(134 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the described functionalities (reviewing isodose lines, DVHs, dose comparison, dose summation, optimized planning, automated template-based simulation) do not inherently require AI/ML.
No
The device is described as radiation treatment planning software, and it explicitly states that one application "simulates an automated template-based radiation treatment plan... intended for treatment evaluation," not for direct treatment. Therapeutic devices are used for treatment, while this device performs planning and evaluation.
No
This device is for radiation treatment planning and evaluation, not for diagnosing diseases or conditions. The "Dose Review" and "Brain Metastases" applications are for planning and displaying treatment, while "Adaptive Hybrid Surgery Analysis" simulates treatment for evaluation. None of these functions involve identifying a medical condition.
Yes
The device description explicitly refers to the components as "applications" and "RT Elements," which are software terms. The summary focuses on software features and verification/validation of the software, with no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the RT Elements are applications for radiation treatment planning. This is a process that uses medical images and patient data to design a plan for delivering radiation therapy.
- Device Description: The description details features related to reviewing radiation dose, planning for radiation treatment of brain metastases, and simulating radiation treatment plans. These are all activities related to treatment planning and evaluation, not diagnostic testing performed on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's purpose is to assist in the planning and evaluation of radiation treatment, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, 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 "Brain Metastases" 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 template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.
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 "Brain Metastases" 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.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users are medical professionals, including but not limited to radiation oncologists, medical physicists or physicians as well as neurosurgeons (for Adaptive Hybrid Surgery Analysis)
The system can be used in a hospital environment, in a doctor's office, at the operating theater in case of Adaptive Hybrid Surgery Analysis
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)
The verification of the RT Elements has been carried out thoroughly both at the top level and on the underlying subsystems. The verification was done according to verification plan to demonstrate that the design specifications are met.
The validation was done in accordance with the validation plan containing usability tests which should ensure that workflows or user interface result in a useful interface.
All test reports were finally rated as successful according to their acceptance criteria. The non-clinical validation has been performed with software 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.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a group of people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2014
Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 85622 Feldkirchen GERMANY
Re: K142108 Trade/Device Name: RT Elements Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 17, 2014 Received: November 21, 2014
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
1
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/Resourcesfor You/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 yours,
Robert A Ochs
Robert A. Ochs. Ph.D. Acting 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)
Device Name RT Elements
Indications for Use (Describe)
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, 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 "Brain Metastases" 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 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 Druq 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
510 (K) SUMMARY RT ELEMENTS
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| Manufacturer: | Brainlab AG
Kapellenstrasse 12
85622 Feldkirchen
Germany
Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 12/5/2014 |
| Device: | RT Elements |
| Trade name: | Elements Dose Review, Elements Brain Metastases, Elements Adaptive
Hybrid Surgery Analysis |
| Common/Classification
Name: | System,Planning,Radiation Therapy Treatment |
| Main Predicate Device: | iPlan RT (K103246) |
| Secondary Predicate
Device: | Not applicable |
| Device classification
name: | Medical charged-particle radiation therapy system |
| Regulatory Class: | Class II |
| Regulation 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
The "Dose Review" application as one RT Element contains features for
review of isodose lines, review of DVHs, dose comparison and dose
summation. |
| | The "Brain Metastases" 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 |
4
meetings or operating rooms.
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 "Brain Metastases" 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.
Operator Profile
Typical users are medical professionals, including but not limited to radiation oncologists, medical physicists or physicians as well as neurosurgeons (for Adaptive Hybrid Surgery Analysis)
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 doctor's office, at the operating theater in case of Adaptive Hybrid Surgery Analysis
- Substantial The RT Elements are part of a new software generation at Brainlab. The equivalence: features provided by the RT Elements including viewing of DICOM RT data, radiation treatment planning for stereotactic radiotherapy treatments is not a new technology for Brainlab. The intended use is considered substantially equivalent to what is possible with iPlan RT as predicate device. The single Elements to not provide the complete features of the predicate device but allow a subset of functionality of the predicate device.
Conclusion: The RT Elements and iPlan RT have identical functionalities in DICOM viewing and identical technical characteristic. The RT functionalities are equivalent to those of iPlan RT.
Verification/validation Verification
The verification of the RT Elements has been carried out thoroughly both at the top level and on the underlying subsystems. The verification was done according to verification plan to demonstrate that the design specifications are met.
summary:
5
Non-clinical validation
The validation was done in accordance with the validation plan containing usability tests which should ensure that workflows or user interface result in a useful interface.
All test reports were finally rated as successful according to their acceptance criteria. The non-clinical validation has been performed with software 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.