RT Elements (4.0)

K223279 · Brainlab AG · MUJ · Mar 14, 2023 · Radiology

Device Facts

• Record ID: K223279
• Device Name: RT Elements (4.0)
• Applicant: Brainlab AG
• Product Code: MUJ · Radiology
• Decision Date: Mar 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned. Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.

Device Story

RT Elements 4.0 is a software suite for radiation therapy treatment planning and dose optimization. It supports stereotactic radiosurgery (SRS), fractionated stereotactic radiotherapy (SRT), and stereotactic body radiation therapy (SBRT). The system processes patient imaging data to facilitate planning for cranial, head and neck, and extracranial lesions. It includes modules for multiple brain metastases, spine SRS, cone-based cranial SRS, quality assurance (RT QA), dose review, and a new brain metastases retreatment review. The software is used by clinicians in a clinical setting to visualize treatment plans, calculate doses (Pencil Beam/Monte Carlo), and account for metal implants. The retreatment review module provides a time-bar visualization of previous treatments to assist clinical decision-making. The device does not generate new clinical data but organizes existing treatment information to improve workflow and oversight.

Clinical Evidence

Clinical evaluation was conducted as part of the design validation process. No specific clinical study metrics (e.g., sensitivity, specificity) are reported. The device relies on software verification (integration and unit tests), usability evaluation (summative and formative for the new Retreatment Review element), and bench testing to demonstrate safety and performance equivalent to the predicate.

Technological Characteristics

Software-based radiation treatment planning system. Supports Multileaf and Circular Conical Collimators. Dose calculation algorithms: Pencil Beam and Monte Carlo (accuracy >3%). GUI utilizes WPF and HTML5. Supports Windows 10 Enterprise and Windows Server 2012/2016/2019. Includes functionality for metal implant material definition and tissue model generation.

Indications for Use

Indicated for radiation treatment planning for stereotactic, conformal, Linac-based radiation therapy of cranial, head and neck, and extracranial lesions.

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, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review (K203681)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a rectangular shape.

March 14, 2023

Brainlab AG % Sadwini Suresh QM Consultant, Regulatory Affairs Olof-Palme-Str. 9 Munchen. BY 81829 GERMANY

Re: K223279/S001

Trade/Device Name: RT Elements (4.0) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: February 13, 2023 Received: February 13, 2023

Dear Sadwini Suresh:

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/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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Lora D. Weidner -S" in a large font on the left side of the image. On the right side of the image, the text "Digitally signed by Lora D. Weidner -S" is present. Below that, the date "2023.03.14 19:25:04 -04'00'" is displayed.

Lora D. Weidner, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223279

Device Name RT Elements 4.0

Indications for Use (Describe)

The device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned. Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.

| 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)

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Image /page/3/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left and the word "BRAINLAB" in pink capital letters on the right. The symbol appears to be three curved lines stacked on top of each other.

# 510(k) Summary

March 13, 2023

| General Information | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Names | RT Elements 4.0 |
| Classification Name | Medical charged-particle radiation therapy system |
| Product Code | MUJ |
| Regulation Number | 892.5050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Device | K203681<br>RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS,<br>Cranial SRS, Spine SRS, RT QA, Dose Review |
| Contact Information | |
| Primary Contact | Sadwini Suresh<br>QM Consultant<br>Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Alternate Contact | Chiara Cunico<br>Senior Manager Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |

#### 1. Indication for Use

The device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.

# 2. Device Description

RT Elements are computed-based software applications for radiation therapy treatment planning and dose optimization for linac-based conformal radiation treatments, i.e. stereotactic radiosurgery (SRS), fractionated stereotactic radiotherapy (SRT) or stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT) for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

The following applications are included in RT Elements 4.0:

- -Multiple Brain Mets SRS
- -Cranial SRS
- -Spine SRS
- Cranial SRS w/ Cones -
- -RT QA

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Image /page/4/Picture/0 description: The image shows the word "BRAINLAB" in pink, with a stylized pink symbol to the left of the word. The symbol appears to be a stylized representation of the brain. The text is in all caps and in a sans-serif font.

- -Dose Review
- -Retreatment Review

# 3. Substantial Equivalence

The Subject Device has similar intended use and technological features as the predicate device. An overview of the similarities and differences can be found in the tables below:

| Topic/ Feature | Predicate Device (RT<br>Elements 3.0 K203681) | Subject Device (RT<br>Elements 4.0) | Comment |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The RT Elements are applications<br>for radiation treatment planning for<br>use in stereotactic, conformal,<br>computer planned, Linac based<br>radiation treatment of cranial, head<br>and neck and extracranial lesions.<br>The Cranial SRS w/ Cones<br>application as one RT Element<br>provides planning and display for<br>functional diseases (e.g. trigeminal<br>neuralgia) or cranial lesion<br>radiation treatment.<br>The Multiple Brain Mets SRS<br>application as one RT Element<br>provides optimized planning and<br>display for cranial multi-metastases<br>radiation treatment planning.<br>The Cranial SRS application as<br>one RT Element provides<br>optimized planning and display for<br>cranial radiation treatment<br>planning.<br>The Spine SRS application as one<br>RT Element provides optimized<br>planning and display for single<br>spine metastases.<br>The RT QA application as one RT<br>Element contains features for<br>patient specific quality assurance.<br>Use RT QA to recalculate patient<br>treatment plans on a phantom to<br>verify that the patient treatment<br>plan fulfills the planning<br>requirements.<br>The Dose Review application as<br>one RT Element contains features<br>for review of isodose lines, review<br>of DVHs, dose comparison and<br>dose summation. | The device is intended for<br>radiation treatment planning for<br>use in stereotactic, conformal,<br>computer planned, Linac based<br>radiation treatment and indicated<br>for cranial, head and neck and<br>extracranial lesions. | The Subject Device has<br>similar indications for use as<br>the Predicate Device. The<br>Subject Device has a revised<br>generic indications for use<br>statement. |
| Topic/ Feature | Predicate Device (RT<br>Elements 3.0 K203681) | Subject Device (RT<br>Elements 4.0) | Comment |
| Applications/Elements<br>Included | • Multiple Brain Mets SRS<br>• Cranial SRS<br>• Spine SRS<br>• Cranial SRS w/ Cones<br>• RT QA<br>• Dose Review | • Multiple Brain Mets SRS<br>• Cranial SRS<br>• Spine SRS<br>• Cranial SRS w/ Cones<br>• RT QA<br>• Dose Review<br>• Brain Mets Retreatment<br>Review | The Subject device has the<br>same Elements included as<br>the Predicate Device.<br>Additionally, RT Elements 4.0<br>has the new Brain Mets<br>Retreatment Review Element. |
| Supported Operating<br>Systems | • Windows 10 Enterprise 1507<br>• Windows 10 Enterprise 1607<br>• Windows 10 Enterprise 1809<br>• Windows Server 2012 R2 64-<br>bit<br>• Windows Server 2016<br>• Windows Server 2019 | • Windows 10 Enterprise 1507<br>• Windows 10 Enterprise 1607<br>• Windows 10 Enterprise 1809<br>• Windows Server 2012 R2 64-<br>bit<br>• Windows Server 2016<br>• Windows Server 2019 | The Subject Device supports<br>the same operating systems<br>as the Predicate Device. |
| Supported<br>Collimators | • Multileaf Collimators<br>• Circular Conical Collimators | • Multileaf Collimators<br>• Circular Conical Collimators | The Subject Device supports<br>the same collimator types as<br>the Predicate Device. |
| GUI Technology | • WPF | • WPF<br>• html5 | The Subject Device has a<br>similar GUI technology as the<br>Predicate Device. Parts of the<br>subject device were<br>transmitted to html5. |
| Dose Calculation<br>Accuracy | Pencil Beam/Monte Carlo:<br>better than 3%<br>Circular Cone:<br>1%/1mm | Pencil Beam/Monte Carlo:<br>better than 3%<br>Circular Cone:<br>1%/1mm | The dose calculation in the<br>Subject Device is the same<br>as in the Predicate Device. |
| Support of Metal<br>Implants | No support of metal implants<br>available. | It is possible to calculate<br>treatment plans for targets with<br>metal implants in the surrounding<br>of the lesion, accounting for a<br>selected material of the implant<br>during dose calculation.<br><br>It is also possible to define the<br>material of implant objects from a<br>given list to be used for tissue<br>model generation | With the Subject Device it is<br>possible to consider metal<br>implants during treatment<br>planning especially for spinal<br>metastasis. |
| Topic/ Feature | Predicate Device (RT<br>Elements 3.0 K203681) | Subject Device (RT<br>Elements 4.0) | Comment |
| Treatment Time Bar | No time bar available. | All objects that are listed in the<br>time bar are shown on the newest<br>MR in the ACS view and are<br>visualized in the 3D view. The<br>metastases are color-coded to<br>provide an overview of when the<br>metastases were treated. | A new feature coming with<br>the new Brain Mets<br>Retreatment Element.<br>It supports the user in<br>decision making. No new<br>data is generated by this<br>feature. Instead it gives the<br>user a better overview of<br>different treatment data |

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Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" on the right. The symbol is a pink abstract design, and the word "BRAINLAB" is also in pink and in all capital letters.

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Image /page/6/Picture/0 description: The image shows the Brainlab logo in pink. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in capital letters on the right. The symbol appears to be a stylized representation of the brain, while the word "BRAINLAB" is written in a bold, sans-serif font.

# 4. Performance Data

#### Verification

#### Software Verification:

Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid.

Software verification verifies all specifications, including SOUP items and cybersecurity. For newly added components, interoperability tests were carried out, in addition to the individual component verification.

# Bench Testina

In addition to the routine software verification, the following tests were carried out:

#### Usability Evaluation:

Summative and Formative Usability Evaluation was carried out specifically for the Retreatment Review Element which is a new application.

#### Clinical Evaluation:

Clinical Evaluation was carried out as a part of the design validation process.

Based on the results gathered during the validation process, it was concluded that the device meets the safety and performance requirements and is safe and effective for its intended use as compared to the predicate device.

# 5. Conclusion

Verification and validation activities carried out established that the set requirements were met and that the device performs as claimed.

The Subject Devices' comparison with the Predicate Device establishes that they have similar functionality, intended use and technological characteristics. Therefore, we believe that the Subject Device can be considered substantially equivalent to the predicate device.