(115 days)
Unifi™ Workspace is a software application that is intended for use in receiving, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). Images and data can be stored, communicated, and displayed within the system or across computer systems. Unifi Workspace provides various image processing and measurement tools to facilitate the interpretation of mammography X-ray, breast tomosynthesis, and other multimodality DICOM medical images and enable diagnosis. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.
Unifi Workspace is typically used by trained professionals, including radiologists, surgeons, technologists, and clinicians and may provide information to be used for screening and diagnostic procedures.
Unifi™ Workspace is a multi-modality software application that can be used for processing and displaying mammography x-ray, breast tomosynthesis, and other multimodality DICOM medical images for reference and diagnostic use by physicians and medical professionals.
The provided text is a 510(k) summary for Hologic's Unifi™ Workspace v1.0.0. It describes the device, its intended use, and a comparison to predicate devices, but it explicitly states that "No clinical studies have been performed." Therefore, there is no information on acceptance criteria for device performance proven by a study, as understood in the context of clinical or performance validation studies.
However, the document does mention "system design control verification and validation tests" and "bench testing, including functional testing and usability testing." While these are not clinical studies proving device performance against specific clinical acceptance criteria, they are the basis of the substantial equivalence claim.
Based on the available text, here's a breakdown of what can be extracted, acknowledging the absence of a performance study proving clinical acceptance criteria:
Absence of Clinical Performance Study:
The document explicitly states: "No clinical studies have been performed." This means that the device's performance against clinical acceptance criteria (e.g., diagnostic accuracy, sensitivity, specificity) as typically proven by large-scale clinical trials or comparative effectiveness studies with human readers, is not available in this filing. The substantial equivalence claim is based on non-clinical testing, functional testing, and usability testing, comparing the new device's features and performance to predicate and reference devices.
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies were performed, there are no acceptance criteria for clinical performance metrics (like sensitivity, specificity, or reader accuracy). The acceptance criteria are implicitly related to the functional and usability performance of the software, demonstrating that it operates as intended and is comparable to the predicate device.
| Acceptance Criteria (Implicit from "Summary of Testing" and "Substantial Equivalence") | Reported Device Performance (Summary of Testing) |
|---|---|
| Functional Equivalence: Device performs image processing, manipulation, display, printing, and archiving as intended and as demonstrated by predicate/reference devices. | "The comparative and other performance testing showed that the overall system demonstrated equivalent performance..." |
| Safety and Effectiveness Equivalence: Device maintains safety and effectiveness standards comparable to the predicate device. | "...and equivalent safety and effectiveness as the predicate (Prima K140960), as well as reference devices (SecurView DX (K103385) and MultiView (K132316)) for specific application features." |
| Usability: The device is usable by trained professionals for its intended purpose. | "...usability testing, was also performed on Unifi™ Workspace." (Implied successful completion based on substantial equivalence claim) |
| Compliance with Standards: Adherence to relevant medical device software and risk management standards (IEC 62304, ISO 14971). | Listed as "Standards" adhered to. (Compliance implied successful demonstration) |
| Compliance with FDA Guidance: Adherence to relevant FDA guidance documents for software, cybersecurity, and human factors. | Listed as "FDA Guidance Documents" adhered to. (Compliance implied successful demonstration) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of a clinical performance study with patients/images. The testing described is "system design control verification and validation tests" and "bench testing."
- Sample Size: Not applicable in the context of a clinical test set. The software itself was tested.
- Data Provenance: Not applicable. If there were images used for functional testing, their provenance is not mentioned, as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical performance study with a "test set" requiring ground truth establishment by experts was performed.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical performance study was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies have been performed." Therefore, there is no effect size of human readers improving with or without AI assistance. The device is a "Picture archiving and communications system," primarily for displaying and manipulating images, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable in the context of a diagnostic algorithm's performance. The device is a workstation software. Its performance relates to its ability to display, process, and manage medical images effectively, not to provide an independent diagnostic output.
7. The Type of Ground Truth Used:
Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the verification and validation (V&V) of this workstation software would be its functional specifications and compliance with industry standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/Machine Learning diagnostic algorithm that requires a "training set" of medical images to learn from. It is a software application for image management and display.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of software device.
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July 11, 2019
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Hologic, Inc. % Ms. Meghan Wakeford Regulatory Affairs Specialist 36 Apple Ridge Road DANBURY CT 06810
Re: K190694
Trade/Device Name: Unifi™ Workspace v1.0.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 6, 2019 Received: June 18, 2019
Dear Ms. Wakeford:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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 medical devices and radiation-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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Indications for Use
510(k) Number (if known) K190694
Device Name Unifi™ Workspace v1.0.0
Indications for Use (Describe)
Unifi Workspace is a software application that is intended for use in receiving, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). Images and data can be stored, communicated, and displayed within the system or across computer systems. Unifi Workspace provides various image processing and measurement tools to facilitate the interpretation of mammography X-ray, breast tomosynthesis, and other multimodality DICOM medical images and enable diagnosis. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.
Unifi Workspace is typically used by trained professionals, including radiologists, surgeons, technologists, and clinicians and may provide information to be used for screening and diagnostic procedures.
Type of Use (Select one or both, as applicable)
| ☑ Transactional Use of STR/Hotel/Short-Term Rental | ☐ Owner Occupied/Homestead |
|---|---|
| ---------------------------------------------------- | ---------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92
| Date Prepared: | July 9, 2019 |
|---|---|
| Manufacturer: | Hologic, Inc.36 Apple Ridge RoadDanbury, CT 06810 USA |
| Establishment Registration #: | 1220984 |
| Contact Person: | Meghan WakefordRegulatory Affairs SpecialistP: 203.702.7819 |
Identification of the Device:
Proprietary/Trade Name: Classification Name: Regulatory Number: Product Code: Device Class: Review Panel:
Device Class:
Unifi™ Workspace v1.0.0 Picture archiving and communication system 21 CFR 892.2050 LLZ Class II Radiology
Identification of the Legally Marketed Predicate Device:
| Trade Name: | Prima |
|---|---|
| Classification Name: | Picture archiving and communication system |
| Regulatory Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | Hologic, Inc. |
| Clearance: | K140960 (cleared June 13, 2014) |
The legally marketed predicate device, Prima, has not been subject to a design-related recall.
Identification of the Legally Marketed Reference Devices:
| Trade Name: | SecurView DX |
|---|---|
| Classification Name: | Picture archiving and communication system |
| Regulatory Number: | 21 CFR 892.2050 |
| Produce Code: | LLZ |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | Hologic, Inc. |
| Clearance: | K103385 (cleared February 2, 2011) |
| Trade Name: | MultiView |
| Classification Name: | Picture archiving and communication system |
| Regulatory Number: | 21 CFR 892.2050 |
| Produce Code: | LLZ |
Class II
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| Review Panel: | Radiology |
|---|---|
| Submitter/510(k) Holder: | Hologic, Inc. |
| Clearance: | K132316 (cleared October 30, 2013) |
The legally marketed reference device, Secur View DX, was subject to a design-related recall in 2012. The software of the reference device is independent of the proposed device, and the software defects noted in the recall do not impact the safety or effectiveness of the subject device. The other legally marketed reference device, MultiView, has not been subject to a design-related recall.
Device Description:
Unifi™ Workspace is a multi-modality software application that can be used for processing and displaying mammography x-ray, breast tomosynthesis, and other multimodality DICOM medical images for reference and diagnostic use by physicians and medical professionals.
Indications for Use:
Unifi™ Workspace is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). Images and data can be stored, communicated, and displayed within the system or across computer systems. Unifi Workspace provides various image processing and measurement tools to facilitate the interpretation of mammography x-ray, breast tomosynthesis, and other multimodality DICOM medical images and enable diagnosis. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.
Unifi™ Workspace is typically used by trained professionals, including radiologists, oncologists, surgeons, technologists, and clinicians and may provide information to be used for screening and diagnostic procedures.
Standards:
- IEC 62304: 2006 Medical device software Software Life Cycle Processes .
- ISO 14971: 2012 Medical devices Application of Risk Management to Medical Devices .
FDA Guidance Documents:
- "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," ● issued on July 28, 2014
- "Guidance for the Content of Premarket Submissions for Software Contained in Medical . Devices," issued on May 11, 2005
- "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software," . issued on January 14, 2005
- . "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on October 2, 2014
- . "Applying Human Factors and Usability Engineering to Medical Devices," issued on February 3, 2016
- . "Off-the-Shelf Software Use in Medical Devices," issued on September 9, 1999
- "Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices," issued on September 6, 2017
Comparison with Predicate Device:
The Unifi™ Workspace and its predicate device, Prima, have the same intended use. The proposed device has similar technological characteristics, application features, and operational use as the predicate device and reference devices, as noted in the comparison matrix below.
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Substantial Equivalence:
| PrimaPredicate (K140960) | SecurView DXReference (K103385) | MultiViewReference (K132316) | Unifi™ WorkspaceProposed | Comparison | |
|---|---|---|---|---|---|
| Indications for Use | Prima is a softwareapplication that isintended for use inreceiving, processing,manipulating,displaying, printing,and archivingmammographyimages as well asother medical imagesand data (e.g. US andMR). Images and datacan be stored,communicated, anddisplayed within thesystem or acrosscomputer systems.Unifi Workspaceprovides variousimage processing andmeasurement tools tofacilitate theinterpretation ofmammography x-ray,breast tomosynthesis,and othermultimodalityDICOM medicalimages and enablediagnosis Lossy | The HologicSecurView DX isintended for selection,display, manipulation,filming and mediainterchange of multi-modality images froma variety of differentmodality systems. Italso interfaces tovarious image storageand printing devicesusing DICOM orsimilar interfacestandards.The device may beused by a trainedphysician for display,manipulation andinterpretation of | MultiView is asoftware applicationthat is intended for usein processing,manipulating, anddisplaying magneticresonance imaging(MRI) images as wellas other multi-modality DICOMmedical images anddata that it receivesfrom various sources(e.g. CT, US,secondary capturedevices, scanners,imaging sources, andimaging gateways).MultiView providesvarious imageprocessing andmeasurement tools tofacilitate theinterpretation of breastMRI images andenable diagnosis.These computer-aidedand/or user-definedprocessing functions | Unifi Workspace is asoftware applicationthat is intended for usein receiving,processing,manipulating,displaying, printing,and archivingmammographyimages as well asother medical imagesand data (e.g. US andMR). Images and datacan be stored,communicated, anddisplayed within thesystem or acrosscomputer systems.Unifi Workspaceprovides variousimage processing andmeasurement tools tofacilitate theinterpretation ofmammography x-ray,breast tomosynthesis,and othermultimodalityDICOM medicalimages and enable | Same as predicate. |
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| compressedmammographicimages must not bereviewed for primaryimage interpretations.Mammographicimages may only beinterpreted using anFDA cleared monitorthat meets technicalspecificationsreviewed and acceptedby the FDA.Prima is typicallyused by trainedprofessionals,including radiologists,oncologists, surgeons,technologists, andclinicians and mayprovide information tobe used for screeningand diagnosticprocedures. | DICOM multi-modality image.The SecurView DXsoftware is typicallyused by trainedprofessionals,including, but notlimited to physicians,radiologists, nurses,medical techniciansand assistants. | include artifactminimization, imagesubtractions, multi-planar reformats, andmaximum intensityprojections. It alsoincludes the followingautomatic functions:physiological analysistools, diffusionsanalysis, andsegmenting of lesions.MultiView alsoprovides tools forautomated targetingfor breastinterventionalprocedures.Lossy compressedmammographicimages and digitizedfilm screen imagesmust not be reviewedfor primary imageinterpretations.Mammographicimages may only beinterpreted using anFDA cleared monitorthat meets technicalspecificationsreviewed and acceptedby the FDA. | diagnosis. Lossycompressedmammographicimages must not bereviewed for primaryimage interpretations.Mammographicimages may only beinterpreted using anFDA cleared monitorthat meets technicalspecificationsreviewed and acceptedby the FDA.Unifi Workspace istypically used bytrained professionals,including radiologists,oncologists, surgeons,technologists, andclinicians and mayprovide information tobe used for screeningand diagnosticprocedures. |
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Level of Concern | Moderate | Moderate | Moderate | Moderate | Same |
|---|---|---|---|---|---|
| Method of Use | Multi-modalityworkstation thatprovides variousimage processing andmeasurement tools tofacilitate diagnosticand non-diagnosticviewing capabilities. | Breast imagingworkstation thatprovides variousimage processing andmeasurement tools tofacilitate diagnosticand non-diagnosticviewing capabilities. | Multi-modalityworkstation thatprovides variousimage processing andmeasurement tools tofacilitate diagnosticand non-diagnosticviewing capabilities. | Multi-modalityworkstation thatprovides variousimage processing andmeasurement tools tofacilitate diagnosticand non-diagnosticviewing capabilities. | Same as predicate |
| Mechanism ofAction | Viewing, patientmanagement, studydata management | Viewing, patientmanagement, studydata management | Viewing, patientmanagement, studydata management | Viewing, patientmanagement, studydata management | Same |
| Operating System | Windows 7 | Windows 7 | Windows 7 | Windows 10 | Similar; both thepredicate andproposed devicesuse Windows OS |
| System Access | Web-based, hosted | Local application | Local application, orweb-based | Local application | Proposed softwareremoved web-basedcapabilitiescompared to thepredicate |
| Support for imagedisplay on mobiledevices | Yes | No | Yes | No | Proposed softwaredoes not supportdisplay on mobiledevices as comparedto the predicate |
| Modalitiessupported ondisplay | US, MR, MG, BTO,DR, CR, SC, CT, andother DICOM formats | US, MR, MG, BTO,DR, CR, SC, CT andother DICOM formats(with Multi-ModalityViewer add-on) | MR, CT, US, SC, andother DICOM formats | US, MR, MG, BTO,DR, CR, SC, CT, andother DICOM formats | Same as predicate |
| DICOM Input forMedical Images | Accept and displayany valid DICOM-standard object | Accept and displayany valid DICOM-standard object | Accept and displayany valid DICOM-standard object | Accept and displayany valid DICOM-standard object | Same as predicate |
| Tomosynthesisimage display | Support for allavailable BTO images | Support for allavailable BTO images | N/A | Support for allavailable BTO images | Same as predicate |
| CAD support | No | Yes | No | Yes | Proposed deviceacceptsMammographyCAD SR objectsproduced byImageChecker CAD(P970058) or otherapplications; sameas SecurView(K103385). |
| Image viewing andmanipulation tools | Window/Level, Pan,Zoom, Invert, Flip,Rotate. View/CreateAnnotations.Scrolling, Cine,Measurement,Magnify, Link datasets | Window/Level, Pan,Zoom, Invert,Magnify, View/CreateAnnotations.Scrolling, Cine,Measurement, ToggleStudy/PatientOverlays, MIP,Intelligent Roaming | Window/Level, Pan,Zoom, Invert, Flip,Rotate, CreateAnnotations.Show/Hide TextOverlay, Probe Tool,Set, Cine, Stack,Radial Stacking,Rotate, Link data sets,Measurement, | Window/Level, Pan,Zoom, Invert, Flip,Rotate, View/CreateAnnotations.Scrolling, Cine,Measurement,Magnify, Link datasets, Sizing modecontrol, ToggleStudy/PatientOverlays, Reset, | Similar: thestandard features forimage review of theproposed device aresimilar to toolsavailable in thepredicate andreference devices. |
| Scrolling, IdentifyROI, MIP | Display text overlays,MIP, IntelligentRoaming | ||||
| MR ImageProcessing | Features not included | N/A | Motion CorrectionDCE Semi-QuantitativeColorization | Motion CorrectionDCE Semi-QuantitativeColorization | Image processingtools of the MRModule forproposed device arethe same featurespresent in thereference device,MultiView(K132316). |
| ApplicationSynchronizationSupport | Yes | Yes | Yes | Yes | Same |
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Summary of Testing:
Hologic, Inc. successfully performed system design control verification and validation tests for the proposed Unifi Workspace device, which are summarized in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) based on a moderate level of concern.
No clinical studies have been performed. Substantial equivalence has been demonstrated by non-clinical testing. Additional bench testing, including functional testing and usability testing, was also performed on Unifi" Workspace. The comparative and other performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate (Prima K140960), as well as reference devices (SecurView DX (K103385) and MultiView (K132316)) for specific application features.
Conclusion:
Based on the information submitted in this premarket notification, Unifi™ Workspace is substantially equivalent to the predicate, Prima (K140960). The intended use, technological characteristics, and operational use are substantially equivalent to the predicate device.
§ 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).