(59 days)
Unknown
The summary mentions "Automated Prostate Segmentation algorithm" and "automated AIF selection algorithm" which could potentially utilize AI/ML, but the document does not explicitly state that AI/ML is used for these functions. The description of performance studies focuses on validation of these algorithms but doesn't detail the underlying technology.
No
The device is described as image processing software for viewing, processing, and analyzing prostate MR images. It does not perform a diagnostic function nor does it provide therapy; instead, it aids trained professionals in visualizing and analyzing data for patient management decisions.
No
The "Intended Use / Indications for Use" section explicitly states, "qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data."
Yes
The device is described as a software package that runs on standard "off-the-shelf" computers and interacts with existing DICOM compliant imaging devices and PACS. It does not include any proprietary hardware components.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states that "qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data." It also emphasizes that "Patient management decisions should not be based solely on the results of qp-Prostate." IVDs are typically intended to provide information for diagnostic purposes.
- Device Description: The device is described as "a medical image viewing, processing and analyzing software package." While it performs quantitative analysis (ADC and PKM post-processing), this is presented as a tool for the user to interpret, not a diagnostic result in itself.
- Nature of the Output: The software provides "MR imaging analysis plug-ins to objectively measure different functional properties in prostate images." This is data and analysis for the trained professional to use in their interpretation, not a diagnostic conclusion.
IVDs are generally defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's stated purpose is to assist trained professionals in the analysis of medical images, not to provide a diagnosis directly.
N/A
Intended Use / Indications for Use
qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of gp-Prostate. qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.
Product codes
LLZ
Device Description
gp-Prostate is a medical image viewing, processing and analyzing software package for use by a trained user or healthcare professional, including radiologists specialized in prostate imaging, urologists and oncologists. These prostate MR images, when interpreted by a trained physician, may yield clinically useful information.
qp-Prostate consists of a modular platform based on a plug-in software architecture. Apparent Diffusion Coefficient (ADC) post-processing and Perfusion - Pharmacokinetics post-processing (PKM) are embedded into the platform as plug-ins to allow prostate imaging quantitative analysis.
The platform runs as a client-server model that requires a high-performance computer installed by QUIBIM inside the hospital or medical clinic network. The server communicates with the Picture Archiving and Communication System (PACS) through DICOM protocol, gp-Prostate is accessible through the web browser (Google Chrome or Mozilla Firefox) of any standard "off-the-shelf" computer connected to the hospital/center network.
The main features of the software are:
-
- Query/Retrieve interaction with PACS;
-
- Apparent Diffusion Coefficient (ADC) post-processing (MR imaging);
-
- Perfusion Pharmacokinetics (PKM) post-processing (MR imaging);
-
- DICOM viewer; and
-
- Structured reporting.
The software provides MR imaging analysis plug-ins to objectively measure different functional properties in prostate images:
- The software can communicate with any Picture Archiving Communications System (PACS) through the DICOM standard. This communication includes standard Query/Retrieve DICOM operations in order to receive prostate MR image studies in qp-Prostate. Once the complete prostate MR study has been received, qp-Prostate will check the available sequences. For a successful launch of qp-Prostate, the study must include at least:
-the T2-weighted MR sequence and the Diffusion Weighted Imaging (DWI) or
-the T2-weighted MR sequence and the Dynamic Contrast Enhanced (DCE) or
-the T2-weighted MR sequence, the DWI and the DCE. - If the DWI sequence is available and it complies with the required acquisition protocol, the Diffusion ADC analysis will be launched. Imaging processing steps, such as spatial smoothing and motion correction between the different b-values are proposed before applying the monoexponential model for ADC calculation. The Diffusion-ADC post-processing and analysis plugin for prostate MR imaging calculates a parameter related to the degree of water molecules mobility in tissues. The Apparent Diffusion Coefficient (ADC)[s/mm²] is given in order to evaluate the diffusion signal decay in regions. The ADC is calculated by applying the mono-exponential model of the diffusion signal, assessing the signal attenuation that occurs at least at two different b values. The final result of the DWI workflow includes ADC parametric maps, which represent the ADC value for each voxel of the image.
- If the DCE sequence is available and it complies with the required acquisition protocol, the Perfusion analysis will be launched. Imaging processing steps, such as spatial smoothing, motion correction and Arterial Input Function (AIF) selection are proposed before applying the standard Tofts model with one input and two compartments for Kirans, kep and ve calculation. The Perfusion - Pharmacokinetics post-processing and analysis plugin for prostate MR imaging calculates parameters related to the vascular environment of the tissue, which are based on the quantitative pharmacokinetic assessment of Dynamic Contrast-Enhanced Magnetic Resonance Images (DCE-MRI). The transfer constant (K(fans)[min']), extraction rate (kep) [min-1] and extra-vascular and extra-cellular volume (ve) [%] are given in order to evaluate the leakage of injected contrast media from intra-vascular to interstitial space. The final results of the DCE workflow include Ktrans, kep and ve parametric maps, which represent perfusion for each voxel of the image.
- The software includes a DICOM viewer to improve the review process of a single study and its related image sequences. The viewer has basic image manipulation and segmentation capabilities and advanced segmentation ones for prostate.
- The software includes a Structured Reporting option for filling a standard PI-RADS® v2.1 template [Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. American College of Radiology].
qp-Prostate does not perform a diagnostic function, but instead allows the radiologist to visualize and analyze DICOM data with the possibility of verifying the quality and editing the output of each step of the process.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
Prostate
Indicated Patient Age Range
Any patient for which PACS MR prostate data exists.
Intended User / Care Setting
Trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation.
Intended use environment: Hospitals / imaging centers or 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
A dataset of prostate clinical cases was used for the validation of the algorithms integrated in qp-Prostate v1.0.0 such as Spatial Smoothing algorithm, Registration algorithm, Automated Prostate Segmentation algorithm, Motion Correction algorithm and automated AIF selection algorithm.
Specific test sets for different algorithms:
- Motion Correction algorithm: 155 DCE-MR and DWI-MR prostate sequences acquired from 155 different patients in different machines with multiple acquisition protocols.
- Registration algorithm: 112 T2-Weighted MR, DCE-MR and 108 DWI-MR prostate sequences acquired from different patients in different machines with multiple acquisition parameters.
- Spatial Smoothing algorithm: 51 transverse T2-weighted, DCE-MR and DWI-MR prostate sequences acquired from 51 different patients in different machines with multiple acquisition protocols.
- AIF selection algorithm: 242 DCE-MR prostate sequences acquired from 242 different patients in different machines with multiple acquisition protocols.
- Prostate Segmentation algorithm: 243 transverse T2-weighted MR prostate sequences acquired from 243 different patients in different machines with multiple acquisition protocols.
Comparison against predicate device (OLEA Sphere, v3.0, K152602): 157 clinical cases of prostate MRI. The dataset includes cases from different three major MRI vendors: Siemens, GE and Philips, magnetic field of 3T and 1.5T cases and different technical parameters that make up the broad spectrum of cases allowed in our recommended protocol (T2w + DWI + DCE). Specifically for the comparison: 157 T2-weighted MR, DCE-MR and 141 DWI-MR prostate sequences acquired from different patients in different machines with multiple acquisition protocols.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PERFORMANCE TESTING - BENCH
The following bench testing was performed on the subject device per the following draft guidance: "Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions" (April 19, 2019) for the unitary validation of the different parts that constitute qp-Prostate. qp-Prostate is aimed for diffusion and perfusion analysis of prostate MR cases, providing quantitative information useful to assist the professional in completing the prostate structured report template.
One of tests is the analysis of digital reference objects (DROs) proposed by QIBA, available for DWI and DCE, considered as ground truth. For both Perfusion-Pharmacokinetics (PKM) and Diffusion-ADC analysis modules, DROs, including presence and absence of noise modeling, are used for technical performance evaluation.
- Diffusion - ADC analysis module: Digital Reference Object Analysis (Diffusion - ADC) using QIBA's Diffusion Weighted Imaging (DWI) Digital Reference Object (DRO).
- Perfusion - Pharmacokinetics analysis module: Digital Reference Object Analysis (Perfusion – Pharmacokinetics) using QIBA's Dynamic Contrast-Enhanced (DCE) MR perfusion DRO.
PERFORMANCE TESTING - CLINICAL
A dataset of prostate clinical cases was used for the validation of the algorithms integrated in qp-Prostate v1.0.0 such as Spatial Smoothing algorithm, Registration algorithm, Automated Prostate Segmentation algorithm, Motion Correction algorithm and automated AIF selection algorithm.
The other assessment is the comparison against the predicate device (OLEA Sphere, v3.0, K152602), using 157 clinical cases of prostate MRI. The dataset includes cases from different three major MRI vendors: Siemens, GE and Philips, magnetic field of 3T and 1.5T cases and different technical parameters that make up the broad spectrum of cases allowed in our recommended protocol (T2w + DWI + DCE).
- Motion Correction algorithm: Performance testing with prostate MR cases, 155 DCE-MR and DWI-MR prostate sequences acquired form 155 different patients in different machines with multiple acquisition protocols.
- Registration algorithm: Performance testing with prostate MR cases, 112 T2-Weighted MR, DCE-MR and 108 DWI-MR prostate sequences acquired from different patients in different machines with multiple acquisition parameters.
- Spatial Smoothing algorithm: Performance testing with prostate MR cases, 51 transverse T2-weighted, DCE-MR and DWI-MR prostate sequences acquired from 51 different patients in different machines with multiple acquisition protocols.
- AIF selection algorithm: Performance testing with prostate MR cases, 242 DCE-MR prostate sequences acquired from 242 different patients in different machines with multiple acquisition protocols.
- Prostate Segmentation algorithm: Performance testing with prostate MR cases, 243 transverse T2-weighted MR prostate sequences acquired from 243 different patients in different machines with multiple acquisition protocols.
- Comparison to the Predicate Device: Comparison to predicate device using 157 T2-weighted MR, DCE-MR and 141 DWI-MR prostate sequences acquired form different patients in different machines with multiple acquisition protocols.
SOFTWARE VERIFICATION & VALIDATION
qp-Prostate software was developed according to FDA recognized consensus standards for software development. Software verification and validation was performed following V&V plans and protocols verifying that product specifications were met.
The tests results demonstrate that qp-Prostate functioned as intended, is acceptable for clinical use, and is as safe and effective as its predicate device, without introducing new questions of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
February 4, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and 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.
QUIBIM S.L. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20005
Re: K203582
Trade/Device Name: qp-Prostate Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 7, 2020 Received: December 7, 2020
Dear Dr. Smith:
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director 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
510(k) Number (if known) K203582
Device Name
ap-Prostate
Indications for Use (Describe)
gp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of qp-Prostate. gp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.
Type of Use (Select one or both, as applicable)
区 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
510(k) SUMMARY QUIBIM's qp-Prostate
K203582
CONTACT DETAILS
Submitter
QUIBIM, S.L.
Avenida Aragón 30, 12th floor, Office I, 46021 Valencia (Spain)
Phone:
- +34 961 243 225 .
- +34 686 784 484 .
Contact Person:
- . Ángel Alberich Bayarri, CEO and Founder of QUIBIM (angel@quibim.com)
- . Belén Fos Guarinos, Quality Assurance and Regulatory Affairs Manager (belenfos@quibim.com)
Date Prepared:
January 28, 2021
DEVICE INFORMATION
Name of Device: qp-Prostate
Common or Usual Name: PACS
Classification Name: 892.2050 Picture archiving and communications system (LLZ)
Regulatory Class: Class II
Classification Panel: Radiology
LEGALLY MARKETED PREDICATE DEVICE
- Manufacturer's name: OLEA Medical (93 avenue des Sorbiers, Zone Athelia IV La Ciotat 13600, France)
- Device's trade name: Olea Sphere v3.0
- . 510(k) number: K152602
- Product code: LLZ ●
4
INTENDED USE / INDICATIONS FOR USE
qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of gp-Prostate. qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.
DEVICE DESCRIPTION
gp-Prostate is a medical image viewing, processing and analyzing software package for use by a trained user or healthcare professional, including radiologists specialized in prostate imaging, urologists and oncologists. These prostate MR images, when interpreted by a trained physician, may yield clinically useful information.
qp-Prostate consists of a modular platform based on a plug-in software architecture. Apparent Diffusion Coefficient (ADC) post-processing and Perfusion - Pharmacokinetics post-processing (PKM) are embedded into the platform as plug-ins to allow prostate imaging quantitative analysis.
The platform runs as a client-server model that requires a high-performance computer installed by QUIBIM inside the hospital or medical clinic network. The server communicates with the Picture Archiving and Communication System (PACS) through DICOM protocol, gp-Prostate is accessible through the web browser (Google Chrome or Mozilla Firefox) of any standard "off-the-shelf" computer connected to the hospital/center network.
The main features of the software are:
-
- Query/Retrieve interaction with PACS;
-
- Apparent Diffusion Coefficient (ADC) post-processing (MR imaging);
-
- Perfusion Pharmacokinetics (PKM) post-processing (MR imaging);
-
- DICOM viewer; and
-
- Structured reporting.
The software provides MR imaging analysis plug-ins to objectively measure different functional properties in prostate images:
- The software can communicate with any Picture Archiving Communications System (PACS) through the DICOM standard. This communication includes standard Query/Retrieve DICOM operations in order to receive prostate MR image studies in qp-Prostate. Once the complete prostate MR study has been received, qp-Prostate will check the available sequences. For a successful launch of qp-Prostate, the study must include at least:
-the T2-weighted MR sequence and the Diffusion Weighted Imaging (DWI) or -the T2-weighted MR sequence and the Dynamic Contrast Enhanced (DCE) or
5
- -the T2-weighted MR sequence, the DWI and the DCE.
-
If the DWI sequence is available and it complies with the required acquisition protocol, the Diffusion ADC analysis will be launched. Imaging processing steps, such as spatial smoothing and motion correction between the different b-values are proposed before applying the monoexponential model for ADC calculation. The Diffusion-ADC post-processing and analysis plugin for prostate MR imaging calculates a parameter related to the degree of water molecules mobility in tissues. The Apparent Diffusion Coefficient (ADC)[s/mm²] is given in order to evaluate the diffusion signal decay in regions. The ADC is calculated by applying the mono-exponential model of the diffusion signal, assessing the signal attenuation that occurs at least at two different b values. The final result of the DWI workflow includes ADC parametric maps, which represent the ADC value for each voxel of the image.
-
If the DCE sequence is available and it complies with the required acquisition protocol, the Perfusion analysis will be launched. Imaging processing steps, such as spatial smoothing, motion correction and Arterial Input Function (AIF) selection are proposed before applying the standard Tofts model with one input and two compartments for Kirans, kep and ve calculation. The Perfusion - Pharmacokinetics post-processing and analysis plugin for prostate MR imaging calculates parameters related to the vascular environment of the tissue, which are based on the quantitative pharmacokinetic assessment of Dynamic Contrast-Enhanced Magnetic Resonance Images (DCE-MRI). The transfer constant (K(fans)[min']), extraction rate (kep) [min-1] and extra-vascular and extra-cellular volume (ve) [%] are given in order to evaluate the leakage of injected contrast media from intra-vascular to interstitial space. The final results of the DCE workflow include Ktrans, kep and ve parametric maps, which represent perfusion for each voxel of the image.
-
The software includes a DICOM viewer to improve the review process of a single study and its related image sequences. The viewer has basic image manipulation and segmentation capabilities and advanced segmentation ones for prostate.
-
The software includes a Structured Reporting option for filling a standard PI-RADS® v2.1 template [Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. American College of Radiology].
qp-Prostate does not perform a diagnostic function, but instead allows the radiologist to visualize and analyze DICOM data with the possibility of verifying the quality and editing the output of each step of the process.
COMPARISON TO PREDICATE DEVICE
The subject and predicate devices are based on the following same technological elements:
- Both devices work with DICOM 3.0 images retrieved from PACS systems, and can . export data back to those PACS systems.
- Both have integrated slice views with MPR, segmentation and ROI tools, and . image filtering.
- . Both devices perform study management and structured report generation.
6
- Both uniquely identify users and maintain audit trails of user actions. ●
- . Both have a modular architecture for analysis tools and include modules for perfusion and diffusion for MR cases.
The following technological differences exist between the subject and predicate devices:
- Olea Sphere can import and export to the local file system, whereas qp-Prostate ● does not.
- . Olea Sphere can perform perfusion calculations for both MR and CT, whereas qp-Prostate only does so for MR data.
- . qp-Prostate software only includes two analysis modules for perfusion (Perfusion – Pharmacokinetics, PKM) and diffusion (Diffusion - ADC) calculations, whereas Olea Sphere includes more modules.
- qp-Prostate software is indicated only for prostate MR images whereas OLEA covers more anatomical areas, including prostate.
Taken individually and together, these differences do not affect the substantial equivalence; both products are still using the same technological basis. Software validation and verification testing, as well as performance data, confirm that the qp-Prostate functionalities do not raise different questions of safety or effectiveness compared to the predicate, and support substantial equivalence.
A table comparing the key features of the subject and predicate devices is provided below.
| Table 1. Comparison of key features of the subject (qp-Prostate, QUIBIM) and the predicate
| device (OLEA Sphere 3.0, OLEA Medical) | ||
|---|---|---|
| FEATURE | qp-Prostate | Olea Sphere V3.0 |
| FEATURE | qp-Prostate | Olea Sphere V3.0
K152602 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| REGULATORY DATA | | |
| Regulatory Class | II | II |
| Regulation name | Picture archiving and
communications
system (PACS) | Picture archiving and
communications system (PACS) |
| Regulation number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Classification Panel | Radiology | Radiology |
| Product code | LLZ | LLZ |
| Manufacturer | QUIBIM | Olea Medical |
| FDA clearance | - | K152602 |
| INTENDED USE | | |
| Indications for use | qp-Prostate is an image processing
software package to be used by
trained professionals, including | Olea Sphere V3.0 is an image
processing software package to
be used by trained professionals |
| FEATURE | qp-Prostate | Olea Sphere V3.0
K152602 |
| | radiologists specialized in prostate
imaging, urologists and oncologists.
The software runs on a standard
"off-the-shelf" workstation and can
be used to perform image viewing,
processing and analysis of prostate
MR images. Data and images are
acquired through DICOM compliant
imaging devices and modalities.
Patient management decisions
should not be based solely on the
results of qp-Prostate. qp-Prostate
does not perform a diagnostic
function, but instead allows the
users to visualize and analyze
DICOM data. | including, but not limited to,
physicians and medical
technicians. The software runs on
a standard "off-the-shelf"
workstation and can be used to
perform image viewing,
processing, image collage and
analysis of medical images. Data
and images are acquired through
DICOM compliant imaging
devices and modalities. |
| CHARACTERISTICS | | |
| Supported image
format | DICOM 3.0 | DICOM 3.0 |
| Type of scans | MR | MR, CT |
| Data import | PACS | PACS or file system |
| Data export | PACS | PACS or file system |
| Image loading and
saving | Yes | Yes |
| Integrated slice viewer | Yes | Yes |
| Multi-planar | Yes | Yes |
| MPR/3D | Yes | Yes |
| Segmentation tools | Yes | Yes |
| ROI tools | Yes | Yes |
| Image Processing | Yes | Yes |
| Study Management
tools | Yes | Yes |
| Structured report
generation | Yes | Yes |
| License Management
System | Yes | Yes |
| Unique user log-in and
password | Yes | Yes |
| User audit trails | Yes | Yes |
| Modular analysis plug-
in | Yes | Yes |
| FEATURE | qp-Prostate | Olea Sphere V3.0
K152602 |
| Intended use
environment | Hospitals / imaging centers or
clinics | Hospitals / imaging centers or
clinics |
| Intended user | Radiologists specialized in
prostate imaging, urologists and
oncologists. | Trained professionals including
but not limited to
physicians and medical
technicians |
| Intended patient
population | Any patient for which PACS MR
prostate data exists. | Any patient for which PACS data
exists. |
| Image post-processing
and analysis plugins | Not included | DCE (for MR Imaging) Kinetics -
semi quantitative maps
(AUC, Peak enhancement map,
Peak percentage enhancement,
Time to maximum enhancement,
Washin, Washout, Relative
washout,
Signal Enhancement Ratio) |
| | DCE (for prostate MR
imaging) Perfusion –
Pharmacokinetics
Modelling
( $K^{trans}$ [min-1], $k_{ep}$ [min-1], $v_e$ [%]) | DCE (for MR imaging) Permeability
– Quantitative parameter maps
( $K^{trans}$ , $k_{ep}$ , $V_p$ , $v_e$ , signal to
concentration time curve
conversion with fixed blood
and tissue T1 values) |
| | Not included | DWI (for MR Imaging) Intra - Voxel
Incoherent Motion IVIM
(ADC, D, D*, f) |
| | DWI (for MR Imaging) Apparent
Diffusion
Coefficient (ADC [mm2/s]) | DWI (for MR Imaging) Apparent
Diffusion Coefficient
(ADC) |
| | Not included | Yes (T1 and T2 Mapping) |
| | Not included | Metabolic (hepatic fat fraction FF) |
7
8
Thus, qp-Prostate device is substantially equivalent to the Olea Sphere V3.0 (K152602) from OLEA Medical.
PERFORMANČE DATA
PERFORMANCE TESTING - BENCH
The following bench testing was performed on the subject device per the following draft guidance: "Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions" (April 19, 2019) for the unitary validation of the different parts that constitute qp
9
Prostate. qp-Prostate is aimed for diffusion and perfusion analysis of prostate MR cases, providing quantitative information useful to assist the professional in completing the prostate structured report template.
One of tests is the analysis of digital reference objects (DROs) proposed by QIBA, available for DWI and DCE, considered as ground truth. For both Perfusion-Pharmacokinetics (PKM) and Diffusion-ADC analysis modules, DROs, including presence and absence of noise modeling, are used for technical performance evaluation.
| Modules | ||
|---|---|---|
| qp-Prostate | ||
| functionality | Test type | Dataset |
| Diffusion - ADC | ||
| analysis module | Digital Reference | |
| Object Analysis | ||
| (Diffusion - ADC) | QIBA's Diffusion | |
| Weighted Imaging | ||
| (DWI) Digital | ||
| Reference Object | ||
| (DRO) | ||
| Perfusion - | ||
| Pharmacokinetics | ||
| analysis module | Digital Reference | |
| Object Analysis | ||
| (Perfusion – | ||
| Pharmacokinetics) | QIBA's Dynamic | |
| Contrast-Enhanced | ||
| (DCE) MR perfusion | ||
| DRO |
Table 2. qp-Prostate's Performance Bench Testing for Diffusion and Perfusion Analysis Modules
PERFORMANCE TESTING - CLINICAL
A dataset of prostate clinical cases was used for the validation of the algorithms integrated in qp-Prostate v1.0.0 such as Spatial Smoothing algorithm, Registration algorithm, Automated Prostate Segmentation algorithm, Motion Correction algorithm and automated AIF selection algorithm.
The other assessment is the comparison against the predicate device (OLEA Sphere, v3.0, K152602), using 157 clinical cases of prostate MRI. The dataset includes cases from different three major MRI vendors: Siemens, GE and Philips, magnetic field of 3T and 1.5T cases and different technical parameters that make up the broad spectrum of cases allowed in our recommended protocol (T2w + DWI + DCE).
Table 3. qp-Prostate's Performance Clinical Testing and Comparison with the Predicate Device
| qp-Prostate
| functionality | Test type | Dataset |
|---|---|---|
| Motion Correction | ||
| algorithm | Performance | |
| testing with | ||
| prostate MR | ||
| cases | 155 DCE-MR and DWI-MR | |
| prostate sequences acquired form | ||
| 155 different patients in different | ||
| machines with multiple acquisition | ||
| protocols | ||
| Registration algorithm | Performance | |
| testing with | 112 T2-Weighted MR, DCE-MR | |
| and 108 DWI-MR prostate | ||
| sequences acquired from different |
10
| prostate MR | patients in different machines with | |
|---|---|---|
| cases | multiple acquisition parameters | |
| Spatial Smoothing | ||
| algorithm | 51 transverse T2-weighted, DCE- | |
| Performance | MR and DWI-MR prostate | |
| testing with | sequences acquired from 51 | |
| prostate MR | different patients in different | |
| cases | machines with multiple acquisition | |
| protocols | ||
| AIF selection | ||
| algorithm | Performance | 242 DCE-MR prostate sequences |
| testing with | acquired from 242 different | |
| prostate MR | patients in different machines with | |
| cases | multiple acquisition protocols | |
| Prostate | ||
| Segmentation | ||
| algorithm | Performance | 243 transverse T2-weighted MR |
| testing with | ||
| prostate MR | ||
| cases | prostate sequences acquired from | |
| 243 different patients in different | ||
| machines with multiple acquisition | ||
| protocols. | ||
| Comparison to the | ||
| Predicate Device | ||
| (OLEA Sphere, v3.0, | ||
| K152602) | 157 T2-weighted MR, DCE-MR | |
| Comparison to | and 141 DWI-MR prostate | |
| predicate | sequences acquired form different | |
| device | patients in different machines with | |
| multiple acquisition protocols |
SOFTWARE VERIFICATION & VALIDATION
gp-Prostate software was developed according to FDA recognized consensus standards for software development. Software verification and validation was performed following V&V plans and protocols verifying that product specifications were met.
The tests results demonstrate that qp-Prostate functioned as intended, is acceptable for clinical use, and is as safe and effective as its predicate device, without introducing new questions of safety and efficacy.
CONFORMANCE STANDARDS
The qp-Prostate complies with the following FDA recognized consensus standards:
- ISO 62304:2006/A1:2016 Medical device software - Software life cycle processes
- ISO 14971 Medical devices Applications of risk management to medical devices ●
- ISO 82304:2016 Health software Part 1: General requirements for product safety ●
- IEC 60601-1 Medical electrical equipment -- Part 1-2: General requirements for basic ● safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- . IEC 62366 Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 80002 Medical device software Part 1: Guidance on the application of ISO 14971 ● to medical device software
11
In addition, the device also complies with the following consensus standards:
- . ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
CONCLUSIONS
qp-Prostate is as safe and effective as the Olea Sphere v3.0. qp-Prostate has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between qp -Prostate and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that qp-Prostate is as safe and effective as the OLEA Sphere v3.0. Thus, gp-Prostate is substantially equivalent.