K Number
K170750
Device Name
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Manufacturer
Date Cleared
2017-08-24

(164 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The "Dose Review" application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation. The "Multiple Brain Mets SRS" application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning. The "Adaptive Hybrid Surgery Analysis" application as one RT Element simulates an automated tadiation treatment plan. The simulated plan is intented for treatment evaluation for example in tumor board meetings or operating rooms. The "Cranial SRS" application as one RT Element provides optimized planning and display for cranial radiation treatment planning. The "Spine SRS" application as one RT Element provides optimized planning and display for single spine metastases. "RT QA" is an accessory to the RT Elements and contains features for patient specific quality assurance. Use "RT QA" to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
Device Description
The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation. The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning. The Adaptive Hybrid Surgery Analysis application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms. The Cranial SRS application as one RT Element provides optimized planning and display for radiation treatment planning for single lesions in the cranium. Cranial SRS 1.0 provides single lesion planning using a Volumetric Modulated Arc Therapy (VMAT) optimization, thus allowing dose modulation with both the MLC leaf positions and the dose rate or gantry speed. It particularly offers planning for lesions in the brain which benefit from dose modulation like large tumors close to organs at risk with a complex geometry. These indications include, but are not limited to Vestibular Schwannomas, Pituitary Adenomas, Meningiomas and Gliomas. Cranial SRS 1.0 can also be used for treating vascular anomalies like arteriovenous malformations (AVMs). The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases. RT QA is an accessory to the RT Elements and contains features for patient specific quality assurance. Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
More Information

K170355 Raystation 6

K142108 RT Elements, K103246 iPlan RT

No
The document describes radiation treatment planning software with various modules for dose review, optimized planning, and quality assurance. While it mentions "optimized planning" and "simulates an automated template-based radiation treatment plan," there is no explicit mention of AI, ML, deep learning, or any related technologies in the provided text. The descriptions focus on standard radiation therapy planning functionalities and verification/validation processes.

No
The device is described as radiation treatment planning software, and it explicitly states its intention for "treatment evaluation" and "simulates an automated radiation treatment plan," not for direct treatment delivery.

No

Explanation: The device is described as an application for radiation treatment planning and quality assurance, not for diagnosing medical conditions. Its function is to simulate and optimize radiation treatment plans, which occurs after a diagnosis has already been made.

Yes

The device description and intended use clearly define the RT Elements as "applications" for radiation treatment planning and quality assurance. The description focuses entirely on the software functionalities and workflows, with no mention of accompanying hardware components required for its operation beyond standard computing infrastructure. The input is DICOM images, which are digital data.

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

Here's why:

  • Intended Use: The intended use clearly states that the RT Elements are applications for radiation treatment planning. This involves using medical images and patient data to design a radiation therapy plan, not to perform tests on biological samples to diagnose or monitor a disease.
  • Device Description: The description details features related to reviewing and optimizing radiation dose distributions, simulating treatment plans, and performing quality assurance on these plans. These are all activities related to the delivery of radiation therapy, not in vitro testing.
  • Input: The input is DICOM image import, which is typical for medical imaging devices used in treatment planning, not for IVDs which typically use biological samples.
  • Anatomical Site: The anatomical sites mentioned (cranial, head and neck, extracranial lesions, brain, spine) are the targets for radiation treatment, not the source of samples for in vitro testing.
  • Intended User: The intended users are medical professionals involved in radiation treatment planning (medical physicists, radiation oncologists, dosimetrists, physicians), not laboratory personnel who typically perform IVD tests.
  • Performance Studies: The performance studies described are focused on verification and validation of the planning and quality assurance workflows, not on the analytical or clinical performance of an in vitro test.

In summary, the device's function is to assist in the planning and quality assurance of radiation therapy, which is a medical treatment procedure. This falls outside the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.

N/A

Intended Use / Indications for Use

The RT Elements are applications for radiation treatment planning for use ins stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

The "Dose Review" application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.

The "Multiple Brain Mets SRS" application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning.

The "Adaptive Hybrid Surgery Analysis" application as one RT Element simulates an automated tadiation treatment plan. The simulated plan is intented for treatment evaluation for example in tumor board meetings or operating rooms.

The "Cranial SRS" application as one RT Element provides optimized planning and display for cranial radiation treatment planning.

The "Spine SRS" application as one RT Element provides optimized planning and display for single spine metastases.

"RT QA" is an accessory to the RT Elements and contains features for patient specific quality assurance.

Use "RT QA" to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.

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

MUJ

Device Description

The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.

The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.

The Adaptive Hybrid Surgery Analysis application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.

The Cranial SRS application as one RT Element provides optimized planning and display for radiation treatment planning for single lesions in the cranium. Cranial SRS 1.0 provides single lesion planning using a Volumetric Modulated Arc Therapy (VMAT) optimization, thus allowing dose modulation with both the MLC leaf positions and the dose rate or gantry speed. It particularly offers planning for lesions in the brain which benefit from dose modulation like large tumors close to organs at risk with a complex geometry. These indications include, but are not limited to Vestibular Schwannomas, Pituitary Adenomas, Meningiomas and Gliomas. Cranial SRS 1.0 can also be used for treating vascular anomalies like arteriovenous malformations (AVMs).

The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases.

RT QA is an accessory to the RT Elements and contains features for patient specific quality assurance.

Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cranial, head and neck, and extracranial lesions.
brain, single spine metastases

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Typical users of the RT Elements are medical professionals who perform radiation treatment planning (medical physicists, radiation oncologists, dosimetrists, physicians, etc.).
The system can be used in a hospital environment, in a clinical planning office.

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)

Verification:
The verification of the existing and new features of the RT Elements has been carried out throughout both at the top level and on the underlying subsystem. Planning through VMAT as well as quality assurance and saving and loading of treatment plans was successfully verified. The verification was done according to verification plans to demonstrate that the design specifications are met.

Validation:
The validation was done according to the validation plans containing usability tests which ensure that workflows or user interface are suitable for radiotherapy treatment planning. Furthermore clinical experts evaluated the clinical suitability of radiation therapy planning using the Cranial SRS and Spine SRS workflows. The acceptance and deliverability of VMAT treatment plans was successfully validated.

All tests reports were rated as successful according to the acceptance criteria. The validation was performed with software versions and units that are considered equivalent to the final version of the product, as warranted by 21 CFR 820.30(g) and which have the UI as planned for the release.

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.

K170355 Raystation 6

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.

K142108 RT Elements, K103246 iPlan RT

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

§ 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

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 24, 2017

Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Str.9 Munchen, 81829 GERMANY

Re: K170750

Trade/Device Name: RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: August 2, 2017 Received: August 7, 2017

Dear Mr. Schwiersch:

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. 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

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

1

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K170750

Device Name

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review

Indications for Use (Describe)

The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

The "Dose Review" application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.

The "Multiple Brain Mets SRS" application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning.

The "Adaptive Hybrid Surgery Analysis" application as one RT Element simulates an automated tadiation treatment plan. The simulated plan is intented for treatment evaluation for example in tumor board meetings or operating rooms.

The "Cranial SRS" application as one RT Element provides optimized planning and display for cranial radiation treatment planning.

The "Spine SRS" application as one RT Element provides optimized planning and display for single spine metastases.

"RT QA" is an accessory to the RT Elements and contains features for patient specific quality assurance.

Use "RT QA" to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.

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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3

510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR RT ELEMENTS

| Manufacturer: | Brainlab AG
Olof-Palme-Str. 9 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 81829 München
Germany |
| | Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 5033 |
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 7/7/2017 |
| Device: | RT Elements |
| Trade name: | Dose Review, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA |
| Common/Classific
ation Name: | System, Planning, Radiation Therapy Treatment |
| Primary
predicate Device: | K170355 Raystation 6 |
| Reference
Devices: | K142108 RT Elements
K103246 iPlan RT |
| Device
classification
name: | Medical charged-particle radiation therapy system |
| Regulatory Class: | Class II |
| Requlation
Number: | 21 CFR 892.5050 |
| Product Code: | MUJ |
| Intended use: | The RT Elements are applications for radiation treatment planning for use in
stereotactic, conformal, computer planned, Linac based radiation treatment of
cranial, head and neck and extracranial lesions. |
| Indications for
use: | The RT Elements are applications for radiation treatment planning for use in
stereotactic, conformal, computer planned, Linac based radiation treatment of
cranial, head and neck and extracranial lesions. |

4

The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.

The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.

The Adaptive Hybrid Surgery Analysis application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.

Content of this submission:

The Cranial SRS application as one RT Element provides optimized planning and display for cranial radiation treatment planning.

The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases.

RT QA is an accessory to the RT Elements and contains features for patient specific quality assurance.

Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.

Device The Dose Review application as one RT Element contains features for review of description: isodose lines, review of DVHs, dose comparison and dose summation.

The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.

The Adaptive Hybrid Surgery Analysis application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.

The Cranial SRS application as one RT Element provides optimized planning and display for radiation treatment planning for single lesions in the cranium. Cranial SRS 1.0 provides single lesion planning using a Volumetric Modulated Arc Therapy (VMAT) optimization, thus allowing dose modulation with both the MLC leaf positions and the dose rate or gantry speed. It particularly offers planning for lesions in the brain which benefit from dose modulation like large tumors close to organs at risk with a complex geometry. These indications include, but are not limited to Vestibular Schwannomas, Pituitary Adenomas, Meningiomas and Gliomas. Cranial SRS 1.0 can also be used for treating vascular anomalies like arteriovenous malformations (AVMs).

5

The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases.

RT QA is an accessory to the RT Elements and contains features for patient specific quality assurance.

Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.

Operator Profile:

Typical users of the RT Elements are medical professionals who perform radiation treatment planning (medical physicists, radiation oncologists, dosimetrists, physicians, etc.).

Patient Population:

There are no demographic, regional or cultural limitations for patients. It is up to the user to decide if the system shall be used to assist a certain procedure

Conditions of use:

The system can be used in a hospital environment, in a clinical planning office.

Dose Calculation algorithms:

The Brainlab pencil beam dose algorithm is based on publications by Mohan et al (1985, 1986, and 1987).

  • ූ Mohan R, Chui C, Lidofsky L; Energy and angular distributions of photons from medical accelerators. (1985) Med. Phys. 12 pp 592 - 597.
  • Mohan R, Chui C, Lidofsky L; Differential pencil beam dose computation model for phot (1986) Med. Phys. 13 pp 64 - 73.
  • · Mohan R, Chui C; Use of fast fourier transforms in calculating dose distributions for irre; shaped fields for three-dimensional treatment planning. (1987) Med. Phys. 14 pp 70 - 7

The Brainlab Monte Carlo algorithm is based on the X-ray Voxel Monte Carlo algorithm developed by Iwan Kawrakow and Matthias Fippel (Kawrakow et al 1996, Fippel et al 1997, Fippel 1999, Fippel et al 1999, Kawrakow and Fippel 2000. Fippel et al 2003. Fippel 2004).

  • · Fippel M: Fast Monte Carlo dose calculation for photon beams based on the VMC algorithm, Medical Physics 26 (1999) 1466-1475.
  • · Fippel M: Efficient particle transport simulation through beam modulating devices Carlo treatment planning, Medical Physics 31 (2004) 1235-1242.
  • · Fippel M. Haryanto F. Dohm O. Nüsslin F. Kriesen S: A virtual photon energy fluer Monte Carlo dose calculation, Medical Physics 30 (2003) 301-311.
  • · Fippel M, Kawrakow I, Friedrich K: Electron beam dose calculations with the VMC and the verification data of the NCI working group, Physics in Medicine and Biolo‹ 501-520.
  • · Fippel M. Laub W. Huber B. Nüsslin F: Experimental investigation of a fast Monte beam dose calculation algorithm, Physics in Medicine and Biology 44 (1999) 303{

6

| | · Kawrakow I, Fippel M: Investigation of variance reduction techniques for Monte
dose calculation using XVMC, Physics in Medicine and Biology 45 (2000) 2163
· Kawrakow I, Fippel M, Friedrich K: 3D Electron Dose Calculation using a Voxel
Carlo Algorithm (VMC), Medical Physics 23 (1996) 445-457. | | | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------|--|--|
| | The accuracy of both algorithms is tested according to IAEA-TECDOC-1540 to
be better than 3%. | | | | |
| | The pencil beam algorithm has limited accuracy for dose calculations near
inhomogeneous areas such as lung or bone tissue or close to the tissue border
(both within a range of a few centimeters). The Monte Carlo algorithm is affected
by the general limitation that in some cases the Hounsfield-Unit values of the CT
scan do not represent the real characteristics of a material (e.g. mass density
and material composition). This may lead to inaccurate dose calculation for non-
human tissue materials (e.g. implants). | | | | |
| Substantial
equivalence: | The RT Elements are the current RT planning software generation of Brainlab.
New in the RT Elements are the following features:

  • Treatment planning using the VMAT optimization algorithm and
  • Optimized arc placement
    VMAT algorithm for dose planning:
    Following the decision making flowchart in appendix A of the guideline
    Evaluating Substantial Equivalence in Premarket Notifications [510(k)] we
    evaluated the substantial equivalence in respect to the new feature VMAT
    algorithm for dose planning between the primary predicate Raystation 6
    (K170355). And the subject device of this submission. The primary predicate is
    legally marketed and the devices have the same intended use. The following
    table compares the technological characteristics of the two devices in respect of
    the VMAT algorithm for dose planning: | | | | |
    | | | | | | |
    | | | | | | |
    | | Technological | Raystation 6 | RT Elements | | |
    | | characteristics | (K170355) | (K170750) | | |
    | | Optimization based on | Yes | Yes | | |
    | | constraints for organs at risk | | | | |
    | | Direct optimization of MLC leaf | Yes | Yes | | |
    | | positions | | | | |
    | | Direct optimization of dose rate
    Direct optimization of gantry | Yes | Yes | | |
    | | speed | Yes | Yes | | |
    | | Possibility to create single or
    multiple-arc plans | Yes | Yes | | |
    | | Possibility to use constant
    dose rate | Yes | Yes | | |
    | | Fulfillment of all accelerator
    constraints | Yes | Yes | | |

7

| Final forward dose calculation

for the optimization resultYesYes
Export of the optimized
treatment plan via DICOM RTYesYes

Optimized arc placement

The primary predicate Raystation 6 (K170355) offers the 3D-CRT optimization module, which is in all relevant parts comparable to the optimized arc placement included in RT Elements. The Raystation 3D-CRT optimization module offers a wide variety of optimization possibilities, while the optimization offered in the RT Elements is restricted to table angle optimization and gantry start and stop angle optimization.

Following the decision making flowchart in appendix A of the guideline Evaluating Substantial Equivalence in Premarket Notifications [510(k)] we evaluated the substantial equivalence in respect of the new feature optimized arc placement between the second predicate device Raystation 6 (K170355) and the subject device of this submission RT Elements (K170750). The predicate device K170355 is legally marketed (decision 1) and the devices have the same intended use (decision 2) The following table compares the technological characteristics of the two devices in respect of the optimized arc placement:

| Technological characteristics | Raystation 6
(K170355) | RT Elements
(K170750) |
|---------------------------------------------------------------|---------------------------|--------------------------|
| Optimization based on organs at risk | Yes | Yes |
| Optimization of table angles | Yes | Yes |
| Optimization of gantry angles | Yes | Yes |
| Final forward dose calculation for the
optimization result | Yes | Yes |
| Export of the optimized treatment
plan via DICOM RT | Yes | Yes |

  • Conclusion: According to these tables all technological characteristics in respect of the VMAT algorithm for dose planning and optimized arc placement of the predicate device and the RT Elements are the same. Therefore these features are substantially equivalent.

8

| Technological
Characteristics of
subject device
compared to reference
devices: | device features
of reference
device
iPlan RT
(K103246) | device features
of reference
device
RT Elements
(K142108) | Device features
of subject
device | |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------|-----|
| | Characteristics | | | |
| | DICOM Viewing | Yes | Yes | Yes |
| | Photon beam
planning | Yes | Yes | Yes |
| | 3rd party
Hardware
support | Yes | Yes | Yes |
| | User interface
control with
touchscreen and
mouse/keyboard | Yes | Yes | Yes |
| | DICOM Image
import | Yes | Yes | Yes |
| | DICOM
Segmentation
import | Yes | Yes | Yes |
| | DICOM RT
Registration
import | Yes | Yes | Yes |
| | DICOM RT
Export | Yes | Yes | Yes |
| | Loading and
Saving | Yes | No | Yes |
| | 3D Viewing | Yes | Yes | Yes |
| | Treatment
workflow
support | Yes | Yes | Yes |
| | Dose
Calculation with
Pencil Beam | Yes | Yes | Yes |
| | Dose
Calculation with
Monte Carlo | Yes | No | Yes |
| | Quality
Assurance
possibilities | Yes | No | Yes |
| | User defined
treatment
templates | Yes | Yes | Yes |

9

| Verification/validation

summary:Verification:
The verification of the existing and new features of the RT Elements has
been carried out throughout both at the top level and on the underlying

been carried out throughout both at the top level and on the underlying subsystem. Planning through VMAT as well as quality assurance and saving and loading of treatment plans was successfully verified. The verification was done according to verification plans to demonstrate that the design specifications are met.

Validation:

The validation was done according to the validation plans containing usability tests which ensure that workflows or user interface are suitable for radiotherapy treatment planning. Furthermore clinical experts evaluated the clinical suitability of radiation therapy planning using the Cranial SRS and Spine SRS workflows. The acceptance and deliverability of VMAT treatment plans was successfully validated.

All tests reports were rated as successful according to the acceptance criteria. The validation was performed with software versions and units that are considered equivalent to the final version of the product, as warranted by 21 CFR 820.30(g) and which have the UI as planned for the release.

10