(63 days)
Not Found
Yes
The device description mentions "automatically and semiautomatically segments normal structures and abnormal structures (for example, nodules and lesions)" and "the system automatically segment and register data sets, and calculate metrics on clinician-identified nodules. When a clinician identifies a seed point for a nodule, the system automatically finds the extent of the nodule." While the terms AI or ML are not explicitly used, these automated segmentation and identification capabilities strongly suggest the use of AI/ML algorithms.
No
The device is a Picture Archiving and Communications System (PACS) that displays, processes, stores, and transfers medical data. It aids in image analysis for diagnosis but does not directly generate therapy.
No
The device is a Picture Archiving and Communications System (PACS) that displays, processes, stores, and transfers medical data. While it provides image analysis and metrics that can aid in diagnosis, the Intended Use states that "it does not directly generate any diagnosis or potential findings." Its role is to provide information for trained medical professionals to interpret and render findings or diagnoses.
Yes
The device description explicitly states it is "software" and describes its functions as data management, display, processing, storage, and transfer of medical data. It runs on "standard personal and business computers" and does not mention any proprietary hardware components. The performance studies focus on software verification and validation and conformance to software/data standards (DICOM, HL7, SMPTE, JPEG2000).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the HealthMyne software is a PACS system that processes and displays medical images and related data. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device's function is image management, processing, and analysis. While it performs quantitative measurements and segmentation, these are applied to medical images, not biological specimens.
- The intended users are medical professionals interpreting images. The software provides information to aid in interpretation, but the diagnosis is made by the trained professional, not directly by the device analyzing a specimen.
The device falls under the category of medical image processing and management software, which is distinct from IVDs.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is listed as "Not Found".
Intended Use / Indications for Use
The HealthMyne software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the HL7 and DICOM (including DICOM-RT) standards, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements, and export the product automatically and semiautomatically segments normal structures and abnormal structures (for example, nodules and lesions), and provides metrics for the structures.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information (for example, image analysis) that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
Product codes
LLZ
Device Description
HealthMyne accesses the information in real-time so that current patients and images are available to a clinician. The clinician can filter and search the patient and image metadata to find the desired patient(s) and/or image(s). The clinician can view the images in various hanging protocol layouts. The layouts contain viewports of the slices within the image set, each annotated with patient information. Within the viewports the clinician can manipulate the image using standard tools: scroll, pan, zoom, window and level, and view the location of the slice in other viewports. The system can automatically segment and register data sets, and calculate metrics on clinician-identified nodules. When a clinician identifies a seed point for a nodule, the system automatically finds the extent of the nodule. Regions of interest (organs and nodules) can be viewed on the 2D data sets as contours and as 3D models. Metrics can be used to aid in analysis of a study, including the American College of Radiology RADS standards, and specifically with this release the LungRADs categories.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM, non-DICOM
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals, including but not limited to radiologists, oncologists, and physicians.
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)
The HealthMyne software has undergone verification and validation to confirm its functional performance. Non clinical testing conformance to the following FDA recognized industry standards applicable to PACS devices: DICOM standard for medical diagnostic images, HL7 standard for patient information, SMPTE display, and the JPEG2000 image standard.
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
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a cascading manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
HealthMyne, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25th Street, NW BUFFALO MN 55313
Re: K153289 Trade/Device Name: HealthMyne Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 31, 2015 Received: January 4, 2016
Dear Mr. Job:
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 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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education 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.
Michael D'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) K153289
Device Name HealthMyne
Indications for Use (Describe)
The HealthMyne software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the HL7 and DICOM (including DICOM-RT) standards, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements, and export the product automatically and semiautomatically segments normal structures and abnormal structures (for example, nodules and lesions), and provides metrics for the structures.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information (for example, image analysis) that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
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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3
Summary of Safety and Effectiveness/510k Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
| Company | HealthMyne, Inc.
918 Deming Way
Madison, WI 53717 |
|------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact | Sigrid Schoepel
Director of Regulatory Affairs
Telephone: 608-833-2610
Email: sigrid.schoepel@healthmyne.com |
| Preparation Date | October 26, 2015 |
| Trade Name | HealthMyne |
| Classification | Class II per 21 CFR 892.2050
Picture Archiving and Communications System |
| Product Code | LLZ |
Marketed Devices
HealthMyne is a software-only medical device that can manage OEM medical diagnostic images that are compatible with the DICOM standard. It performs functions similar to those currently available in the VitreaAdvanced software cleared for marketing via 510(k) K121213 by Vital Images, Inc.
Device Description
HealthMyne accesses the information in real-time so that current patients and images are available to a clinician. The clinician can filter and search the patient and image metadata to find the desired patient(s) and/or image(s). The clinician can view the images in various hanging protocol layouts. The layouts contain viewports of the slices within the image set, each annotated with patient information. Within the viewports the clinician can manipulate the image using standard tools: scroll, pan, zoom, window and level, and view the location of the slice in other viewports. The system can automatically segment and register data sets, and calculate metrics on clinician-identified nodules. When a clinician identifies a seed point for a nodule, the system automatically finds the extent of the nodule. Regions of interest (organs and nodules) can be viewed on the 2D data sets as contours and as 3D models. Metrics can be used to aid in analysis of a study, including the American College of Radiology RADS standards, and specifically with this release the LungRADs categories.
Intended Use
The HealthMyne software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the HL7 and DICOM (including DICOM-RT) standards, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements, and export the information. The product automatically and semi-automatically
4
segments normal structures and abnormal structures (for example, nodules and lesions), and provides metrics for the structures.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information (for example, image analysis) that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
Comparison with Predicate
HealthMyne performs many diagnostic image management picture archiving and communications functions available in the predicate device as shown in the following comparison chart. Its intended uses are similar to those of the predicate.
| Element | Submission - HealthMyne 2015 Rel 2 | Predicate - VitreaAdvanced 6.6
(K121213) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Device Name | HealthMyne | VitreaAdvanced* |
| 510(k) owner | HealthMyne, Inc. | Vital Images, Inc. |
| Supports
mammography | No. | No. |
| Operating
System | Windows, Linux | Windows |
| Platform | Client-server | Client-server |
| JPG/JPG 2000 | Supported using third-party Kakadu
tool. ISO 10918/15444 | Supported. See DICOM conformance
statement at vitalimages.com. |
| Images are
stored/
compressed/
uncompressed | Both. Lossy used to indicate
loading/for display only and lossless
loaded simultaneously, unless DICOM
contains lossy only. | Both. Users can choose to compress
images. |
| Local archive:
Server level/
archive level | No separate archive due to software-
only product. Redundant data storage
recommended to the customer. | Yes. Available as a separate product. |
| DICOM
compliant | Yes. See conformance statement. | Yes. See conformance statement at
vitalimages.com. |
| HL7 support | Yes. See conformance statement. | No reference to HL7. |
| Study lists | Yes. | Yes. |
| Ability to filter
and search
study list | Yes. Can set up custom filters.
Dynamic (freeform) search and
matching. Also customizable, indexed
search parameters. | Yes. Can set up custom filters. Search and
matching. |
| View study-
related
documents | Yes. Presentation states and regions of
interest/nodules. | Yes. Presentation states and regions of
interest/nodules. |
| Manage
pushed studies | Yes. This product supports only
pushed studies. No studies originate
within this product. | Yes. This product can import and export
using DICOM. |
| Element | Submission - HealthMyne 2015 Rel 2 | Predicate - VitreaAdvanced 6.6
(K121213) |
| View current
and prior
studies at the
same time | Yes. Called current study and prior
study. Prior studies have a large
"PRIOR" label in each viewport. | Yes. Can select series from different
studies for the same patient. |
| Re-organize
series in a
study (for
viewing) | Yes. Has a thumbnail view with the
ability to drag and drop the thumbnail
into a viewport. Cannot save the
order. | Yes. Can drag and drop a viewport image
to another viewport. |
| Create
separate
displays | Yes. Can display a viewport as a single
viewport, can select a viewport layout
and add series to it. | Yes. Can display a viewport as a single
viewport, can select a viewport layout and
add series to it. |
| Cycle through
series | Yes. Can show the "next" and
"previous" sets of series. | Yes. Can show the "next" and "previous"
sets of series. |
| Image display
modes | Yes. Static and manual cine. | Yes. Static and manual cine. |
| Display color
images | Yes. | Yes. |
| Select images | Yes. There is an active image indicator.
The active image can be chosen or is
automatically set based on tool use. | Yes. Select images to group and/or
perform functions. |
| Delete images | Yes. Only with PACS admin privileges
and from the admin console. | Yes. Can delete images from the viewer
window. |
| Sort images | Yes. Sorting and grouping are by
system-defined rules. | Yes. Sorting and grouping are by system-
defined rules. |
| Scrolling
through slices | Yes. Linked series are scrolled
together. Can "swipe" on a scroll bar
to move through slices quickly. Can
lock/unlock scrolling through every
image. | Yes. Grouped series are scrolled together. |
| Zoom in/out | Yes. Default settings and can zoom
interactively. | Yes. Default settings and can zoom
interactively. |
| Pan an image | Yes. | Yes. |
| Rotate an
image | Yes. In 3D. | Yes. Can flip 2D images and rotate 2D and
3D images. |
| 3D images | Yes. | Yes. |
| 3D MIP | No. | Yes. |
| Create oblique
planes | No. | Yes. |
| Standard
viewport
layouts | Yes. Viewport layouts that are
independent of any modality or
common features of series. | Yes. Viewport layouts that are
independent of any modality or common
features of series. |
| Custom
layouts | No. Viewport layouts and hanging
protocols are factory-default. | Yes. Viewport layouts can be set by the
user. |
| Element | Submission - HealthMyne 2015 Rel 2 | Predicate – VitreaAdvanced 6.6
(K121213) |
| Labels | Yes. There are labels in the viewport for patient, study, and image information. | Yes. There are labels in the viewport for patient, study, and image information. |
| Orientation labels | Yes. | Yes. |
| Cross-reference indicator | Yes. There is a cutline in linked viewports to indicate intersection. | No. Use of cross-hair markers. |
| Location indicator | Yes. There is a cross-hair tool to show a point of interest. | Yes. There is a cross-hair tool to show a point of interest, also used to change the axis in 3D rotation. |
| View DICOM data | Yes. You can view the DICOM information about the patient, study, and current image. | Yes. You can view the DICOM information about the patient, study, and current image. |
| Create MPR images | Yes. MPRs from the external source are supported/displayed and can create multi-planar reconstructions of 2D images. | Yes. Can create multi-planar reconstructions of 2D images and set options for display. |
| Window/level across series | Yes. W/L settings are applied to the active image and any linked images. | Yes. Must group series to link W/L. |
| Window/level presets | Yes. Factory default. | Yes. Factory defaults and can save window/level settings. |
| Adjust window/level | Yes. Can interactively adjust the window and level. | Yes. Can interactively adjust the window and level. |
| Post-processing of images | Yes. Can create multi-planar reconstructions of 2D images and 3D views of contours. | Yes. Can create multi-planar reconstructions of 2D images and 3D views. |
| Annotation | Yes. User can display annotations and can add and edit callouts. | Yes. User can display annotations and can add and edit callouts. |
| Measuring tools | Yes. Pixel intensity/location and ruler. | Yes. Ruler. |
| Metrics | Yes. Image analysis metrics. | Yes. Image analysis metrics. |
| ACR RADS categories | Yes. Architecture in place to display RADS categories, initial implementation is for LungRADS. | Yes. References the Fleischner society guidelines. LungRADS's risk stratification is based on the Fleischner society guidelines. |
| Store presentation states | Yes. Can save certain visualization settings. | Yes. Can save certain visualization settings. |
| Detect image/patient issues | Yes. Can view patients and studies with errors. | Yes. Can view patients and studies with errors. |
| Print reports | No. | Yes. Can export and print reports. |
| Element | Submission – HealthMyne 2015 Rel 2 | Predicate - VitreaAdvanced 6.6
(K121213) |
| Custom
hanging
protocols | No. Comes with factory-default
hanging protocols. | No. Comes with factory-default layouts. |
| Custom filters | Yes. Can set filters to affect the studies
listed. | Yes. Can set filters to affect the studies
listed. |
| Set reading
state | Yes. Can mark a study as read. | Yes. Can mark a study as read. |
| Custom search
groups | Yes. Can set "codes" to index
elements for searching (for example,
referring physician or sets of exam
types) for faster auto-complete during
search. | Yes. Can set searches using matches and
ranges on the column headings. |
| Display RTP
structures | Yes. Supports DICOM RT structures. | Yes. Supports DICOM RT structures. |
| Register
images | Yes. Can automatically and/or
manually register images. | Yes. Can manually synchronize datasets in
viewers. Only applies to MPRs and 3D
images. |
| Segment
regions of
interest (ROIs) | Yes. Can automatically generate ROIs
and also manually identify nodules for
automatic generation of nodule ROIs. | Yes. Can automatically generate ROIs and
also manually identify nodules for
automatic generation of nodule ROIs. |
| Edit ROIs | Yes. Can edit the shape of nodules in
three dimensions. | Yes. Can edit ROIs in three dimensions. |
| Manual nodule
detection | Yes. Manual click to identify nodules,
automatic segmentation of the
volume. | Yes. Manual click to identify nodules,
automatic segmentation of the volume. |
| Automatic
nodule
detection | No. | Yes. Automatic detection of nodules in
current study if nodules identified in
previous studies, and the reverse. |
| Nodule display
modes | Yes. View nodules independently or in
reference to other anatomy. | Yes. View nodules independently or in
reference to other anatomy. |
| Image fusion | No. | Yes. Create a fused 3D image by
combining series. |
| Timeline
comparison | No. | Yes. Compare between nodules in studies
of elapse time between scans, doubling
time, percent growth |
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Summary of Studies
The HealthMyne software has undergone verification and validation to confirm its functional performance. Non clinical testing conformance to the following FDA recognized industry standards applicable to PACS devices: DICOM standard for medical diagnostic images, HL7 standard for patient information, SMPTE display, and the JPEG2000 image standard.
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Conclusion
It is the opinion of HealthMyne, Inc. that the HealthMyne software is substantially equivalent to similar image management options available in the predicate device. HealthMyne does not include any new indications for use with regards to the management of medical diagnostic image information, nor does use of this software result in any new potential hazards.