Autofuse
Device Facts
| Record ID | K233572 |
|---|---|
| Device Name | Autofuse |
| Applicant | Pymedix |
| Product Code | LLZ · Radiology |
| Decision Date | Mar 6, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
Autofuse is a software package that provides physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume operation, volume rendering, registration and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, and other medical specialties. Autofuse is not intended for mammography.
Device Story
Autofuse is a standalone medical imaging software application for radiotherapy professionals. It ingests DICOM-compliant medical images (CT, MR, PET, RT Dose) from PACS or other clinical systems. The software provides tools for image display, annotation, volume rendering, and co-registration (including deformable registration) of multi-modal images. It allows users to draw Regions of Interest (ROI) and export results to radiation treatment planning systems. Used in clinical settings on off-the-shelf computers, the device assists clinicians in visualizing and analyzing anatomical and functional data to support treatment planning workflows. It does not perform automated segmentation or manual registration editing. The output is viewed by clinicians to inform clinical decision-making in oncology and radiation therapy.
Clinical Evidence
No clinical data. Bench testing only. Software verification and validation were performed in a simulated clinical environment using virtual machines to confirm device specifications meet user needs and intended use, following FDA guidance and AAPM standards (TG-53, TG-132).
Technological Characteristics
Software-only device; runs on off-the-shelf (OTS) hardware. OS: Ubuntu 22.04. Connectivity: DICOM-compliant (DIMSE/TLS). Features: Rigid and deformable image registration, volume rendering, ROI contouring, and DICOM-RT import/export. No hardware components. Software development follows ISO 13485 and 21 CFR 820 design controls.
Indications for Use
Indicated for physicians in diagnostic radiology, oncology, and radiation therapy planning to compare, display, annotate, register, and fuse DICOM-compliant medical images. Not intended for mammography.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Velocity AIS (K081076)
Reference Devices
- Eclipse Treatment Planning System, v16.1 (K201607)
Submission Summary (Full Text)
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March 6, 2024
Image /page/0/Picture/1 description: The image contains the logo for 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Pymedix % Trey Thorsen RA Consultant Lean RAQA 131 E Loch Lomond Pl ORO VALLEY, AZ 85737
### Re: K233572
Trade/Device Name: Autofuse Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: January 30, 2024 Received: February 2, 2024
Dear Trey Thorsen:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding 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 mediation-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.
Loran Weiner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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### Indications for Use
Submission Number (if known)
#### K233572
Device Name
Autofuse
Indications for Use (Describe)
Autofuse is a software package that provides physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume operation, volume rendering, registration and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, and other medical specialties. Autofuse is not intended for mammography.
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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### 1. APPLICANT INFORMATION
| Pymedix Company Contact | |
|-------------------------|------------------------|
| Name: | Kris Huang |
| Title: | Co-CEO, CTO |
| Phone Number: | 513-693-5845 |
| Email: | kris.huang@pymedix.com |
| Official Correspondent | |
| Name: | Trey Thorsen |
| Title: | RA consultant |
| Phone Number: | 850-450-3932 |
| Email: | treyt@leanraqa.com |
### 2. DEVICE INFORMATION
| Device Name: | Picture Archiving and Communication System |
|----------------------|------------------------------------------------|
| Common Name: | Medical Imaging Software |
| Classification Name: | Medical image management and processing system |
| Model(s): | Autofuse |
| Regulation Number: | 21 CFR § 892.2050 |
| Product Code: | LLZ |
| Class: | II |
### 3. PREDICATE DEVICES
| Predicate Type | 510(k)<br>Number | Name of Device | Name of Manufacturer |
|------------------|------------------|---------------------------------------------|---------------------------------|
| Primary Device | K081076 | Velocity AIS | Velocity Medical Solutions, LLC |
| Reference Device | K201607 | Eclipse Treatment<br>Planning System, v16.1 | Varian Medical Systems, Inc |
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#### 4. DEVICE DESCRIPTION
Autofuse is a software application providing relevant tools for Radiotherapy professionals to use while creating treatment plans.
The Autofuse device is a Picture Archiving and Communication System (medical imaging software). Autofuse provides medical image processing designed to facilitate the oncology or other clinical specialty workflow by allowing the comparison of medical imaging data from different modalities, points in time, and / or scanning protocols. The product provides users with the means to display, co-register and analyze medical images from multiple modalities including PET, CT, RT Dose and MR; draw Regions of Interest (ROI); and import / export results to/from commercially available radiation treatment planning systems and PACS devices. Co-registration includes deformable registration technology that can be applied to DICOM data including diagnostic and planning image volumes, structures, and dose.
Autofuse is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
#### 5. INDICATIONS FOR USE
Autofuse is a software package that provides physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume operation, volume rendering, registration and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, and other medical specialties.
Autofuse is not intended for mammography.
| Characteristic | Proposed Device | Predicate Device | Remark |
|------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------|
| Device | Autofuse | Velocity AIS | N/A |
| Manufacturer | Pymedix, Inc. | Velocity Medical<br>Solutions, LLC | N/A |
| 510(k) Number | TBD | K081076 | N/A |
| Product Common<br>Name | Picture Archiving and<br>Communication System<br>(Medical Imaging<br>Software) | Picture Archiving and<br>Communication System<br>(Medical Imaging<br>Software) | Same |
| Product Code | LLZ | LLZ | Same |
| Classification | II | II | Same |
| Device description | Autofuse is a software<br>application providing<br>relevant tools for<br>Radiotherapy<br>professionals to use | Velocity is a software<br>application providing<br>relevant tools for<br>Radiotherapy<br>professionals to use | Similar |
#### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
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while creating treatment plans.
The Autofuse device is a Picture Archiving and Communication System (medical imaging software). Autofuse provides medical image processing designed to facilitate the oncology or other clinical specialty workflow by allowing the comparison of medical imaging data from different modalities, points in time, and / or scanning protocols. The product provides users with the means to display, co-register and analyze medical images from multiple modalities including PET. CT. RT Dose and MR; draw Regions of Interest (ROI): and import / export results to/from commercially available radiation treatment planning systems and PACS devices. Coregistration includes deformable registration technology that can be applied to DICOM data including diagnostic and planning image volumes, structures, and dose.
Autofuse is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
while creating treatment plans.
The Velocity device is a Picture Archiving and Communication System (medical imaging software). Velocity provides medical image processing designed to facilitate the oncology or other clinical specialty workflow by allowing the comparison of medical imaging data from different modalities, points in time, and / or scanning protocols. The product provides users with the means to display, co-register and analyze medical images from multiple modalities including PET. SPECT. CT, RT Dose and MR; draw Regions of Interest (ROI), calculate and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions; and import / export results to/from commercially available radiation treatment planning systems and PACS devices. Co-registration includes deformable registration technology that can be applied to DICOM data including diagnostic and planning image volumes, structures, dose, and automatic anatomical
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| | | | atlas-based<br>segmentation tools. | | |
|------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | Velocity is used as a<br>stand-alone application<br>on recommended Off-<br>The-Shelf<br>(OTS)computers<br>supplied by the<br>company or by the end-<br>user. | | |
| | Indications for Use | Autofuse is a software<br>product that provides<br>physicians a means for<br>comparison of medical<br>data including imaging<br>data that is DICOM<br>compliant. It allows the<br>display, annotation,<br>volume operation,<br>volume rendering,<br>registration and fusion of<br>medical images as an aid<br>during use by diagnostic<br>radiology, oncology,<br>radiation therapy<br>planning, and other<br>medical specialties.<br>Autofuse is not intended<br>for mammography. | VelocityAIS (VelocityAI)<br>is a standalone software<br>product that provides<br>the physician a means<br>for comparison of<br>medical imaging data<br>from multiple DICOM<br>conformant imaging<br>modality sources. It<br>allows the display,<br>annotating, volume<br>rendering, registration<br>and fusing of medical<br>images as an aid during<br>use by diagnostic<br>radiology, oncology,<br>radiation therapy<br>planning and other<br>medical specialties.<br>VelocityAIS (VelocityAI)<br>is not intended for<br>mammography<br>diagnosis. | Similar | |
| General Usage/Performance Features | | | | | |
| | Image Study<br>Importation | CT/MR/PET | DICOM,<br>PET/SPECT/CT/MRI;<br>Dose | Similar. The<br>most commonly<br>used imaging<br>modalities used<br>in radiation<br>treatment<br>planning are<br>DICOM-format<br>CT, MR, and<br>PET images. | |
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| | | | Autofuse does<br>allow import of<br>DICOM-RT<br>Dose, but it is<br>considered a<br>DICOM-RT<br>object<br>associated with<br>a scan, not an<br>imaging<br>modality itself.<br>This difference<br>does not bring<br>up any new<br>questions of<br>safety or<br>efficacy. | |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Structure<br>Import, Save &<br>Export to Treatment<br>Planning Systems | Yes | Yes | Same | |
| Volume Rendering | Yes | Yes | Same | |
| Advanced<br>Visualization and<br>Navigation Features | Yes | Yes | Same | |
| Volume Operations | No | No | Same | |
| Diagnostic Image<br>Registration | Yes | Yes | Same | |
| Image Fusion | Yes; Anatomical and<br>Functional Images | Yes; Anatomical and<br>Functional Images | Same | |
| ROI & Contouring | Yes | Yes | Same | |
| Manual Contouring<br>Tools | Yes | Yes | Same | |
| Image Analysis | Yes | Yes | Same | |
| Plan Review of<br>Imported Plans or<br>Created Dose<br>Composites | No | No | Same | |
| Oncology Workflow<br>Automation | No | No | Same | |
| Image/ROI Export<br>to DICOM RT | Yes | Yes | Same | |
| Secure Login and<br>Data Storage | No | Yes | Velocity uses<br>an application-<br>level login.<br>Autofuse is<br>intended to run<br>on a secure | |
| | | | workstation and<br>logs OS-level<br>information of<br>the user logged<br>in and running<br>the application.<br>Data storage<br>and user<br>authentication<br>is handled by<br>the underlying<br>workstation OS,<br>not the<br>Autofuse<br>application.<br>This difference<br>does not bring<br>up any new<br>questions of | |
| | | | safety or<br>efficacy. | |
| Operating System<br>Platform | Ubuntu 22.04 | Microsoft Windows XP<br>32 bit only/ Windows 7,<br>Vista, MAC OSX 10.6 | Autofuse is<br>intended for<br>use in a secure<br>Linux-based<br>computing<br>environment.<br>This difference<br>does not bring<br>up any new<br>questions of<br>safety or<br>efficacy. | |
| Multimodality DICOM Import | | | | |
| Import and Display<br>DICOM CT, MR,<br>DS, PET, RTS, RTP | Yes | Yes | Same | |
| Advanced Visualization and Navigation | | | | |
| General Image<br>Viewer with View<br>Layout Selection<br>and Toolbars | Yes | Yes | Same | |
| User Scaling of<br>Image Volumes | No | No | Same | |
| Biological Effective<br>Dose (BED) Scaling | No | No | Same | |
| Y-90 Microsphere<br>Dosimetry | No | No | Same | |
| conversion of<br>SPECT to DS | | | | |
| | Automated Image-Based Registration | | | |
| Manual Registration<br>Editing | No | Yes | Autofuse does<br>not allow<br>manual<br>registration.<br>AAPM TG-132<br>states "direct,<br>unguided<br>manual<br>adjustment of a<br>deformation<br>vector field is<br>not<br>recommended".<br>This difference<br>does not bring<br>up any new<br>questions of<br>safety or<br>efficacy. | |
| Auto Rigid<br>Registration | Yes | Yes | Same | |
| Deformable<br>Registration | Yes | Yes | Same | |
| Inverse Deformable<br>Registration | No | No | Same | |
| Structure Guided<br>Deformable | No | No | Same | |
| | Segmentation (Manual Contouring Tools and Atlas Segmentation) | | | |
| Manual Contouring<br>Tools | Yes | Yes | Same | |
| Atlas Auto-<br>Segmentation | No | Yes | Autofuse does<br>not contain or<br>use atlases for<br>auto-<br>segmentation.<br>This difference<br>does not bring<br>up any new<br>questions of<br>safety or<br>efficacy. | |
| Image Analysis with Volumetric Graphs | | | | |
| Histograms and<br>Voxel Assessment<br>Graphs | Yes | Yes | Same | |
| | DVH Statistics<br>Display | Yes | Yes | Same |
| | Plan Review | | | |
| | Storage and Display<br>of DICOM RT Plans | No | No | Same |
| | Lesion Volume<br>Tracking by<br>Associating<br>Structure with<br>Name Tag | No | No | Same |
| | Navigator Semi-Automated Workflows | | | |
| | Semi-automatic<br>Workflows to Assist<br>with Common<br>Clinical Image<br>Registration &<br>Analysis Tasks | No. Image registration is<br>fully automated with no<br>user-facing workflow. | No | Same |
| | Adaptive Navigators<br>to Assist in Offline<br>Dose Review:<br>Includes workflows<br>to create adaptive<br>CT based on CBCT<br>Registration, copy<br>plan to adaptive CT,<br>and compare dose | No | No | Same |
| | Security | | | |
| | Logging of<br>Database Activity | No | Yes | Database<br>activity is<br>timestamped,<br>tagged by user<br>and logged for<br>all transactions.<br>This difference<br>does not bring<br>up any new<br>questions of<br>safety or<br>efficacy. |
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### 7. PERFORMANCE DATA
#### 7.1 Non-clinical performance Data
Software Verification and Validation Testing Software verification and validation 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. The primary objective of the design validation testing process was to ensure
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documented confirmation that the device specifications meet user needs and the intended use through thorough testing in a simulated environment as part of the Design Control Process. Test results demonstrate conformance to applicable requirements and specifications.
The following references provide external standards and quidelines that are used, in part, for the definition of the quidelines provided in this document:
- 21 CFR Part 820, Quality System (QS) Regulation/Medical Device Good Manufacturing . Practices, US Food and Drug Administration
- . ISO 13485:2016. Medical devices - Quality management systems - Requirements for regulatory purposes, International Organization for Standardization
- ISO/DIS 10013 Quality management systems - Guidance for documented information, International Organization for Standardization
- Glossary of Computerized System and Software Development Terminology. Division of . Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, August 1995.
- . AAPM Report No. 062 - American Association of Physicists in Medicine Radiation Therapy Committee Task Group 53: Quality assurance for clinical radiotherapy treatment planning (1998) ICRU Report 83 - Prescribing, Recording, and Reporting Intensity-Modulated Photon-Beam Therapy (IMRT)
- AAPM Report No. 132 Use of image registration and fusion algorithms and techniques in ● radiotherapy: Report of the AAPM Radiation Therapy Committee Task Group No. 132 (2017)
Non-clinical validation testing was performed in the Staging Environment (SE), which consists of a network of virtual machines (VMs) within a Kernel Virtual Machine (KVM) hypervisor. The network of VMs is designed to mimic a typical clinical set up including a departmental CT scanner and a radiology PACS communicating with unencrypted DIMSE communications or TLS-encrypted DIMSE communications.
#### 7.2 Biocompatibility
Not applicable. Autofuse is software.
#### 7.3 Clinical performance data
No clinical study is included in this submission.
### 8. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is substantially equivalent, and performs as well as or better than the predicate device.
