(28 days)
No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML applications in medical devices.
No.
This device is an application for radiation treatment planning, not for delivering radiation treatment itself. It assists medical professionals in planning, not performing, therapeutic interventions.
No
Explanation: The device is described as an application for radiation treatment planning and quality assurance, not for diagnosing diseases or conditions. Its purpose is to plan and verify radiation treatments based on existing diagnoses.
Yes
The device is described as "applications for radiation treatment planning" and "released as a system" of "separate subsystem[s]". The description focuses entirely on software functionalities and validation, with no mention of accompanying hardware components or hardware-specific testing.
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. This involves using software to plan how radiation will be delivered to a patient's body to treat lesions. This is a therapeutic planning activity, not a diagnostic one.
- Device Description: The device is described as applications for radiation treatment planning. It focuses on creating treatment plans, reviewing doses, and performing quality assurance on those plans.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples from the human body (like blood, tissue, etc.) to provide diagnostic information about a disease or condition. IVDs are specifically designed for this type of analysis.
Therefore, the RT Elements system falls under the category of medical devices used for treatment planning, not in vitro diagnostics.
N/A
Intended Use / 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 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 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.
Product codes
MUJ
Device Description
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. There are several applications defined as an RT Element.
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 design input an review activities. The system can be seen as container and documents compatibility between the elements. In addition, validation activities of the RT Elements are documented in the system as well as service and user documents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, head and neck, extracranial, spine
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K170750 RT Elements 1.3
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SPECIAL 510 (K) SUMMARY 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: | 2/26/2019 |
| Device: | RT Elements |
| Trade name: | Dose Review, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA,
Adaptive Hybrid Surgery Analysis |
| Common/Classific
ation Name: | System, Planning, Radiation Therapy Treatment |
| Primary
predicate Device: | K170750 RT Elements 1.3 |
| Device
classification
name: | Medical charged-particle radiation therapy system |
| Regulatory Class: | Class II |
| Regulation
Number: | 21 CFR 892.5050 |
| Product Code: | MUJ |
| 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 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 |
| | 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 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. There are several applications
defined as an RT Element.
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
design input an review activities. The system can be seen as container and
documents compatibility between the elements. In addition, validation activities
of the RT Elements are documented in the system as well as service and user
documents. |
| 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). |
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.
4
5
- · 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
Special 510(k)
submission: | The RT Elements are cleared with K170750
The 510(k) for the new RT Elements generation is triggered by the new
optimization algorithm implemented in Multiple Brain Mets SRS 2.0. The
algorithm was rewritten in order to increase robustness and consider additional
objectives. It was successfully verified and validated that optimization results of
the new algorithm is equivalent to the algorithm used in the predicate device.
Changes to the remaining RT Elements have been investigated and found to be
uncritical and equivalent to the predicate device. The intended use did not
change. |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
equivalence: | The RT Elements have been verified and validated according to Brainlab
procedures for product design and development. The information provided by
Brainlab in this Special 510(k) application supports the claim of substantial
equivalence to the predicate device. |
6
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.