(63 days)
No
The document describes a standard DICOM image viewer with manipulation and measurement tools. There is no mention of AI, ML, or any related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is described as a diagnostic and analysis tool for medical images, displaying and managing them for diagnostic quality. Its intended use focuses on reviewing, manipulating, and visualizing medical image data, which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "ZeeroMED View software is intended for use as a diagnostic and analysis tool for diagnostic images..."
Yes
The device is explicitly described as "ZeeroMED View Software" and a "Web-based DICOM medical image viewer." The description focuses solely on the software's functionality for displaying, managing, and manipulating DICOM images, without mentioning any accompanying hardware components that are part of the regulated device. The performance studies also focus on software verification and validation.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the software is intended for use as a diagnostic and analysis tool for diagnostic images. This directly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. While the input is imaging data rather than a biological specimen, the purpose is still diagnostic analysis.
- Diagnostic Quality Images: The description mentions that ZeeroMED View displays and manages diagnostic quality DICOM images. This further reinforces its role in the diagnostic process.
- Use by Medical Professionals: The intended users are listed as hospitals, imaging centers, radiologists, and reading practices, all of whom are involved in medical diagnosis.
- Image Processing: The device mentions image processing, which is a common function in diagnostic imaging software.
While the device doesn't analyze biological specimens in the traditional sense of an IVD, the regulatory definition of IVD can encompass software used for the analysis and interpretation of diagnostic data derived from the human body, such as medical images. The key is its intended use in providing information for diagnosis.
The fact that it's a software tool for analyzing diagnostic images for the purpose of diagnosis strongly indicates it falls under the purview of IVD regulation.
N/A
Intended Use / Indications for Use
"ZeeroMED View software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. ZeeroMED View displays and manages diagnostic quality DICOM images. ZeeroMED View is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. ZeeroMED View is not intended for diagnostic use on mobile devices.
Contraindications: The ZeeroMED View is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel."
Product codes
LLZ
Device Description
"The ZeeroMED View Software, or ZeeroMED View, is a Web-based DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. ZeeroMED View is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. ZeeroMED View enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software."
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
US, CT, MRI, XRay
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
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)
"Performance Testing (Measurement Accuracy) was conducted on the ZeeroMED View system to determine measurement accuracy when performing the various distance and area measurements."
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font, also in blue. The logo is simple and professional, and it is easily recognizable.
O3 Enterprise SRL % Jorge Millan, Ph.D. Regulatory Affairs Manager Sigma Biomedical 7600 NW 69th Avenue MEDLEY FL 33166
May 5, 2020
Re: K200546
Trade/Device Name: ZeeroMED View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 6, 2020 Received: March 6, 2020
Dear Dr. Millan:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| 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 below.
510(k) Number (if known)
Device Name
ZeeroMED View
Indications for Use (Describe)
ZeeroMED View software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. ZeeroMED View displays and manages diagnostic quality DICOM images. ZeeroMED View is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. ZeeroMED View is not intended for diagnostic use on mobile devices.
Contraindications: The ZeeroMED View is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14) of the image. It is a form, so I will create an html representation of the form. I will use tables to represent the form, with labels on the left and values on the right. I will also include the other text in the form.
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Image /page/3/Picture/0 description: The image shows the logo for ZeeroMED Enterprise View. The logo features a green tree inside of a circle with a blue sky and white clouds in the background. The word "Enterprise" is written in green and black letters, and the words "ZeeroMED View" are written in black letters.
510K Summary – Feb 20, 2020
- K200546 510(K) Summary
Submitter Information
| Submitter | 03 ENTERPRISE SRL
Padriciano 99, 34149, Trieste, Italy |
|------------------|------------------------------------------------------------------------------------|
| Contact: | Jorge Millan, PhD
Sigma Biomedical
7600 NW 69th Avenue, Medley FL 33166, USA |
| Telephone number | (786) 416-5587 |
| Fax number | (305) 328-4511 |
| E-mail | sigmabiomedical@gmail.com |
| Date prepared: | February 21, 2020 |
Subject Device Name
| Trade/Proprietary Name: | ZeeroMED View |
|---|---|
| Regulation Number: | 892.2050 |
| Regulation Name: | Picture Archiving and Communication System |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
Predicate Devices
| Predicate Devices: | MedDream |
|---|---|
| Regulation Number: | 892.2050 |
| Regulation Name: | Picture Archiving and Communication System |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
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Image /page/4/Picture/0 description: The image shows the ZeeroMED Enterprise logo. The logo features a green tree inside of a black circle. The text "Enterprise" is written in green and black next to the logo. The words "ZeeroMED View" are written in black to the right of the word "Enterprise".
Device Description:
The ZeeroMED View Software, or ZeeroMED View, is a Web-based DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. ZeeroMED View is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. ZeeroMED View enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software.
Indications for Use:
ZeeroMED View software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. ZeeroMED View displays and manages diagnostic quality DICOM images. ZeeroMED View is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. ZeeroMED View is not intended for diagnostic use on mobile devices.
Contraindications: The ZeeroMED View is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
Non-Clinical Data:
Non-clinical product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes:
Software Verification and Validation
Software verification and validation testing were conducted on the ZeeroMED View system and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.
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Image /page/5/Picture/0 description: The image contains a logo with the word "Enterprise" in green font. Next to the logo, the text "ZeeroMED View 510K Summary - Feb 20, 2020" is displayed. The text provides a summary of the ZeeroMED view as of February 20, 2020. The image appears to be a header or title slide for a presentation or document related to ZeeroMED.
Performance Testing (Measurement Accuracy) was conducted on the ZeeroMED View system to determine measurement accuracy when performing the various distance and area measurements.
Predicate Devices
The O3 ENTERPRISE system is equivalent to the MEDDREAM Picture Archiving and Communications system by Softneta UAB cleared under K162011.
Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]: ZeeroMED View is comparable with and substantially equivalent to MedDream Picture Archiving and Communications System.
Technical Characteristics Comparison:
The basic and main technical features of the subject device are the same as the predicated device
Feature Comparison:
Subject device has similar features and functionality as the predicate device:
Product comparison
| Feature | ZeeroMED View | MedDream |
|---|---|---|
| K# | K162011 | |
| Intended Use | ZeeroMED View software is | |
| intended for use as a diagnostic | ||
| and analysis tool for diagnostic | ||
| images for hospitals, imaging | ||
| centers, radiologists, reading | ||
| practices and any user who | ||
| requires and is granted access to | ||
| patient image, demographic and | ||
| report information. ZeeroMED | ||
| View displays and manages | ||
| diagnostic quality DICOM | ||
| images. ZeeroMED View is not | ||
| intended for diagnostic use with | ||
| mammography images. Usage for | ||
| mammography is for reference | ||
| and referral only. ZeeroMED | ||
| View is not intended for | ||
| diagnostic use on mobile devices. | MedDream is a software | |
| medical imaging system used | ||
| to receive DICOM images, | ||
| scheduling information and | ||
| textual reports, organize and | ||
| store them in an internal | ||
| format, and to make that | ||
| information available across a | ||
| network via web and | ||
| customized user interfaces. | ||
| Software is intended for use as | ||
| a diagnostic, review, and | ||
| analysis tool by trained | ||
| professionals such as | ||
| radiologists, physicians, | ||
| clinicians. |
Contraindications: The
MedDream is not intended for
the acquisition of
mammographic image data
and is meant to be used by |
| | Contraindications:
The
ZeeroMED View is not intended
for the acquisition of
mammographic image data and is
meant to be used by qualified
medical personnel. | qualified medical personnel
only who are qualified to
create and diagnose medical
image data. |
| Mammographic use | No | No |
| DICOM image loading and visualization | Yes | Yes |
| Patient study search data | Yes | Yes |
| User authentication | Yes | Yes |
| Window level | Yes | Yes |
| Rotate/pan/zoom/fit to screen | Yes | Yes |
| Image display operations | Flip horizontal, vertical
Rotate left, right
Reset
Magnification
Scroll
Layout 1x1 -3x3
Thumbnails left, right, top,
bottom
PET fusion
Volumetric rendering | Flip horizontal, vertical
Rotate left, right
Clear transform
Magnification
Scroll
Layout 1x1 -3x3
Thumbnails left, right, top,
bottom
PET Fusion
Volumetric rendering |
| Measurement functions | Line, angle between lines,
polyline, area, elliptical area,
polygonal area, edit, delete | Line, angle, polyline, area,
volume, ellipse, Cobb
angle, calibration line, VTI
Show angles, edit, delete |
| Annotations | Text | Text |
| Report Generation | Yes | Yes |
| Print reports | PDF | PDF |
| Export | Yes | Yes |
| Share function | Yes | Yes |
| DICOM Windowing | Yes | Yes |
| Low Pass Filter | Yes | No |
| Imaging modalities | US, CT, MRI, XRay | US, CT, MRI, XRay |
| Communications | DICOM | DICOM |
| Operating System for Diagnostic Viewing | Windows, Linux, Mac | Windows, Linux, Mac |
| Browser supported | Edge, Firefox, Chrome | Edge, Firefox, Chrome |
| Mobile Device Support for Viewing | No | No |
| Transfer/Storage/Display of Medical images | Yes | Yes |
| Network access | Connects to existing PACS | Connects to existing PACS |
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Image /page/6/Picture/0 description: The image shows the word "Enterprise" with the "Enter" part in green and the "prise" part in black. To the left of the word is a circular logo with a light blue background, a white cloud, and a green number 3 in the center. The logo is surrounded by a black circle. The image appears to be a company logo or branding element.
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Image /page/7/Picture/0 description: The image shows the ZeeroMED View logo. The logo consists of a circular icon with a blue sky and white clouds, with the number 3 in green in the center. To the right of the icon is the word "Enterprise" in green and black, followed by the text "ZeeroMED View" in black.
Evaluation of similarities and differences:
- ZeeroMED View and MedDream have similar intended use, functionality and similar Web technologies. In terms of use and functions both systems access, upload and display DICOM images and metadata and provide tools and resources to the physician for study review and analysis. Both systems are hosted in Web servers and are equipped with security features and user authentication.
- . Differences between both systems consist in user interface layout, navigation, icon coloring and overall system presentation. In addition, MedDream provides additional functionality such as volumetric measurements.
Conclusions:
The subject device has similar technology characteristics and has the similar intended use and functionality as legally marketed devices. There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness. The non-clinical performance test data and software verification demonstrate that the ZeeroMED View system performs comparably to and it is as safe and effective as the predicate device. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, ZeeroMED View is substantially equivalent to the predicate that is currently marketed for the same intended use.