(59 days)
Yes
The device description mentions "pre-defined hotspots that are highlighted when hovering with the mouse pointer over the segmented region," which implies an automated segmentation process likely driven by AI/ML. Additionally, the "Mentions AI, DNN, or ML" field is marked as "Yes".
No
Explanation: The device is a Picture Archiving and Communications System (PACS) with oncology specific tools for viewing, manipulating, and quantifying medical images for diagnostic purposes, not for providing therapy.
Yes
The device aids in the interpretation and quantitative analysis of medical images (PSMA PET/CT) for oncology, including identifying and quantifying regions of interest, which is a diagnostic function.
Yes
The device description explicitly states it is a "software platform" with installation configurations (cloud or local server) and communication protocols (http, DICOM). It handles digital medical images (DICOM files) and provides software tools for image display, manipulation, quantification, and reporting. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that aPROMISE X is used for the acceptance, transfer, storage, image display, manipulation, quantification, and reporting of digital medical images acquired using nuclear medicine (NM) imaging, specifically PSMA PET/CT. This involves analyzing images of the patient's body, not specimens taken from the body (like blood, urine, or tissue).
- The device processes and analyzes medical images. While it performs quantitative analysis, this analysis is based on the uptake of a tracer within the body as captured by the imaging modality, not on the chemical or biological properties of a specimen.
Therefore, aPROMISE X falls under the category of medical imaging software or a Picture Archiving and Communications System (PACS) with advanced analysis tools, rather than an In Vitro Diagnostic device.
No
The provided text explicitly states "Control Plan Authorized (PCCP) and relevant text Not Found". This indicates no mention of FDA review, approval, or clearance of a PCCP for this device.
Intended Use / Indications for Use
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.
Product codes
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
nuclear medicine (NM) imaging, using PSMA PET/CT. Whole body PET, CT
Anatomical Site
Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals and researchers / Healthcare clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key results: These results demonstrate that aPROMISE X performs in accordance with specifications and meets user needs and intended uses.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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
- 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
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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) |
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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)
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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
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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.
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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.