(141 days)
Not Found
No
The document describes software for radiation treatment planning and dose optimization, but there is no mention of AI, ML, or related terms. The performance studies focus on software verification, usability, and clinical evaluation, not on the performance metrics typically associated with AI/ML models.
No.
This device is software for radiation treatment planning and dose optimization, not a device that directly administers therapy or has a therapeutic effect itself.
No
The device is described as software for radiation treatment planning and dose optimization, intended for therapeutic purposes (radiation treatment) rather than diagnosing a condition.
Yes
The device description explicitly states that "RT Elements are computed-based software applications". The summary of performance studies focuses on software verification and usability evaluation, with no mention of hardware components or their validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiation treatment planning" and "dose optimization" for radiation therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description reinforces that the software is for "radiation therapy treatment planning and dose optimization."
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information about a patient's disease state or condition based on such analysis. IVDs are specifically designed for these types of diagnostic purposes.
The device is clearly intended for use in the planning and delivery of radiation therapy, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications 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.
Product codes
MUJ
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 (SBRT), 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
- -Dose Review
- -Retreatment Review
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
cranial, head and neck, and extracranial lesions
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Testing:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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 |
| RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, | |
| Cranial SRS, Spine SRS, RT QA, Dose Review | |
| Contact Information | |
| Primary Contact | Sadwini Suresh |
| QM Consultant | |
| Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | |
| Alternate Contact | Chiara Cunico |
| Senior Manager Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: chiara.cunico@brainlab.com |
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
4
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
Elements 3.0 K203681) | Subject Device (RT
Elements 4.0) | Comment |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
The Cranial SRS w/ Cones
application as one RT Element
provides planning and display for
functional diseases (e.g. trigeminal
neuralgia) or cranial lesion
radiation treatment.
The Multiple Brain Mets SRS
application as one RT Element
provides optimized planning and
display for cranial multi-metastases
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 RT QA application as one RT
Element 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 Dose Review application as
one RT Element contains features
for review of isodose lines, review
of DVHs, dose comparison and
dose summation. | 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. | The Subject Device has
similar indications for use as
the Predicate Device. The
Subject Device has a revised
generic indications for use
statement. |
| Topic/ Feature | Predicate Device (RT
Elements 3.0 K203681) | Subject Device (RT
Elements 4.0) | Comment |
| Applications/Elements
Included | • Multiple Brain Mets SRS
• Cranial SRS
• Spine SRS
• Cranial SRS w/ Cones
• RT QA
• Dose Review | • Multiple Brain Mets SRS
• Cranial SRS
• Spine SRS
• Cranial SRS w/ Cones
• RT QA
• Dose Review
• Brain Mets Retreatment
Review | The Subject device has the
same Elements included as
the Predicate Device.
Additionally, RT Elements 4.0
has the new Brain Mets
Retreatment Review Element. |
| Supported Operating
Systems | • Windows 10 Enterprise 1507
• Windows 10 Enterprise 1607
• Windows 10 Enterprise 1809
• Windows Server 2012 R2 64-
bit
• Windows Server 2016
• Windows Server 2019 | • Windows 10 Enterprise 1507
• Windows 10 Enterprise 1607
• Windows 10 Enterprise 1809
• Windows Server 2012 R2 64-
bit
• Windows Server 2016
• Windows Server 2019 | The Subject Device supports
the same operating systems
as the Predicate Device. |
| Supported
Collimators | • Multileaf Collimators
• Circular Conical Collimators | • Multileaf Collimators
• Circular Conical Collimators | The Subject Device supports
the same collimator types as
the Predicate Device. |
| GUI Technology | • WPF | • WPF
• html5 | The Subject Device has a
similar GUI technology as the
Predicate Device. Parts of the
subject device were
transmitted to html5. |
| Dose Calculation
Accuracy | Pencil Beam/Monte Carlo:
better than 3%
Circular Cone:
1%/1mm | Pencil Beam/Monte Carlo:
better than 3%
Circular Cone:
1%/1mm | The dose calculation in the
Subject Device is the same
as in the Predicate Device. |
| Support of Metal
Implants | No support of metal implants
available. | It is possible to calculate
treatment plans for targets with
metal implants in the surrounding
of the lesion, accounting for a
selected material of the implant
during dose calculation.
It is also possible to define the
material of implant objects from a
given list to be used for tissue
model generation | With the Subject Device it is
possible to consider metal
implants during treatment
planning especially for spinal
metastasis. |
| Topic/ Feature | Predicate Device (RT
Elements 3.0 K203681) | Subject Device (RT
Elements 4.0) | Comment |
| Treatment Time Bar | No time bar available. | All objects that are listed in the
time bar are shown on the newest
MR in the ACS view and are
visualized in the 3D view. The
metastases are color-coded to
provide an overview of when the
metastases were treated. | A new feature coming with
the new Brain Mets
Retreatment Element.
It supports the user in
decision making. No new
data is generated by this
feature. Instead it gives the
user a better overview of
different treatment data |
5
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.
6
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.