MRCP+ v1.0
Device Facts
| Record ID | K183133 |
|---|---|
| Device Name | MRCP+ v1.0 |
| Applicant | Perspectum Diagnostics, Ltd. |
| Product Code | LLZ · Radiology |
| Decision Date | Jan 9, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | AI/ML, Software as a Medical Device, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K183133 · Jan 9, 2019 | MRCP+ v1.0 | Perspectum Diagnostics, Ltd. | In-vivo MRCP datasets from healthy volunteers and patients with suspected hepatobiliary disease | In-vivo clinical data was used to assess the precision, repeatability, and reproducibility of the MRCP+v1 software across different MR scanners and field strengths. | In-vivo performance testing; Precision; Repeatability; Reproducibility; Hepatobiliary disease |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| In-vivo performance assessment (precision/repeatability/reproducibility) | Healthy volunteers and patients with suspected hepatobiliary disease | Not applicable for this study | Repeatability and reproducibility of volumetric and ductal measurements (Tree Volume, Gallbladder Volume, Duct dimensions) |
Indications for Use
MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data. MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder. Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment. MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols. MRCP+v1 is suitable for all patients not contra-indicated for MRI.
Device Story
MRCP+v1 is a standalone software device for quantitative assessment of biliary system structures. It takes DICOM 3.0 compliant MRCP datasets as input. A trained operator (radiographer/technician) uses the software to perform interactive segmentation and labelling of the biliary tree, gallbladder, and tubular structures. The device calculates 3D models, measures bile duct widths, detects regions of variation (ROV), and performs regional volumetric analysis. Output is a summary report used by radiologists and clinicians to supplement conventional radiology reports for diagnosis and treatment planning. Used in clinical settings on general-purpose workstations. Benefits include standardized, quantitative metrics to assist in hepatobiliary assessment.
Clinical Evidence
No clinical trials; evidence based on bench performance testing and in-vivo studies. Bench testing used digital synthetic phantoms and physical phantoms (clinical and tube-width) to assess algorithmic accuracy, repeatability, and reproducibility. In-vivo testing used volunteer data across multiple MR manufacturers (Siemens, GE, Philips) and field strengths (1.5T, 3T). Results showed high repeatability and reproducibility for tree/gallbladder volumes and duct measurements (median, min, max, IQR). Intra- and inter-operator variability were within prescribed acceptance criteria.
Technological Characteristics
Standalone software application; non-invasive; non-sterile. Operates on general-purpose workstations (Apple/Mac OS). Inputs: DICOM 3.0 compliant MRCP datasets. Processing: Interactive segmentation, labelling, and quantitative volumetric analysis. Standards: IEC 62304, IEC 62366-1, DICOM 3.0, ISO 14971, ISO 13485.
Indications for Use
Indicated for use in the general patient population not contra-indicated for MRI, for the non-invasive, quantitative assessment of biliary system structures.
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
- IQQA-Liver Multimodality Software (K131498)
Submission Summary (Full Text)
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January 9, 2019
Perspectum Diagnostics Ltd Jaco Jacobs Chief Quality and Regulatory Compliance Officer 23-38 Hythe Bridge Street OXFORD, OX1 2ET OXFORDSHIRE UNITED KINGDOM
Re: K183133
Trade/Device Name: MRCP+ v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 9, 2018 Received: November 13, 2018
Dear Jaco Jacobs:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K183133
Device Name MRCP+v1
## Indications for Use (Describe)
MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data.
MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.
Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, vield information that may assist in biliary system assessment.
MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired MR scanners using supported MRCP acquisition protocols.
MRCP+v1 is suitable for all patients not contra-indicated for MRI.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <div> <span> <span style="font-size:16px">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|------------------------------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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RA317
Date Prepared:
7th of January 2019
Image /page/3/Picture/4 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is in bold, black letters, and the word "Diagnostics" is in gray letters. To the right of the words is a colorful circular logo with a trademark symbol.
K 183133
# 1. Submitter Details
Address:
Perspectum Diagnostics Ltd 23-38 Hythe Bridge Street Oxford. Oxfordshire, OX1 2ET. United Kingdom
Owner/Operator Number: 10056574
Establishment Registration Number: 3014232555
Contact Person:
Dr Jaco Jacobs jaco.jacobs@perspectum-diagnostics.com +44 (0) 1865 655329
# 2. Subject Device
Legal manufacturer: Common name: Device name/Trade name: 510(k) Number: Classification Regulation: Regulation Name: Device Classification: Device Panel: Device Product Code:
Perspectum Diagnostics Ltd MRCP+, MRCP+v1 MRCP+ 1.0 K183133 21 CFR 892.2050 Radiological Image Processing System Class II Radiology LLZ
# 3. Predicate Details
Legal Manufacturer: EDDA Technology Inc. Common name: IQQA-Liver Device name/Trade name: IQQA-Liver Multimodality Software 510(k) Number: K131498 Classification Regulation: 21 CFR 892.2050 Radiological Image Processing System Regulation Name: Device Classification: Class II Device Panel: Radiology Device Product Code: LLZ
No reference devices were used to support this submission.
# 4. Device Description
#### 4.1. General
MRCP+v1 is a standalone software device. The purpose of the MRCP+v1 device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator, typically a radiographer or technician trained in radiological anatomy, loads as input into the MRCP+v1
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Image /page/4/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The logo consists of the word "Perspectum" in a bold, dark gray font, with the word "Diagnostics" in a lighter gray font underneath. To the right of the text is a circular graphic with four colored sections: yellow, blue, green, and pink. The pink section is a half-circle, while the other three sections are quarter-circles.
device previously acquired MRCP data. The device is intended to be used by a trained operator to generate metrics in the form of a summary report to enable reporting by a radiologist for subsequent interpretation and diagnosis by a clinician.
MRCP+v1 is designed to utilize DICOM 3.0 compliant MRCP datasets, acquired on supported MR scanners, to display the fluid-filled tubular structures in the abdomen, including the intra- and extrahepatic biliary tree, gallbladder and pancreatic ductal system.
Analysis and evaluation tools include:
- Segmentation of structures utilising user input of seeding points .
- Interactive labelling of segmented areas .
- Quantitative measurement derived from segmentation and labelling results. .
MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.
The radiologist may use existing radiological tools to report on the biliary tree. The reviewing radiologist needs to take into consideration the device's limitations and accuracy during review. The MRCP+v1 report is intended to supplement a conventional radiology report, for interpretation by a clinician.
MRCP+v1 does not replace the usual procedures for assessment of the biliary system by a reviewing radiologist or interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.
The metrics are intended to be used as an additional input to radiologists and clinicians in addition to that provided by conventional MRCP.
In consequence, the product is considered to have no adverse effect on health since the results only serve to augment the information that the radiologists and clinicians will utilize for final review and/or interpretation. In this regard, MRCP+v1 presents a low level of concern with respect to patient safety.
MRCP+v1 is suitable for all patients not contra-indicated for MRI.
#### 4.2. Sterilization and Shelf Life
MRCP+ is a standalone software device thus it is non-invasive and non-sterile. The shelf life of MRCP+ is indefinite as long as the manufacturer continues to support the device. Both sterilization and shelf life characteristics are equivalent of the predicate device.
#### 4.3. Biocompatibility
MRCP+v1 is a standalone software device thus it is non-contact and non-invasive. No biocompatibility testing was deemed necessary to demonstrate the safety and effectiveness of MRCP+v1 does not does not consists of materials that differ from the predicate device.
#### 4.4. Software
MRCP+v1 was successfully validated and verified against the requirements specification and it's intended use. The results from the validation and verification activities, documented in this submission, corroborate that MRCP+v1
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Image /page/5/Picture/1 description: The image is a logo for Perspectum Diagnostics. The word "Perspectum" is in bold, black font, and the word "Diagnostics" is in a smaller, gray font. To the right of the words is a colorful circle made up of four different colors: yellow, green, blue, and pink. The letters "TM" are in the upper right corner of the circle.
meets the product requirement specifications and intended use, which is deemed to be substantially equivalent to the predicate (see section below).
Validation and verification activities were conducted in a controlled environment and in compliance with IEC 62304, ISO 13485:2016 and 21 CFR 820. MRCP+v1 is in compliance with the DICOM standard and is issued with a DICOM conformance statement.
The verification and validation activities conducted demonstrate that MRCP+v1 is at least as safe and effective as the predicate device and does not introduce any new risks.
#### 4.5. Electromagnetic and Electrical Safety
MRCP+v1 is a standalone software device. There are no electrical safety risks associated with the direct use of the MRCP+v1 device. No electromagnetic or electrical safety testing was deemed necessary to demonstrate the safety and effectiveness of MRCP+v1.
# 5. Intended Use
## Intended Use
MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data.
MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.
Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment.
MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols.
MRCP+v1 is suitable for all patients not contra-indicated for MRI.
## Subject and Predicate Device Comparison
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence.
| Similarities Comparison | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | MRCP+v1 (Subject) | IQQA-Liver (Predicate) |
| Intended Use and<br>Indications for Use | MRCP+v1 is indicated for use as a software-<br>based image processing system for non-<br>invasive, quantitative assessment of biliary<br>system structures by facilitating the<br>generation, visualisation and review of<br>three-dimensional quantitative biliary<br>system models and anatomical image data. | IQQA-Liver Multimodality is a PC-based, self-<br>contained, non-invasive image analysis<br>software application for reviewing multiphase<br>images derived from CT scanners and MR<br>scanners. Combining image viewing,<br>processing and reporting tools, the software is<br>designed to support the visualization, |
| Similarities Comparison | | |
| Characteristic | MRCP+v1 (Subject) | IQQA-Liver (Predicate) |
| | MRCP+v1 calculates quantitative three-<br>dimensional biliary system models that<br>enable measurement of bile duct widths and<br>automatic detection of regions of variation<br>(ROV) of tubular structures. MRCP+v1<br>includes tools for interactive segmentation<br>and labelling of the biliary system and<br>tubular structures. MRCP+v1 allows for<br>regional volumetric analysis of segmented<br>tree-like, tubular structures and the | evaluation and reporting of liver and<br>physician-identified lesions.<br>The software supports a workflow based on<br>automated image registration for viewing and<br>analysing multiphase volume datasets. It<br>includes tools for interactive segmentation<br>and labelling of liver segments and vascular<br>structures.<br>The software provides functionalities for |
| | gallbladder.<br>Combining image viewing, processing and<br>reporting tools, the metrics provided is<br>designed to support physicians in the<br>visualization, evaluation and reporting of<br>hepatobiliary structures. These models and<br>the physical parameters derived from the<br>models, when interpreted by a trained<br>physician, yield information that may assist<br>in biliary system assessment.<br>MRCP+v1 is designed to utilize DICOM<br>compliant MRCP datasets, acquired on<br>supported MR scanners using supported<br>MRCP acquisition protocols.<br>MRCP+v1 is suitable for all patients not | manual or interactive segmentation of<br>physician-identified lesions, interactive<br>definition of virtual resection plane, and<br>allows for regional volumetric analysis of such<br>lesions in terms of size, position, margin and<br>enhancement pattern, providing information<br>for physician's evaluation and treatment<br>planning.<br>The software is designed for use by trained<br>professionals, including physicians and<br>technicians.<br>Image source: DICOM. |
| Target Population | contra-indicated for MRI.<br>Patients suitable to undergo an MRI scan and<br>not contra-indicated for MRI. | Patients suitable to undergo an MRI/CT scan<br>and not contra-indicated for MRI/CT. |
| Device User | Trained operator with a background in<br>radiological anatomy, such as an MR<br>radiographer/ MR technician. | Trained professionals, including physicians<br>and technicians. |
| Report User | Interpreting clinician, reporting radiologist | N/A |
| Device Use<br>Environment | Installation of MRCP+v1 is controlled and<br>installed on general purpose workstations. In<br>the context of use, MRCP+v1 reports are<br>made available through existing MDDS<br>software devices. | IQQA-Liver is accessed from a cloud-based<br>server. |
| Anatomical<br>Location | Abdomen, liver, biliary tree, gallbladder | Abdomen, Liver, Gallbladder |
| Energy<br>Considerations | Software only application. The device, a<br>standalone software application, does not<br>deliver or depend on energy delivered to or<br>from patients. | Software only application. The device, a<br>standalone software application, does not<br>deliver or depend on energy delivered to or<br>from patients. |
| Similarities Comparison | | |
| Characteristic | MRCP+v1 (Subject) | IQQA-Liver (Predicate) |
| Design: Purpose | Standalone software application to facilitate<br>the import and visualization of MR data sets<br>encompassing the abdomen, including the<br>liver with functionality independent of the<br>MRI equipment vendor. | Standalone software application to facilitate<br>the import and visualization of MR and CT<br>data sets encompassing the abdomen,<br>including the liver with functionality<br>independent of the OEM equipment vendor. |
| | Combining image viewing, processing and<br>reporting tools, the metrics provided are<br>designed to support physicians in the<br>visualization, evaluation and reporting of<br>hepatobiliary structures. | Combining image processing, viewing and<br>reporting tools, the software supports the<br>visualization, evaluation and reporting of body<br>imaging scans and physician identified lesions. |
| Design: Tools | MRCP+v1 calculates quantitative three-<br>dimensional biliary system models that<br>enable measurement of bile duct widths and<br>automatic detection of regions of variation<br>(ROV) of tubular structures. MRCP+v1<br>includes tools for interactive segmentation<br>and labelling of the biliary system and<br>tubular structures. MRCP+v1 allows for<br>regional volumetric analysis of segmented<br>tree-like, tubular structures and the<br>gallbladder. | Manual or interactive segmentation of<br>physician-identified lesions and allows for<br>regional volumetric analysis of such lesions in<br>terms of size, position, margin and<br>enhancement pattern. |
| Design: Supported<br>Modalities | DICOM 3.0 compliant MR data. | DICOM 3.0 compliant MR data from CT/ MRI<br>scanners. |
| Compatibility with<br>the environment | Installation of MRCP+v1 is controlled and is<br>installed on general purpose workstations<br>within a controlled networked environment.<br>MRCP+v1 reads in local files compliant with | Cloud -based server access requiring a<br>networked computer with the hospital<br>intranet.<br>Reads in DICOM 3.0 compliant MR data from |
| | DICOM 3.0. | CT/ MRI scanners. |
| Performance | Validated with digital synthetic<br>phantoms/raw data, phantom scans, and in-<br>vivo scans. | Experimental results on simulated images<br>containing structures of interest. Phantom<br>data. Retrospective in-vivo data. |
| Supported Systems | Validated across all supported<br>manufacturers.…
