UniSyn Molecular Imaging (6-3-1)

K231047 · Convergent Imaging Solutions · LLZ · Sep 1, 2023 · Radiology

Device Facts

• Record ID: K231047
• Device Name: UniSyn Molecular Imaging (6-3-1)
• Applicant: Convergent Imaging Solutions
• Product Code: LLZ · Radiology
• Decision Date: Sep 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

UniSyn Molecular Imaging is a SaMD for visualization, manipulation, and analysis of medical images (CT, PET, SPECT, MR). Used by radiology/nuclear medicine professionals in clinical settings; integrates with PACS. Inputs include multi-modal medical image data; software performs coregistration, multi-planar reformatting (MPR), and maximum intensity projection (MIP) rendering. Provides tools for zooming, panning, triangulation, and ROI delineation (2D/3D) to compute statistics (area, volume, SUV). Includes dosimetry module for absorbed dose estimation using S-Value coefficients based on computational human models. Outputs include processed images, quantitative measurements, and reports for clinical review. Assists clinicians in diagnostic assessment and therapeutic planning by providing fused anatomical/functional views and radiation dose estimates.

Clinical Evidence

Bench testing only. Validation of dosimetry model compared estimates against published data and OLINDA/EXM v1.0 (K033960). Evaluated radionuclides included F-18, Ga-177, Tc-99m, and Y-90. Normal organ dosimetry showed mean relative differences <2% compared to published data. Tumor dosimetry (3.9 to 600 cc) showed mean relative differences ranging from <1% to 6.5% compared to OLINDA/EXM v1.0. All results met the <10% relative difference acceptance criteria.

Technological Characteristics

SaMD for image processing and dosimetry. Supports CT, PET, SPECT, MR modalities. Features include MPR, MIP, triangulation, and ROI segmentation tools. Dosimetry module uses S-Value coefficients based on computational human models. Software architecture supports thick-client deployment and PACS integration. No specific hardware materials or energy sources; software-based processing.

Indications for Use

Indicated for qualified radiology and nuclear medicine professionals to perform image registration, fusion display, multi-planar reformatting, maximum intensity projection, and quantitative measurements (area, volume, SUV) of CT, PET, SPECT, and MR images. Also indicated for estimating radiation dose from internally administered radioactive products in diagnostic or therapeutic procedures.

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

• UNISYN (K081987)

Reference Devices

• OLINDA/EXM v1.0 (K033960)
• 3D-RD-S (K212587)
• OLINDA/EXM V2.0 (K163687)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

K231047

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 | [e-mail] | |
| 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

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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 < 2%) below the acceptance criteria.

Validation of tumor dosimetry was based on comparisons to the sphere model of OLINDA/EXM v1.0 (K033960). These comparisons included tumor sizes ranging from 3.9 to 600 cc. The overall across all tumor sizes was excellent with mean relative differences that ranged from <1% up to 6.5%, depending on the radionuclide.

The performance data exhibit high concordance with data found in published literature and generated by FDA-cleared devices and met the acceptance criteria. We have demonstry model implemented in UniSyn MI has been validated, and the performance data provided demonstrate that UniSyn Molecular Imaging (6-3-1) performs comparably to the predicate device that is currently marketed for the same intended use.

## 21 CFR 807.92(a)(5)

# 21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)