(57 days)
No reference devices were used to support this submission.
No
The summary describes image processing, segmentation, and quantitative measurement tools, but does not mention AI, ML, or related terms like deep learning. The description focuses on user-guided segmentation and calculation based on these segmentations.
No.
The "Intended Use / Indications for Use" section states that the device is "for non-invasive, quantitative assessment of biliary system structures" and its output "yield information that may assist in biliary system assessment." It also mentions that the device is designed to "support physicians in the visualization, evaluation and reporting of hepatobiliary structures" and is intended as "an additional input to radiologists and clinicians in addition to that provided by conventional MRCP." The "Device Description" also clarifies that it "does not replace the usual procedures for assessment of the biliary system by a reviewing radiologist or interpreting clinician." This indicates the device is for diagnostic and assessment purposes, not for providing therapy.
Yes
The device assists in the "assessment of biliary system structures" and generates quantitative measurements and models that "may assist in biliary system assessment" and "subsequent interpretation and diagnosis by a clinician." This indicates its role in providing information for diagnostic purposes.
Yes
The device description explicitly states "MRCP+v1 is a standalone software device." The intended use and device description focus entirely on software-based image processing, analysis, and reporting of existing MRCP data. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- MRCP+v1's Function: MRCP+v1 is a software-based image processing system that analyzes medical images (MRCP datasets) acquired from within the patient's body. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's 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." This involves processing images, not analyzing biological specimens.
- Input Data: The input data is "DICOM compliant MRCP datasets," which are medical images, not biological samples.
While the device provides information that "may assist in biliary system assessment" and is used in a clinical setting, its function is based on image analysis, not the analysis of samples taken from the body. Therefore, it falls under the category of a medical device, specifically a software medical device for image processing and analysis, rather than an In Vitro Diagnostic.
N/A
Intended Use / 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 MR scanners using supported MRCP acquisition protocols.
MRCP+v1 is suitable for all patients not contra-indicated for MRI.
Product codes
LLZ
Device Description
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant MRCP datasets, MR data, MRCP data
Anatomical Site
Abdomen, liver, biliary tree, gallbladder, hepatobiliary structures
Indicated Patient Age Range
Not Found. Stated as "suitable for all patients not contra-indicated for MRI."
Intended User / Care Setting
Trained operator with a background in radiological anatomy, such as an MR radiographer/MR technician. Report users are interpreting clinicians, reporting radiologists.
Installation of MRCP+v1 is controlled and installed on general purpose workstations. In the context of use, MRCP+v1 reports are made available through existing MDDS software devices.
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
Performance testing included digital synthetic phantoms/raw data, phantom scans, and in-vivo scans (healthy volunteer and patients with suspected hepatobiliary disease). Specific sample sizes are not provided.
Summary of Performance Studies
Study Type: Bench performance testing and In-vivo performance testing.
Bench Performance Testing:
- Validated MR Systems: Siemens (MAGNETOM Prisma 3T, MAGNETOM Avantofit 1.5T), GE (Discovery MR750 3T, Optima MR450w 1.5T), Philips (Achieva 3T, Achieva 1.5T).
- Algorithmic Accuracy (Digital Synthetic Data):
- Clinical Phantom: 95% CI Upper Limit of Agreement 0.9mm, 95% CI Lower Limit of Agreement -0.9mm.
- Tube Width Phantom: 95% CI Upper Limit of Agreement 1.3mm, 95% CI Lower Limit of Agreement -0.6mm.
- Device Accuracy (Physical Phantoms):
- Clinical Phantom: 95% Cl Upper Limit of Agreement 1.0 mm, 95% Cl Lower Limit of Agreement -1.1mm.
- Tube Width Phantom: 95% Cl Upper Limit of Agreement 0.7mm, 95% Cl Lower Limit of Agreement -0.9mm.
- Precision (Physical Phantoms):
- Clinical Phantom: Repeatability (Upper Limit 0.4 mm, Lower Limit -0.4 mm), Reproducibility (Upper Limit 0.5 mm, Lower Limit -1.1 mm).
- Tube Width Phantom: Repeatability (Upper Limit 0.3 mm, Lower Limit -0.3 mm), Reproducibility (Upper Limit 0.7 mm, Lower Limit -0.8 mm).
In-vivo Performance Testing:
- Validated MR Systems: Siemens (MAGNETOM Prisma 3T, MAGNETOM Avantofit 1.5T), GE (Discovery MR750 3T, Optima MR450w 1.5T).
- Precision (In-vivo data from volunteers):
- Repeatability:
- Tree Volume (ml): 95% CI Upper Limit 3.4, Lower Limit -3.5.
- Gallbladder Volume (ml): 95% CI Upper Limit 4.4, Lower Limit -9.4.
- 3-5mm (%): 95% CI Upper Limit 17.7, Lower Limit -19.2.
- 5-7mm (%): 95% CI Upper Limit 8.5, Lower Limit -8.0.
- Greater than 7mm (%): 95% CI Upper Limit 1.6, Lower Limit -1.8.
- Less than 3mm (%): 95% CI Upper Limit 20.2, Lower Limit -19.2.
- Duct Median (mm): 95% CI Upper Limit 1.7, Lower Limit -2.0.
- Duct Minimum (mm): 95% CI Upper Limit 1.9, Lower Limit -2.2.
- Duct Maximum (mm): 95% CI Upper Limit 3.2, Lower Limit -2.9.
- Duct IQR (mm): 95% CI Upper Limit 1.8, Lower Limit -1.7.
- Reproducibility:
- Tree Volume (ml): 95% CI Upper Limit 4.7, Lower Limit -6.9.
- Gallbladder Volume (ml): 95% CI Upper Limit 13.8, Lower Limit -18.4.
- 3-5mm (%): 95% CI Upper Limit 27.8, Lower Limit -15.8.
- 5-7mm (%): 95% CI Upper Limit 10.8, Lower Limit -11.8.
- Greater than 7mm (%): 95% CI Upper Limit 2.6, Lower Limit -3.1.
- Less than 3mm (%): 95% CI Upper Limit 30.8, Lower Limit -23.4.
- Duct Median (mm): 95% CI Upper Limit 2.6, Lower Limit -2.8.
- Duct Minimum (mm): 95% CI Upper Limit 2.6, Lower Limit -2.8.
- Duct Maximum (mm): 95% CI Upper Limit 4.0, Lower Limit -3.5.
- Duct IQR (mm): 95% CI Upper Limit 1.9, Lower Limit -2.3.
- Repeatability:
- Intra- and Inter- Operator:
- Intra-Operator:
- Tree Volume (ml): 95% Cl Upper Limit 0.9, Lower Limit -0.6.
- Gallbladder Volume: 95% Cl Upper Limit 0.0, Lower Limit 0.0.
- 3-5mm (%): 95% Cl Upper Limit 7.4, Lower Limit -7.7.
- 5-7mm (%): 95% Cl Upper Limit 5.0, Lower Limit -5.1.
- Greater than 7mm: 95% Cl Upper Limit 3.9, Lower Limit -4.7.
- Less than 3mm (%): 95% Cl Upper Limit 11.7, Lower Limit -10.7.
- Duct Median (mm): 95% Cl Upper Limit 0.4, Lower Limit -0.4.
- Duct Minimum (mm): 95% Cl Upper Limit 0:5, Lower Limit -0.4.
- Duct Maximum (mm): 95% Cl Upper Limit 2.0, Lower Limit -1.6.
- Duct IQR (mm): 95% Cl Upper Limit 0.5, Lower Limit -0.4.
- Inter-Operator:
- Tree Volume (ml): 95% Cl Upper Limit 3.6, Lower Limit -6.8.
- Gallbladder Volume: 95% Cl Upper Limit 0.6, Lower Limit -0.7.
- 3-5mm (%): 95% Cl Upper Limit 16.8, Lower Limit -11.1.
- 5-7mm (%): 95% Cl Upper Limit 6.3, Lower Limit -6.3.
- Greater than 7mm: 95% Cl Upper Limit 1.4, Lower Limit -1.7.
- Less than 3mm (%): 95% Cl Upper Limit 12.3, Lower Limit -17.4.
- Duct Median (mm): 95% Cl Upper Limit 1.1, Lower Limit -1.8.
- Duct Minimum (mm): 95% Cl Upper Limit 1.0, Lower Limit -1.3.
- Duct Maximum (mm): 95% Cl Upper Limit 2.0, Lower Limit -3.2.
- Duct IQR (mm): 95% Cl Upper Limit 1.6, Lower Limit -1.9.
- Intra-Operator:
Key results:
- Algorithmic accuracy for quantifying tubular structures from MRCP data is high.
- MRCP+v1 is highly accurate when quantifying tubular structures from physical phantoms, with limited variability.
- MRCP+v1 is highly repeatable and reproducible across field strengths and manufacturers when quantifying hepatobiliary structures from in-vivo acquired datasets.
- Variation introduced by operator analysis is well within prescribed acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used to support this submission.
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).
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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
1
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
2
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) |
|---|
| ------------------------------------------------- |
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
4
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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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 | ||
| 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. | IQQA-Liver Multimodality is a PC-based, self- | |
| contained, non-invasive image analysis | ||
| software application for reviewing multiphase | ||
| images derived from CT scanners and MR | ||
| scanners. Combining image viewing, | ||
| processing and reporting tools, the software is | ||
| designed to support the visualization, | ||
| Similarities Comparison | ||
| Characteristic | MRCP+v1 (Subject) | IQQA-Liver (Predicate) |
| 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 | evaluation and reporting of liver and | |
| physician-identified lesions. | ||
| The software supports a workflow based on | ||
| automated image registration for viewing and | ||
| analysing multiphase volume datasets. It | ||
| includes tools for interactive segmentation | ||
| and labelling of liver segments and vascular | ||
| structures. | ||
| The software provides functionalities for | ||
| 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 | manual or interactive segmentation of | |
| physician-identified lesions, interactive | ||
| definition of virtual resection plane, and | ||
| allows for regional volumetric analysis of such | ||
| lesions in terms of size, position, margin and | ||
| enhancement pattern, providing information | ||
| for physician's evaluation and treatment | ||
| planning. | ||
| The software is designed for use by trained | ||
| professionals, including physicians and | ||
| technicians. | ||
| Image source: DICOM. | ||
| Target Population | contra-indicated for MRI. | |
| Patients suitable to undergo an MRI scan and | ||
| not contra-indicated for MRI. | Patients suitable to undergo an MRI/CT scan | |
| and not contra-indicated for MRI/CT. | ||
| Device User | Trained operator with a background in | |
| radiological anatomy, such as an MR | ||
| radiographer/ MR technician. | Trained professionals, including physicians | |
| and technicians. | ||
| Report User | Interpreting clinician, reporting radiologist | N/A |
| Device Use | ||
| Environment | Installation of MRCP+v1 is controlled and | |
| installed on general purpose workstations. In | ||
| the context of use, MRCP+v1 reports are | ||
| made available through existing MDDS | ||
| software devices. | IQQA-Liver is accessed from a cloud-based | |
| server. | ||
| Anatomical | ||
| Location | Abdomen, liver, biliary tree, gallbladder | Abdomen, Liver, Gallbladder |
| Energy | ||
| Considerations | Software only application. The device, a | |
| standalone software application, does not | ||
| deliver or depend on energy delivered to or | ||
| from patients. | Software only application. The device, a | |
| standalone software application, does not | ||
| deliver or depend on energy delivered to or | ||
| from patients. | ||
| Similarities Comparison | ||
| Characteristic | MRCP+v1 (Subject) | IQQA-Liver (Predicate) |
| Design: Purpose | Standalone software application to facilitate | |
| the import and visualization of MR data sets | ||
| encompassing the abdomen, including the | ||
| liver with functionality independent of the | ||
| MRI equipment vendor. | Standalone software application to facilitate | |
| the import and visualization of MR and CT | ||
| data sets encompassing the abdomen, | ||
| including the liver with functionality | ||
| independent of the OEM equipment vendor. | ||
| Combining image viewing, processing and | ||
| reporting tools, the metrics provided are | ||
| designed to support physicians in the | ||
| visualization, evaluation and reporting of | ||
| hepatobiliary structures. | Combining image processing, viewing and | |
| reporting tools, the software supports the | ||
| visualization, evaluation and reporting of body | ||
| imaging scans and physician identified lesions. | ||
| Design: Tools | 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. | Manual or interactive segmentation of | |
| physician-identified lesions and allows for | ||
| regional volumetric analysis of such lesions in | ||
| terms of size, position, margin and | ||
| enhancement pattern. | ||
| Design: Supported | ||
| Modalities | DICOM 3.0 compliant MR data. | DICOM 3.0 compliant MR data from CT/ MRI |
| scanners. | ||
| Compatibility with | ||
| the environment | Installation of MRCP+v1 is controlled and is | |
| installed on general purpose workstations | ||
| within a controlled networked environment. | ||
| MRCP+v1 reads in local files compliant with | Cloud -based server access requiring a | |
| networked computer with the hospital | ||
| intranet. | ||
| Reads in DICOM 3.0 compliant MR data from | ||
| DICOM 3.0. | CT/ MRI scanners. | |
| Performance | Validated with digital synthetic | |
| phantoms/raw data, phantom scans, and in- | ||
| vivo scans. | Experimental results on simulated images | |
| containing structures of interest. Phantom | ||
| data. Retrospective in-vivo data. | ||
| Supported Systems | Validated across all supported | |
| manufacturers. | Supported MR/CT systems. | |
| Standards | IEC 62304, IEC 62366-1, DICOM 3.0, ISO | |
| 14971, ISO 13485 | DICOM | |
| System/Operating | Apple/Mac OS | Standard PC hardware |
| System | ||
| Materials | Not applicable, standalone software. | Not applicable, standalone software. |
| Biocompatibility | Not applicable, standalone software. | Not applicable, standalone software. |
| Sterility | Not applicable, standalone software. | Not applicable, standalone software. |
| Electrical Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Mechanical Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Chemical Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Thermal Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Radiation Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Differences Comparison | ||
| Characteristic | MRCP+v1 (Subject) | IQQA-Liver (Predicate) |
| Manufacturer | Perspectum Diagnostics Ltd | EDDA Technologies |
| No new concerns with regards to safety and effectiveness are raised due to different manufacturer. Perspectum Diagnostics Ltd designed and manufactured MRCP+v1 under a QSR complaint quality management system using appropriate design controls and an ISO 14971 compliant risk management process. MRCP+v1 underwent a substantive performance evaluation. | ||
| Intended Use and | ||
| 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. | IQQA-Liver Multimodality is a PC-based, self-
contained, non-invasive image analysis
software application for reviewing multiphase
images derived from CT scanners and MR
scanners. Combining image viewing,
processing and reporting tools, the software is
designed to support the visualization,
evaluation and reporting of liver and
physician-identified lesions.
The software supports a workflow based on
automated image registration for viewing and
analysing multiphase volume datasets. It
includes tools for interactive segmentation
and labelling of liver segments and vascular
structures.
The software provides functionalities for
manual or interactive segmentation of
physician-identified lesions, interactive
definition of virtual resection plane, and
allows for regional volumetric analysis of such
lesions in terms of size, position, margin and
enhancement pattern, providing information
for physician's evaluation and treatment
|
| Similar intended use and therefore does not raise any new concerns with regards to safety and effectiveness. | | |
| Target Population | Indicted for use in the general population for
any patients that are not contra-indicated
for MRI. | Indicted for use in the general population for
any patients that are not contra-indicated for
MRI and CT. |
| Differences Comparison | | |
| Characteristic | MRCP+v1 (Subject) | IQQA-Liver (Predicate) |
| No new risks are associated with the difference in imaging modalities between the subject and predicate device,
both subject and predicate device utilise DICOM 3.0 compliant files as an input. DICOM is the most common format
for storing and transmitting medical images and is used by most manufactures of radiological imaging devices
including MRI and CT. | | |
| Device User | Trained operator with a background in
radiological anatomy, such as an MR
radiographer/ MR technician | Trained professionals, including physicians
and technicians |
| Operators are trained and the effectiveness of the training is evaluated on an ongoing basis. Inter- and intra-reader
assessments are performed periodically and as part of training to maintain the quality of reporting and to limit
variability and bias. | | |
| Device Use
Environment | Installation of MRCP+v1 is controlled and
installed on general purpose workstations at
PD's image analysis centre. In the context of
use, MRCP+v1 reports are made available
through QAS. | IQQA-Liver is accessed from a cloud-based
server. |
| The medium which through data is accessed is primarily based on business operational needs. Transfer of data
through a cloud-based portal represent similar risks. Both are standalone software devices, MRCP+ does not have
any network functionality and merely processes DICOM 3.0 compliant datasets. | | |
| The difference in the use environment does not pose any new risks and the performance and safety characteristics
of the subject device and the chosen predicate can be considered equivalent with regard to the device use
environment. | | |
| Design: Supported
Modalities | DICOM 3.0 compliant MR data. | DICOM 3.0 compliant MR data from CT/ MRI
scanners. |
| Does not raise any new concerns with regards to safety and effectiveness. MRI is a non-ionising radiation imaging
modality. | | |
| Performance | Validated with digital synthetic
phantoms/raw data, phantom scans, and in-
vivo (healthy volunteer and patients with
suspected hepatobiliary disease) scans. | Experimental results on simulated images
containing structures of interest. Phantom
data. Retrospective in-vivo data. |
| MRCP+v1 underwent substantive validation. Does not raise any new concerns with regards to safety and
effectiveness. | | |
| Supported Systems | Validated across all supported MR
manufacturers. | Supported MR/CT systems. |
| Does not raise any new concerns with regards to safety and effectiveness. | | |
| Standards | IEC 62304, IEC 62366-1, DICOM 3.0, ISO
14971, ISO 13485 | DICOM |
| Does not raise any new concerns with regards to safety and effectiveness. | | |
| System/Operating
System | Apple/Mac OS | Standard PC hardware |
| Does not raise any new concerns with regards to safety and effectiveness. | | |
6
RA317
7
RA317
Image /page/7/Picture/2 description: The image is a logo for Perspectum Diagnostics. The word "Perspectum" is in bold, dark gray letters, and the word "Diagnostics" is in light gray letters underneath. To the right of the words is a colorful circular logo with four different colors on the top half and two shades of pink on the bottom half.
8
Image /page/8/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font. Below it, the word "Diagnostics" is written in a lighter gray font. To the right of the text is a circular logo with four colored sections: blue, yellow, green, and pink.
The major differences between the predicate and subject devices are listed, along with a justification statement as to why the differences do not impact safety and effectiveness.
9
RA317
Image /page/9/Picture/2 description: The image contains the logo for Perspectum Diagnostics. The word "Perspectum" is in bold, dark gray font, and the word "Diagnostics" is in a lighter gray font underneath. To the right of the text is a circular logo with four colored sections on top (blue, yellow, green) and a pink section on the bottom. The logo is clean and modern.
Discussion
A comparison between the subject and predicate devices is summarised above.
The subject device is substantially equivalent to the predicate device, both regulated under regulation 21 CFR 892.2050. Substantial equivalence is based on the following observations:
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Image /page/10/Picture/1 description: The image shows the Perspectum Diagnostics logo. The logo consists of the word "Perspectum" in bold, dark gray letters, with the word "Diagnostics" in a lighter gray font underneath. To the right of the text is a circular graphic with four colored sections on top (blue, yellow, green, and white) and a pink section on the bottom. The graphic also has a trademark symbol in the upper right corner.
- The indications for use and intended uses of both the subject device and predicate device are, for the . purpose of substantial equivalence determination, equivalent.
- . The subject and predicate devices include software applications which utilise MR data to visualise and enable quantification of physiological characteristics in the abdomen.
- The subject and predicate devices are both standalone software applications to facilitate the import and . visualization of MR data sets.
- . Both the subject and predicate devices are designed to run on general-purpose computing hardware.
- . Both the subject device and the predicate device include tools to facilitate the import and visualization of data sets and include tools to enable the manipulation of the views and to enable the quantification and analysis of segmented structures.
- Both the subject device and the predicate device include tools for interactive segmentation and labelling of . abdominal structures and allow for regional volumetric analysis of segmented abdominal structures.
- Performance testing demonstrates that the subject device performs at least as safely and effectively as the . proposed predicate.
In conclusion, the subject device does not present any new potential safety risk when compared to the chosen predicate device and performs in accordance with its use characteristics and intended use.
6. Performance Testing
MRCP+v1 underwent full performance testing under controlled conditions to corroborate that it is safe and effective to use. The performance testing conducted demonstrates that MRCP+v1 is at least as safe and effective as the predicate device and does not introduce any new risks.
6.1. Performance Testing — Bench
Validated MR Systems
MRCP+v1 underwent bench performance testing on the following MR Systems:
| Manufacturer | Model | Field Strength |
|---|---|---|
| Siemens | MAGNETOM Prisma | 3T |
| Siemens | MAGNETOM Avantofit | 1.5T |
| GE | Discovery MR750 | 3T |
| GE | Optima MR450w | 1.5T |
| Philips | Achieva | 3T |
| Philips | Achieva | 1.5T |
Algorithmic Accuracy
The accuracy of the MRCP+v1 algorithm was assessed against the duct file specification of the physically printed phantoms, a dataset of digital synthetic data. The results of which are summarized below:
| Algorithmic Accuracy – Digital Synthetic Data | ||
|---|---|---|
| 95% CI Upper Limit of Agreement | 95% CI Lower Limit of Agreement | |
| Clinical Phantom | 0.9mm | -0.9mm |
| Tube Width Phantom | 1.3mm | -0.6mm |
11
Image /page/11/Picture/1 description: The image contains the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, sans-serif font, with the word "Diagnostics" in a smaller, lighter font underneath. To the right of the text is a circular logo with four colored sections: yellow, green, blue, and pink. The pink section is a semi-circle, while the other three colors are quarter-circles.
It can be said that the algorithmic accuracy of MRCP+v1 when used to quantify tubular structures from acquired MRCP data is high when not presented with the variability introduced by phantom or in-vivo scanning.
Device Accuracy
The accuracy of the MRCP+v1 device was assessed using two different phantoms. The results over both are summarized below:
| Algorithmic Accuracy - Physical Phantoms | ||
|---|---|---|
| 95% Cl Upper Limit of Agreement | 95% Cl Lower Limit of Agreement | |
| Clinical Phantom | 1.0 mm | -1.1mm |
| Tube Width Phantom | 0.7mm | -0.9mm |
Two different types of phantom, a clinical and tubewidth, were used in the bench performance testing. It can be seen that the variability introduced due to the acquisition of phantom data is limited and MRCP+v1 is highly accurate when quantifying tubular structures.
Precision
Precision of the MRCP+v1 device was assessed using two different phantoms. The results over both are summarized below:
| Repeatability | Reproducibility | |||
|---|---|---|---|---|
| Phantom Type | Upper Limit of | |||
| Agreement (mm) | Lower Limit of | |||
| Agreement (mm) | Upper Limit of | |||
| Agreement (mm) | Lower Limit of | |||
| Agreement (mm) | ||||
| Clinical Phantom | 0.4 | -0.4 | 0.5 | -1.1 |
| Tube Width Phantom | 0.3 | -0.3 | 0.7 | -0.8 |
As demonstrated in the table above, the variation introduced by repeated acquisitions and different scanners does not significantly affect the performance of MRCP+v1. It can be stated that MRCP+v1 is highly repeatable and reproducible.
Performance Testing — In-vivo 6.2.
Validated MR Systems
MRCP+v1 underwent in-vivo performance testing on the following MR Systems:
| Manufacturer | Model | Field Strength |
|---|---|---|
| Siemens | MAGNETOM Prisma | 3T |
| Siemens | MAGNETOM Avantofit | 1.5T |
| GE | Discovery MR750 | 3T |
| GE | Optima MR450w | 1.5T |
Precision
The precision of MRCP+v1 was assessed using in-vivo data acquired from volunteers. The results of which are summarized below and demonstrate that across the metrics reported, MRCP+v1 is highly repeatable and reproducible across field strengths and manufacturers when quantifying hepatobiliary structures from in-vivo acquired datasets.
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Image /page/12/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, sans-serif font in black. Below it, the word "Diagnostics" is written in a smaller, gray font. To the right of the text is a circular logo with four colored sections on top (blue, yellow, green, and white) and two pink semi-circles on the bottom.
| Repeatability | ||
|---|---|---|
| Measure | 95% CI Upper Limit of | |
| Agreement | 95% CI Lower Limit of | |
| Agreement | ||
| Tree Volume (ml) | 3.4 | -3.5 |
| Gallbladder Volume (ml) | 4.4 | -9.4 |
| 3-5mm (%) | 17.7 | -19.2 |
| 5-7mm (%) | 8.5 | -8.0 |
| Greater than 7mm (%) | 1.6 | -1.8 |
| Less than 3mm (%) | 20.2 | -19.2 |
| Repeatability | |||
|---|---|---|---|
| Measure | 95% Cl Upper Limit of | ||
| Agreement | 95% Cl Lower Limit of | ||
| Agreement | |||
| Duct Median (mm) | 1.7 | -2.0 | |
| Duct Minimum (mm) | 1.9 | -2.2 | |
| Duct Maximum (mm) | 3.2 | -2.9 | |
| Duct IQR (mm) | 1.8 | -1.7 |
| Reproducibility | ||
|---|---|---|
| Measure | 95% CI Upper Limit of | |
| Agreement | 95% CI Lower Limit of | |
| Agreement | ||
| Tree Volume (ml) | 4.7 | -6.9 |
| Gallbladder Volume (ml) | 13.8 | -18.4 |
| 3-5mm (%) | 27.8 | -15.8 |
| 5-7mm (%) | 10.8 | -11.8 |
| Greater than 7mm (%) | 2.6 | -3.1 |
| Less than 3mm (%) | 30.8 | -23.4 |
| Reproducibility | ||
|---|---|---|
| Measure | 95% CI Upper Limit of | |
| Agreement | 95% CI Lower Limit of | |
| Agreement | ||
| Duct Median (mm) | 2.6 | -2.8 |
| Duct Minimum (mm) | 2.6 | -2.8 |
| Duct Maximum (mm) | 4.0 | -3.5 |
| Duct IQR (mm) | 1.9 | -2.3 |
Intra- and Inter- Operator
As demonstrated below the variation introduced by operator analysis is well within the prescribed acceptance criteria set for performance testing with only a slightly larger variation introduced by having two readers read the same study compared to the same reader performing a second analysis blinded.
13
Image /page/13/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font, while the word "Diagnostics" is written in a lighter gray font and is placed below and slightly to the right of "Perspectum". To the right of the text is a circular logo with four colored sections: blue, yellow, green, and pink. The top half of the circle is divided into three sections, while the bottom half is a single pink section.
RA317
| Intra-Operator | Inter-Operator | |||
|---|---|---|---|---|
| Measure | 95% Cl Upper Limit of | |||
| Agreement | 95% Cl Lower Limit of | |||
| Agreement | 95% Cl Upper Limit | |||
| of Agreement | 95% Cl Lower Limit of | |||
| Agreement | ||||
| Tree Volume (ml) | 0.9 | -0.6 | 3.6 | -6.8 |
| Gallbladder Volume | 0.0 | 0.0 | 0.6 | -0.7 |
| 3-5mm (%) | 7.4 | -7.7 | 16.8 | -11.1 |
| 5-7mm (%) | 5.0 | -5.1 | 6.3 | -6.3 |
| Greater than 7mm | 3.9 | -4.7 | 1.4 | -1.7 |
| Less than 3mm (%) | 11.7 | -10.7 | 12.3 | -17.4 |
| Duct Median (mm) | 0.4 | -0.4 | 1.1 | -1.8 |
| Duct Minimum (mm) | 0:5 | -0.4 | 1.0 | -1.3 |
| Duct Maximum (mm) | 2.0 | -1.6 | 2.0 | -3.2 |
| Duct IQR (mm) | 0.5 | -0.4 | 1.6 | -1.9 |
7. Conclusion
In summary, Perspectum Diagnostics conclude and are satisfied that MRCP+v1 is:
- MRCP+v1 is substantially equivalent to IQQA-Liver .
- MRCP+v1 does not raise any new concerns with regards to safety and efficacy .
- The differences between MRCP+v1 and IQQA-Liver do not impact safety and effectiveness ●
- The intended use/indications for use of the subject device are substantially equivalent .
- . The technological characteristics of the subject device are substantially equivalent