(70 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the software as using "advanced analysis algorithms" and "advanced automated methods" which are not necessarily indicative of AI/ML. The description focuses on automation of manual tasks and image processing techniques.
No
The device is a diagnostic tool that provides data for clinical decision-making, but it is explicitly stated that it is not intended to determine or recommend a course of action or treatment. Therapeutic devices are designed for treatment.
Yes
The device analyzes DICOM-compliant cardiovascular images to provide quantitative data on blood flow to the heart and its major vessels, which is intended to support qualified healthcare practitioners for clinical decision making.
Yes
The device description explicitly states that HeartScan is a "web-accessible image analysis software application" and that it "does not interface directly with any MR or data collection equipment, instead HeartScan imports data files previously generated by such equipment." This confirms it is a software-only device that processes pre-existing data.
Based on the provided information, HeartScan is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- HeartScan's Function: HeartScan analyzes images acquired from an MR scanner. It processes and quantifies data from these images, which are representations of the body's internal structures and blood flow, not biological specimens themselves.
- Intended Use: The intended use clearly states that HeartScan analyzes "DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners." It provides "quantitative data" to "support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making." This is consistent with image analysis software used in medical imaging, not IVD testing.
Therefore, HeartScan falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible, quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartScan is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Product codes
LLZ
Device Description
Morpheus HeartScan is a web-accessible image analysis software application. The application is intended to visualize and quantify cardiac-specific MRI data in DICOM format. HeartScan has features for loading, saving, generating screen displays, and aggregating flow statistics.
Pre-existing MR images are uploaded via the web to the HeartScan software application where image corrections (specific to aliasing errors) are applied to the set of images prescribed by the user. Automatic or manual vessel segmentation is performed and advanced analysis algorithms are applied to quantify blood flow. The images and blood flow can be simultaneously visualized at any plane using multi-planar reconstruction (MPR) with color flow fusion. Reproducible test results are produced and stored in the image study.
HeartScan does not interface directly with any MR or data collection equipment, instead HeartScan imports data files previously generated by such equipment. The software application applied advanced automated methods to avoid tedious, time-consuming manual methods. The software does not perform any functions which cannot be accomplished by a trained user utilizing manual tracing methods; the purpose of the software is to save time and automate potential error-prone manual tasks.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Heart, major vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified cardiologist, radiologist or other licensed professional healthcare practitioners
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)
Nonclinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate device, and that no new issues of safety and effectiveness were raised. The HeartScan software was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:
- Digital Imaging and Communications in Medicine (DICOM); PS 3.1 3.20 . (2011)
- Medical device software Software Life Cycle Process, IEC 62304 .
- Medical devices Application of risk management to medical devices, 14971 ● Second edition 2007-03-01
- Medical Devices Application of Usability Engineering to Medical Devices, ISO 62366
Nonclinical verification and validation test results establish that the device generates reproducible data. Specific test cases were created during verification that included multiple analysis of the same ROI within the same dataset to confirm that the device generated the same output within an acceptable criterion. Additionally, validation between HeartScan and the predicate device included analyzing the same datasets and ROI to confirm that HeartScan outputs were within a clinically acceptable range compared to that of the predicate. Results conclude that HeartScan is capable of generating clinically acceptable reproducible data in comparison with a similar currently marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
leus
APR 0 3 2014
K133937
Page 1 of 4
510(k) Summary Prepared November 6, 2013 (Revised: March 14, 2014)
| Sponsor: | Morpheus Imaging, Inc |
|---|---|
| Contact Person: | John Axerio-Cilies Ph.D. |
| Address: | 1700 4th St. MC 2522 Byers Hall 214 |
| San Francisco, California 94158-2330 | |
| Telephone: | 650 391 7111 |
| Fax: | 650 319 7231 |
| Submission Date: | November 6, 2013 |
| Device Name: | HeartScan Software |
| Common Name: | Radiology Imaging Software |
| Classification: | |
| Regulatory Class: | |
| Review Category: | |
| Classification Panel: | II |
| 21 CFR 892.2050 (LLZ) | |
| Radiology |
A. Legally Marketed Predicate Devices
The Morpheus HeartScan software device is substantially equivalent to the MedVoxel Systems Inc. Med Voxel HeartPro Software System (K103565).
B. Device Description:
Morpheus HeartScan is a web-accessible image analysis software application. The application is intended to visualize and quantify cardiac-specific MRI data in DICOM format. HeartScan has features for loading, saving, generating screen displays, and aggregating flow statistics.
Pre-existing MR images are uploaded via the web to the HeartScan software application where image corrections (specific to aliasing errors) are applied to the set of images prescribed by the user. Automatic or manual vessel segmentation is performed and advanced analysis algorithms are applied to quantify blood flow. The images and blood flow can be simultaneously visualized at any plane using multi-planar reconstruction (MPR) with color flow fusion. Reproducible test results are produced and stored in the image study.
1
Image /page/1/Picture/0 description: The image shows the word "orpheus" with a heart symbol replacing the "O". The text is written in a simple, handwritten style, giving it a personal and informal feel. The heart symbol adds a touch of affection or love to the name, creating a unique visual representation.
HeartScan does not interface directly with any MR or data collection equipment, instead HeartScan imports data files previously generated by such equipment. The software application applied advanced automated methods to avoid tedious, time-consuming manual methods. The software does not perform any functions which cannot be accomplished by a trained user utilizing manual tracing methods; the purpose of the software is to save time and automate potential error-prone manual tasks.
C. Intended Use
HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible, quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartScan is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
D. Substantial Equivalence
The submission device is substantially equivalent to MedVoxel Systems Inc. MedVoxel HeartPro Software Application (K103565) as described in the table below:
| Feature/Specification | Predicate Device | Subject Device |
|---|---|---|
| MedVoxel HeartPro Software | Morpheus HeartScan Software | |
| Application K103565 | ||
| Indication for use | HeartPro consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible. quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartPro is intended to be used to support qualified cardiologist, radiologist or other licensed professional health care practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient. | HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible. quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartScan is intended to be used to support qualified cardiologist, radiologist or other licensed professional health care practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient. |
| Intended Users | qualified cardiologist, radiologist or other licensed professional health care practitioners | qualified cardiologist, radiologist or other licensed professional health care practitioners |
| Class | II | II |
Table 1 Comparison Table
2
| C |
|---|
| വനന്തവുമാനായിരുന്നു. അവലംബം പ്രശസ്തമായി പ്രവർത്തിച്ചു. അവലംബം പ്രശസ്തമായി പ്രവർത്തിച്ചു. അവലംബം പ്രശസ്തമായി പ്രവർത്തിച്ചു. അവലംബം പ്രശസ്തമായി പ്രവർത്തിച്ചു. അവലംബം പ്ര |
| ا ان ان ان الحدث ت |
:
・
:
.
| Feature/Specification | Predicate Device
MedVoxel HeartPro Software
Application K103565 | Subject Device
Morpheus HeartScan Software |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21CFR 892.2050 | 21CFR 892.2050 |
| Code | LLZ | LLZ |
| Data Acquisition | | |
| Workstation | Yes | Yes |
| operating system | | |
| Images from all MRI
scanners supported | Yes both 1.5T and 3.0 T | Yes both 1.5T and 3.0 T |
| Image input | Supports DICIOM 3.0 | Supports DICOM 3.0 |
| Data acquisition
protocol for blood
flow analysis | Cardiovascular images: multi-phase.
multi-slice and velocity encoded
images acquired from MRI scanners | Cardiovascular images: multi-phase.
multi-slice and velocity encoded
images acquired from MRI scanners |
| Workflow | | |
| User Interactions | User can browse, select and load
CMRI scan files: save and load
analyses; export to files; generate
reports with quantitative data; display
DICOM information | User can browse, select and load CMRI
scan files; save and load analyses;
export to files; generate reports with
quantitative data; display DICOM
information |
| Image manipulation | Pan/zoom; magnify; maximize and
minimize; adjust window level,
contrast, brightness; single image
ROI placement; automated 2D ROI
copy/edit functions; 2D velocity
color map. | Pan/zoom; magnify; maximize and
minimize; scroll through slice stack;
adjust window level, contrast,
brightness; single image ROI
placement; automated 2D ROI
copy/edit functions; 2D velocity color
map. |
| ROI vessel contour
detection and editing | Automatic contour detection with
user input; can be changed manually | Automatic contour detection with user
input; can be changed manually |
| Data Analysis | | |
| 2D measurements | ROI tools and statistics | ROI tools and statistics |
| Quantitative
assessment of cardiac
function | Measurement algorithm generates
clinical data, including parameters
such as net blood flow rate, and net
blood flow volume. | Measurement algorithm generates
clinical data, including parameters such
as net blood flow rate, and net blood
flow volume. |
| Phase Aliasing Error
Correction | Phase alias error correction provided
via user interface | No |
| Eddy Current
Correction (ECC) | Yes | Yes |
| Data Output: | | |
| Dynamic display of
ventricular
contractions | Yes | Yes |
| Comparative review | 2D | 2D |
| Measurement
Information | Blood flow chart displayed; Net
blood flow rate; Net blood flow
volume | Blood flow chart displayed; Net blood
flow rate; Net blood flow volume |
.
.
.
.
.
3
orpheus
K133937
Page 4 of 4
E. Performance Data
Nonclinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate device, and that no new issues of safety and effectiveness were raised. The HeartScan software was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:
- Digital Imaging and Communications in Medicine (DICOM); PS 3.1 3.20 . (2011)
- Medical device software Software Life Cycle Process, IEC 62304 .
- Medical devices Application of risk management to medical devices, 14971 ● Second edition 2007-03-01
- Medical Devices Application of Usability Engineering to Medical Devices, ISO 62366
Nonclinical verification and validation test results establish that the device generates reproducible data. Specific test cases were created during verification that included multiple analysis of the same ROI within the same dataset to confirm that the device generated the same output within an acceptable criterion. Additionally, validation between HeartScan and the predicate device included analyzing the same datasets and ROI to confirm that HeartScan outputs were within a clinically acceptable range compared to that of the predicate. Results conclude that HeartScan is capable of generating clinically acceptable reproducible data in comparison with a similar currently marketed device.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
Morpheus Imaging, Inc. % John Axerio-Cilies, Ph.D. CEO 1700 4th Street MC 2522 Byers Hall 214 SAN FRANCISCO CA 95158-2330
Re: K133937
Trade/Device Name: HeartScan Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 14, 2014 Received: March 25, 2014
Dear Dr. Axerio-Cilies:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any i with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Dr. Axerio-Cilies
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fdagov/McdicalDevices/Salietv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES . Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133937
Device Name Morpheus HeartScan
Indications for Use (Describe)
HeartScan consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartScan specifically analyzes the blood flow to the heart and its multi-slice, multi-phase and velocity encoded MR images. It provides clinically relevant and reproducible, quantitative data and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by HeartScan is intended to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clintended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
September (301) 443-6740 EF