(134 days)
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 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.
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.
The document provided is a 510(k) premarket notification for the "RT Elements" software, which is used for radiation treatment planning. It states that the device is substantially equivalent to a predicate device, iPlan RT (K103246). However, the document does not contain specific acceptance criteria, detailed study results, or the other requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details). The provided text describes the general verification and validation process but lacks the quantitative data needed to answer the questions comprehensively.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the document:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | The verification was done according to the verification plan to demonstrate that the design specifications are met. All test reports were finally rated as successful according to their acceptance criteria. |
| Not specified in the provided document. | Usability tests were performed to ensure workflows and user interface result in a useful interface. |
2. Sample size used for the test set and data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of experts: Not specified.
- Qualifications: Not specified.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not specified. The document describes software for treatment planning, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies standalone testing as part of "verification" where "design specifications are met." However, no specific performance metrics or studies are detailed. The "Adaptive Hybrid Surgery Analysis" application "simulates an automated template-based radiation treatment plan," which suggests algorithmic processing.
7. The type of ground truth used:
- Not specified. The document generically refers to "design specifications" and "verification plan" being met. For a radiation treatment planning system, ground truth would likely involve clinically validated treatment plans, phantom measurements, or expert-defined anatomical structures and dose distributions.
8. The sample size for the training set:
- Not applicable/Not specified. This is a software for treatment planning, not a machine learning model that typically undergoes a distinct "training" phase with a specific dataset in the way a diagnostic AI would. The "Adaptive Hybrid Surgery Analysis" application is template-based, not described as a deep learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, for the reasons outlined in point 8.
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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.
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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
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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)
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510 (K) SUMMARY RT ELEMENTS
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| Manufacturer: | Brainlab AGKapellenstrasse 1285622 FeldkirchenGermanyPhone: +49 89 99 15 68 0Fax: +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 AdaptiveHybrid Surgery Analysis |
| Common/ClassificationName: | System,Planning,Radiation Therapy Treatment |
| Main Predicate Device: | iPlan RT (K103246) |
| Secondary PredicateDevice: | Not applicable |
| Device classificationname: | 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 instereotactic, conformal, computer planned, Linac based radiation treatment ofcranial, head and neck, and extracranial lesions |
| Indications for use: | The RT Elements are applications for radiation treatment planning for use instereotactic, conformal, computer planned, Linac based radiation treatment ofcranial, head and neck, and extracranial lesionsThe "Dose Review" application as one RT Element contains features forreview of isodose lines, review of DVHs, dose comparison and dosesummation. |
| The "Brain Metastases" application as one RT Element provides optimizedplanning and display for cranial multi-metastases radiation treatment planning. | |
| The "Adaptive Hybrid Surgery Analysis" application as one RT Elementsimulates an automated template-based radiation treatment plan. Thesimulated plan is intended for treatment evaluation for example in tumor board |
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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:
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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.
§ 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.