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

K190664 · Brainlab AG · MUJ · Apr 12, 2019 · Radiology

Device Facts

• Record ID: K190664
• Device Name: RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
• Applicant: Brainlab AG
• Product Code: MUJ · Radiology
• Decision Date: Apr 12, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning. 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. The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation. 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 treatment planning requirements. 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.

Device Story

RT Elements is a suite of radiation treatment planning applications used by medical professionals (physicists, oncologists, dosimetrists) in clinical settings. It processes patient imaging data to generate radiation treatment plans for cranial, head/neck, and extracranial lesions. The system includes specialized modules for Multiple Brain Mets SRS, Cranial SRS, Spine SRS, and Adaptive Hybrid Surgery Analysis (which simulates automated template-based plans for evaluation). It also includes Dose Review for plan analysis and RT QA for phantom-based plan verification. The device uses pencil beam and Monte Carlo dose calculation algorithms to transform input data into optimized dose distributions. Healthcare providers use the output to evaluate and finalize treatment plans, potentially improving clinical decision-making and treatment accuracy for patients undergoing radiation therapy.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing, verification, and validation activities. Verification confirmed design specifications were met. Validation included usability testing and clinical expert evaluation of workflow suitability. Dose calculation accuracy for both pencil beam and Monte Carlo algorithms was tested against IAEA-TECDOC-1540 standards, demonstrating accuracy better than 3%.

Technological Characteristics

Software-based radiation treatment planning system. Algorithms: Pencil beam (Mohan et al.) and Monte Carlo (X-ray Voxel Monte Carlo, Kawrakow/Fippel). Connectivity: Networked clinical environment. Deployment: System of integrated subsystems. Accuracy: <3% per IAEA-TECDOC-1540.

Indications for Use

Indicated for radiation treatment planning for stereotactic, conformal, computer-planned, linac-based radiation therapy of cranial, head and neck, and extracranial lesions. No specific demographic, age, or gender limitations.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• RT Elements 1.3 (K170750)

Submission Summary (Full Text)

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April 12, 2019

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

Re: K190664

Trade/Device Name: RT Elements Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: March 11, 2019 Received: March 15, 2019

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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, 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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# Indications for Use

510(k) Number (if known)

#### K190664

Device Name RT Elements

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

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.

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

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.

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.

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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# SPECIAL 510 (K) SUMMARY RT ELEMENTS

| Manufacturer: | Brainlab AG<br>Olof-Palme-Str. 9<br>81829 München<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 2/26/2019 |
| Device: | RT Elements |
| Trade name: | Dose Review, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA,<br>Adaptive Hybrid Surgery Analysis |
| Common/Classific<br>ation Name: | System, Planning, Radiation Therapy Treatment |
| Primary<br>predicate Device: | K170750 RT Elements 1.3 |
| Device<br>classification<br>name: | Medical charged-particle radiation therapy system |
| Regulatory Class: | Class II |
| Regulation<br>Number: | 21 CFR 892.5050 |
| Product Code: | MUJ |
| Indications for<br>use: | The RT Elements are applications for radiation treatment planning for use in<br>stereotactic, conformal, computer planned, Linac based radiation treatment of<br>cranial, head and neck and extracranial lesions.<br>The Dose Review application as one RT Element contains features for review of<br>isodose lines, review of DVHs, dose comparison and dose summation.<br>The Multiple Brain Mets SRS application as one RT Element provides<br>optimized planning and display for cranial multi-metastases radiation treatment<br>planning.<br>The Adaptive Hybrid Surgery Analysis application as one RT Element |
| | The Cranial SRS application as one RT Element provides optimized planning<br>and display for cranial radiation treatment planning. |
| | The Spine SRS application as one RT Element provides optimized planning and<br>display for single spine metastases. |
| | RT QA is an accessory to the RT Elements and contains features for patient<br>specific quality assurance. |
| | Use RT QA to recalculate patient treatment plans on a phantom to verify that the<br>patient treatment plan fulfills the planning requirements. |
| Device<br>description: | The RT Elements are applications for radiation treatment planning for use in<br>stereotactic, conformal, computer planned, Linac based radiation treatment of<br>cranial, head and neck, and extracranial lesions. There are several applications<br>defined as an RT Element.<br>The RT Elements are released as a system. Each RT Element is released as a |
| | separate subsystem including risk analysis, verification and usability as well as<br>design input an review activities. The system can be seen as container and<br>documents compatibility between the elements. In addition, validation activities<br>of the RT Elements are documented in the system as well as service and user<br>documents. |
| Operator Profile: | Typical users of the RT Elements are medical professionals who perform<br>radiation treatment planning (medical physicists, radiation oncologists,<br>dosimetrists, physicians, etc.). |
| Patient<br>Population: | There are no demographic, regional or cultural limitations for patients. It is up to<br>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<br>algorithms: | The Brainlab pencil beam dose algorithm is based on publications by Mohan et<br>al (1985, 1986, and 1987). |
| | • Mohan R, Chui C, Lidofsky L; Energy and angular distributions of photons from medical<br>accelerators. (1985) Med. Phys. 12 pp 592 - 597. |
| | • Mohan R, Chui C, Lidofsky L; Differential pencil beam dose computation model for phot<br>(1986) Med. Phys. 13 pp 64 - 73. |
| | • Mohan R, Chui C; Use of fast fourier transforms in calculating dose distributions for irre<br>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<br>algorithm developed by Iwan Kawrakow and Matthias Fippel (Kawrakow et al<br>1996, Fippel et al 1997, Fippel 1999, Fippel et al 1999, Kawrakow and Fippel<br>2000, Fippel et al 2003, Fippel 2004). |

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.

K190664

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- · 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 fluel 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 Bioloj 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!
- 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 inhomoqeneous 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 nonhuman tissue materials (e.g. implants).

| Reason for the<br>Special 510(k)<br>submission: | The RT Elements are cleared with K170750<br>The 510(k) for the new RT Elements generation is triggered by the new<br>optimization algorithm implemented in Multiple Brain Mets SRS 2.0. The<br>algorithm was rewritten in order to increase robustness and consider additional<br>objectives. It was successfully verified and validated that optimization results of<br>the new algorithm is equivalent to the algorithm used in the predicate device.<br>Changes to the remaining RT Elements have been investigated and found to be<br>uncritical and equivalent to the predicate device. The intended use did not<br>change. |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>equivalence: | The RT Elements have been verified and validated according to Brainlab<br>procedures for product design and development. The information provided by<br>Brainlab in this Special 510(k) application supports the claim of substantial<br>equivalence to the predicate device. |

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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 subsystem. 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 planning 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 RT Elements workflows.

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.