(153 days)
Not Found
No
The description explicitly states that analysis is performed using "standardized algorithms and user input" and mentions "validated and reproducible quantification methods," which are characteristic of traditional image processing and analysis techniques, not AI/ML. There is no mention of AI, ML, deep learning, or any related concepts.
No.
The device is a software that analyzes medical images to support clinical decision-making and is explicitly stated as "not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient," which disqualifies it as a therapeutic device.
Yes
The device is described as software that displays and analyzes medical images to support clinical decision-making by qualified healthcare professionals for cardiac function, indicating its role in diagnosis.
Yes
The device is explicitly described as "a software" that displays and analyzes medical images. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Segment CMR analyzes medical images (specifically MR images) of the cardiovascular system. It does not analyze blood, tissue, or other biological samples.
- The purpose of an IVD is to provide information about a physiological or pathological state. While Segment CMR provides data to support clinical decision-making regarding cardiac function and blood flow, it does so by analyzing images, not by directly testing biological specimens.
The device is a software tool for analyzing medical images, which falls under the category of medical image analysis software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system and across PACS system. The data produced by Segment CMR is intended to support qualified cardiologist, radiologist or other licensed professional healthcare for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Product codes
LLZ
Device Description
Segment CMR is a software that displays and analyzes multi-slice, multiphase and velocity encoded DICOM compatible medical MR images. Segment CMR provides quantitative measures for analysis of function of the cardiovascular system. The data produced by Segment CMR is intended to be used to support qualified cardiologist, radiologist or other professional healthcare practitioners for clinical decision making. Functional, flow, valve, vessel, and tissue analysis is performed using standardized algorithms and user input. The quantification methods are validated and reproducible. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population.
MR images may be imported from various sources including images stored on portable media, network storage devices, and other vendor systems and supports cardiovascular MR images from all of the major MRI scanner vendors.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images (Magnetic Resonance)
Anatomical Site
Cardiovascular system
Indicated Patient Age Range
pediatric (from newborn) and adult population
Intended User / Care Setting
qualified cardiologist, radiologist or other licensed professional healthcare
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documented according to FDA's Guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". It was concluded that Segment CMR was considered as "moderate" level of concern. Extensive testing of the software package is performed by an automated test suite prior to commercial release, exactly like the predicate device Segment. As a complement to this, manual testing is performed by programmers and the program is evaluated by two beta test sites. In addition, the predicate device Segment, on which Segment CMR is built upon, is used by more than 200 research groups.
Bench, Animal and Clinical Studies:
Each of the features for Segment CMR has been clinically evaluated by using both bench, animal and clinical studies. The studies are validation or application studies using establish methods as reference standard. Since the subject device is no treatment device there is no randomized control in the studies. The studies were performed in US or in Europe. Since the subject device is not intended to be used for treatment, the identification of primary safety endpoint and primary effectiveness endpoint are not applicable. The results by the studies show that the values from the evaluated features in Segment CMR were in good agreement with values from the reference method. No adverse advents or complications associated with the subject device were observed in the studies. Based on the clinical performance as documented in the performance studies, Segment CMR was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K090833, K073194, K111833, K100352
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
Medviso AB % Einar Heiberg, Ph.D. Founder, Vice President, CTO Griffelvägen 3 Lund SE-224 67 SWEDEN
Re: K163076 Trade/Device Name: Segment CMR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 3, 2016 Received: March 14, 2017
Dear Dr. Heiberg:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163076
Device Name Segment CMR
Indications for Use (Describe)
Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system and across PACS system. The data produced by Segment CMR is intended to support qualified cardiologist, radiologist or other licensed professional healthcare for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq 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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510 (k) Summary 5
5.1 Submitter
Medviso AB Griffelvägen 3 SE-224 67 Lund, Sweden +46-76-1836442
Date Prepared: October 1, 2016
Contact Person: Einar Heiberg, PhD, Founder, CTO, +46-76-1836442, einar@medviso.com
5.2 Device
Device Trade Name: Segment CMR
Device Common Name: Cardiovascular MRI analysis software
Classification Name: Class II - System, Image Processing
Regulation Number: 892.2050
Product Code: LLZ
5.3 Predicate Device
- . Segment (K090833) Medviso AB Griffelvägen 3 224 67 Lund Sweden
- CMRtools and plugins Ventricular tools and Thalassemia tools ● (K073194) Cardiovascular Imaging Solutions Ltd 53 Cavendish Road London SW12 0BL UK
- Virtue including module HARP (K111833, K100352) ● Myocardial solutions 1204 Village Market Pl 290 Morrisville, NC 27560 USA
MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com
Image /page/3/Picture/18 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small, light blue squares that form an oval shape. The squares are more concentrated near the word and become more sparse as they move away from it.
Page 5-1 of 5
4
Device Description 5.4
Device Description
Segment CMR is a software that displays and analyzes multi-slice, multiphase and velocity encoded DICOM compatible medical MR images. Segment CMR provides quantitative measures for analysis of function of the cardiovascular system. The data produced by Segment CMR is intended to be used to support qualified cardiologist, radiologist or other professional healthcare practitioners for clinical decision making. Functional, flow, valve, vessel, and tissue analysis is performed using standardized algorithms and user input. The quantification methods are validated and reproducible. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population.
MR images may be imported from various sources including images stored on portable media, network storage devices, and other vendor systems and supports cardiovascular MR images from all of the major MRI scanner vendors.
ર.5 Intended Use
Indications for Use
Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system and across PACS system. The data produced by Segment CMR is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com
Image /page/4/Picture/10 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small squares, also in light blue, that create a curved shape above and below the text. The squares appear to be fading or dissolving away from the center towards the edges of the curved shape.
Page 5-2 of 5
5
Application Specification
The medical purpose for Segment CMR is to analyze Cardiac Magnetic Resonance (CMR) images. Conditions or disease to be diagnosed by CMR imaging are heart diseases such as myocardial infarction, cardiac failure, cardiomyopathy and valvular disease.
Patient Population
Segment CMR is intended for use in both pediatric population (from newborn to adolescent) and adult population.
Comparison to Predicate Device
Both Segment CMR and the predicate devices are support tools which provide the clinician with relevant clinical data to support diagnoses by analyzing CMR images. All analysis features provided by Segment CMR are also provided by one or more of the predicate device. The difference in the indications for use is the extension of the patient population to also include pediatric population for the ventricular analysis. According to validation in scientific publications and the risk management analysis for Segment CMR, the inclusion of pediatric population does not affect the safety and effectiveness of the device.
5.6 Technological Characteristics
Seqment CMR and the predicate device are both software packages that can be used for the analysis of multi-slice, multi-frame and phase encoded DICOM-compliant MR image data sets. None of the devices comes into direct contact with the patient.
The proposed and predicate devices provide a user interface with items for selecting images and adjusting image viewing. They perform data analysis by using standardized algorithms and user inputs to delineate the myocardial and vascular walls from surrounding tissue and blood (wall contours). The proposed and predicate devices render wall contours either fully automatically, semi-automatically, manually or in combination providing clinically relevant data. The technological differences between Segment CMR and the predicated devices are that different algorithms in use for the automatic seqmentation approaches and relaxometry measurements. The proposed and predicate devices can be operated from a personal computer. Segment CMR has substantially equivalent features and specifications to the predicate devices.
MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com
Image /page/5/Picture/12 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small, light blue squares that appear to be fading in and out. The squares are more concentrated near the word and become more sparse as they move away from it.
Page 5-3 of 5
6
5.7 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documented according ty FDA's Guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". It was concluded that Segment CMR was considered as "moderate" level of concern. Extensive testing of the software package is performed by an automated test suite prior to commercial release, exactly like the predicate device Segment. As a complement to this, manual testing is performed by programmers and the program is evaluated by two beta test sites. In addition, the predicate device Segment, on which Segment CMR is built upon, is used by more than 200 research groups.
Bench, Animal and Clinical Studies
Each of the features for Segment CMR has been clinically evaluated by using both bench, animal and clinical studies. The studies are validation or application studies using establish methods as reference standard. Since the subject device is no treatment device there is no randomized control in the studies. The studies were performed in US or in Europe. Since the subject device is not intended to be used for treatment, the identification of primary safety endpoint and primary effectiveness endpoint are not applicable. The results by the studies show that the values from the evaluated features in Segment CMR were in good agreement with values from the reference method. No adverse advents or complications associated with the subject device were observed in the studies. Based on the clinical performance as documented in the performance studies, Segment CMR was found to have a safety and effectiveness profile that is similar to the predicate device.
MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com
Image /page/6/Picture/9 description: The image shows the word "MEDVISO" in a light teal color. The word is surrounded by a pattern of small teal squares that form an oval shape around the word. The squares are more concentrated near the center of the oval and become more sparse towards the edges.
Page 5-4 of 5
7
5.8 Conclusion
We conclude that the subject device Segment CMR is as safe and effective as the predicate devices. All identified hazards for Segment CMR have been mitigated to accepted levels of the residual risk and the overall risk residual evaluation concluded that the risk of Segment CMR is acceptable. The risks associated with the use of Segment CMR are acceptable when weighted against the benefits of the patient. The extension of pediatric use for the left ventricular analysis did not, according to the hazard analysis, increase the overall residual risk and by evaluating safety and effectiveness, the benefits with pediatric use can be considered to outweigh the risks. Segment CMR performs in accordance with its intended use as well as the cardiovascular MRI image analysis products currently on the market. Identical to the predicate devices, Segment CMR does not in any way alter the MRI imaging data in the analytical process. Segment CMR provides assistance to a professionally trained physician and all of the information is subject to his/her oversight and control. Medviso AB considers the features of Segment CMR to be substantially equivalent to the subset of features in common with the predicate devices Segment. CMRtools and Virtue including module HARP.
MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com
Image /page/7/Picture/5 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small, light blue squares that form a curved shape above and below the word. The squares are arranged in a way that creates a sense of movement or flow around the word. The background of the image is white.
Page 5-5 of 5