Who is the manufacturer of Unifi Workspace v1.0.0?

Hologic, Inc. filed the 510(k) submission for Unifi Workspace v1.0.0 (K190694).

What is the FDA product code for Unifi Workspace v1.0.0?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Unifi Workspace v1.0.0?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Unifi Workspace v1.0.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Unifi Workspace v1.0.0

K190694 · Hologic, Inc. · LLZ · Jul 11, 2019 · Radiology

Device Facts

Record ID	K190694
Device Name	Unifi Workspace v1.0.0
Applicant	Hologic, Inc.
Product Code	LLZ · Radiology
Decision Date	Jul 11, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

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.

Device Story

Unifi Workspace is a multi-modality software application for viewing, processing, and archiving medical images (mammography, breast tomosynthesis, US, MR, etc.). It functions as a PACS workstation. Physicians and clinicians use the software to manipulate images via tools like window/level, pan, zoom, rotation, and measurement. It supports CAD SR object display. The device is used in clinical settings by trained professionals to facilitate diagnostic interpretation. It does not support mobile display. It integrates into existing hospital IT environments to receive and display DICOM-standard objects. The software aids clinical decision-making by providing enhanced visualization and measurement tools, potentially improving diagnostic accuracy and workflow efficiency for breast imaging and other modalities.

Clinical Evidence

No clinical studies performed. Substantial equivalence demonstrated via non-clinical bench testing, including system design control verification, functional testing, and usability testing. Performance is equivalent to predicate and reference devices.

Technological Characteristics

Software-based PACS workstation. Operates on Windows 10. Supports DICOM standard input/output. Features include image processing (window/level, pan, zoom, rotation, cine, measurement, MIP, intelligent roaming) and MR-specific tools (motion correction, DCE semi-quantitative colorization). Complies with IEC 62304 (software life cycle) and ISO 14971 (risk management).

Indications for Use

Indicated for trained professionals including radiologists, surgeons, technologists, and clinicians for the viewing, processing, and interpretation of mammography, breast tomosynthesis, and other multimodality DICOM medical images for screening and diagnostic procedures.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Prima (K140960)

Reference Devices

SecurView DX (K103385)
MultiView (K132316)
ImageChecker CAD (P970058)

Related Devices

K140960 — PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM · Hologic, Inc. · Jun 13, 2014
K080351 — DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI · Dexela, Ltd. · Apr 22, 2008
K112439 — SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 · Fujifilm Medical System U.S.A., Inc. · Oct 17, 2011
K103385 — SECURVIEW DX DIAGNOSTIC WORKSTATION · Hologic, Inc. · Feb 2, 2011
K150415 — NilRead · Perceptive Software · Jun 12, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ July 11, 2019 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "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." {3}------------------------------------------------ # Traditional 510(k) Summary K190694 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 Road Danbury, CT 06810 USA | | Establishment Registration #: | 1220984 | | Contact Person: | Meghan Wakeford Regulatory Affairs Specialist P: 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 {4}------------------------------------------------ | 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. {5}------------------------------------------------ # Substantial Equivalence: | | Prima Predicate (K140960) | SecurView DX Reference (K103385) | MultiView Reference (K132316) | Unifi™ Workspace Proposed | Comparison | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | Indications for Use | Prima 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 | The Hologic SecurView DX is intended for selection, display, manipulation, filming and media interchange of multi- modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards. The device may be used by a trained physician for display, manipulation and interpretation of | MultiView is a software application that is intended for use in processing, manipulating, and displaying magnetic resonance imaging (MRI) images as well as other multi- modality DICOM medical images and data that it receives from various sources (e.g. CT, US, secondary capture devices, scanners, imaging sources, and imaging gateways). MultiView provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis. These computer-aided and/or user-defined processing functions | 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 | Same as predicate. | {6}------------------------------------------------ | 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. Prima 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. | DICOM multi- modality image. The SecurView DX software is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants. | include artifact minimization, image subtractions, multi- planar reformats, and maximum intensity projections. It also includes the following automatic functions: physiological analysis tools, diffusions analysis, and segmenting of lesions. MultiView also provides tools for automated targeting for breast interventional procedures. Lossy compressed mammographic images and digitized film screen 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. | 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. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {7}------------------------------------------------ | Level of Concern | Moderate | Moderate | Moderate | Moderate | Same | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Method of Use | Multi-modality workstation that provides various image processing and measurement tools to facilitate diagnostic and non-diagnostic viewing capabilities. | Breast imaging workstation that provides various image processing and measurement tools to facilitate diagnostic and non-diagnostic viewing capabilities. | Multi-modality workstation that provides various image processing and measurement tools to facilitate diagnostic and non-diagnostic viewing capabilities. | Multi-modality workstation that provides various image processing and measurement tools to facilitate diagnostic and non-diagnostic viewing capabilities. | Same as predicate | | Mechanism of Action | Viewing, patient management, study data management | Viewing, patient management, study data management | Viewing, patient management, study data management | Viewing, patient management, study data management | Same | | Operating System | Windows 7 | Windows 7 | Windows 7 | Windows 10 | Similar; both the predicate and proposed devices use Windows OS | | System Access | Web-based, hosted | Local application | Local application, or web-based | Local application | Proposed software removed web-based capabilities compared to the predicate | | Support for image display on mobile devices | Yes | No | Yes | No | Proposed software does not support display on mobile devices as compared to the predicate | | Modalities supported on display | US, MR, MG, BTO, DR, CR, SC, CT, and other DICOM formats | US, MR, MG, BTO, DR, CR, SC, CT and other DICOM formats (with Multi-Modality Viewer add-on) | MR, CT, US, SC, and other DICOM formats | US, MR, MG, BTO, DR, CR, SC, CT, and other DICOM formats | Same as predicate | | DICOM Input for Medical Images | Accept and display any valid DICOM- standard object | Accept and display any valid DICOM- standard object | Accept and display any valid DICOM- standard object | Accept and display any valid DICOM- standard object | Same as predicate | | Tomosynthesis image display | Support for all available BTO images | Support for all available BTO images | N/A | Support for all available BTO images | Same as predicate | | CAD support | No | Yes | No | Yes | Proposed device accepts Mammography CAD SR objects produced by ImageChecker CAD (P970058) or other applications; same as SecurView (K103385). | | Image viewing and manipulation tools | Window/Level, Pan, Zoom, Invert, Flip, Rotate. View/Create Annotations. Scrolling, Cine, Measurement, Magnify, Link data sets | Window/Level, Pan, Zoom, Invert, Magnify, View/Create Annotations. Scrolling, Cine, Measurement, Toggle Study/Patient Overlays, MIP, Intelligent Roaming | Window/Level, Pan, Zoom, Invert, Flip, Rotate, Create Annotations. Show/Hide Text Overlay, Probe Tool, Set, Cine, Stack, Radial Stacking, Rotate, Link data sets, Measurement, | Window/Level, Pan, Zoom, Invert, Flip, Rotate, View/Create Annotations. Scrolling, Cine, Measurement, Magnify, Link data sets, Sizing mode control, Toggle Study/Patient Overlays, Reset, | Similar: the standard features for image review of the proposed device are similar to tools available in the predicate and reference devices. | | | | | Scrolling, Identify ROI, MIP | Display text overlays, MIP, Intelligent Roaming | | | MR Image Processing | Features not included | N/A | Motion Correction DCE Semi- Quantitative Colorization | Motion Correction DCE Semi- Quantitative Colorization | Image processing tools of the MR Module for proposed device are the same features present in the reference device, MultiView (K132316). | | Application Synchronization Support | Yes | Yes | Yes | Yes | Same | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ## 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.