(61 days)
No reference devices were used in this submission.
No
The summary describes automated processes and calculations based on DICOM data and dose volume histograms, but it does not mention the use of AI, ML, deep learning, or any related terms. The description focuses on image registration, analysis of anatomical changes, dose projection, and reporting, which can be achieved through traditional algorithms and software logic.
No.
The device analyzes and visualizes data to aid radiation oncology professionals in monitoring treatment plans, rather than directly applying therapy.
No
The device aids in treatment planning and monitoring by analyzing imaging data and treatment plans, and flagging risks, but it does not make a diagnosis.
Yes
The device is explicitly described as a "stand-alone software medical device" and the description focuses solely on software functionalities and testing. There is no mention of accompanying hardware components or hardware-specific verification/validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RTapp's Function: RTapp analyzes and visualizes medical imaging data (DICOM compliant) to aid in radiation oncology treatment planning and monitoring. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for "comparison of imaging data" and "aid during use by radiation oncology." This aligns with image analysis and treatment planning support, not in vitro testing.
- Device Description: The description focuses on processing and displaying imaging data, analyzing dose, and generating reports based on this data. There is no mention of analyzing biological samples.
Therefore, based on the provided information, RTapp is a medical imaging software device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RTapp™ is a stand-alone software that provides a means for comparison of imaging data that is DICOM compliant. It allows the registration and display of medical images as an aid during use by radiation oncology.
Product codes
LLZ
Device Description
RTapp™ v2.0 is a stand-alone software medical device. RTapp analyzes and visualizes the day-to-day variations in a radiation therapy patient's individual anatomical structures and the effect of those changes on the treatment dose; it is an aid during use by radiation oncology.
The RTapp software:
- Automatically queries and retrieves treatment plan data and images from any DICOM compliant equipment.
- Automatically processes all patient's treatment fractions, flagging and presenting ● an advance warning of treatment plans at risk with an email notification.
- Monitors and evaluates treatment plan performance in real time by using the Plan ● Performance Dose Volume Histogram (DVH). The DVH projects the amount of dose to be delivered.
- . Displays Deformable Image Registration contours, cross correlation metrics and flagging of large deformations.
- Projects when Organs At Risk will exceed dose constraints.
- . Dose estimation
- Generates reports as PDF with images and graphs.
RTapp is intended for use by radiation oncology professionals in a hospital/clinical setting for any patient undergoing radiation therapy based on a treatment plan. RTapp is NOT intended as a treatment planning software and cannot be used to generate radiotherapy treatment plans.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant imaging data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncology professionals in a hospital/clinical setting
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
Non-clinical, verification and validation (V&V) performance testing was conducted on anonymized, retrospective, clinically-relevant data using computer systems for single and multi-users that met minimum configuration specifications in order to test the device design requirements and user needs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing: Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The RTapp software is considered a "Major" level of concern. Non-clinical, verification and validation (V&V) performance testing was conducted on anonymized, retrospective, clinically-relevant data using computer systems for single and multi-users that met minimum configuration specifications in order to test the device design requirements and user needs. RTapp™ v2.0, which includes some offthe-shelf software, underwent V&V testing and regression analysis of manual test suites interfacing with external DICOM servers. The following features for comparing DICOM-compliant images were tested: automated and manual workflows, image visualization, alignment, settings for configuring the dashboard and visual displays, user interface, importing and exporting DICOM data, processing and loading time, dose volume histogram graphs, and reports. All test protocols passed, and acceptance criteria were met indicating successful verification and validation of the subject device and substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains 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.
SegAna, Inc. % Ms. Jennifer Bosley, Sr. Director of Quality & Regulatory Affairs 3259 Progress Drive ORLANDO FL 32826
Re: K212887
Trade/Device Name: RTapp™ v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 8, 2021 Received: September 10, 2021
Dear Ms. Bosley:
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 801 and Part 809); 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
1
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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K212887
Device Name
RTapp™ v2.0
Indications for Use (Describe)
RTapp™ is a stand-alone software that provides a means for comparison of imaging data that is DICOM compliant. It allows the registration and display of medical images as an aid during use by radiation oncology.
| 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) |
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Image /page/3/Picture/0 description: The image is a logo for SegAna. The logo features a stylized representation of lungs in blue, with a red target symbol superimposed over the center. Below the lung graphic, the word "SegAna" is written in a sans-serif font, also in blue. The overall design is clean and modern, suggesting a focus on precision and targeting within the field of lung health or diagnostics.
510(k) Summary
I. SUBMITTER
SegAna. Inc. 3259 Progress Drive Orlando, FL 32826 USA
Telephone: 866-347-0898 Contact Person: Jennifer Bosley, MBA, RAC Date Prepared: November 9, 2021
II. DEVICE
| 510(k) Number: | K212887 |
|---|---|
| Name of Device: | RTapp™ v2.0 |
| Common/Usual Name: | Image Processing Aid to Radiation Therapy Treatment Planning |
| Classification Name: | Medical Image Management and Processing System |
| Regulation Number: | 21 CFR §892.2050 |
| Regulatory Class: | II |
| Product Code: | LLZ - System, Image Processing, Radiological |
III. PREDICATE DEVICE
RTapp™ v1.0 (K191610, SegAna, Inc.) This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
RTapp™ v2.0 is a stand-alone software medical device. RTapp analyzes and visualizes the day-to-day variations in a radiation therapy patient's individual anatomical structures and the effect of those changes on the treatment dose; it is an aid during use by radiation oncology.
The RTapp software:
- Automatically queries and retrieves treatment plan data and images from any DICOM compliant equipment.
- Automatically processes all patient's treatment fractions, flagging and presenting ● an advance warning of treatment plans at risk with an email notification.
- Monitors and evaluates treatment plan performance in real time by using the Plan ● Performance Dose Volume Histogram (DVH). The DVH projects the amount of dose to be delivered.
4
- . Displays Deformable Image Registration contours, cross correlation metrics and flagging of large deformations.
- Projects when Organs At Risk will exceed dose constraints.
- . Dose estimation
- Generates reports as PDF with images and graphs.
RTapp is intended for use by radiation oncology professionals in a hospital/clinical setting for any patient undergoing radiation therapy based on a treatment plan. RTapp is NOT intended as a treatment planning software and cannot be used to generate radiotherapy treatment plans.
V. INDICATIONS FOR USE
RTapp™ is a stand-alone software that provides a means for comparison of imaging data that is DICOM compliant. It allows the registration and display of medical images as an aid during use by radiation oncology.
The Indications For Use statement for RTapp™ v2.0 is identical to the predicate device. Both the subject and predicate devices have the same intended use and indications for use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of the subject device and the predicate device are the same, Deformable Image Registration using an "Optical-Flow" algorithm for the comparison of DICOM-compliant imaging data as an aid in radiation oncology. The following difference exists between the subject and predicate device:
- . Predicate device only imports data for comparison, while the subject device can import and export data.
VII. PERFORMANCE DATA
Performance data was provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The RTapp software is considered a "Major" level of concern.
Non-clinical, verification and validation (V&V) performance testing was conducted on anonymized, retrospective, clinically-relevant data using computer systems for single and multi-users that met minimum configuration specifications in order to test the device design requirements and user needs. RTapp™ v2.0, which includes some offthe-shelf software, underwent V&V testing and regression analysis of manual test
5
suites interfacing with external DICOM servers. The following features for comparing DICOM-compliant images were tested: automated and manual workflows, image visualization, alignment, settings for configuring the dashboard and visual displays, user interface, importing and exporting DICOM data, processing and loading time, dose volume histogram graphs, and reports. All test protocols passed, and acceptance criteria were met indicating successful verification and validation of the subject device and substantial equivalence to the predicate device.
VIII. CONCLUSION
Non-clinical performance data show the RTapp™ v2.0 is substantially equivalent to the predicate device. The software verification and validation demonstrate that the RTapp™ v2.0 device should perform as intended in the specified use conditions.