(200 days)
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.
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.
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.
Here's a breakdown of the acceptance criteria and study details for the Myomics Q device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with specific thresholds for each performance metric. Instead, the performance tests verify the proper functioning of features and quantitative comparisons against a reference device within a certain margin. The implicit acceptance criterion for the quantitative comparisons is that the results should be "very similar" and fall within a ±5% deviation from the reference device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Verification | |
| Proper installation of Myomics Q on appropriate OS (Window) | Passed (SPPT001) |
| Import cardiac MR Images function working properly | Passed (SPPT002) |
| Export cardiac MR Images function working properly | Passed (SPPT003) |
| Patient information function working properly | Passed (SPPT004) |
| Series overview function working properly | Passed (SPPT005) |
| Contour drawing functions (Endocardium, Epicardium, Move, Pinch, Nudge, Curved Line, Free Hand, Smoothing, Undo, Redo, Restart, Delete, Confirm, Zooming, Panning, Windowing) working properly | Passed (SPPT006) |
| T1 analysis function working properly (T1 Image or T1 Map display) | Passed (SPPT007) |
| T2 analysis function working properly (T2 Image or T2 Map display) | Passed (SPPT008) |
| LGE analysis function working properly (LGE Image display) | Passed (SPPT009) |
| Quantitative Comparison (Implicit Acceptance Threshold: ≤ ±5% deviation from cvi42) | |
| Results of Myomics Q are very similar to cvi42 in polar map report in Native T1 analysis | The results of Myomics Q 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). This deviation is attributed to user contour accuracy and is not considered to affect clinical performance. (SPPT010) |
| Results of Myomics Q are very similar to cvi42 in polar map report in Post T1 analysis | The results of Myomics Q 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). This deviation is attributed to user contour accuracy and is not considered to affect clinical performance. (SPPT011) |
| Results of Myomics Q are very similar to cvi42 in polar map report in T2 analysis | The results of Myomics Q 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). This deviation is attributed to user contour accuracy and is not considered to affect clinical performance. (SPPT012) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size (number of cases or images) used for the performance tests (SPPT010, SPPT011, SPPT012). It only refers to "the results" and "data."
- Data Provenance: The document does not provide information on the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish ground truth for the test set. The quantitative performance tests (SPPT010, SPPT011, SPPT012) compare Myomics Q's results against those of the cvi42 software (the reference device/control group), which itself is a cleared product. The discussion indicates that a "user contour accuracy" within the software impacts the results, implying the ground truth for comparison is derived from the cvi42 output based on how contours are drawn.
4. Adjudication Method for the Test Set
- No adjudication method is mentioned or implied, as the comparison is primarily between the subject device (Myomics Q) and a reference software (cvi42). The variability is explicitly linked to "how the contour is drawn," suggesting a single user, or an assumed consistent user, performed the contouring on both systems for comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The study described is a bench test comparing the subject device's performance to a reference software, not comparing human readers with and without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a standalone performance assessment was conducted for Myomics Q. The "Performance Test" section (7.3) and "Discussion" (7.4) describe "bench tests" where Myomics Q's output is compared directly to cvi42's output. The document explicitly states, for quantitative comparison, that "the quantitative is depending on the user contour accuracy," suggesting the user interaction (drawing contours) is part of the process that leads to the final quantitative results being compared. However, the evaluation is of the software's calculation capabilities post-contouring, rather than a human-in-the-loop scenario. The device itself is a "software application" for analysis.
7. Type of Ground Truth Used
- The "ground truth" for the quantitative performance comparisons (SPPT010, SPPT011, SPPT012) appears to be the results obtained from the cvi42 software (the reference device), which served as the control group in the bench tests.
8. The Sample Size for the Training Set
- The document does not provide any information regarding the sample size used for the training set. This is a post-market notification for a new device, and the data provided focuses on validation rather than training details.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.
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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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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
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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)
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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
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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.
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SUBSTANTIAL EQUIVALENCI ್ರೆ
| Subject Device | Primary Device | Reference Device | EquivalenceResult | |
|---|---|---|---|---|
| Manufacturer | Phantomics Inc. | Circle Cardiovascular Imaging Inc. | Circle Cardiovascular Imaging Inc. | |
| Device Name | Myomics Q | cmr42 | cvi42 | UniqueInformation |
| 510(k) Number | K211432 | K082628 | K141480 | |
| Regulation Number | 21CFR892.2050 | 21CFR892.2050 | 21CFR892.2050 | ☑ Same☐ Similar☐ Different |
| Regulation Name | Medical Image Management andProcessing System | Medical Image Management andProcessing System | Medical Image Management andProcessing 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 forviewing, post-processing and analysisof cardiac magnetic resonance (MR)images in a Digital Imaging andCommunications in Medicine(DICOM) Standard format. It enables:• Importing cardiac MRimages in DICOM format. | cmr 42 is intended to be used forviewing, post-processing and analysisof cardiac magnetic resonance (MR)images in a Digital Imaging andCommunications in Medicine(DICOM) Standard format.It enables; | Cvi42 vascular analysis add-on is animage analysis software package add-on for evaluating CT and MR imagesof blood vessels. Combining digitalimage processing and visualizationtools such as multiplanerreconstruction (MPR), thin/thinkmaximum intensity projection (MIP) | ☑ Same☐ Similar☐ Different |
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| • Supporting clinicaldiagnostics by analysis ofcardiac MR images usingdisplay functionality such aspanning, windowing,zooming throughseries/slices of the images.* | • Importing Cardiac MR Images inDICOM format | thin and think, inverted MIP thin andthink, volume rendering technique(VRT), curved planner reformation,processing tools such as bone removal(based on both single energy and dualenergy) table removal and evaluationtools (vessel centerline calculation,lumen calculation, stenosiscalculation) and reporting tools (lesionlocation, lesion characteristics) andkey images), the software package isdesigned to support the physician inconforming the presence or absence ofphysician identified lesion in blood | OS(Operating System) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| • Supporting clinicaldiagnostics analysis of theheart in cardiac MR imagesand signal intensity. | • Supporting clinical diagnostics byqualitative analysis of the cardiacMR images using displayfunctionality such as panning,windowing, zooming, navigationthrough series/slices and phases. | vessels and evaluation, documentationand follow up of any such lesions. | information as part of a comprehensivediagnostic decision-making process.This device is a software applicationthat can be used as a stand-aloneproduct or in a network environment.The target population for the device isnot restricted, however the imageacquisition by a cardiac MR scannermay limit the use of the device forcertain sectors or the public. | professionals, experienced inexamining and evaluatingcardiovascular MR images, for thepurpose of obtaining diagnosticinformation as part of a comprehensivediagnostic decision-making process.cmr 42 is a software application thatcan be used as a standalone product orin a networked environment.The target population for the cmr42 isnot restricted, however the imageacquisition by a cardiac magneticresonance scanner may limit the use ofthe device for certain sectors of thegeneral public. | be used as a stand-alone product or ina networked environment.The target population for the cvi42 isnot restricted. | Window | Mac OS, Microsoft, Windows | Mac OS, Microsoft, Windows | ||||
| • Software package isdesigned to support thephysician-to-physiciancompliance assessment,document and follow upheart disease by cardiacMRI. | • Supporting clinical diagnostics byquantitative measurement of theheart and adjacent vessels incardiac MR images, specificallydistance, area, volume and mass | It shall be used by qualified medicalprofessionals, experienced inexamining and evaluatingcardiovascular CT or MR images, forthe purpose of obtaining diagnosticinformation as part of a comprehensivediagnostic decision-making process. | cmr 42 shall not be used to view oranalyze images of any part of the bodyexcept the cardiac magnetic resonanceimages acquired from a cardiovascularmagnetic resonance scanner. | DICOM Compliantnetworking | Yes | Yes | Yes | SameSimilarDifferent | ||||
| It shall be used by qualified medicalprofessionals, experienced inexamining and evaluatingcardiovascular MR images, for thepurpose of obtaining diagnostic | • Supporting clinical diagnostics byusing area and volumemeasurements for measuring LVfunction and derived parameterscardiac output and cardiac indexin long axis and short axis cardiacMR images | cvi42 is a software application that can | image from all MRI | Yes | Yes | Yes | SameSimilarDifferent | Display of Images | Study & Series | Study & Series | Study & Series | SameSimilarDifferent |
| • Flow quantifications based onvelocity 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 | SameSimilarDifferent | ||||||
| Quantitiesassessment ofcardiac function | Yes(Myocardiac) | Yes(Myocardiac and Blood Flow) | Yes(Myocardiac and Blood Flow) | SameSimilarDifferent | ||||||||
| Corresponding Tool | Yes(Contour) | Yes(Contour) | Yes(Contour) | SameSimilarDifferent | ||||||||
| Reports containingvisualization ofimages andquantitativeparameters | T1, T2T1 & T2 MappingLate Gd Enhancement (LGE) | T1, T2T1 & T2 MappingLate Gd Enhancement (LGE)PerfusionFlow Analysis | T1, T2T1 & T2 MappingLate Gd Enhancement (LGE)PerfusionFlow Analysis | SameSimilarDifferent |
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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”. TheRegulation is related to the Medical Image Management andProcessing System.It is the same point between the subject device (Myomics Q)and the predicate device (cmr42) including the referencedevice (cvi42). |
| Regulation Name | The proposed regulation name is Medical ImageManagement and Processing System in accordance with21CFR892.2050.The subject device and predicate device are an imageanalysis software for evaluating cardiac MR images.It is the same point between the subject device (Myomics Q)and the predicate device (cmr42) including the referencedevice (cvi42). |
| Classification | In accordance with same regulation number(21CFR892.2050), FDA provide the regulatoryclassification. It is Class II and same point between thesubject 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 fileonly. It is same point |
| DICOM Compliantnetworking | All devices are derived and saved to MR DICOM Image fileonly. It is same point. |
| Display of Images | All devices make to display clinical study and series relatedto cardiac MR DICOM Image. It is same point |
| Corresponding Tool | All devices control the contour tool for post-processing. It issame point. |
-
Same points between the subject device and the predicate device
-
Similar points between the subject device and the predicate device
| Same Items | Description |
|---|---|
| ------------ | ------------- |
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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 withMac OS, Microsoft including Window O.S.Although the OS (Operating System) is different betweensubject device and predicate device including referencedevice, Window O.S. is common O.S. under both devices.In addition, Software Validation of the subject device byutilizing Window O.S. had been conducted.Thus, this different point is not effected to safety andeffectiveness of the subject device. |
| Store images | The subject device is intended to save the image file as thefollowing file format name; dcm, json, csv, niiHowever, predicated device is intended to save the imagefile as following file format name; PDF, DMLAlthough the file format name is different between subjectdevice and predicate device including reference device,Software Validation of the subject device by utilizing the fileformat such as dcm, json, csb, nii, had been conducted.Thus, this different point is not effected to safety andeffectiveness of the subject device. |
| Quantities assessment ofcardiac function | The subject device is intended to analyze and assess themyocardiac data. However, predicated device and referencedevice are intended to analyze and assess the blood flow dataincluding myocardiac data. |
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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 subjectdevice 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 andeffectiveness of the subject device. | The subject device is intended to display the reportcontaining T1, T2, T1 & T2 Mapping and LGE Data.However, predicated device and reference device areintended to display the report containing perfusion and flowanalysis including T1, T2, T1 & T2 Mapping and LGE DataAlthough the display parameter is different between subjectdevice and predicate device including reference device,Software Validation for displaying parameter of the subjectdevice, had been conducted.Thus, this different point is not effected to safety andeffectiveness of the subject device. |
|---|---|
| Reports containingvisualization of images andquantitative parameters |
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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 – Programmableelectrical medical systems (PEMS) | IEC 62304:2006+A1:2015 FDA Guidance (“Guidance for theContent of Premarket Submissions forSoftware Contained in MedicalDevices”) FDA Guidance (“Content of PremarketSubmissions for Management ofCybersecurity 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 andcvi42) is installed on the appropriate system requirement(OS: window) So, To verify that the pre-requisite iscompleted 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 workingproperly. | |
| SPPT006 | ContourDrawing,ImageTools | EndocardiumContourEpicardiumContourMovePinchNudgeCurved LineFree Hand | To verify that contour drawing functions are workingproperly. |
| SmoothingUndoRedoRestartDeleteConfirmZoomingPanningWindowing | |||
| 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 polarmap report in Native T1analysis. | • 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 polarmap report in Post T1analysis. | • 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 polarmap 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 |
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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.
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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.
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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.
§ 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).