Who is the manufacturer of Myomics Q?

Phantomics, Inc. filed the 510(k) submission for Myomics Q (K211432).

What is the FDA product code for Myomics Q?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Myomics Q?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Myomics Q?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Myomics Q

K211432 · Phantomics, Inc. · LLZ · Nov 23, 2021 · Radiology

Device Facts

Record ID	K211432
Device Name	Myomics Q
Applicant	Phantomics, Inc.
Product Code	LLZ · Radiology
Decision Date	Nov 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Myomics Q is intended to be used for viewing, post-processing and analysis of cardiac magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables: - Importing cardiac MR images in DICOM format. - Supporting clinical diagnostics by analysis of cardiac MR images using display functionality such as panning, windowing, zooming through series/slices of the images. - Supporting clinical diagnostics analysis of the heart in cardiac MR images and signal intensity. - Software package is designed to support the physician compliance assessment, document and follow up heart disease by cardiac MRI. It shall be used by qualified medical professionals, experienced in examining cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. This device is a software application that can be used as a stand-alone product or in a network environment.

Device Story

Myomics Q is a software application for qualitative and quantitative analysis of cardiac MR images. It imports DICOM-formatted cardiac MR images; provides tools for viewing (panning, windowing, zooming) and manual contouring (endocardium/epicardium) for T1, T2, and Late Gadolinium Enhancement (LGE) analysis. Operated by qualified medical professionals in hospital or private practice settings, the device functions as a stand-alone or networked application. Users perform manual contouring to generate polar map reports for T1 and T2 analysis. The output assists physicians in assessing cardiac function and heart disease. By providing standardized visualization and quantitative measurement tools, the device supports clinical decision-making and patient follow-up.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated by comparing Myomics Q against reference device cvi42. Testing included verification of DICOM import/export, patient data display, and contouring tools. Quantitative analysis of Native T1, Post T1, and T2 polar maps showed results within ±5% of cvi42, attributed to user-dependent contouring variability. Software validation followed IEC 62304 and FDA cybersecurity guidance.

Technological Characteristics

Software-only medical device (SaMD). Operates on Windows OS. Supports DICOM standard for image input/output. Features include manual contouring tools (endocardium, epicardium, move, pinch, nudge, freehand), windowing, panning, and zooming. Connectivity via network or stand-alone. No hardware components. Software validation conducted per IEC 62304:2006+A1:2015.

Indications for Use

Indicated for viewing, post-processing, and analysis of cardiac MR images in DICOM format. Intended for use by qualified medical professionals experienced in cardiovascular MR image evaluation to support clinical diagnostics, compliance assessment, documentation, and follow-up of heart disease. No specific age or gender restrictions; use may be limited by cardiac MR scanner acquisition capabilities.

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

cmr42 (K082628)

Reference Devices

cvi42 (K141480)

Related Devices

K163076 — Segment CMR · Medviso AB · Apr 5, 2017
K241922 — Myomics · Phantomics, Inc. · Feb 28, 2025
K130228 — SUITEHEART · Neosoft, LLC · Mar 20, 2013
K232007 — CAAS MR Solutions · Pie Medical Imaging BV · Feb 1, 2024
K082628 — CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 · Circle Cardiovascular Imaging, Inc. · Nov 20, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue. Phantomics Inc. % Milly Milly Regulatory Affairs Consultant KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 REPUBLIC OF KOREA Re: K211432 Trade/Device Name: Myomics Q Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 13, 2021 Received: October 4, 2021 Dear Milly Milly: 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211432 Device Name Mynomics Q Myomics O is intended to be used for viewing, post-processing and analysis of cardiac magnetic resonance (MR) images in a Digital Imaging and Communications in Medi-cine (DICOM) Standard format. It enables: - Importing cardiac MR images in DICOM format. - Supporting clinical diagnostics by analysis of cardiac MR images using display functionality such as panning, windowing, zooming through series/slices of the images. * - Supporting clinical diagnostics analysis of the heart in cardiac MR images and signal intensity. - Software package is designed to support the physician compliance assessment, document and follow up heart disease by cardiac MRI. It shall be used by qualified medical professionals, experienced in examining cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. This device is a soft-ware application that can be used as a stand-alone product or in a network environment. The target population for the device is not restricted, however the image acquisition by a cardiac MR scanner may limit the use of the device for certain sectors or the public. 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Phantomics. The logo consists of a stylized head with a closed eye above the word "PHANTOMICS" in blue, sans-serif font. The logo is simple and modern. # 510(k) SUMMARY This summary of 510(k) for K211432 –safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: Sept 13, 2021 ### 1. INFORMATION 1.1 Submitter Information - = Submitter Name: Phantomics Inc. - 트 Address - : B-1224, 247, Gonghang-daero, Gangseo-gu, Seoul, 07803, Republic of Korea - . ■ Telephone Number: +82-2-6347-2019 Fax: +82-504-329-2510 ### 1.2 Contact Person ■ - . Name: Milly (Consultant / KMC, Inc.) - Address: Rm. No. 1709, 123, Digital-ro 26-gil, Guro-gu, 08390, Republic of Korea - Telephone Number: +82-70-8965-5554 " Fax: +82-2-2672-0579 - . E-mail: milly@kmcerti.com ### 2. DEVICE INFORMATION - 2.1 Trade Name / Proprietary Name: Myomics Q - 2.2 Common Name: Image Processing System - 2.3 Classification Name: Medical Image Management and Processing System - 2.4 Product Code: LLZ - 2.5 Classification Regulation: 21CFR 892.2050 - 2.6 Device Class: 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) - 2.7 Classification Panel: Radiology {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Phantomics. The logo consists of a circular icon with a stylized figure inside, above the word "PHANTOMICS" in a sans-serif font. The color of the logo is a light blue. ### 3. PREDICATE DEVICE | Item | Predicate Device | Reference Device | |--------------------------|------------------------------------|------------------------------------| | Manufacturer | Circle Cardiovascular Imaging Inc. | Circle Cardiovascular Imaging Inc. | | Device Name (Trade Name) | cmr42 | cvi42 | | 510(k) Number | K082628 | K141480 | ### 4. SUBJECT DEVICE DESCRIPTION Myomics Q is software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. This device has a graphical user interface which allows users to analyze cardiac MR Images qualitatively and quantitatively. ### 5. INDICATIONS FOR USE Myomics Q is intended to be used for viewing, post-processing and analysis of cardiac magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables: - Importing cardiac MR images in DICOM format. . - . Supporting clinical diagnostics by analysis of cardiac MR images using display functionality such as panning, windowing, zooming through series/slices of the images. * - Supporting clinical diagnostics analysis of the heart in cardiac MR images and signal . intensity. - Software package is designed to support the physician compliance assessment, . document and follow up heart disease by cardiac MRI. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. This device is a software application that can be used as a stand-alone product or in a network environment. The target population for the device is not restricted, however the image acquisition by a cardiac MR scanner may limit the use of the device for certain sectors or the public. {5}------------------------------------------------ # SUBSTANTIAL EQUIVALENCI ್ರೆ | | Subject Device | Primary Device | Reference Device | Equivalence Result | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Manufacturer | Phantomics Inc. | Circle Cardiovascular Imaging Inc. | Circle Cardiovascular Imaging Inc. | | | Device Name | Myomics Q | cmr42 | cvi42 | Unique Information | | 510(k) Number | K211432 | K082628 | K141480 | | | Regulation Number | 21CFR892.2050 | 21CFR892.2050 | 21CFR892.2050 | ☑ Same ☐ Similar ☐ Different | | Regulation Name | Medical Image Management and Processing System | Medical Image Management and Processing System | Medical Image Management and Processing System | ☑ Same ☐ Similar ☐ Different | | Classification | Class II | Class II | Class II | ☑ Same ☐ Similar ☐ Different | | Product Code | LLZ | LLZ | LLZ | ☑ Same ☐ Similar ☐ Different | | Indication for use | Myomics Q is intended to be used for viewing, post-processing and analysis of cardiac magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables: • Importing cardiac MR images in DICOM format. | cmr 42 is intended to be used for viewing, post-processing and analysis of cardiac magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables; | Cvi42 vascular analysis add-on is an image analysis software package add- on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) | ☑ Same ☐ Similar ☐ Different | {6}------------------------------------------------ | • Supporting clinical diagnostics by analysis of cardiac MR images using display functionality such as panning, windowing, zooming through series/slices of the images.* | • Importing Cardiac MR Images in DICOM format | thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood | | | | | | OS (Operating System) | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------|----------------|----------------------------|----------------------------|------------------------------| | • Supporting clinical diagnostics analysis of the heart in cardiac MR images and signal intensity. | • Supporting clinical diagnostics by qualitative analysis of the cardiac MR images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases. | vessels and evaluation, documentation and follow up of any such lesions. | | information as part of a comprehensive diagnostic decision-making process. This device is a software application that can be used as a stand-alone product or in a network environment. The target population for the device is not restricted, however the image acquisition by a cardiac MR scanner may limit the use of the device for certain sectors or the public. | professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cmr 42 is a software application that can be used as a standalone product or in a networked environment. The target population for the cmr42 is not restricted, however the image acquisition by a cardiac magnetic resonance scanner may limit the use of the device for certain sectors of the general public. | be used as a stand-alone product or in a networked environment. The target population for the cvi42 is not restricted. | | | Window | Mac OS, Microsoft, Windows | Mac OS, Microsoft, Windows | | | • Software package is designed to support the physician-to-physician compliance assessment, document and follow up heart disease by cardiac MRI. | • Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR images, specifically distance, area, volume and mass | It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. | | | cmr 42 shall not be used to view or analyze images of any part of the body except the cardiac magnetic resonance images acquired from a cardiovascular magnetic resonance scanner. | | | DICOM Compliant networking | Yes | Yes | Yes | Same Similar Different | | It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic | • Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR images | cvi42 is a software application that can | image from all MRI | Yes | Yes | Yes | Same Similar Different | Display of Images | Study & Series | Study & Series | Study & Series | Same Similar Different | | | • Flow quantifications based on velocity encodes images | It shall be used by qualified medical | Store images | File Format: dcm, json, csv, nii | File Format: PDF, XML | File Format: PDF, XML | Same Similar Different | | | | | | | Quantities assessment of cardiac function | Yes (Myocardiac) | Yes (Myocardiac and Blood Flow) | Yes (Myocardiac and Blood Flow) | Same Similar Different | | | | | | | | | | Corresponding Tool | Yes (Contour) | Yes (Contour) | Yes (Contour) | Same Similar Different | | | | | | | | | | Reports containing visualization of images and quantitative parameters | T1, T2 T1 & T2 Mapping Late Gd Enhancement (LGE) | T1, T2 T1 & T2 Mapping Late Gd Enhancement (LGE) Perfusion Flow Analysis | T1, T2 T1 & T2 Mapping Late Gd Enhancement (LGE) Perfusion Flow Analysis | Same Similar Different | | | | | | | | | Page 4 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ page 4 {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for "PHANTOMICS". The logo features a stylized head with closed eyes above the word "PHANTOMICS" in blue, sans-serif font. The head is drawn with simple lines, giving it a minimalist and modern appearance. | Same Items | Description | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation Number | The proposed regulation number is “21CFR892.2050”. The Regulation is related to the Medical Image Management and Processing System. It is the same point between the subject device (Myomics Q) and the predicate device (cmr42) including the reference device (cvi42). | | Regulation Name | The proposed regulation name is Medical Image Management and Processing System in accordance with 21CFR892.2050. The subject device and predicate device are an image analysis software for evaluating cardiac MR images. It is the same point between the subject device (Myomics Q) and the predicate device (cmr42) including the reference device (cvi42). | | Classification | In accordance with same regulation number (21CFR892.2050), FDA provide the regulatory classification. It is Class II and same point between the subject device (Myomics Q) and the predicate device (cmr42) including the reference device (cvi42). | | Product Code | The proposed product code of the subject device is “LLZ”. It is the same product code with the predicate device (cmr42) including the reference device (cvi42). | | Image from all MRI | All devices are derived and saved to MR DICOM Image file only. It is same point | | DICOM Compliant networking | All devices are derived and saved to MR DICOM Image file only. It is same point. | | Display of Images | All devices make to display clinical study and series related to cardiac MR DICOM Image. It is same point | | Corresponding Tool | All devices control the contour tool for post-processing. It is same point. | 1) Same points between the subject device and the predicate device 2) Similar points between the subject device and the predicate device | Same Items | Description | |------------|-------------| |------------|-------------| {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for "PHANTOMICS". The logo consists of a stylized graphic above the word "PHANTOMICS" in all capital letters. The graphic appears to be a stylized representation of a face or head, possibly suggesting a futuristic or technological theme. The text is in a sans-serif font and a blue color. | Indication for use | Although specific indication for use is similar between the | |--------------------|-------------------------------------------------------------| | | subject device and the predicate device including the | | | reference device, all devices (subject device, predicate | | | device and reference device) are intended to be used for | | | viewing, post-processing and analysis of cardiac magnetic | | | resonance (MR) images in a Digital Imaging and | | | Communications in Medicine (DICOM) Standard format. It | | | is same point. | # 3) Different points between the subject device and the predicate device | Same Items | Description | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | OS (Operating System) | The subject device is available with window O.S. However, predicated device and reference device are available with Mac OS, Microsoft including Window O.S. Although the OS (Operating System) is different between subject device and predicate device including reference device, Window O.S. is common O.S. under both devices. In addition, Software Validation of the subject device by utilizing Window O.S. had been conducted. Thus, this different point is not effected to safety and effectiveness of the subject device. | | Store images | The subject device is intended to save the image file as the following file format name; dcm, json, csv, nii However, predicated device is intended to save the image file as following file format name; PDF, DML Although the file format name is different between subject device and predicate device including reference device, Software Validation of the subject device by utilizing the file format such as dcm, json, csb, nii, had been conducted. Thus, this different point is not effected to safety and effectiveness of the subject device. | | Quantities assessment of cardiac function | The subject device is intended to analyze and assess the myocardiac data. However, predicated device and reference device are intended to analyze and assess the blood flow data including myocardiac data. | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for "PHANTOMICS". The logo consists of a stylized graphic above the word "PHANTOMICS", which is written in a sans-serif font. The graphic appears to be a stylized representation of a person or figure. The color of the logo is a light blue. | Although the assessment data are different between subject device and predicate device including reference device, Software Validation for the analysis of the subject device, had been conducted. Thus, this different point is not effected to safety and effectiveness of the subject device. | The subject device is intended to display the report containing T1, T2, T1 & T2 Mapping and LGE Data. However, predicated device and reference device are intended to display the report containing perfusion and flow analysis including T1, T2, T1 & T2 Mapping and LGE Data Although the display parameter is different between subject device and predicate device including reference device, Software Validation for displaying parameter of the subject device, had been conducted. Thus, this different point is not effected to safety and effectiveness of the subject device. | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reports containing visualization of images and quantitative parameters | | {12}------------------------------------------------ # 7. NON-CLINICAL DATA ## 7.1 Safety Test The safety requirement is not required because it is stand-alone software. ### 7.2 Software The following tests were performed to assess effectiveness of software of the device. The test was performed in accordance with following standards. | No. | Test Items | Standards | |-----|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | General requirement for safety – Programmable electrical medical systems (PEMS) | IEC 62304:2006+A1:2015 FDA Guidance (“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”) FDA Guidance (“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”) | ### 7.3 Performance Test The following tests were performed to assess effectiveness of the device to support equivalence between subject device and reference device related to predicate device. The test was performed in accordance with following standards. | Test ID | Test Item | Standard | | |---------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | SPPT001 | Pre-requisite Verification | This test checks whether Test Software (Myomics Q and cvi42) is installed on the appropriate system requirement (OS: window) So, To verify that the pre-requisite is completed for the execution of qualifi-cation | | | SPPT002 | Import cardiac MR Images | To verify that import function is working. | | | SPPT003 | Export cardiac MR Images | To verify that export MR images function is working. | | | SPPT004 | Patient Data | To verify that patient information function is working. | | | SPPT005 | Series Overview | To verify that series overview function is working properly. | | | SPPT006 | Contour Drawing, Image Tools | Endocardium Contour Epicardium Contour Move Pinch Nudge Curved Line Free Hand | To verify that contour drawing functions are working properly. | | | Smoothing Undo Redo Restart Delete Confirm Zooming Panning Windowing | | | | SPPT007 | T1 Analysis | • To verify that T1 analysis function is working properly. * T1 Analysis is just T1 Image or T1 Map, but is not the analysis function of T1 Map automatically. | | | SPPT008 | T2 Analysis | • To verify that T2 analysis function is working properly. * T2 Analysis is just T2 Image or T2 Map, but is not the analysis function of T2 Map automatically. | | | SPPT009 | LGE Analysis | • To verify that LGE analysis function is working properly. * LGE Analysis is just LGE Image, but is not the analysis function of LGE Image automatically. | | | SPPT010 | Quantitative compare of polar map report in Native T1 analysis. | • To verify that the results of Myomics Q are very similar to the results of cvi42 in polar map report in Native T1 analysis. * The quantitative is depending on the user contour accuracy. So, few deviation could be happened until ±5% between both s/w | | | SPPT011 | Quantitative compare of polar map report in Post T1 analysis. | • To verify that the results of Myomics Q are very similar to the results of cvi42 in polar map report in Post T1 analysis. * The quantitative is depending on the user contour accuracy. So, few deviation could be happened until ±5% between both s/w | | | SPPT012 | Quantitative compare of polar map report in T2 analysis. | • To verify that the results of Myomics Q are very similar to the results of cvi42 in polar map report in T2 analysis * The quantitative is depending on the user contour accuracy. So, few deviation could be happened until ±5% between both s/w | | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image contains the word "PHANTOMICS" in a sans-serif font. Above the word is a logo that appears to be a stylized face inside of a circle. The text and logo are in blue. {14}------------------------------------------------ ### 7.4 Discussion According to IEC 62304:2006+A1:2015 including "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", Software Validation applied of cybersecurity risk management is passed to ensure safety and performance for subject device (Myomics O). In addition, under bench test, control group is cvi42 because predicated device (cmr42) is end of production anymore. Although cvi42 is improved production from cmr42, cvi 42 includes same intended used and same function for Cardiac MR Image. So, cvi42 is control group because of reference product. For the bench test between subject device (Myomics Q) and reference device (cvi42), both s/w demonstrate substantial equivalent of O.S. (Reference Test ID: SPPT001), DICOM Image Importing Function (Reference Test ID: SPPT002), DICOM Image Exporting Function (Reference Test ID: SPPT003), display of patient information (Reference Test ID: SPPT004), display of patient data (Cardiac MR Image; Series/Study Image) (Reference Test ID: SPPT005), contour control function (Reference Test ID: SPPT006) as a post-processing, display for T1 Map (Reference Test ID: SPPT007), for T2 Map (Reference Test ID: SPPT008) and for LGE Viewing (Reference Test ID: SPPT009), Especially, both S/W are operated with almost quantitative evaluation Native T1 Map (Reference Test ID: SPPT010), Post T1 Map (Reference Test ID: SPPT011) and T2 Map (Reference Test ID: SPPT012) in the Polar Map. Quantitative evaluation are performed in cvi42 and Myomics Q for the analysis functions of Native T1 Map, Post T1 Map and T2 Map. The results of Myomics O did not show a difference of more than ±5% compared to the results of cvi42 (95% of cvi42 results < Myomics Q Results < 105% of cvi42 results). Its deviation could be happened. The reason that the test result of Myomics Q and the result of cvi42 do not match 100% is because the value of the Polar Map Report may vary slightly depending on how the contour is drawn. It leads the result values are slightly different depending on how the contour is drawn, but the result is almost the same. And, its data is just referenced to check image file, but it is not affected to directly clinical parameter for diagnostic justification of intended user. So, ±5% deviation data between subject device and reference device are not affected to clinical performance to achieve intended use. According to above discussion, we claim the both S/W could be substantial equivalent. {15}------------------------------------------------ # 8. CONCLUSION Under the comparing substantial equivalence between the subject device and the predicate device including reference device, there are the same points such as general information, some technical and material information. Although there is some deviation for comparing point between subject device and predicate device including reference device, the safety and performance test reports are supported to the safety and effectiveness by discussion of software validation and bench test. In this regard, we conclude that the subject device is substantially equivalent to the predicate device.