Who is the manufacturer of aPROMISE X?

Exini Diagnostics AB filed the 510(k) submission for aPROMISE X (K220590).

What is the FDA product code for aPROMISE X?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for aPROMISE X?

510(k) clearance (submission type: Traditional).

Does aPROMISE X use AI or machine learning?

Yes. aPROMISE X (K220590) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like aPROMISE X?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like aPROMISE X get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

aPROMISE X

K220590 · Exini Diagnostics AB · LLZ · Apr 29, 2022 · Radiology

Device Facts

Record ID	K220590
Device Name	aPROMISE X
Applicant	Exini Diagnostics AB
Product Code	LLZ · Radiology
Decision Date	Apr 29, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
PSMA PET/CT hotspot segmentation	Machine-learning model	—	—	—	—	—	—
PSMA PET/CT hotspot quantification	Machine-learning model	—	—	—	—	—	—

Indications for Use

aPROMISE X is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging. using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.

Device Story

aPROMISE X is a software-only medical image management and processing system for oncology. It accepts PSMA PET/CT DICOM images via manual upload or direct PACS integration. The system provides a 4-panel viewer (PET, CT, fusion, MIP) for clinicians to review studies. It features an AI-enabled automated segmentation model for skeleton and soft tissue organs and a machine-learning algorithm to detect high-intensity regions of interest (hotspots) in PET data. Users review these hotspots, manually adjust or confirm them, and perform quantitative analysis (SUVmax, SUVmean, SUVpeak, Volume, LI, ITLV). The device is used in clinical settings by healthcare professionals. It facilitates clinical decision-making by providing reproducible, efficient quantitative assessments of tracer uptake. The output is a signed report exported as JPG or DICOM, aiding in the identification and reporting of suspicious lesions.

Clinical Evidence

Bench testing only. Digital phantom validation confirmed accuracy, linearity, and limit of detection for SUV and volume metrics. Comparison to predicate (K211655) demonstrated equivalent performance in marking and quantitative assessment. An analytical performance study showed the device enables more reproducible and efficient quantification compared to manual methods while maintaining diagnostic performance.

Technological Characteristics

Software-only medical image management system. Operates on Windows/macOS via Chrome browser. Deployed via cloud or local server. Complies with DICOM 3 standard. Features AI-enabled automated segmentation of skeleton/soft tissue and machine-learning based hotspot detection. Quantifies SUV metrics (max, mean, peak, volume, LI, ITLV). No patient-contacting components; no electrical/EMC requirements.

Indications for Use

Indicated for healthcare professionals and researchers for the management, display, and quantitative analysis of PSMA PET/CT nuclear medicine images in oncology patients.

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

Exini aPROMISE (K211655)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & 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. EXINI Diagnostics AB % Donna-Bea Tillman, Ph.D. Senior Consultant Biologics Consulting Group, Inc. 1555 King Street. Suite 300 ALEXANDRIA VA 22314 Re: K220590 Trade/Device Name: aPROMISE X Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: February 28, 2022 Received: March 1, 2022 Dear Donna-Bea Tillman: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 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 (QS) 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 medical devices and radiation-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, Julie Sullivan, Ph.D. Assistant Director Nuclear Medicine and Radiation Therapy Branch Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220590 Device Name aPROMISE X ### Indications for Use (Describe) aPROMISE X is intended to be used by healthcare professionals and researchers for acceptance, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis. | 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for aPROMISE X is provided below. #### 1. SUBMITTER ### K220590 | Applicant: | EXINI Diagnostics AB Ideon Science Park Scheelevägen 27 223 70 Lund Sweden | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Aseem Anand, Ph.D. Vice President EXINI Diagnostics AB Ideon Science Park, Scheelevägen 27, SE-223 70 Lund, Sweden Tel: +46706604084 aseem.anand@exini.com | | Submission Correspondent: | Donna-Bea Tillman, Ph.D. Senior Consultant Biologics Consulting 1555 King Street, Suite 300 Alexandria, Virginia 22314 (410) 531-6542 dtillman@biologicsconsulting.com | | Date Prepared: | February 28, 2022 | ### 2. DEVICE | Device Trade Name: | aPROMISE X | |----------------------|-------------------------------------------------------------------| | Device Common Name: | Picture Archiving and Communication System | | Classification Name: | 21 CFR 892.2050 Medical Image Management and Processing System | | Regulatory Class: | II | | Product Code: | LLZ | ### 3. PREDICATE DEVICE Predicate Device: Exini aPROMISE (K211655) {4}------------------------------------------------ ### DEVICE DESCRIPTION 4. aPROMISE (automated PROstate specific Membrane Antigen Imaging SEgmentation) X is an updated version of previously cleared device, aPROMISE v 1.2.1 (K211655), with a web interface where users can upload body scans of PSMA PET/CT image data in the form of DICOM files, review patient studies and share study assessments within a team. The software platform has two installation configurations: either deployed to a cloud infrastructure or to a local server at a clinical facility. The software platform can communicate via http-protocol as described in part 18 of the DICOM standard. This compatibility enables direct transmission of DICOM data from a PACS to aPROMISE X. Manual upload via aPROMISE X user interface is also supported. The software complies with the Digital Imaging and Communications in Medicine (DICOM) 3 standard. Multiple scans can be uploaded for each patient and the system provides a separate review for each study. The review page display studies in a 4-panel view showing PET, CT, PET/CT fusion and maximum intensity projection (MIP) simultaneously and includes the option to display each view separately. The device is used to review entire patient studies, using image visualization and analysis tools for users to identify and mark regions of interest (ROIs). While reviewing image data, users can mark ROIs by selecting from pre-defined hotspots that are highlighted when hovering with the mouse pointer over the segmented region, or by manual drawing, i.e selecting individual voxels in the image slices to include as hotspots. Selected or drawn hotspots are subject to automatic quantitative analysis. The user can review the results of this quantitative analysis and determine which hotspots should be reported as suspicious lesions. To create a report the signing user is required to confirm quality control, and electronically sign the report preview. Signed reports are saved in the device and can be exported as a JPG or DICOM file. ### INTENDED USE/INDICATIONS FOR USE 5. aPROMISE X is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging. using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis. ### SUBSTANTIAL EQUIVALENCE 6. # Comparison of Indications aPROMISE X and the predicate aPROMISE have identical Indication for Use statements. ## Technological Comparisons The table below compares the key technological feature of the subject device aPROMISE X to the predicate devices, Exini aPromise (K211655). {5}------------------------------------------------ | Specification/ Characteristic | aPROMISE X (proposed device) | aPROMISE 1.2.1 (predicate device) | Comparison to predicate | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | | | | | Intended user | Health care professionals and researchers | Health care professionals and researchers | No difference | | Intended use environment | Healthcare clinics | Healthcare clinics | No difference | | Classification | 21 CFR 892.2050 System, Image Processing, Radiological (LLZ) Class II | 21 CFR 892.2050 System, Image Processing, Radiological (LLZ) Class II | No difference | | Installation | Web-based service accessed through cloud infrastructure or local server network with personal log-in. | Web-based service accessed through cloud infrastructure with personal log-in. | Equivalent The difference involves an additional option for product deployment. The difference does not affect the clinical use of the device and does not raise different questions of safety or effectiveness. | | Operating system | Windows or macOS with Chrome browser | Windows or macOS with Chrome browser | No difference | | DICOM compatibility and Imaging Modalities | DICOM 3: Whole body ● PET ● CT | DICOM 3: Whole body ● PET ● CT | No difference | | Image upload | Via file selector or drag and drop from a local computer or network. Upload can handle zip files. Semiautomatic transfer via http- protocol enabling direct transmission of DICOM data if integrated with a PACS. | Via file selector or drag and drop from a local computer or network. Upload can handle zip files. | Equivalent The difference involves an additional option for image upload. The difference does not affect the clinical use of the device and does not raise different questions of safety or effectiveness. | | Support for multiple scans | Yes, multiple scans can be analyzed one at a time. | Yes, multiple scans can be analyzed one at a time. | No difference | | Specification/ Characteristic | aPROMISE X (proposed device) | aPROMISE 1.2.1 (predicate device) | Comparison to predicate | | Colormaps | A selection of commonly used colormaps supported: For PET image: • Cool • Inverted grayscale • Grayscale with overflow • Hot Iron • Spectrum • Warm For CT image: • Grayscale | A selection of commonly used colormaps supported: For PET image: • Cool • Inverted grayscale • Grayscale with overflow • Hot Iron • Spectrum • Warm For CT image: • Grayscale | No difference | | Zoom | Automatically adjusted image size. Manually adjustable zoom in planar views | Automatically adjusted image size. Manually adjustable zoom in planar views | No difference | | Windowing | Manual adjustment of windowing. Slider or selection form a drop- down menu for PET. Click'n'drag or selection from a drop-down menu for CT | Manual adjustment of windowing. Slider or selection form a drop- down menu for PET. Click'n'drag or selection from a drop-down menu for CT | No difference | | Image layouts | 4 panel view showing PET, CT, PET/CT fusion and MIP simultaneously and option to display each view separately. Coronal, axial and sagittal views can be displayed | 4 panel view showing PET, CT, PET/CT fusion and MIP simultaneously and option to display each view separately. Coronal, axial and sagittal views can be displayed | No difference | | Intensity display | Local intensity displayed in left corner of the image when hovering over image | Local intensity displayed in left corner of the image when hovering over image | No difference | | Hotspot display | Segmented hotspots can be displayed in planar views if the user turns on the hotspot segmentation display option from the control panel resulting in | Segmented hotspots can be displayed in planar views if the user turns on the hotspot segmentation display option from the control panel resulting in | No difference | | Specification/ Characteristic | aPROMISE X (proposed device) | aPROMISE 1.2.1 (predicate device) | Comparison to predicate | | | visually presenting pre- defined hotspots in the viewer. | visually presenting pre- defined hotspots in the viewer. | | | Organ Segmentation | AI enabled automated segmentation of skeleton and soft tissue organs. | AI enabled automated segmentation of skeleton and soft tissue organs. | Equivalent The option to segment the prostate is removed since it is no longer needed as a result of the new hotspot detection model. The difference does not affect the clinical use of the device and does not raise different question of safety or effectiveness. | | Pre-definition of Hotspot | Algorithm, using a machine-learning model to detect high local intensity regions of interest in the PET series. | Algorithm, using an analytical model to detect high local intensity regions of interest in the PET series. | Equivalent Same feature but adjusted method for the detection of high local intensity regions to segment as hotspots. The difference does not affect the clinical use of the device and do not raise different questions of safety or effectiveness. | | Hotspot pre- selection | No hotspot pre-selection occurs. It is always the user who needs to select hotspots to include for quantification and reporting. All detected high local intensity ROIs can be shown for review by the user. | No hotspot pre-selection occurs. It is always the user who needs to select hotspots to include for quantification and reporting. All detected high local intensity ROIs can be shown for review by the user. | No difference | | Hotspot verification | The user can select pre- defined segmentation of hotspots or segment each hotspot manually that are considered to be lesions by the user. | The user can select pre- defined segmentation of hotspots or segment each hotspot manually that are considered to be lesions by the user. | No difference | | Hotspot Quantification | Standard Uptake Values (SUV): -SUV-max | Standard Uptake Values (SUV): -SUV-max | No difference | | Specification/ Characteristic | aPROMISE X (proposed device) | aPROMISE 1.2.1 (predicate device) | Comparison to predicate | | | -SUV-mean -SUV-peak -Volume -Lesion Index (LI) -Intensity-weighted Tissue Lesion Volume (ITLV) | -SUV-mean -SUV-peak -Volume -Lesion Index (LI) -Intensity-weighted Tissue Lesion Volume (ITLV) | | | Quality Control | SW enforced requirement to verify the user review of - Image quality - PET/CT image - Patient study data - Reference values - Study is not a superscan | SW enforced requirement to verify the user review of - Image quality - PET/CT image - Patient study data - Reference values - Study is not a superscan | No difference | | User confirmation for report generation | User completion of the Quality Control and report preview confirmation by electronic signature using user-ID and password is required for report creation | User completion of the Quality Control and report preview confirmation by electronic signature using user-ID and password is required for report creation | No difference | | Report (Summary page export) | The user can export the report with quantification results of a study to the hard drive (jpg or DICOM Secondary Capture) or PACS (DICOM Secondary Capture). | The user can export the report with quantification results of a study to the hard drive (jpg or DICOM Secondary Capture. | No difference | | CSV export | Supports export of study and quantification values as a CSV file for all created reports | Supports export of study and quantification values as a CSV file for all created reports | No difference | #### Table 1: Technological Comparison {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ### 7. PERFORMANCE DATA ## Sterilization and Shelf Life aPROMISE X consists entirely of software; accordingly, there are no sterilization concerns. As a software only device, shelf-life (including performance date) is also not applicable because of low likelihood of time-dependent product degradation. # Biocompatibility Testing There are no direct or indirect patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device. # Electrical safety and electromagnetic compatibility (EMC) Not applicable. The subject device is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type. # 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." The software for this device was considered as a moderate level of concern. # Bench Testing Exini performed the following studies verify and validate the performance of aPROMISE. - . Digital Phantom Validation Study. This study assessed the accuracy, linearity, and limit of detection of aPROMISE X against the known values of a digital reference object (NEMA phantom). All SUV and volume quantification tests of aPROMISE X met their predetermined acceptance criteria. - . Comparison to Predicate. This study demonstrated the equivalent performance of aPROMISE X as compared to the previous version, predicate aPROMISE v1.2.1 (K211655) for standard functions in marking and quantitative assessments of user defined region of interest in PSMA PET/CT. - Analytical Performance in Clinical Study. This study compared the performance of aPROMISE X to that of clinicians and demonstrated that aPROMISE X enables the automated quantification of tracer uptake are more reproducible, and efficient than those obtained manually. The study demonstrated that aPROMISE X enables the reader to achieve a higher efficiency and quantitative consistency, while maintaining the diagnostic performance of the physicians. These results demonstrate that aPROMISE X performs in accordance with specifications and meets user needs and intended uses. {10}------------------------------------------------ # Animal Testing Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device. # Clinical Data Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device. #### CONCLUSION 8. Based on the detailed comparison, the differences between the subject and predicate devices do not raise new questions of safety and effectiveness. Software verification and performance testing demonstrate that the device performs according to the device requirements. Therefore, the aPROMISE X device can be found substantially equivalent to the predicate device.

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