(15 days)
Not Found
No
The summary describes standard PACS functionalities like image display, storage, manipulation, and filtering, without mentioning any AI/ML specific features or performance metrics.
No.
The device is a PACS software primarily for managing, displaying, and processing medical images and data, intended to aid professionals in rendering findings or diagnoses, but it does not directly generate diagnostic information or provide therapy.
No
Explanation: The "Intended Use" section explicitly states, "It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings." This indicates it's a tool for viewing and manipulating images, not for automatic diagnosis.
Yes
The device is described as "HealthMyne PACS software" and its description focuses entirely on software functionalities like displaying, processing, storing, and transferring medical data and images. It explicitly states the client software runs on "standard personal and business computers," implying it is a software application running on existing hardware, not a dedicated hardware device.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The HealthMyne PACS software is a system for managing, displaying, processing, storing, and transferring medical images and related data. It works with images acquired from various imaging modalities (like CT, MRI, etc.), not with biological samples.
- Intended Use: The intended use clearly states it's for managing and displaying medical data from imaging equipment for interpretation by trained medical professionals. It does not involve analyzing biological samples.
Therefore, the HealthMyne PACS software falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The HealthMyne PACS 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 PACS software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM (including DICOM-RT) standard, 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.
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 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
The HealthMyne PACS 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 PACS software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM (including DICOM-RT) standard, 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.
The client software is designed to run on standard personal and business computers.
HealthMyne PACS 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM (including DICOM-RT) standard images
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 PACS 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, 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).
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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" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three faces in profile, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
Healthmyne, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313
Re: K152186
Trade/Device Name: Healthmyne PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 4, 2015 Received: August 5, 2015
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 devicerelated 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/ResourcesforYou/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,
Robert A Ochs
Robert Ochs, Ph.D. Acting 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) K152186
Device Name HealthMyne PACS
Indications for Use (Describe)
The HealthMyne PACS 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 PACS software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM (including DICOM-RT) standard, 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.
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 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 | June 15, 2015, Revised July 17, 2015 |
| Trade Name | HealthMyne PACS |
| Classification | Class II per 21 CFR 892.2050
Picture Archiving and Communications System |
| Product Code | LLZ |
Marketed Devices
HealthMyne PACS is a new 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 Horizon Medical Imaging software cleared for marketing via 510(k) K043146 by McKesson Medical Imaging Company.
Device Description
HealthMyne PACS 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.
Intended Use
The HealthMyne PACS 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 PACS software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM (including DICOM-RT) standard, 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.
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 that is interpreted
4
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 PACS 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 | Predicate - McKesson (K043146) | Submission - HealthMyne |
|---|---|---|
| Device Name | Horizon Medical Imaging | HealthMyne PACS (HM PACS) |
| 510(k) owner | McKesson Medical Imaging Company | HealthMyne, Inc. |
| Supports | ||
| mammography | Yes. | No. |
| Operating | ||
| System | The product uses a client-server | |
| architecture utilizing Windows and | ||
| web-based platforms. | The product uses a client-server | |
| architecture utilizing Windows and | ||
| Linux platforms. | ||
| Image storage/ | ||
| compression | Supports JPEG200 and compression. | Supports JPEG2000 and compression. |
| DICOM | ||
| compliant | Yes. | Yes. |
| Worklists | Yes. | Yes |
| Filter and search | ||
| capabilities | Yes. | Yes. |
| Ability to search | ||
| studies | Yes. Specific searchable fields. | Yes. Dynamic (freeform) search and |
| matching. Also customizable, indexed | ||
| search parameters. | ||
| View study- | ||
| related | ||
| documents | Yes. Can view reports/documents. | Yes. Presentation states and RT Struct |
| (regions of interest) | ||
| Priority "stat" | ||
| studies | Yes. Customizable priority settings and | |
| email notification. | Yes. Studies with a DICOM priority tag | |
| ("Stat" studies) are given priority order | ||
| (top of the list) in the exam view. | ||
| Manage pushed | ||
| studies | Yes. Configurable whether studies from | |
| other systems can be sent to this | ||
| product. | Yes. This product supports only pushed | |
| studies. No studies originate within this | ||
| product. | ||
| View current and | ||
| prior studies at | ||
| the same time | Yes. Called anchor (labeled with an A) | |
| study and reference (labeled with an R) | ||
| study. | Yes. Called current study and prior | |
| study. Prior studies have a large | ||
| “PRIOR" label in each viewport. | ||
| Open studies | ||
| with no digital | ||
| images | Yes | No |
| Re-organize | ||
| series in a study | ||
| (for viewing) | Yes. Has a thumbnail view and a | |
| viewport selector to choose which | ||
| viewport to populate. Can save the | ||
| order. | Yes. Has a thumbnail view with the | |
| ability to drag and drop the thumbnail | ||
| into a viewport. Cannot save the order. | ||
| Element | Predicate - McKesson (K043146) | Submission - HealthMyne |
| Display all study | ||
| images in one | ||
| viewport | Yes. Can choose to make a viewport | |
| show all images within a study. | No. | |
| Create separate | ||
| displays | Yes. Can select to show just a single | |
| series in a set of windows. | 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 cine. | Yes. Static and manual cine. |
| Select images | Yes. There is an active image indicator | |
| and the active image can be chosen. | ||
| Can flag/bookmark an image. | Yes. There is an active image indicator. | |
| The active image can be chosen or is | ||
| automatically set based on tool use. | ||
| Delete images | Yes. With the right permission and | |
| from the client/web software. | Yes. Only with PACS admin privileges | |
| and from the admin console. | ||
| Sort images | Yes. Can choose a sort order in the | |
| viewport layout. | Yes. Sorting and grouping are by | |
| system-defined rules. | ||
| Copy images | Yes. Can copy an image to the | |
| clipboard. | No. | |
| Scrolling through | ||
| slices | Yes. Linked series are scrolled together. | |
| Can perform "power scrolling" to move | ||
| through slices quickly. | Yes. Linked series are scrolled together. | |
| Can "swipe" on a scroll bar to move | ||
| through slices quickly. Can lock/unlock | ||
| scrolling through every image. | ||
| Zoom in/out | Yes. Default settings and can zoom | |
| interactively. | Yes. Default settings and can zoom | |
| interactively. | ||
| Magnify an area | Yes. Can select an area of an image and | |
| zoom on just that area. | No, though a similar tool allows a user | |
| to magnify a region interactively. | ||
| Pan an image | Yes | 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 | Yes. | No. Viewport layouts and hanging |
| protocols are factory-default. | ||
| Labels | Yes. There are labels in the viewport for | |
| patient, study, and image information. | ||
| Can toggle the display on/off. | Yes. There are labels in the viewport for | |
| patient, study, and image information. | ||
| Orientation | ||
| labels | Yes. | Yes. |
| Cross-reference | ||
| indicator | Yes. There are cross-reference lines to | |
| indicate intersection. | Yes. There is a cutline in linked | |
| viewports to indicate intersection. | ||
| View DICOM | ||
| data | Yes. You can view the DICOM | |
| information about the patient and | ||
| study, and the pixel information. | Yes. You can view the DICOM | |
| information about the patient, study, | ||
| and current image. | ||
| Create MPR | ||
| images | Yes. Images can be saved only in the | |
| advanced version of the product. | No. MPRs from the external source are | |
| supported/displayed. | ||
| Element | Predicate - McKesson (K043146) | Submission - HealthMyne |
| Window/level | ||
| determination | Determined by the product's lookup | |
| tables (5 variations), the scanner's | ||
| lookup table, or a histogram. | Determined by a lookup table function | |
| (linear) and the W/L values of the | ||
| image. If the image has a custom | ||
| lookup table or a fixed W/L, those | ||
| settings are used instead of allowing | ||
| changing of W/L. | ||
| If no W/L, then a histrogram is used. | ||
| Window/level | ||
| across series | Yes. W/L settings can be applied to | |
| selected images, series, or all visible. | Yes. W/L settings are applied to the | |
| active image and any linked images. | ||
| Window/level | ||
| presets | Yes. Factory-default and customer- | |
| defined. | Yes. Factory default. | |
| 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 sharpen/smooth images | |
| except for mammography. | No. No post-processing. | |
| Annotation | Yes. Can add temporary (per session) or | |
| permanent annotations. | Yes. Display only. | |
| Measuring tools | Yes. Linear, scale, angles, and pixel | |
| intensity of a point. | Yes. Pixel intensity and location. | |
| Store | ||
| presentation | ||
| states | Yes. Can group and save visualization | |
| settings. | No. Only display of presentation states. | |
| Detect | ||
| image/patient | ||
| issues | Yes. Has a "QA" feature to indicate | |
| patient mismatch/image issues. | Yes. Can view patients and studies with | |
| errors. | ||
| Print reports | Yes. | No. |
| Custom hanging | ||
| protocols | Yes. | No. Comes with factory-default hanging |
| protocols. | ||
| Custom filters | Yes. Can set filters to affect the studies | |
| listed. | Yes. Can set filters to affect the studies | |
| listed. | ||
| Set reading state | Yes. Ability to set study status. | Yes. Can mark a study as read. |
| Custom search | ||
| groups | No. | Yes. Can set "codes" to index elements |
| for searching (for example, referring | ||
| physician or sets of exam types) for | ||
| faster auto-complete during search. | ||
| Display radiation | ||
| therapy | ||
| information | Yes. Supports DICOM RT information. | Yes. Supports DICOM RT structures. |
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6
Summary of Studies
The HealthMyne PACS 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, SMPTE display, and the JPEG2000 image standard.
7
Conclusion
It is the opinion of HealthMyne, Inc. that HealthMyne PACS software is substantially equivalent to similar image management options available in the predicate device. HealthMyne PACS does not include any new indications for use with regards to the management of medical diagnostic images, nor does use of this software result in any new potential hazards.