(106 days)
No reference devices were used in this submission.
Unknown
While the device performs complex image analysis, registration, and prediction ("Projects when Organs At Risk will exceed dose constraints"), the summary does not explicitly mention the use of AI or ML algorithms. The description of "automatic processing" and "flagging" could potentially be rule-based or algorithmic without necessarily employing AI/ML. The lack of information on training/test sets further supports this uncertainty.
No
The device is a software tool designed to aid radiation oncology professionals by analyzing and visualizing day-to-day variations in patient anatomy and the effect on treatment dose. It provides information and warnings but does not directly deliver therapy or have a direct therapeutic effect on the patient.
No
The device description states that RTapp analyzes and visualizes data to aid radiation oncology professionals. Its functions, such as flagging at-risk treatment plans, monitoring treatment plan performance, and projecting dose constraints for organs at risk, are related to evaluating and optimizing treatment rather than diagnosing a patient's condition. While it processes imaging data and performs "Dose estimation," this is in the context of treatment monitoring and planning, not disease diagnosis. The "Intended Use" also specifies it's an "aid during use by radiation oncology," which primarily focuses on treatment aspects.
Yes
The device is explicitly described as "stand-alone software" and a "cloud-based software medical device." The description focuses solely on software functionalities and data processing, with no mention of accompanying hardware components required for its primary function. While it interacts with DICOM-compliant equipment for data, the device itself is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- RTapp's Function: RTapp analyzes and processes medical imaging data (DICOM compliant images, specifically mentioning CT images) to aid in radiation oncology. It focuses on image registration, dose analysis, and monitoring treatment plan performance based on these images.
- No Specimen Analysis: There is no mention of RTapp analyzing any biological specimens taken from the patient. Its input is imaging data, not biological samples.
Therefore, RTapp falls under the category of medical imaging software or radiation therapy planning/monitoring software, 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 v1.0 is a stand-alone, cloud-based software medical device with secure access via a private internet web portal. RTqpp 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; 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, CT images
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
Not Found
Summary of Performance Studies
Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Although the RTqpp software was considered a "major" level of concern by the FDA, a failure or latent flaw in the software will not directly result in serious injury or death to the patient or user. The major level of concern was determined because the software was considered related to RT treatment planning and QA.
Key Metrics
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).
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October 1, 2019
SegAna, LLC % Ms. Jennifer Bosley Principal Consultant Jennifer Bosley Consulting 10336 Wittenberg Way ORLANDO, FL, 32832
Re: K191610
Trade/Device Name: RTapp™ v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: Class II Product Code: LLZ Dated: July 2, 2019 Received: July 3, 2019
Dear Jennifer 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
1
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 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,
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) K191610
Device Name
RTapp™ v1.0
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 shows a logo for SegAna LLC. The logo features a stylized blue outline of lungs with a red target symbol in the center. Below the lung graphic, the text "SegAna LLC" is displayed in a bold font. Underneath "SegAna LLC", there is smaller text that reads "Real-Time Adaptive Guidance for Enhanced Targeted Therapy".
510(k) Summary
I. SUBMITTER
SegAna LLC 3259 Progress Drive Orlando, FL 32826 USA
SegAna Phone: (484) 291-1087 Contact Person: Rodney Bosley, President & CEO Date Prepared: July 2, 2019
II. DEVICE
| 510(k) Number: | K191610 |
|---|---|
| Name of Device: | RTapp ™ v1.0 |
| Common or Usual Name: | Image Processing Aid to Radiation Therapy Treatment Planning |
| Classification Name: | Picture archiving and communications systems |
| Regulation Number: | 21 CFR §892.2050 |
| Regulatory Class: | II |
| Product Code: | LLZ – System, Image Processing, Radiological |
III. PREDICATE DEVICE
Velocity™ 4.0 (K173636, Varian Medical) This predicate was not subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
RTapp v1.0 is a stand-alone, cloud-based software medical device with secure access via a private internet web portal. RTqpp 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; 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.
Differences in Indications For Use:
The Indications For Use for RTapp are not identical to the predicate device; however, the indications for use of the RTapp falls within the intended use of the predicate device and, therefore, the two devices have the same intended use. The differences do not alter the intended use of the device nor does it affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use: comparison of DICOM-compliant imaging data as an aid in radiation oncology.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Comparison of DICOM-compliant imaging data as an aid in radiation oncology is the technological principle for both the subject and predicate devices.
The subject and predicate devices are based on the following same technological elements:
- Software devices
- Imports and compares imaging data with CT images through DICOM
The following differences exist between the subject and predicate device:
- Predicate imports DICOM, PET/SPECT/CT/MRI images. Subject device imports DICOM, CT images only.
- . Predicate can be used with diagnostic radiology, oncology, radiation therapy planning and other medical specialties. Subject device used with radiation oncology.
- Predicate is used to aid in creating treatment plans. Subject device is used to review daily treatment dose and compare it to established treatment plan dose.
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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 for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Although the RTqpp software was considered a "major" level of concern by the FDA, a failure or latent flaw in the software will not directly result in serious injury or death to the patient or user. The major level of concern was determined because the software was considered related to RT treatment planning and QA.
VIII. CONCLUSIONS
Non-clinical data support the safety and efficacy of the device. The software verification and validation demonstrate that the RTqpp device should perform as intended in the specified use conditions.