(142 days)
No
The description focuses on image processing, visualization, measurement tools, and a dosimetry model based on computational human models and S-Values. There is no mention of AI, ML, or related concepts like training data or algorithms that learn from data.
No
The device aids in estimating radiation dose from internal radioactivity resulting from diagnostic or therapeutic procedures, but it does not directly administer therapy or provide a therapeutic effect. Its primary functions are image registration, visualization, and analysis of medical image data, along with dose estimation.
Yes
The device aids in image registration and fusion display, provides measurements, and estimates radiation dose, all of which contribute to understanding a patient's medical condition or response to treatment, which are characteristics of a diagnostic device.
Yes
The device description explicitly states that UniSyn Molecular Imaging (MI) is a Software as a Medical Device (SaMD). The description focuses solely on the software's functionalities for image visualization, manipulation, analysis, and dose estimation, without mentioning any accompanying hardware components that are part of the medical device itself.
Based on the provided information, UniSyn is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- UniSyn analyzes medical images: UniSyn's intended use and description clearly state that it processes and analyzes scanned image data from medical scanners (CT, PET, SPECT, MR, etc.) and planar nuclear medicine images. It does not analyze biological samples.
- Focus on image processing and analysis: The device description details features like image registration, fusion display, multi-planar reformat, maximum intensity projection, measurements on images (area, volume, SUV), ROI tools, segmentation tools, and absorbed dose estimation based on image data. These are all related to image processing and analysis, not the analysis of biological specimens.
Therefore, UniSyn falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Product codes
LLZ, IYX
Device Description
UniSyn Molecular Imaging (MI) is a Software as a Medical Device (SaMD) that supports the visualization, manipulation and analysis of medical image data acquired or used in radiology and nuclear medicine centers. UniSyn Ml is only intended to be used by qualified radiology and nuclear medicine professionals. Univer-interface components: a patient study browser and the UniSyn MI viewer. The software is available in both thick and can be integrated to launch from PACS software.
Using UniSyn MI users can coregister anatomical and visualize them in fused and/or standalone display, e.g. single or multi-modal combinations of PET, SPECT, CT, and MR images. Users can also visualize and process planar nuclear medicine (NM) images acquired as single of multi-frame images. The layout of the UniSyn MI viewer is highly customisable, a typical layout for a PET/CT study would include of the PET and CT series in multiplanar reformatted (MPR) views as well as a 3D maximum-intensity (MIP) projection rendering of the PET series.
UniSyn MI provides tools to zoom, pan, stack, and window-level the displayed series. Our triangulation tool can be used to localize a single anatomical point of interest among all MPR and MP views of the rest (RO) tools are available to delineate 2D and 3D regions and then compute image statistics within those regions, e.g. ROI area/volumes, minimum, mean and standard deviation of image pixel values. Various image segmentation tools are included with UniSyn MI to facilitate ROI delineation based on image pixel data.
UniSyn MI includes a tool for absorbed dose estimation associated with internally deposited with diagnostic and therapeutic medical procedures. Absorbed dose estimates are based on single- or multi-time point activity measurements of molecular images and absorbed dose coefficients (S-Values) that are based on computational human models.
Once a user has completed their review or analysis of a given study, UniSyn MI provides tools to generate reports and export exemplary image data to share with referring physicians to substantiate their findings.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PET, SPECT, MR, planar nuclear medicine (NM) images
Anatomical Site
human body / whole organ / tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified radiology and nuclear medicine professionals
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
Performance testing was not required for functionality that is shared with the predicate (K081987). This functionality was verified and validated using existing verification and validation testing protocols.
Performance testing was completed to validate the technological characteristics of the dosimetry model used in UniSyn MI. Various radionuclides including Fluorine-18, Gallium-177, Technitium-99m, and Yttrium-90 were evaluated. For all tests, dose estimates were compared to reference values described below. Relative differences (reported as percentages) were used to characterize agreement. The acceptance criteria was set as a relative difference at or below 10%.
Validation of normal organ dosimetry was based on comparisons to values from published data. Data evaluated for both male and female patients demonstrated high overall aith published data demonstrating relative differences (mean relative differences
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
September 1, 2023
Convergent Imaging Solutions Mathew Thomas President 36 Rideau River Lane Ottawa, Ontario K1S 0X1 Canada
Re: K231047
Trade/Device Name: UniSyn Molecular Imaging (6-3-1) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, IYX Dated: August 2, 2023 Received: August 2, 2023
Dear Mathew Thomas:
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
1
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 (OS) 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 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,
Daniel M. Krainak, Ph.D. Assistant Director 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
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
UniSyn Molecular Imaging (6-3-1)
Indications for Use (Describe)
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
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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| 510(k) #: K231047 | 510(k) Summary | Prepared on: 2023-09-01 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Convergent Imaging Solutions | |
| Applicant Address | 36 Rideau River Lane Ottawa ON K1S 0X1 Canada | |
| Applicant Contact Telephone | 1-613-212-0063 | |
| Applicant Contact | Mr. Mathew Thomas | |
| Applicant Contact Email | mathew.thomas@convergentimaging.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | UniSyn Molecular Imaging (6-3-1) | |
| Common Name | Medical image management and processing system | |
| Classification Name | System, Image Processing, Radiological | |
| Regulation Number | 892.2050 | |
| Product Code | LLZ | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K081987 | UNISYN | LLZ |
| K033960 | (Reference Device) OLINDA/EXM v1.0 | IYX |
| K212587 | (Reference Device) 3D-RD-S | IYX |
| K163687 | (Reference Device) OLINDA/EXM V2.0 | IYX |
Device Description Summary
UniSyn Molecular Imaging (MI) is a Software as a Medical Device (SaMD) that supports the visualization, manipulation and analysis of medical image data acquired or used in radiology and nuclear medicine centers. UniSyn Ml is only intended to be used by qualified radiology and nuclear medicine professionals. Univer-interface components: a patient study browser and the UniSyn MI viewer. The software is available in both thick and can be integrated to launch from PACS software.
21 CFR 807.92(a)(4)
Using UniSyn MI users can coregister anatomical and visualize them in fused and/or standalone display, e.g. single or multi-modal combinations of PET, SPECT, CT, and MR images. Users can also visualize and process planar nuclear medicine (NM) images acquired as single of multi-frame images. The layout of the UniSyn MI viewer is highly customisable, a typical layout for a PET/CT study would include of the PET and CT series in multiplanar reformatted (MPR) views as well as a 3D maximum-intensity (MIP) projection rendering of the PET series.
UniSyn MI provides tools to zoom, pan, stack, and window-level the displayed series. Our triangulation tool can be used to localize a single anatomical point of interest among all MPR and MP views of the rest (RO) tools are available to delineate 2D and 3D regions and then compute image statistics within those regions, e.g. ROI area/volumes, minimum, mean and standard deviation of image pixel values. Various image segmentation tools are included with UniSyn MI to facilitate ROI delineation based on
4
image pixel data.
UniSyn MI includes a tool for absorbed dose estimation associated with internally deposited with diagnostic and therapeutic medical procedures. Absorbed dose estimates are based on single- or multi-time point activity measurements of molecular images and absorbed dose coefficients (S-Values) that are based on computational human models.
Once a user has completed their review or analysis of a given study, UniSyn MI provides tools to generate reports and export exemplary image data to share with referring physicians to substantiate their findings.
Intended Use/Indications for Use
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure materials. UniSyn should not be used to deviate from approved product dosing and administrations. Refer to the product's prescribing information for instructions.
Indications for Use Comparison
This device has the same intended use as the predicate device (K081987) and the intended use of the reference device K163687 OLINDA/ EXM V2.0.
Technological Comparison
In all aspects except dosimetry, UniSyn Molecular Imaging has the same technological characteristics and functionality as the predicate device K081987. In the dosimetry aspect, Unisyn Molecular Imaging has the same technological characteristics of the reference device (OLINDA/EXM v2.0, K163687) as they both support whole organ / tissue absorbed dose estimates due to the administration of radiopharmaceuticals using S-Value calculations.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance testing was not required for functionality that is shared with the predicate (K081987). This functionality was verified and validated using existing verification and validation testing protocols.
Performance testing was completed to validate the technological characteristics of the dosimetry model used in UniSyn MI. Various radionuclides including Fluorine-18, Gallium-177, Technitium-99m, and Yttrium-90 were evaluated. For all tests, dose estimates were compared to reference values described below. Relative differences (reported as percentages) were used to characterize agreement. The acceptance criteria was set as a relative difference at or below 10%.
Validation of normal organ dosimetry was based on comparisons to values from published data. Data evaluated for both male and female patients demonstrated high overall aith published data demonstrating relative differences (mean relative differences