagnose a patient's medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of hardware components including a water phantom, carriage system, manual control unit, water basin, pump, control unit with electrometer, and motor controller, in addition to the software program.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The THALES 3D MR SCANNER system is designed to measure the characteristics of radiation beams used in irradiation units (likely for radiation therapy). It measures physical properties of the beam itself, not biological samples from a patient.
Intended Use: The intended use is for commissioning and quality assurance of irradiation units, and for generating data for treatment planning systems. This is related to the equipment used for treatment, not the diagnosis of a patient's condition.

The device is a measurement and quality assurance tool for medical equipment, not a diagnostic test performed on patient samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The THALES 3D MR SCANNER system is designed to measure the characteristic radiation beam for an irradiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.

Product codes (comma separated list FDA assigned to the subject device)

IYE

Device Description

The THALES 3D MR SCANNER system consists of a water phantom with a carriage system, a manual control unit and a software program. A water basin with the corresponding pump, a control unit with an electrometer, and a motor controller are integrated in the carriage system. The software program is used to control the three axes of the water basin, perform measurements and analyse measured data.

The software program has the following properties: Acquisition of measured data, analysis, and recording of photon beams with the water phantom. Generation and export of beam data libraries for a treatment planning system (TPS) for commissioning of irradiation units. The software program is equipped with a central database and/or a file system for central storage of all recorded data for different irradiation units within a large hospital network with different sites. The software program offers the option of defining different user levels to support the typical clinical workflows.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

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 61010, EMC in accordance with IEC 60601-1-2 and dosimeter requirements in accordance with IEC 60731. MRI safety has been tested in accordance with applicable ASTM standards.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191646

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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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June 3, 2020

Image /page/0/Picture/1 description: The image shows the logo for 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 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 % Mr. Martin Pfabel Director Quality Management & Regulatory Affairs Zeppelinstrasse 23 21337 Lueneburg. Lower Saxony GERMANY

Re: K200907

Trade/Device Name: Thales 3D MR Scanner Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: March 31, 2020 Received: April 6, 2020

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/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 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 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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200907

Device Name THALES 3D MR SCANNER

Indications for Use (Describe)

The THALES 3D MR SCANNER system is designed to measure the characteristic radiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 THALES 3D MR Scanner 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: 968113-
Owner/Operator Number: 9019434 |
| Official Correspondent: | Martin Pfabel
Zeppelinstrasse 23
21337 Lueneburg
Germany
Phone: +49 4131 951167
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: | 31 March 2020 |

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Device(s) Identification:

Device trade name: Common name:

THALES 3D MR scanner 3D water phantom

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 THALES 3D MR SCANNER system consists of a water phantom with a carriage system, a manual control unit and a software program. A water basin with the corresponding pump, a control unit with an electrometer, and a motor controller are integrated in the carriage system. The software program is used to control the three axes of the water basin, perform measurements and analyse measured data.

The software program has the following properties: Acquisition of measured data, analysis, and recording of photon beams with the water phantom. Generation and export of beam data libraries for a treatment planning system (TPS) for commissioning of irradiation units. The software program is equipped with a central database and/or a file system for central storage of all recorded data for different irradiation units within a large hospital network with different sites. The software program offers the option of defining different user levels to support the typical clinical workflows.

Indications for use:

The THALES 3D MR SCANNER system is designed to measure the characteristic radiation beam for an irradiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.

Predicate device:

Device Name:	BEAMSCAN MR
510k number:	K191646
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.

Parameter	Predicate device	Proposed device	Evaluation
	BEAMSCAN MR	THALES 3D MR
		Scanner
Intended Use	The PTW water
phantom system
BEAMSCAN MR is
intended for dosimetry
measurements in
radiotherapy systems.
The device is
intended to determine
the beam
characteristics of the
radiotherapy system
(beam data
acquisition) during the
commissioning and/or
for periodic quality
assurance procedures
according to the QA
plan of the
responsible medical
physicist. The system
can also be used at
combined MRI-
Radiation Therapy
systems with static
magnetic fields of up
to 1.5T.	The THALES 3D MR
SCANNER system is
designed to measure
the characteristic
radiation beam for an
irradiation unit. The
beam data is stored
in the software
program and can be
exported from there
for use during
commissioning in a
treatment planning
system (TPS) or for
quality assurance.
The THALES 3D MR
SCANNER system
can be used with
irradiation units with
integrated magnetic
resonance imaging
and a magnetic field
of less than or equal
to 0.35 tesla.	Similar
The intended use of
both systems covers
the quality assurance
for radiation therapy
systems as part of
regular quality checks,
commissioning or
other occasions.
Both systems are
further indicated for
use with integrated
magnetic resonance
imaging of magnetic
field.
The predicate device
is indicated to be used
in combined MRI-
Radiation therapy
systems with static
magnetic fields up to
1.5 Tesla.
The proposed device
can be used with
irradiation units with
integrated magnetic
resonance imaging
and a magnetic field
of less than or equal
to 0.35 tesla.
Scanning range	408mm * 355mm *
248mm
(model for ViewRay)	380mm * 380mm *
242mm	Similar
The scanning ranges
are nearly identical
Parameter	Predicate device
BEAMSCAN MR	Proposed device
THALES 3D MR
Scanner	Evaluation
Tank shape	Square	Square	Identical
Wall material	PMMA	PMMA	Identical
Chamber holder
orientation	Horizontal and vertical	Horizontal and
vertical	Identical
Motor scanning mode	Step by step	Step by step	Identical
Step size	0.1mm	0.1mm	Identical
Maximum speed	30mm/s	40mm/s	Similar
The THALES system
has a higher
maximum speed
which allows a faster
scanning process
Position accuracy	+/-0.1mm	+/- 0.25mm
(at 0.35Tesla)	Similar
The difference in
accuracy does not
affect the safety or the
effectiveness of the
proposed system.
The construction
requirements on
phantoms in
accordance with IEC
60731 have been met.
Reproducibility	+/-0.1mm	+/- 0.25mm
(at 0.35Tesla)	Similar
The difference in
reproducibility does
not affect the safety or
the effectiveness of
the proposed system.
The construction
requirements on
phantoms in
accordance with IEC
60731 have been met.
MRI compatible	Up to 1.5 Tesla	Up to 0.35 Tesla	Different
The LAP system is
indicated for use with
integrated magnetic
resonance imaging of
magnetic fields less or
equal than 0.35T
Parameter	Predicate device
BEAMSCAN MR	Proposed device
THALES 3D MR
Scanner	Evaluation
			while the predicate
device is indicated to
be used in a static
magnetic field up to
1.5 Tesla. The
difference in MR
compatibility does not
affect the safety or
effectiveness of the
system while the
target system of the
proposed device
(ViewRay MRidian)
only provides a static
magnetic field of 0.35
Tesla or less.
LAP has tested the
performance and
safety aspects with
the target system and
can confirm that the
proposed device can
be used in the
respective MRI
environment.
Electrometer channels	2 entries	2 entries	Identical
Electrometer
resolution	10 fA	1 fA	Different
The electrometer
resolution for the
proposed device is
better (10x better)
than the predicate
device's.
Electrical safety	IEC 61010	IEC 61010	Identical
Dosimeter testing	IEC 60731	IEC 60731	Identical
Electromagnetic
compatibility	IEC 60601-1-2:2007	IEC 60601-1-2:2015	Identical

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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 61010, EMC in accordance with IEC 60601-1-2 and dosimeter requirements in accordance with IEC 60731. MRI safety has been tested in accordance with applicable ASTM standards.

Conclusion:

LAP GmbH Laser Applikationen believes that the THALES 3D MR Scanner is substantially equivalent to currently legally marketed devices. The device does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.