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 used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.

The SecurView DX is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.

Device Description

The Hologic SecurView DX is mainly a software product. It is used for visualization and manipulation of digital radiology images. The SecurView DX is a multi-modality review workstation software focused on mammographic applications. The software can drive high-resolution displays (FDA cleared for Mammography), a PC mouse, a keyboard, optional lower resolution monitors and dedicated workflow keypad.

The software accepts standard or multi-frame mammography images that have been created according to the "FOR PRESENTATION" specification of the DICOM Standard with no compression or using lossless compression. Image processing is external to the SecurView DX software.

The software accepts standard or multi-frame multimodality images of US, MR, DR, CR, SC, CT, PET, and other DICOM formats for display and manipulation on high resolution displays (FDA cleared for mammography) or on other lower resolution color displays in 2-D or 3-D view.

The SecurView DX software can be used in a single or in a multi-workstation configuration.

AI/ML Overview

The provided 510(k) summary for SecurView DX (K103385) describes a software product that is substantially equivalent to its predicate device (K062107). This means the primary "study" proving its acceptance involves demonstrating that the modified device behaves essentially the same as the previously cleared device, with minor changes that do not raise new questions of safety or effectiveness.

Therefore, the documentation does not contain information about a traditional clinical study with acceptance criteria and reported device performance metrics in the way one might expect for a novel device or AI algorithm with specific performance claims. Instead, the acceptance is based on demonstrating substantial equivalence through a comparison of features and by verifying that the modified software continues to function as intended.

Below is an attempt to structure the requested information based on the provided document, highlighting what is present and what is absent due to the nature of a substantial equivalence submission for a software update.

Acceptance Criteria and Device Performance for SecurView DX (K103385)

Given that this is a 510(k) submission for substantial equivalence of a software update (SecurView DX, K103385) to a predicate device (SecurView DX, K062107), the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate device and verification that the modified software performs its intended functions without introducing new safety or effectiveness concerns. There isn't a separate, quantifiable performance outcome defined with specific thresholds for sensitivity, specificity, etc., as would be the case for a device with a quantifiable diagnostic claim.

The primary acceptance criteria for this submission are that the modified device is substantially equivalent to the predicate device in terms of intended use, indications for use, and conformance to relevant standards, and that the modifications do not introduce new safety or effectiveness issues.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Demonstrated via Substantial Equivalence and Verification)	Reported Device Performance (as demonstrated by comparison and testing)
Intended Use	Remain identical to the predicate device: selection, display, manipulation, filming and media interchange of multi-modality images; interfacing to storage and printing devices. Used by trained physicians for display, manipulation, and interpretation of mammographic and other DICOM multi-modality images on FDA-cleared displays.	Identical to the predicate device.
Indications for Use	Remain identical to the predicate device.	Identical to the predicate device.
Software Functionality	All administrative, service, user preference, exam receiving/viewing, printing, PACS archive connectivity, image viewing tools, annotation/measurement tools, and data exchange functions to be performed as per predicate device, with the addition of displaying information/images from FDA-cleared external devices (e.g., AIE Region of Interest Image Enhancement).	Modified software performs all functions as per the predicate. The new capability to display information/images from FDA-cleared external devices (K062059) is implemented and functions as intended, providing visual integration for such external inputs.
Hardware Compatibility	Be compatible with specified hardware requirements (processor, memory, hard disks, displays, networking, removable media, keypad) as per predicate, or higher/same.	Compatible with the specified hardware requirements (same or greater for memory, hard disks, networking, removable media).
Operating System	Compatible with Windows XP (as per predicate) or higher (Windows 7).	Compatible with Windows XP and Windows 7.
Safety and Effectiveness	No new questions of safety or effectiveness are raised by the modifications. Development follows ISO 13485, 21 CFR Part 820 Quality System, including risk analysis, requirements, design, system verification, and system validation. Conforms to ACR/NEMA DICOM PS 3. Bench testing designed to simulate clinical factors successfully undergone.	The modifications do not raise new questions of safety or effectiveness. The quality system processes (risk analysis, reviews, verification, validation) were applied. Bench testing was successfully completed, confirming the modified software functions as intended and safely in a simulated environment. The device conforms to DICOM standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable or not specified in the document. This submission relies on demonstrating substantial equivalence through comparison to the predicate and internal verification/validation activities of the software changes. There is no mention of a "test set" in the context of clinical images or patient data for performance evaluation. The "bench testing designed to simulate clinical factors" implies internal testing, not a formal clinical trial with a defined patient sample size.
Data Provenance: Not applicable or not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This type of information is not typically part of a substantial equivalence submission for a software update of this nature, as there isn't a "ground truth" establishment in the context of a diagnostic performance study.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a formal test set requiring adjudication in the context of a clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

No, an MRMC comparative effectiveness study was not done. The SecurView DX is a viewing workstation and does not incorporate AI in the sense of a diagnostic algorithm to which human readers would be compared or assisted by for specific diagnostic tasks with an effect size measurement. The mention of "AIE Region of Interest Image Enhancement for Digital Mammography software, cleared as K062059" refers to an external, separate medical device whose output SecurView DX can display, not an AI component integrated into SecurView DX itself for diagnostic assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The SecurView DX is a display and manipulation software, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

Not applicable. Ground truth, in the context of diagnostic performance, is not discussed as there is no diagnostic performance study described for this submission. The "ground truth" for the software's functionality is its adherence to specifications and its ability to correctly display and manipulate medical images, similar to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set of images.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

Summary

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510(k) Summary SecurView DX

FEB - 2 2011

Product Name: SecurView DX

Product Classification Name: Picture archiving and communication system

Product Classification Code: LLZ CFR Section: 892.2050

Classification Panel: Radiology · Class II

.. . Manufacturer: Hologic, Inc. *** 35 Crosby Drive Bedford, MA 01730 USA

Contact Person: Gail Yaeker-Daunis Telephone Number: (203) 731-8337 Fax Number: (203) 731-8440

Date Prepared: January 5, 2011

Predicate Device: K062107 SecurView DX, Hologic Inc.

Predicate Device Description: ----

.. The Hologic SecurView DX is mainly a software product. It is used for visualization and manipulation of digital radiology images. The SecurView DX is a multi-modality review workstation software focused on mammographic applications. The software can drive high-resolution displays (FDA cleared for Mammography), a PC mouse, a keyboard, optional lower resolution monitors and dedicated workflow keypad.

The SecurView DX software can be used in a single or in a multi-workstation configuration.

The minimum computer requirements to run the Secur View DX software are:

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Hologic, Inc.

♥ Windows Operating System
. Intel CPU with a clock rate of 2.0 GHz or greater
2.0 GB RAM or greater .
140 GB Hard drive or greater, operating at 160 Mb/s or greater .
CD-ROM/R
10/100 Base -T Network Interface .

Intended Use:

The device may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images using FDA cleared displays for screening and diagnostic mammography, as well as any other 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.

Comparison with Predicate Device:

The modified SecurView DX is substantially equivalent to the SecurView DX previously cleared as K062107 as described above and has the same indications and intended use.

The comparison table below shows that the modified Secur View DX is substantially equivalent to the predicate with the exception of the following features:

Ability to run on both Windows XP or Windows 7 or higher Operating System .
Ability to display information or images calculated by separate medical devices . cleared by FDA, such as: AIE Region of Interest Image Enhancement for Digital Mammography software, cleared as K062059.

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	COMPARISON TABLE
Hardware	SecurView DX K062107	Modified Device
Processor	Dual Processor Intel CPUwith clock rate of 2.0 GHzor higher	Same
Memory	2.0 GB RAM	Same or greater
Hard Disks	140 GB total	Same or greater
Display	Multiple display systems(display with graphicscontroller) which has beenFDA cleared formammography specificmedical diagnosticapplications & OptionalColor High ContrastDisplay for multimodalityimage review other thanmammography	SameMultiple display systems(displays and graphicscontrollers) which have beenFDA cleared formammography specificmedical diagnosticapplications and optionaladditional displays formultimodality image reviewother than mammography
Networking	Network Interface Card(NIC) 10/100 Base-T	Same or greater
Removable Media	CD-ROM/R	Same or greater
Keypad	Custom keypad single clickaccess to commonly usedfeatures	Same
Operating System	Windows XP	Same (Windows XP) orhigher, Windows 7
Memory	2.0 GB RAM	Same or greater
Hard Disks	140 GB total	Same or greater
Software	SecurView DX K062107	Modified SecurView DX
Administrativefunctions	A menu exists for administrator usewhich includes access to functionssuch as:User account administration Setting system wide defaults Patient List administration	Same
Servicefunctions	A menu exists for a service userwhich includes access to functionssuch as:DICOM settings License administration	Same
User Preferenceselection	A menu exists for radiologist userswhich includes access to functionssuch as:Setting individual preferences Setting personal workflow andReportflows (series ofconfigurable hanging snapshotscreated as user preferences andassociated with different typesof studies	Same
ReceivingExams	Images are transmitted to theSecurView DX software accordingto the DICOM standard.Modalities supported include:MG, MR, US, CT, SC, CR, PET,DR, and multiframe mammographyimagesAfter an exam has been received bythe software, an entry is added tothe patient list.	Same
Viewing Exams	All exams which are stored on thesystem appear in a patient list. Theuser selects exams from this list forviewing.	Same
Printing	Images can be printed on DICOMprinters	Same
PACS ArchiveConnectivity	The system can perform aQuery/Retrieve operation on aDICOM archive to retrieve studiesof interest	Same
Image viewingtools	The software provides tools forimage viewing and manipulationsuch as:Window / Level Magnification Window Display at variableresolutions Image Pan Rotation Mirroring Image inversion Display of CAD results Display of patientdemographic information Multimodality Viewer has cinemode tools for multiframe images,breast MR CAD analysis tools andbreast MR motion correction	Same with addition of abilityto display information orimages calculated by separatemedical devices cleared byFDA, such as:AIE Region of InterestImage Enhancement forDigital Mammographysoftware, cleared asK062059
Annotation andMeasurementtools	The software provides tools for:Free hand drawing Ellipse drawing Ability to add textualannotations Ability to measure features	Same
Send GSPS orSC images toother DICOMnodes	The system can send grayscalesoftcopy presentation state (GSPS)objects or secondary captureDICOM images to other DICOMnodes	Same
Export Image	Capable of export to local storagein TIFF format de-identified suchthat image file content contains nopatient identifying informationCapable of exporting DICOMformat images	Same
ApplicationSynchronizationand DataExchange	Provides synchronization interfaceto synchronize patient and patientdata with external applications suchas RIS, data tracking systems,dictation systems, etc.	Same

DISON TA r

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Safety and Effectiveness - Performance Standards:

The SecurView DX software is specified, validated and tested by Hologic, Inc., under a registered ISO 13485 and 21 CFR Part 820 Quality System.

The SecurView DX software conforms to the ACR/NEMA Digital Imaging Communications in Medicine PS 3 (DICOM) Standard. Hologic publishes a DICOM Conformance Statement.

A comprehensive Operator's Manual is provided with each system, to facilitate intended operation.

Conclusion:

The modified SecurView DX software is substantially equivalent to the predicate software in terms of intended use, indications of use and conformance to the DICOM standard. The Secur View DX software changes were specified, validated and tested by Hologic, Inc., under an ISO 13485 and 21 CFR Part 820 Quality System. The following quality assurance measures were applied to the device software modification:

Risk Analysis .
Requirements Reviews �
Design Reviews .
System Verification ●
System Validation �

The modified software has successfully undergone bench testing designed to simulate clinical factors.

Based on the information supplied in this 510(k), Hologic concludes that the modified device is substantially equivalent to the predicate device and is safe and effective.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002

Ms. Gail Yaeker-Daunis, MBA, RAC Sr. Regulatory Affairs Specialist Hologic, Inc. 36 Apple Ridge Road DANBURY CT 06810

FEB - 2 2011

Re: K103385

Trade/Device Name: SecurView DX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 10, 2011 Received: January 12, 2011

Dear Ms. Yaeker-Daunis:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Pastel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use

Premarket Notification: SecurView DX

510(k) No.

Device Name: SecurView D

Indications For Use

The SecurView DX is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Division Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K Number

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Regulation Number and Section

§ 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).