(69 days)
RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs image management and digital image processing (centralized specification and reformatting) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol.
RadUnity is indicated for use by qualified radiology professionals and specialists.
RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation.
RadUnity is stand-alone software device (SaMD) which allows centralized specification, management, standardization, and networking of CT images. RadUnity's software ingests DICOM CT image data and reformats them according to predefined user preferences.
Radunity processes industry standard DICOM imaging studies. Currently, the RadUnity solution only processes computed tomography (CT) images. The data may flow into the system from PACS, a post-processing system, or any DICOM node (e.g., directly from a modality unit). The data is transferred for image processing and standardization. The data is then routed to user defined DICOM destinations and output in DICOM format.
RadUnity is fundamentally a workflow management system which performs image processing and standardization which allows the clinical user to view the CT images with consistent formatting.
RadUnity provides the user with the ability to duplicate current clinical workflow steps required to generate images for qualified clinician interpretation that may involve automatic or manual steps. The RadUnity solution requires manual user interaction to generate and route images to DICOM destinations for qualified clinician interpretation.
The input DICOM images needed for RadUnity are referred to as "source volumes". These source volumes are commonplace in the radiology community today (e.g., lung or bone reconstructions) and contain the needed information to create soft tissue and other thicker slice and lower resolution image volumes.
The provided document is a 510(k) Summary for the RadUnity (Version 1.0.0) device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies for novel performance claims.
The document indicates that RadUnity is a software medical device (SaMD) that receives, processes (centralized specification and reformatting), and transfers medical images (CT only) using the DICOM protocol. It is intended for use by qualified radiology professionals and specialists and not for primary diagnostic review.
Therefore, the information regarding acceptance criteria and the study proving the device meets these criteria is not explicitly detailed in the provided text in the manner one might expect for a device with a diagnostic claim (e.g., sensitivity, specificity for detecting a specific condition). The regulatory submission focuses on demonstrating that the device functions similarly to cleared predicate devices for image management and processing.
However, based on the non-clinical performance testing and software verification and validation section, we can infer some aspects of "acceptance criteria" through the lens of substantial equivalence.
Here's an attempt to answer your questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria (e.g., specific accuracy metrics) and corresponding reported device performance for RadUnity in its own right, because it is not intended for primary diagnostic review. Instead, the document discusses aspects of "equivalence" to predicate devices.
The "performance" is generally described in relation to its functional equivalence to predicate devices:
| Acceptance Criteria Category (Inferred from Equivalence Discussion) | Reported Device Performance (Inferred from "SE Discussion") |
|---|---|
| Intended Use Equivalence | RadUnity is equivalent to the primary predicate (AquariusAPS server) and secondary predicate (Centricity PACS-IW with Universal Viewer) in receiving, processing, managing, and transferring DICOM CT images. Differences (RadUnity only processes CT, not other modalities) do not raise new questions of safety or effectiveness. |
| Technological Characteristics Equivalence | Device Type: Same as predicates (SaMD).Operating Environment: Equivalent to predicates (local web browser-based GUI communicating to local image processing server). Minor differences do not raise safety/effectiveness concerns.Computer Hardware: Equivalent to predicates (industry standard computer hardware). Minor differences do not raise safety/effectiveness concerns.Operating Systems Supported: Equivalent to predicates (Microsoft Windows, Internet Browser). More current versions but equivalent functionality. |
| Functional Equivalence | Graphic User Interface: Equivalent to predicates (Web browser based). Minor differences do not raise safety/effectiveness concerns.Image Input Type: Equivalent to predicates for DICOM CT images (RadUnity does not require other DICOM types). No new safety/effectiveness questions.Interoperability: Equivalent to predicates (receive/transfer DICOM CT images using DICOM protocols). Minor differences do not raise safety/effectiveness concerns. |
| DICOM Tag Processing | Equivalent to predicates (capable of performing actions based on DICOM tags). Minor differences do not raise safety/effectiveness concerns. |
| Image Presentation/Generation Settings | Equivalent to predicates (control image generation and presentation settings, like 'Profiles' functionality being similar to 'Smart Reading Protocols'). Minor differences do not raise safety/effectiveness concerns. |
| Image Management | Equivalent to secondary predicate Centricity PACS-IW's 'Smart Reading Protocols' (configuring source volume specific profile mapping and applying to future images). |
| Image Processing Functionality | Equivalent to predicates (Filtering, Smoothing, Edge Enhancement, MPR, MIP, MinIP). Minor differences do not raise new questions of safety and effectiveness. |
| Image Export | Equivalent to predicates (export reformatted images/sequences to DICOM capable destinations). Minor differences do not raise safety/effectiveness concerns. |
| Automation Functionality | Equivalent to primary (Autobatch) and secondary (Smart Reading Protocols) predicates (e.g., 'Profile' functionality for layout, series placement, automatic post-processing). |
| Software V&V & Cybersecurity | Design requirements successfully met, intended use and user needs validated. Conforms to FDA's cybersecurity guidance and DICOM standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "No clinical performance data was necessary to claim substantial equivalence."
This indicates that clinical data (and thus a clinical test set with specific sample sizes from a particular provenance) was not used or required for this 510(k) submission. The evaluation was primarily based on non-clinical performance (software verification and validation) and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Given that no clinical performance data was necessary, and RadUnity is not intended for primary diagnostic review, there is no mention of a test set with ground truth established by experts in the provided text.
However, for Usability validation testing, it is mentioned that it "was performed by U.S. Board Certified Radiologists." This suggests experts were involved in testing the usability of the device, but not for establishing ground truth on image content for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no clinical test set for diagnostic performance or ground truth establishment is mentioned, there is no information on adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or mentioned. The device is not intended for primary diagnostic review, and its purpose is image management and processing. Therefore, human reader improvement with/without AI assistance is not a relevant metric for this specific device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document discusses "Software verification and validation testing," which would encompass standalone algorithm performance testing against design requirements. While the specifics of these tests are not detailed, the statement "The software verification and validation testing verified that the design requirements were successfully met. The Intended use and user needs were successfully validated" indicates that the algorithm's functional performance was evaluated.
The device itself, as "RadUnity's software," performs the image processing and reformatting functions. This is inherently a standalone algorithmic function, though it requires "manual user interaction to generate and route images to DICOM destinations for qualified clinician interpretation."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the software verification and validation, the "ground truth" would be the design requirements and expected functional outputs of the software, as opposed to clinical ground truth derived from pathology or expert consensus on a disease. The output of RadUnity is processed images reformed and standardized according to user preferences, which are then transferred to other devices for interpretation.
8. The sample size for the training set
No information about a training set is provided. RadUnity's function is image processing and reformatting based on predefined user preferences and DICOM standards, not a machine learning model that would typically require a training set. If there's an underlying AI component (which isn't explicitly stated but could be implied by "digital image processing" in some modern contexts), the training data details are not included in this summary.
9. How the ground truth for the training set was established
As no training set is mentioned, no information is provided on how ground truth for a training set was established.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
RadUnity Corp. % James Luker Sr. Regulatory Consultant Innolitics 1101 West 34th St #220 Austin, Texas 78705
Re: K242810
November 26, 2024
Trade/Device Name: RadUnity (Version 1.0.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 15, 2024 Received: September 18, 2024
Dear James Luker:
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.
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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).
Your device is also subject to, among other requirements, the Quality System (QS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Jessica Lamb
Jessica Lamb, PhD Assistant Director, Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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
510(k) Number (if known) K242810
Device Name RadUnity (Version 1.0.0)
Indications for Use (Describe)
RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs imagement and digital image processing (centralized specification and reformating) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol.
RadUnity is indicated for use by qualified radiology professionals and specialists.
RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the text "RadUnity" in a bold, sans-serif font. Below the text is a graphic that appears to be a stylized representation of a connection or link. On the left, there are three wavy lines that converge into a rounded square shape, and on the right, there are three straight lines extending from the same square shape.
(Per 21 CFR 807.92)
1. CONTACT INFORMATION
| Company Name | RadUnity Corp. |
|---|---|
| Address | 2127 Regent Street Madison WI 53726 |
| Phone Number | 716 560 7751 |
| Fax Number | N/A |
| Company Representative | Timothy Szczykutowicz |
| tim@radunity.com | |
| Primary Contact | Timothy Szczykutowicz |
| Primary Contact Phone Number | 716 560 7751 |
| Primary Contact Email | tim@radunity.com |
| Date Summary Prepared | August 8, 2024 |
2. DEVICE INFORMATION
| Trade Name | RadUnity (Version 1.0.0) |
|---|---|
| Common Name | Radiologic image processing system |
| Product Code | LLZ |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Medical image management and processing system |
| Class | 2 |
| Review Panel | Radiology |
| 510(k) Summary |
|---|
| Page 1 of 19 |
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Image /page/5/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic of three horizontal lines. The lines on the left side of the image are wavy, and they connect to a black square in the middle of the image. The lines on the right side of the image are straight.
(Per 21 CFR 807.92)
3. PRIMARY PREDICATE DEVICE INFORMATION
| Predicate Device Name | AquariusAPS Server |
|---|---|
| Predicate Device KNumber | K061214 |
| Product Code | LLZ |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture Archiving and CommunicationsSystem |
| Class | 2 |
| Review Panel | Radiology |
4. SECONDARY PREDICATE DEVICE INFORMATION
| Predicate Device Name | Centricity PACS-IW with Universal Viewer |
|---|---|
| Predicate Device KNumber | K123174 |
| Product Code | LLZ |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture Archiving and CommunicationsSystem |
| Class | 2 |
| Review Panel | Radiology |
5. DEVICE DESCRIPTION
RadUnity is stand-alone software device (SaMD) which allows centralized specification, management, standardization, and networking of CT images. RadUnity's software ingests DICOM CT image data and reformats them according to predefined user preferences.
| 510(k) Summary | |
|---|---|
| Page 2 of 19 |
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Image /page/6/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a black shape that looks like a rounded square with three horizontal lines extending from the right side. On the left side of the shape are three wavy lines that connect to the shape.
(Per 21 CFR 807.92)
Radunity processes industry standard DICOM imaging studies. Currently, the RadUnity solution only processes computed tomography (CT) images. The data may flow into the system from PACS, a post-processing system, or any DICOM node (e.g., directly from a modality unit). The data is transferred for image processing and standardization. The data is then routed to user defined DICOM destinations and output in DICOM format.
RadUnity is fundamentally a workflow management system which performs image processing and standardization which allows the clinical user to view the CT images with consistent formatting.
RadUnity provides the user with the ability to duplicate current clinical workflow steps required to generate images for qualified clinician interpretation that may involve automatic or manual steps. The RadUnity solution requires manual user interaction to generate and route images to DICOM destinations for qualified clinician interpretation.
The input DICOM images needed for RadUnity are referred to as "source volumes". These source volumes are commonplace in the radiology community today (e.g., lung or bone reconstructions) and contain the needed information to create soft tissue and other thicker slice and lower resolution image volumes.
6. SUBJECT DEVICE INTENDED USE/INDICATIONS FOR USE
RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs image management and digital image processing (centralized specification and reformatting) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol.
RadUnity is indicated for use by qualified radiology professionals and specialists.
RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation.
7. SUBJECT DEVICE CONTRAINDICATIONS FOR USE
RadUnity has no specific contraindications.
However, the following Precautions are applicable to RadUnity:
- The RadUnity Graphic User Interface (GUI) is not intended for primary diagnostic review.
- RadUnity is not intended for mammographic image review or interpretation, ●
- RadUnity should not not be used outside of its stated Intended Use/Indications for Use, ●
510(k) SummaryPage 3 of 19
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Image /page/7/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a symbol that consists of three wavy lines on the left, connected to a black square in the middle, and three straight lines on the right. The symbol is centered below the word.
(Per 21 CFR 807.92)
- Users should not attempt to circumvent RadUnity cybersecurity controls, ●
- RadUnity should not be used for real-time imaging applications.
- . RadUnity should not be used Use for non-CT imaging datasets,
- . Source volume images must be axial CT images in Hounsfield units (i.e., no volume renderings, dual-energy material basis images, quantitative perfusion maps, sagittal/coronal/oblique plane images, MIP images, minIP images or any other images not containing axial CT image data in units of Hounsfield unit).
8. SUBSTANTIAL EQUIVALENCE DISCUSSION
8.1.Primary Predicate Device Intended Use/Indications for Use
The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
8.2.Secondary Predicate Device Intended Use/Indications for Use
Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.
Typical users of this system are trained professionals, including but not limited to radiologists,
| 510(k) Summary |
|---|
| Page 4 of 19 |
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(Per 21 CFR 807.92)
physicians, nurses, medical technicians, and assistants.
8.3.Intended Use/Indications for Use Equivalence Discussion
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Equivalence Discussion |
|---|---|---|---|
| RadUnity (Version 1.0.0)RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs image management and digital image processing (centralized specification and reformatting) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol. RadUnity is indicated for use by qualified radiology professionals and specialists. RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation. | Terarecon AquariusAPS Server (K061214)The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed | GE Centricity PACS-IW (K123174)Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained | Equivalent to Primary Predicate Terarecon AquariusAPS Server (K061214)-The subject RadUnity device and the primary predicate device AquariusAPS server are intended to receive, process and transfer DICOM CT images using the DICOM protocol. The AquariusAPS server is intended to receive, process, manage and transfer DICOM images from additional imaging modalities such as EBT, CT, MRI and other volumetric or planar medical imaging modalities. RadUnity is not intended for use for these additional DICOM imaging modalities.Additionally, RadUnity does not process raw sinogram or projection data from CT images which is equivalent to the AquariusAPS serverRadUnity functions in an equivalent manner in terms of safety and effectiveness to AquariusAPS server in the receipt, processing, management and transferring of DICOM CT images. |
| and accepted by FDA. | but not limited to radiologists, physicians, nurses, medical technicians, and assistants. | AquariusAPS server are intended to provide pre-processing of images and to remove the need for an image review system to perform these activities. This is a primary area of equivalence to the AquariusAPS server primary predicate device. RadUnity includes the ability to view images in order to facilitate the processing functionality but is not intended to be used as the primary review software. The PACS system which receives the processed images from RadUnity is intended for the diagnostic review aspect. This is equivalent to the AquariusAPS server in terms of functionality, safety and effectiveness. RadUnity is not intended for mammographic image review or interpretation. The AquariusAPS server is intended for interpretation of mammographic images under specific circumstances. RadUnity's clinical workflow does not include review/interpretation of mammographic images. Therefore, the lack of mammographic image review/interpretation functionality does not change RadUnity's intended use in relation to the primary predicate device or raise different questions of safety or effectiveness as compared to the Aquarius predicate device. | |
| Equivalent to Equivalent toPrimary Predicate GECentricity PACS-IW(K123174)- | |||
| The Centricity PACS-IW with | |||
| universal viewer secondary | |||
| predicate device is intended to | |||
| communicate, process and | |||
| display DICOM CT images | |||
| (and other DICOM modalities) | |||
| and transfer the images via the | |||
| DICOM protocol via the | |||
| network. Therefore, RadUnity | |||
| and the secondary predicate | |||
| Centricity PACS-IW with | |||
| universal viewer share the | |||
| same intended use. The | |||
| Centricity PACS-IW with | |||
| universal viewer device | |||
| supports additional DICOM | |||
| imaging modalities and image | |||
| review functionality that are | |||
| not needed by RadUnity to | |||
| accomplish it's intended use in | |||
| a safe and effective manner. | |||
| The Centricity PACS-IW with | |||
| universal viewer secondary | |||
| predicate device includes the | |||
| technological characteristic of | |||
| 'Smart Reading Protocols | |||
| (SPR)'. This characteristic | |||
| allows the user to set the image | |||
| 'view' for source volumes and | |||
| then apply the view to future | |||
| images. This technologic | |||
| characteristic is equivalent to | |||
| RadUnity's 'Profiles' which | |||
| allows the user to configure | |||
| source volume specific profile | |||
| mapping and apply it to future | |||
| images. This characteristic is | |||
| the reason for selecting the | |||
| Centricity PACS-IW with | |||
| universal viewer as a | |||
| secondary predicate device. |
510(k) SummaryPage 5 of 19
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(Per 21 CFR 807.92)
510(k) Summary Page 6 of 19
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| 510(k) Summary |
|---|
| Page 7 of 19 |
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| RadUnity and the CentricityPACS-IW with universalviewer device have anequivalent intended use. Thedifferences do not raisedifferent questions of safety oreffectiveness. |
|---|
| 510(k) Summary |
|---|
| Page 8 of 19 |
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(Per 21 CFR 807.92)
8.4.Predicate Device Comparison Table
| Characteristic | RadUnity (Version 1.0.0) | AquariusAPS server (K061214) (Primary Predicate) | Centricity PACS-IW with Universal Viewer (K123174) (Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Regulation Name | Medical image management and processing system | Picture archiving and communications system | Picture archiving and communications system | FDA regulation name has changed for 21 CFR 892.2050 from 'Picture archiving and communications system' to 'Medical image management and processing system'. The update in name does not fundamentally change the purpose/intended use of the associated medical devices. |
| Product Code | LLZ | LLZ | LLZ | Same |
| Regulatory Class | 2 | 2 | Same | |
| Submission type | 510(k) | 510(k) | Same | |
| GMP Exempt | No | No | No | Same |
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Technological Characteristics Comparison |
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Image /page/13/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes a black square with rounded corners. To the left of the square are three wavy lines, and to the right of the square are three straight lines. The graphic appears to be a logo.
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Device Type | Software medicalDevice (SaMD) | Software medicalDevice (SaMD) | Software medicalDevice (SaMD) | Same- Both the subject andpredicate devices are SaMD |
| OperatingEnvironment | Local web browser-based user-facingapplication, networkserver for imageprocessing utilizingcommerciallyavailablecomputer platformsand operatingsystems. | Locally installed user-facing application,network server forimage processingutilizing commerciallyavailable computerplatforms andoperating systems. | Deployed overconventional TCP/IPnetworkinginfrastructureavailable in mosthealthcareorganizations andutilizes commerciallyavailablecomputer platformsand operatingsystems. | Equivalent-RadUnity utilizes a locallyinstalled Web browserbased user-facing graphicaluser interface (GUI) whichcommunicates to a localimage processing server.This configuration isequivalent to the primaryand secondary predicatedevice operatingenvironmentconfigurations.There may be minordifferences betweenRadUnity and the predicatedevices for thistechnological characteristic.However, these do not raiseany different questions onsafety of effectiveness ofthe RadUnity device ascompared to the predicatedevices. |
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Image /page/14/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that appears to be a stylized representation of radiation. The graphic includes three wavy lines that converge into a black circle, from which three straight lines extend.
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| ComputerHardware | RadUnity softwareruns on industrystandard computerhardware whichmeets the minimumspecification. | AquariusAPS serversoftware runs onindustry standardcomputer hardwarewhich meets theminimum specification. | Centricity PACS-IWwith universal viewerserver software runson industry standardcomputer hardwarewhich meets theminimum specification | Equivalent-The subject RadUnity deviceand the predicate devicesutilize commerciallyavailable computerplatforms and operatingsystems. The specifics maydiffer to some degree basedon the timeframes in whichthe predicate devices werecleared. However, this doesnot raise any differentquestions on safety ofeffectiveness of the device. |
| OperatingSystemsSupported | Computer runningMicrosoft Windows10/11 with MicrosoftEdge (minimumsupported version128) and GoogleChrome browsers(minimum version126) | Microsoft Windows,Internet Explorer | Microsoft Windows,Internet Explorer | Equivalent-The RadUnity subjectdevice, the primary andsecondary predicate deviceutilize the MicrosoftWindows OS as well as anInternet Browser. Thesubject RadUnity versionsare more current than thepredicate's due to thetimeframe that the deviceswere cleared. However, thisdoes not raise any differentquestions on safety ofeffectiveness of theRadUnity device. |
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Image /page/15/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes three sine waves on the left, a black rounded square in the middle, and three horizontal lines on the right. The sine waves appear to be connected to the left side of the rounded square, and the horizontal lines are connected to the right side of the rounded square.
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Graphic UserInterface | Web browser based | Web browser based | Web browser based | Equivalent-The subject RadUnity deviceas well as the primary andsecondary predicate devicesutilize a Web-basedbrowser.There may be minordifferences for thistechnological characteristicbetween RadUnity and thepredicate devices. Howeverthese do not raise anydifferent questions onsafety of effectiveness. |
| Image inputtype | DICOM CT images | DICOM CT, EBT, MRIand other volumetric or NM,CR,PET, DX, XAplanar images | DICOM CT, MRI, US,and other DICOMimages | Equivalent-The subject RadUnity deviceis currently intended to useonly DICOM CT images. Theprimary and secondarypredicates includeadditional DICOM imagingmodalities. RadUnity andthe predicate devices areequivalent in terms ofDICOM CT image input type.RadUnity's intended usedoes not require otherDICOM image types.This difference does notraise any new questions ofsafety and effectiveness. |
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Image /page/16/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes three wavy lines that connect to a black square. Three straight lines extend from the other side of the black square. The image is simple and uses a limited color palette.
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Interoperability | RadUnity receives (as input), CT imagesfrom CT acquisitiondevices which useDICOM transferprotocols.RadUnity transfersthe processed imagesusing DICOM transferprotocols | AquariusAPS serverreceives (as input), CT,EBT, MRI and othervolumetric or planarmedical imagingmodalities, fromimaging acquisitiondevices which usesDICOM transferprotocols.AquariusAPS servertransfers the processedimages using DICOMtransfer protocols | Centricity PACS-IWwith Universal Viewerreceives (as input), CT,US, NM, MRI andother medical imagingmodalities, fromimaging acquisitiondevices which usesDICOM transferprotocols.Centricity PACS-IWwith Universal Vieweris designed to bedeployed overconventional TCP/IPnetworkinginfrastructureavailable in mosthealthcareorganizations | Equivalent-RadUnity and the primaryand secondary predicatedevices are intended toreceive DICOM CT imagesfrom image acquisitiondevices and transfer theprocessed images using theDICOM transfer protocol.There may be minordifferences for thistechnological characteristicbetween RadUnity and thepredicate devices. However,these do not raise anydifferent questions onsafety of effectiveness. |
| DICOM Tags | RadUnity is capableof performing actionsbased on DICOM tagscontained in images | AquariusAPS server iscapable of performingactions based onDICOM tags containedin images | Centricity PACS-IWwith Universal Vieweris capable ofperforming actionsbased on DICOM tagscontained in images | Equivalent-RadUnity and the primaryand secondary predicatedevices perform actionsbased on DICOM tags.There may be minordifferences for thistechnological characteristicbetween RadUnity and thepredicate devices. However,these do not raise anydifferent questions onsafety of effectiveness. |
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Image /page/17/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes three wavy lines on the left, connected to a black square in the middle. Three straight lines extend from the right side of the black square.
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| ImagePresentation | RadUnity's ProfileBuilder user interfaceallows the user tocontrol imagegeneration andpresentationsettings. | AquariusAPS includesan 'Auto Batch'function which is usedto automaticallygenerate reformattedimages. | Centricity PACS-IWwith Universal Viewer,user interface allowsthe user to controlimage presentationand generationsettings. | Equivalent-RadUnity and the primary(AquariusAPS) andsecondary predicate(Centricity PACS-IW withUniversal Viewer) haveequivalent functionality interms of imagepresentation/generationsettings. There may beminor differences for thistechnological characteristicbetween RadUnity and thepredicate devices. Howeverthese do not raise anydifferent questions onsafety of effectiveness. |
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Image /page/18/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic of three wavy lines that connect to a black circle. Three straight lines extend from the other side of the circle. The image is in black and white.
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| ImageManagement | RadUnity 'maps'profiles to specificexam types (e.g., bytelling RadUnity thetypical order/studydescription andscanner protocolsused for the examtype)RadUnity allows theuser to configuresource volumespecific profilemapping and apply itto future images. Theuser can also modifyreconstructionextents (i.e., whatpart of a sourcevolume is used forRadUnity processingfor a specific profilereformat). | AquariusAPS server iscapable of creatingimages and imagesequences in a varietyof formats. However, itis not known whetherthe AquariusAPS Serverdevice is capable ofapplying those formatsto future images. | The Smart ReadingProtocols (SPR) withinthe Centricity PACS-IWwith Universal Viewerallows the user to setthe image 'view' forsource volumes andthen apply the view tofuture images. | Equivalent-RadUnity 's ability toconfigure source volumespecific profile mapping ismost equivalent to thesecondary predicate's(Centricity PACS-IW) SmartReading Protocols (SPR) asthe setting for sourcevolumes and the applicationof the setting(s) to futureimages is equivalent. Theprimary predicate(AquariusAPS server) cancreate image/sequences ina variety of formats.However, it is not knownwhether the Aquariusdevice is capable ofapplying those formats tofuture images.RadUnity's functionality isequivalent to the secondarypredicate's as the outcomeis essentially the same andtherefore would beequivalent in terms ofsafety and effectiveness. |
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Image /page/19/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a symbol that appears to be a black square with rounded corners. To the left of the square are two wavy lines, and to the right are three straight, horizontal lines.
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Imageprocessingfunctionality | RadUnity has thefollowing imageprocessingfunctionality:• Filtering◦ Smoothing◦ EdgeEnhancement• MultiplanarReformatting(MPR)• MaximumIntensityProjection (MIP)• MinimumIntensityProjection(MinIP) | AquariusAPS server hasthe following imageprocessingfunctionality:• Filtering• MultiplanarReformatting(MPR)• MaximumIntensityProjection (MIP)• MinimumIntensityProjection (MinIP) | Centricity PACS-IWwith Universal Viewerhas the followingimage processingfunctionality:• Edgeenhancement• Changing theimage planefrom one planeto another• MultiplanarReformatting(MPR)• MaximumIntensityProjection(MIP)• MinimumIntensityProjection(MinIP) | Equivalent-The subject RadUnity deviceand the predicate deviceshave equivalent imagingprocessing functionality.Minor differences do notraise any new questions ofsafety and effectiveness. |
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Image /page/20/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that appears to be a stylized representation of radiation. The graphic includes three wavy lines that converge into a black circle, from which three straight lines extend.
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Image Export | RadUnity is capableof exportingreformatted imagesand image sequencesto DICOM capabledestinations | AquariusAPS server iscapable of exportingreformatted imagesand image sequencesto DICOM capabledestinations | Centricity PACS-IWwith Universal Vieweris capable of exportingreformatted imagesand image sequencesto DICOM capabledestinations | Equivalent-The subject RadUnity deviceand the primaryAquariusAPS server areintended to perform imageprocessing/reformattingand transfer the images viathe DICOM protocol to animage review system. |
| The secondary CentricityPACS-IW with UniversalViewer device is alsocapable of exporting imagesand image sequences toDICOM capable destinationsbut includes an imagereview system. | ||||
| RadUnity and the primary(AquariusAPS) andsecondary predicate(Centricity PACS-IW withUniversal Viewer) haveequivalent functionality interms of imageimage/sequence | ||||
| exportation. There may beminor differences for thistechnological characteristicbetween RadUnity and thepredicate devices. However,these do not raise anydifferent questions onsafety of effectiveness. |
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Image /page/21/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a graphic that includes three horizontal lines, two wavy lines, and a black square with rounded corners. The graphic appears to be a stylized representation of radiation or energy. The overall design is simple and clean, with a focus on the text and the graphic element.
(Per 21 CFR 807.92)
| Characteristic | RadUnity (Version1.0.0) | AquariusAPS server(K061214)(Primary Predicate) | Centricity PACS-IWwith Universal Viewer(K123174)(Secondary Predicate) | SE Discussion |
|---|---|---|---|---|
| Automationfunctionality | RadUnity includes'Profile' functionalitywhich allows the userto set up the imagesin a user-preferredlayout: layout, imageseries placement,automatic post-processing, etc.. | AquariusAPS serverincludes 'Autobatch'functionality.AutoBatch generatesreformatted images onCT data that has beenpushed to theAquariusAPS server. | Centricity PACS-IWwith Universal Viewerincludes 'SmartReading Protocols'(SRP). SRP's allow theuser to set up theimages in a user-preferred layout:viewports layout,image seriesplacement, automaticpost-processing, etc.. | Equivalent-The subject RadUnitydevice's Profile'functionality is equivalentto the primary predicateAquariusAPS server's'Autobatch' functionalityand the secondarypredicate Centricity PACS-IW with Universal Viewer's'Smart Reading Protocols'functionality. The secondarypredicate's 'Smart ReadingProtocols' appear to be acloser match to RadUnity's'Profiles' functionality thanthe primary predicate's'Autobatch' functionality.The differences betweenRadUnity's and the 'Profiles'functionality and CentricityPACS-IW with UniversalViewer 'Smart ReadingProtocols' do not raise newquestions relating to safetyor effectiveness. |
9. PERFORMANCE DATA
9.1.Software Verification and Validation Testing
Software verification and validation testing were 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."
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Image /page/22/Picture/0 description: The image shows the word "RadUnity" in bold, black font. Below the word is a black square with rounded corners. To the left of the square are three wavy lines, and to the right of the square are three straight lines. The lines appear to be connected to the square.
(Per 21 CFR 807.92)
The software verification and validation testing verified that the design requirements were successfully met. The Intended use and user needs were successfully validated.
RadUnity includes Cybersecurity functionality and information which conforms to FDA's September 23, 2023 °Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' guidance.
RadUnity conforms with DICOM standards (i.e., NEMA DICOM PS3.5 2024e).
RadUnity's validation activities included Usability validation testing which was performed by U.S. Board Certified Radiologists.
As the intended use, functionality and performance of the subject device and the predicate device are equivalent, the result of the performance testing is evidence that the RadUnity performs in an equivalent manner to the AquariusAPS Server primary predicate and secondary predicate devices.
9.2.Clinical Performance Testing
No clinical performance data was necessary to claim substantial equivalence.
10. CONCLUSION
The RadUnity device shares similar technological characteristics, intended use, and functionality with the predicate devices. There are no differences between the devices that raise new questions of safety and effectiveness.
Furthermore, non-clinical performance test data and software verification and validation demonstrate that RadUnity performs comparably to the predicate device in terms of safety and effectiveness.
Based on the device comparisons and the acceptable testing results, it is determined that RadUnity is substantially equivalent to the predicate devices.
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§ 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).