(200 days)
No
The summary describes standard image viewing and quantitative analysis tools, with no mention of AI, ML, or related concepts. The performance studies focus on comparing quantitative measurements to a predicate device, not on evaluating algorithmic performance metrics typical of AI/ML.
No.
The device is described as a software application for viewing, post-processing, and analysis of cardiac MR images for diagnostic purposes, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "Supporting clinical diagnostics by analysis of cardiac MR images" and "for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process."
Yes
The device description explicitly states "Myomics Q is software application" and "This device is a software application". The intended use also describes it as a "software application". There is no mention of accompanying hardware components.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "supporting clinical diagnostics by analysis of cardiac MR images" and "supporting clinical diagnostics analysis of the heart... and signal intensity." It also mentions supporting "the physician compliance assessment, document and follow up heart disease by cardiac MRI." These phrases clearly indicate a diagnostic purpose.
- Role in Diagnosis: The device is intended to be used by qualified medical professionals "for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process." This directly links the device's function to the diagnostic process.
- Analysis of Biological Samples (Indirectly): While the device doesn't directly analyze a biological sample in the traditional sense (like blood or tissue), it analyzes images derived from the patient's body (cardiac MR images). These images are a representation of the biological state of the heart and are used to make diagnostic decisions about that biological state. Regulatory bodies often consider devices that analyze images for diagnostic purposes as falling under the IVD umbrella, especially when they provide quantitative or qualitative information used in diagnosis.
- Comparison to Predicate/Reference Devices: The predicate and reference devices listed (cmr42 and cvi42) are known to be medical devices used in the diagnostic evaluation of cardiac MR images. This further supports the classification of Myomics Q as a diagnostic device.
While the device is software and doesn't directly interact with a biological sample in a lab setting, its function is to provide information derived from the patient's body (through imaging) that is used by medical professionals to make a diagnosis. This aligns with the definition and scope of In Vitro Diagnostic devices in many regulatory frameworks.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cardiac magnetic resonance (MR) images
Anatomical Site
heart, cardiac, cardiovascular
Indicated Patient Age Range
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.
Intended User / Care Setting
qualified medical professionals, experienced in examining cardiovascular MR images / stand-alone product or in a network environment
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)
Study Type: Non-clinical bench test.
Sample Size: Not specified.
Key Results: The safety requirement is not required because it is stand-alone software. The software was tested for effectiveness according to IEC 62304:2006+A1:2015 and FDA Guidance documents. Performance tests (SPPT001 to SPPT012) were conducted to assess various functions including importing/exporting DICOM images, patient data handling, series overview, contour drawing/image tools, and T1/T2/LGE analysis. Quantitative comparison of polar map reports in Native T1, Post T1, and T2 analysis between Myomics Q and the reference device (cvi42) showed that the results of Myomics Q were very similar, with deviations within ±5%. This deviation is attributed to user contour accuracy and is not considered to affect clinical performance for diagnostic justification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Quantitative compare of polar map report in Native T1 analysis: The results of Myomics Q are very similar to the results of cvi42; few deviation could be happened until ±5% between both s/w.
Quantitative compare of polar map report in Post T1 analysis: The results of Myomics Q are very similar to the results of cvi42; few deviation could be happened until ±5% between both s/w.
Quantitative compare of polar map report in T2 analysis: The results of Myomics Q are very similar to the results of cvi42; few deviation could be happened until ±5% between both s/w.
Predicate Device(s)
Reference Device(s)
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).
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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
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
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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 | 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 | | | | | | | | |
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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”. 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. |
-
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 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. |
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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 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 | |
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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 – 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 | |
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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