(63 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets those criteria:
The provided document (K200546) is a 510(k) summary for the ZeeroMED View software, establishing substantial equivalence to a predicate device, MedDream.
Crucially, this document does not describe a study that proves the device meets specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence to a legally marketed predicate device based on technical characteristics and functionality.
Therefore, most of the requested information regarding "acceptance criteria" for diagnostic performance and a "study that proves the device meets the acceptance criteria" (in the sense of a clinical diagnostic performance study) is not present in the provided text.
The "acceptance criteria" here are implicitly tied to the demonstration of substantial equivalence, meaning the device must perform similarly and be as safe and effective as the predicate. The "study" proving this is primarily the non-clinical product evaluation, including software verification and validation, and performance testing for measurement accuracy, rather than a clinical trial assessing diagnostic performance against a ground truth.
Here's an explanation based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative diagnostic performance acceptance criteria (e.g., sensitivity, specificity thresholds) or report such performance metrics. The "performance" being assessed and demonstrated is the similarity in technical characteristics and functionality compared to the predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Demonstrated Similarity to Predicate) |
|---|---|
| Safety and Effectiveness: No new questions regarding safety or effectiveness compared to predicate. | "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." |
| Measurement Accuracy: Ability to accurately perform various distance and area measurements. | "Performance Testing (Measurement Accuracy) was conducted on the ZeeroMED View system to determine measurement accuracy when performing the various distance and area measurements." (Specific results not provided in this summary, but presumably demonstrated sufficient accuracy for the intended use.) |
| Software Reliability/Robustness: Software functions as intended with a "moderate" level of concern. | "Software verification and validation testing were conducted on the ZeeroMED View system... Documentation includes level of concern [moderate], software requirements and specifications, design architecture, risk analysis and software validation and verification." |
| Functional Equivalence: Possesses similar features and functionality to the predicate. | A detailed "Feature Comparison" table (on page 5) is provided, showing near-identical functionalities like DICOM image loading/visualization, patient study search, user authentication, image display operations (flip, rotate, zoom, scroll, layout, PET fusion, volumetric rendering), measurement functions (line, angle, polyline, area), annotations, report generation, etc. |
| Technical Equivalence: Basic technical features are the same as the predicate. | "The basic and main technical features of the subject device are the same as the predicated device." |
| Intended Use Equivalence: Shares the same intended use as the predicate (with specific contraindications/limitations). | Both devices are "intended for use as a diagnostic and analysis tool for diagnostic images..." with specific exclusions for mammography and mobile devices. Comparison table on page 5 details this. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set with a "sample size" in the context of diagnostic performance evaluation. The "test set" for the software verification and validation would refer to the internal software testing data, not a patient image dataset for diagnostic performance assessment. No information on data provenance (country of origin, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no external "test set" requiring expert-established ground truth for diagnostic performance is described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication for ground truth is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done or described. This device is a PACS viewer, not an AI-assisted diagnostic tool in the sense of a CADe/CADx system that would typically undergo MRMC studies to assess AI's impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI diagnostic algorithm; it's a medical image viewer. Standalone performance as commonly understood for AI algorithms is not relevant to this device's regulatory pathway as presented. The "standalone performance" here relates to its software functionality and measurement accuracy as a display and analysis tool, which was tested during software V&V.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the software verification and validation, the "ground truth" would be the expected performance of the software functions (e.g., a measurement tool should calculate distances correctly based on known image properties, display functions should work as per specifications). This is established through internal engineering testing and validation against defined software requirements. It's not a clinical ground truth like pathology or expert consensus on disease presence.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning product that requires a "training set" of medical images in the common sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" described for this non-AI device.
Summary of what the document does convey regarding validation:
The validation for ZeeroMED View primarily consists of:
- Software Verification and Validation: This assesses the software's functionality, adherence to specifications, and reliability according to FDA guidance (specifically, for a "moderate" level of concern). This includes risk analysis.
- Performance Testing (Measurement Accuracy): This specific non-clinical test confirms that the device's measurement tools (distance, area) provide accurate results.
- Comparison to Predicate Device: The core of the 510(k) submission relies on demonstrating that ZeeroMED View shares the same intended use, technical characteristics, and functionality as a legally marketed predicate device (MedDream), and that any differences do not raise new questions of safety or effectiveness. This comparison serves as the "proof" for substantial equivalence.
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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
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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) |
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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 SRLPadriciano 99, 34149, Trieste, Italy |
|---|---|
| Contact: | Jorge Millan, PhDSigma Biomedical7600 NW 69th Avenue, Medley FL 33166, USA |
| Telephone number | (786) 416-5587 |
| Fax number | (305) 328-4511 |
| 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 isintended for use as a diagnosticand analysis tool for diagnosticimages for hospitals, imagingcenters, radiologists, readingpractices and any user whorequires and is granted access topatient image, demographic andreport information. ZeeroMEDView displays and managesdiagnostic quality DICOMimages. ZeeroMED View is notintended for diagnostic use withmammography images. Usage formammography is for referenceand referral only. ZeeroMEDView is not intended fordiagnostic use on mobile devices. | MedDream is a softwaremedical imaging system usedto receive DICOM images,scheduling information andtextual reports, organize andstore them in an internalformat, and to make thatinformation available across anetwork via web andcustomized user interfaces.Software is intended for use asa diagnostic, review, andanalysis tool by trainedprofessionals such asradiologists, physicians,clinicians.Contraindications: TheMedDream is not intended forthe acquisition ofmammographic image dataand is meant to be used by |
| Contraindications:TheZeeroMED View is not intendedfor the acquisition ofmammographic image data and ismeant to be used by qualifiedmedical personnel. | qualified medical personnelonly who are qualified tocreate and diagnose medicalimage 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, verticalRotate left, rightResetMagnificationScrollLayout 1x1 -3x3Thumbnails left, right, top,bottomPET fusionVolumetric rendering | Flip horizontal, verticalRotate left, rightClear transformMagnificationScrollLayout 1x1 -3x3Thumbnails left, right, top,bottomPET FusionVolumetric rendering |
| Measurement functions | Line, angle between lines,polyline, area, elliptical area,polygonal area, edit, delete | Line, angle, polyline, area,volume, ellipse, Cobbangle, calibration line, VTIShow angles, edit, delete |
| Annotations | Text | Text |
| Report Generation | Yes | Yes |
| Print reports | ||
| 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.
§ 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).