(115 days)
No
The document describes standard image processing and display functionalities for medical images. There is no mention of AI, ML, deep learning, or any related terms or concepts. The performance studies focus on non-clinical testing and equivalence to predicate devices, not on the performance metrics typically associated with AI/ML algorithms (e.g., AUC, sensitivity, specificity from a training/test set).
No
This device is a software application for processing and displaying medical images to facilitate diagnosis, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that "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." It also mentions that the device "may provide information to be used for screening and diagnostic procedures." The "Device Description" section also notes it is for "diagnostic use by physicians and medical professionals."
Yes
The device description explicitly states it is a "multi-modality software application" and the intended use describes its function as receiving, manipulating, displaying, printing, and archiving images and data, all of which are software-based operations. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue). The intended use and device description clearly state that Unifi Workspace is used for processing and displaying medical images (mammography, US, MR). These are images of the body itself, not analyses of biological samples.
- The device description focuses on image manipulation, display, and processing. This aligns with the function of a medical image viewer and workstation, not an in vitro diagnostic test.
- The intended users are medical professionals who interpret images. This is consistent with the use of medical imaging software.
Therefore, Unifi Workspace falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
mammography X-ray, breast tomosynthesis, US, MR, DR, CR, SC, CT, and other multimodality DICOM medical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Unifi Workspace is typically used by trained professionals, including radiologists, oncologists, surgeons, technologists, and clinicians.
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
Additional bench testing, including functional testing and usability testing, was also performed on Unifi" Workspace.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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)
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3
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 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.