(121 days)
No
The document describes image processing and registration techniques, including deformable registration, but does not mention AI, ML, or related terms like deep learning or neural networks. The focus is on traditional image processing and analysis tools.
No.
The device is a software package that provides comparison of medical data and images as an aid for various medical specialties, including diagnostic radiology, oncology, and radiation therapy planning. It is not intended for active treatment or diagnosis, but rather to facilitate the workflow of professionals involved in those areas.
No.
Autofuse is described as a software package that allows the comparison of medical imaging data and aids in various medical specialties like oncology and radiation therapy planning. While it involves medical images and analysis, its primary function is not to diagnose conditions itself, but rather to process and present data to assist physicians in their diagnostic and treatment planning activities. The "Intended Use" states it's an "aid during use," meaning it supports the diagnostic process rather than performing it.
Yes
The device description explicitly states "Autofuse is a software application" and "Autofuse is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers". It processes medical imaging data and provides tools for analysis and comparison, all within the software itself. While it interacts with hardware (OTS computers, PACS devices), the medical device itself is the software application.
Based on the provided information, Autofuse is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Autofuse's Function: Autofuse is a software package that processes and displays medical imaging data (PET, CT, MR, RT Dose). It aids physicians in comparing and analyzing these images for purposes like diagnosis, treatment planning (especially radiation therapy), and monitoring.
- No Specimen Analysis: The description of Autofuse does not mention any analysis of biological specimens. Its input is imaging data, not samples from the body.
Therefore, Autofuse falls under the category of medical imaging software used for image processing, display, and analysis, rather than an IVD device.
N/A
Intended Use / 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, CT, RT Dose and MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / diagnostic radiology, oncology, radiation therapy planning, and other medical specialties.
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)
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 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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).
1
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
2
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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3
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)
Number | Name of Device | Name of Manufacturer |
|------------------|------------------|---------------------------------------------|---------------------------------|
| Primary Device | K081076 | Velocity AIS | Velocity Medical Solutions, LLC |
| Reference Device | K201607 | Eclipse Treatment
Planning System, v16.1 | Varian Medical Systems, Inc |
4
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 | |
| Solutions, LLC | N/A | ||
| 510(k) Number | TBD | K081076 | N/A |
| Product Common | |||
| Name | Picture Archiving and | ||
| Communication System | |||
| (Medical Imaging | |||
| Software) | Picture Archiving and | ||
| Communication System | |||
| (Medical Imaging | |||
| Software) | Same | ||
| Product Code | LLZ | LLZ | Same |
| Classification | II | II | Same |
| Device description | Autofuse is a software | ||
| application providing | |||
| relevant tools for | |||
| Radiotherapy | |||
| professionals to use | Velocity is a software | ||
| application providing | |||
| relevant tools for | |||
| Radiotherapy | |||
| professionals to use | Similar |
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
5
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
6
| | | | atlas-based
segmentation tools. | | |
|------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | Velocity is used as a
stand-alone application
on recommended Off-
The-Shelf
(OTS)computers
supplied by the
company or by the end-
user. | | |
| | Indications for Use | Autofuse is a software
product 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. | VelocityAIS (VelocityAI)
is a standalone software
product that provides
the physician a means
for comparison of
medical imaging data
from multiple DICOM
conformant imaging
modality sources. It
allows the display,
annotating, volume
rendering, registration
and fusing of medical
images as an aid during
use by diagnostic
radiology, oncology,
radiation therapy
planning and other
medical specialties.
VelocityAIS (VelocityAI)
is not intended for
mammography
diagnosis. | Similar | |
| General Usage/Performance Features | | | | | |
| | Image Study
Importation | CT/MR/PET | DICOM,
PET/SPECT/CT/MRI;
Dose | Similar. The
most commonly
used imaging
modalities used
in radiation
treatment
planning are
DICOM-format
CT, MR, and
PET images. | |
7
| | | | Autofuse does
allow import of
DICOM-RT
Dose, but it is
considered a
DICOM-RT
object
associated with
a scan, not an
imaging
modality itself.
This difference
does not bring
up any new
questions of
safety or
efficacy. | |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Structure
Import, Save &
Export to Treatment
Planning Systems | Yes | Yes | Same | |
| Volume Rendering | Yes | Yes | Same | |
| Advanced
Visualization and
Navigation Features | Yes | Yes | Same | |
| Volume Operations | No | No | Same | |
| Diagnostic Image
Registration | Yes | Yes | Same | |
| Image Fusion | Yes; Anatomical and
Functional Images | Yes; Anatomical and
Functional Images | Same | |
| ROI & Contouring | Yes | Yes | Same | |
| Manual Contouring
Tools | Yes | Yes | Same | |
| Image Analysis | Yes | Yes | Same | |
| Plan Review of
Imported Plans or
Created Dose
Composites | No | No | Same | |
| Oncology Workflow
Automation | No | No | Same | |
| Image/ROI Export
to DICOM RT | Yes | Yes | Same | |
| Secure Login and
Data Storage | No | Yes | Velocity uses
an application-
level login.
Autofuse is
intended to run
on a secure | |
| | | | workstation and
logs OS-level
information of
the user logged
in and running
the application.
Data storage
and user
authentication
is handled by
the underlying
workstation OS,
not the
Autofuse
application.
This difference
does not bring
up any new
questions of | |
| | | | safety or
efficacy. | |
| Operating System
Platform | Ubuntu 22.04 | Microsoft Windows XP
32 bit only/ Windows 7,
Vista, MAC OSX 10.6 | Autofuse is
intended for
use in a secure
Linux-based
computing
environment.
This difference
does not bring
up any new
questions of
safety or
efficacy. | |
| Multimodality DICOM Import | | | | |
| Import and Display
DICOM CT, MR,
DS, PET, RTS, RTP | Yes | Yes | Same | |
| Advanced Visualization and Navigation | | | | |
| General Image
Viewer with View
Layout Selection
and Toolbars | Yes | Yes | Same | |
| User Scaling of
Image Volumes | No | No | Same | |
| Biological Effective
Dose (BED) Scaling | No | No | Same | |
| Y-90 Microsphere
Dosimetry | No | No | Same | |
| conversion of
SPECT to DS | | | | |
| | Automated Image-Based Registration | | | |
| Manual Registration
Editing | No | Yes | Autofuse does
not allow
manual
registration.
AAPM TG-132
states "direct,
unguided
manual
adjustment of a
deformation
vector field is
not
recommended".
This difference
does not bring
up any new
questions of
safety or
efficacy. | |
| Auto Rigid
Registration | Yes | Yes | Same | |
| Deformable
Registration | Yes | Yes | Same | |
| Inverse Deformable
Registration | No | No | Same | |
| Structure Guided
Deformable | No | No | Same | |
| | Segmentation (Manual Contouring Tools and Atlas Segmentation) | | | |
| Manual Contouring
Tools | Yes | Yes | Same | |
| Atlas Auto-
Segmentation | No | Yes | Autofuse does
not contain or
use atlases for
auto-
segmentation.
This difference
does not bring
up any new
questions of
safety or
efficacy. | |
| Image Analysis with Volumetric Graphs | | | | |
| Histograms and
Voxel Assessment
Graphs | Yes | Yes | Same | |
| | DVH Statistics
Display | Yes | Yes | Same |
| | Plan Review | | | |
| | Storage and Display
of DICOM RT Plans | No | No | Same |
| | Lesion Volume
Tracking by
Associating
Structure with
Name Tag | No | No | Same |
| | Navigator Semi-Automated Workflows | | | |
| | Semi-automatic
Workflows to Assist
with Common
Clinical Image
Registration &
Analysis Tasks | No. Image registration is
fully automated with no
user-facing workflow. | No | Same |
| | Adaptive Navigators
to Assist in Offline
Dose Review:
Includes workflows
to create adaptive
CT based on CBCT
Registration, copy
plan to adaptive CT,
and compare dose | No | No | Same |
| | Security | | | |
| | Logging of
Database Activity | No | Yes | Database
activity is
timestamped,
tagged by user
and logged for
all transactions.
This difference
does not bring
up any new
questions of
safety or
efficacy. |
8
9
10
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
11
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.