(139 days)
Harp 2.06, K100352
Virtue marketed by Diagnosoft, Inc. K111833
No
The description focuses on traditional image processing techniques (SENC processing methods) and quantitative measurements derived from these methods. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The performance studies rely on traditional statistical methods like Limit of Agreement and correlation coefficients, not metrics typically associated with AI/ML model evaluation (e.g., AUC, sensitivity/specificity of a classification model).
No
The device is described as an "image processing device" that provides quantitative measurements and reports for physician interpretation to support diagnosis, but it does not directly treat or alleviate a medical condition.
Yes
The software "performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements," which are then "interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis." This indicates its role in providing information used for diagnostic purposes.
Yes
The device is explicitly described as "software that runs on Windows-based operating systems" and its function is to process and analyze images acquired by a separate hardware device (MRI system). It does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- MyoStrain's function: MyoStrain software processes medical images (MRI) acquired from a patient's heart. It analyzes the motion of the heart muscle based on these images.
- No biological samples: The device does not interact with or analyze any biological samples taken from the patient. Its input is image data.
Therefore, MyoStrain falls under the category of medical image processing software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis.
Product codes
LNH
Device Description
The Myocardial Solutions Myostrain is software that runs on Windows-based operating systems to view and analyze SENC MR images of the heart in DICOM format. MyoStrain quantifies regional and global cardiac function from SENC images by implementing the SENC processing methods. With a friendly graphic user interface, users are able to analyze SENC MR images and obtain fast and reproducible measurements of myocardial strain, ejection fraction, and volumes. Measurements are collected presented on screen as a report showing values as colors and numbers, and this report can be printed or exported in digital format.
Mentions image processing
MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
strain-encoded (SENC) images, which are acquired by MRI systems
Anatomical Site
heart / cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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
Accuracy of MyoStrain measurements determined by the Limit of Agreement (LOA). Sample size N=23 of healthy subjects and patients. LOA for LVEF: (-13,+10), LVEDV: (-40,+35), LVESV: (-19,+21), LVSV: (-36,+29), LVMass: (-19,+30).
Strain calculations accuracy based on tests using a mechanical phantom with known actual strain values. Phantom analysis demonstrated that MyoStrain has the acceptable LOA of (-5,+5).
Correlation coefficients compared to Diagnosoft VIRTUE 5.51 measurements (gold standard cardiac MRI) for LV EF, End-Diastolic Volume (EDV), End-Systolic Volume (ESV), Mass, and Stroke Volume (SV). Targeted correlation coefficients: EF: R=0.79, p
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Myocardial Solutions % Ms. Linda Horne Regulatory Affairs Specialist 3000 RDU Center Drive, Suite 117 MORRISVILLE NC 27560
February 14, 2019
Re: K182756
Trade/Device Name: MyoStrain 5.1 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 15, 2019 Received: January 16, 2019
Dear Ms. Horne:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182756
Device Name
MyoStrain 5.1
Indications for Use (Describe)
MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
Myocardial Solutions MyoStrain® (per 21CFR 807.92)
I. SUBMITTER
Myocardial Solutions Inc. 3000 RDU Center Drive Suite 117 Morrisville, NC 27560
Telephone: 919-459-9102 Fax: 919-882-1815
Contact Person: Linda Horne Date Prepared: September 26, 2018
II. DEVICE
Name of Device: MyoStrain 5.1 Common or Usual Name: MyoStrain Classification Name: Magnetic resonance diagnostic device (21 CFR 892.1000) Regulatory Class: II Product Code: LNH
III. PREDICATE DEVICE
Harp 2.06 marketed by Diagnosoft, Inc., K100352 This predicate has not been subject to a design-related recall
Reference Device Virtue marketed by Diagnosoft, Inc. K111833 This reference device has not been subject to a design related recall
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IV. DEVICE DESCRIPTION
The Myocardial Solutions Myostrain is software that runs on Windows-based operating systems to view and analyze SENC MR images of the heart in DICOM format. MyoStrain quantifies regional and global cardiac function from SENC images by implementing the SENC processing methods. With a friendly graphic user interface, users are able to analyze SENC MR images and obtain fast and reproducible measurements of myocardial strain, ejection fraction, and volumes. Measurements are collected presented on screen as a report showing values as colors and numbers, and this report can be printed or exported in digital format.
V. INDICATIONS FOR USE
MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart. A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis.
The indications for Use statement for MyoStrain is not identical to the predicate device: however, the difference do not alter the intend use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the diagnosis of cardiac issues by analyzing cardiac MRIs.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological principle for the subject and the predicate device is based on the use of the same feature of MR tagging to generate temporary spatial modulation of magnetization in the tissue. These MR tagging deforms with contraction and relaxation of the myocardium and can, therefore, be used to track and quantify the deformation. Both the subject and predicate device measure deformation in the form of cardiac strain computed from the MRI images. At a high level, the subject and predicate devices use the following same technological elements:
- MR Tagging Pulse Sequences: Both uses images acquired by MRI pulse sequences . based on MR Tagging
- Produce measurements of strain, specifically the longitudinal and circumferential strains ●
- Use of a Standalone computer system running Windows 7, 8.1 or 10 ●
The following technological difference exist between the subject and the predicate devices:
- The subject has the MR Tagging planes parallel to the imaging slice, therefore producing ● what is called strain-encoded (SENC) MRI images, while predicate device uses MR Tagging orthogonal to the imaging plane
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- The subject measures the strain in the through-plane direction, while the predicate device measures it in the in-plane directions.
- . The SENC images used in the subject device are acquired in as fast as one heartbeat acquisition, which is much faster than typical MR Tagging acquisition used in the predicate device.
VII. ACCURACY OF MYOSTRAIN MEASUREMENTS
The accuracy of MyoStrain measurements are determined by the Limit of Agreement (LOA). The LOA is the range that covers the 95% of differences between the measurement of the two devices. For example, if MyoStrain measures LVEF of 67%, the LOA of (-13,+10) means that 95% for a large number LVEF values of the same subject measured using the gold standard Cine MRI will lie between 54% and 77%. The LOA depends on many factors, including images quality and inter-operator and inter-observer variabilities. This LOA was originally based on two predicate devices (Diagnosoft HARP for Strain, Diagnosoft VIRTUE for traditional measurements), however these ranges have been reduced to reflect measured accuracy in MyoStrain.
To demonstrate the accuracy of MyoStrain measurements, we calculated the correlation coefficients using Diagnosoft VIRTUE 5.51 measurements of the LV EF, End-Diastolic Volume (EDV), End-Systolic Volume (ESV), Mass, and Stroke Volume (SV). We considered the measurements accurate by requiring that the variations in global measurements due to workstation and user variability to be within the accepted cutoffs of published guidelines and clinical results. We specified that targeted correlation coefficients of the global measures generated by MyoStrain, in comparison to the gold standard cardiac MRI, must be equal or better than the following: EF: R=0.79, p