McKesson Radiology Mammography Plus by MCKESSON MEDICAL IMAGING COMPANY

McKesson Radiology Mammography Plus™ ("Mammography Plus"), is an accessory to McKesson Radiology Station™, a component of McKesson Radiology™. McKesson Radiology is medical image and information management software that is intended to receive, transmit, store, archive, manage, display, print and process digital medical images, digital medical video and associated patient and medical information. McKesson Radiology™ includes a suite of standalone, web-enabled software components, and is intended for installation and use with off-the-shelf hardware that meets or exceeds minimum specifications.

McKesson Radiology Station™ is the primary software component used for processing and presentation of medical images on display devices with network access to McKesson Radiology. McKesson Radiology Station is intended to process and display lossless and non-lossed medical images provided from DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography, Magnetic Resonance Imaging. Ultrasound, and Nuclear Medical images obtained from other DICOM-compliant modalities.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Mammographic images may only be interpreted using cleared monitors intended for mammography display.

McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists. non-radiology specialists, physicians and technologists.

Device Description

Mammography Plus, an accessory to the McKesson Radiology Station, the radiology viewing component of McKesson Radiology, consists of image display and manipulation tools that help radiologists zoom in onto an image, interpret Computer Aided Detection (CAD) findings, navigate through and visualize digital mammography and Digital Breast Tomosynthesis (DBT) images, compare historically similar images, and configure their reading environment.

Mammography Plus uses the underlying capabilities of McKesson Radiology's diagnostic viewer, McKesson Radiology Station, to integrate specialized functionality into the diagnostic reading workflows. The McKesson Radiology Station viewer interfaces with the McKesson Radiology Platform to access patient and study information.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the McKesson Radiology Mammography Plus device:

The provided documents (K142850) do not contain typical acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, AUC) or a dedicated clinical study demonstrating these metrics against ground truth. Instead, the submission focuses on verifying the device's functionality and image quality against established standards and its substantial equivalence to a predicate device for its intended use as a PACS accessory with mammography viewing and manipulation tools.

The "Performance Data" section describes verification and validation testing, which are typically aimed at ensuring the device meets its design specifications and complies with relevant regulatory and consensus standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative "acceptance criteria" related to diagnostic performance (e.g., sensitivity, specificity) for the device itself. The acceptance is based on functional verification, compliance with standards, and demonstration of substantial equivalence.

Acceptance Criterion (Implicit/Standard-based)	Reported Device Performance
Functional Verification:	Functioned as intended.
ISO 13485:2003 Compliance	Verification and validation testing performed.
IEC 62304:2006 Compliance	Verification and validation testing performed.
ISO 14971:2007/ EN 14971:2012 Compliance	Verification and validation testing performed.
NEMA XR 22-2006 (Image Quality)	Bench testing included testing to conform to this standard.
NEMA XR 23-2006 (Image Quality)	Bench testing included testing to conform to this standard.
IEC/ ISO 10918-1:1994 (Image Quality)	Bench testing included testing to conform to this standard.
NEMA PS 3.1 - 3.20 (2014) DICOM Compliance	Bench testing included testing to conform to this standard.
AAPM TG18 Test Patterns (Display Performance)	Bench testing performed using these patterns in conjunction with AAPM On-line Report No. 03.
SMPTE Test Pattern (Display Performance)	Bench testing performed using this pattern (RP 133-1991).
MQSA Compliance	Bench testing included testing to conform to this act.
Usability Assessments	Performed (compared to predicate).
Image Quality Assessments	Performed (compared to predicate).
Substantial Equivalence to Predicate	Observed results demonstrated substantial equivalence with predicate devices.

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

The document does not describe a "test set" in the context of a diagnostic performance study with patient data. The testing described is primarily focused on functional verification, image quality assessment, and usability. Therefore, there is no information provided on the sample size or data provenance (country, retrospective/prospective) for a clinical test set as one would typically find for a diagnostic AI algorithm.

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

As there is no mention of a diagnostic performance study with a clinical test set, there is no information provided on the number of experts or their qualifications for establishing ground truth for such a test set.

4. Adjudication Method for the Test Set

Since a diagnostic performance study with a clinical test set is not described, there is no information on adjudication methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device is characterized as an accessory for image display and manipulation, not as a diagnostic AI tool that directly provides CAD findings (though it supports interpretation of CAD findings from other systems).

6. Standalone Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance evaluation) for diagnostic accuracy is not described in the provided text. The device's performance is gauged by its ability to meet design specifications, adhere to industry standards for image quality and display, and its usability as an accessory.

7. Type of Ground Truth Used

For the described verification and validation, the "ground truth" is implicitly related to:

Design Specifications: The device's intended functionality.
Consensus Standards: (e.g., NEMA, AAPM, DICOM) which define expected behavior for image display and processing.
Predicate Device Performance: Used for comparison in usability and image quality assessments.

There is no mention of pathology, outcomes data, or expert consensus on patient cases being used as ground truth for diagnostic accuracy in a clinical study.

8. Sample Size for the Training Set

The document does not describe a machine learning algorithm or AI model requiring a "training set." McKesson Radiology Mammography Plus is presented as software for image display, manipulation, and workflow integration for mammography images, including support for CAD findings (presumably from other CAD systems). Therefore, no information on a training set size is provided.

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

Since no training set is mentioned as part of the device's development, this information is not applicable and not provided.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 12, 2015

McKesson Medical Imaging Company % Mr. Paul Sumner Director, Regulatory Affairs McKesson Technologies, Inc. 5995 Windward Parkway ALPHARETTA GA 30005

Re: K142850

Trade/Device Name: McKesson Radiology Mammography Plus™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 15, 2014 Received: December 17, 2014

Dear Mr. Sumner:

This letter corrects our substantially equivalent letter of January 6, 2015.

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2-Mr. Sumner

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert A Ocks

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142850

Device Name

McKesson Radiology Mammography Plus™

Indications for Use (Describe)

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Mammographic images may only be interpreted using cleared monitors intended for mammography display.

McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists. non-radiology specialists, physicians and technologists.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Empowenniq Healthcare

510(k) SUMMARY McKesson Medical Imaging Company's McKesson Radiology Mammography Plus Device

McKesson Medical Imaging Company 130 - 10711 Cambie Road Richmond, B.C. Canada, V6X 3G5

510(k) Owner and Contact:	Gilbert Wong Vice President, Regulatory Operations McKesson Medical Imaging Company 130 - 10711 Cambie Road Richmond, BC Canada V6X 3G5
	Phone: 604-279-5422 Fax: 604-279-5468
	E-mail: Gilbert.Wong@McKesson.com
Date Prepared:	December 15, 2014
Proprietary Name:	McKesson Radiology Mammography Plus™
Common/Usual Name:	PACS
Classification Name:	Picture Archiving Communications System
Classification Regulation:	21 CFR 892.2050
Classification Product Code:	LLZ
Device Class:	Class II
Classification Panel:	Radiology Devices
Predicate Devices:	Hologic, Inc. SecurView DX Diagnostic Workstation (K103385)

Intended Use / Indications for Use

McKesson Radiology Mammography Plus™ ("Mammography Plus"), is an accessory to McKesson Radiology Station™, a component of McKesson Radiology™. McKesson Radiology is medical image and information management software that is intended to receive, transmit, store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information. McKesson Radiology™ includes a suite of standalone, web-enabled software components, and is intended for installation and use with off-the-shelf hardware that meets or exceeds minimum specifications.

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Empowering Healthcare

McKesson Radiology Station is the primary software component used for processing and presentation of medical images on display devices with network access to McKesson Radiology. McKesson Radiology Station is intended to process and display lossless and non-lossless compressed medical images provided from DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography, Magnetic Resonance Imaging, Ultrasound, and Nuclear Medicine, as well as medical images obtained from other DICOM-compliant modalities.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Mammographic images may only be interpreted using cleared monitors intended for mammography display.

McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.

Technological Characteristics

Performance Data

Verification and validation testing were performed on Mammography Plus to ensure it met all design specifications and documentation was provided as recommended by FDA's guidance for industry and FDA staff entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" which included usability and image quality assessments compared to the predicate(s). Performance testing was conducted to verify compliance with specified design requirements in accordance with ISO 13485:2003, IEC 62304:2006 and ISO 14971:2007/ EN 14971:2012. Additionally, performance testing, specifically bench testing, included testing to conform to consensus standards such as NEMA XR 22-2006, NEMA XR 23-

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Emponening Healthcare

2006, IEC/ ISO 10918-1:1994, NEMA PS 3.1 - 3.20 (2014) Digital Imaging and Communications in Medicine (DICOM), American Association of Physicists in Medicine (AAPM) TG18 Test Patterns used in conjunction with Assessment of Display Performance for Medical Imaging Systems (AAPM On-line Report No. 03), Society of Motion Picture and Television Engineers (SMPTE) Test Pattern Recommended Practice: Specifications for Medical Diagnostic Imaging Test Pattern for Television Monitors and Hard-Copy Recording Cameras, RP 133-1991 and the Mammography Ouality Standards Act (MQSA) (AS AMENDED BY MQSRA of 1998 and 2004).

In all instances, Mammography Plus functioned as intended and the observed results demonstrated substantial equivalence with the predicate devices.

Substantial Equivalence

Mammography Plus is substantially equivalent to the identified predicate devices which include Hologic SecurView DX Diagnostic Workstation (K103385), as well as other similar, if not identical, legally commercially available devices in U.S. Interstate commerce. Specifically, Mammography Plus has the same general intended use and similar indications for use, technological characteristics and principles of operation compared to these previously cleared predicate devices.

As with the predicate device(s), Mammography Plus provides end users with the ability for specialized mammography features such as support for interpretation of Computer Aided Detection Structured Reports (CAD SR), Quadrant Zoom, Historical Similar Images (HSI), Zoom to Fit Anatomy, Zoom to Match Region of Interest (ROI), Unviewed Images Tool. Back-to-Back Placement of Images, and Background Air Suppression. Mammography Plus like the predicate device also provides enhanced features which include processing and displaying Digital Breast Tomosynthesis (DBT) images, and DBT-specific tools such as Display Protocols, Scrolling Mode, Cine Speed, Orientation Indications, Toggling between 2D and 3D Views, and reconstruction of thinslab visualizations from the DBT slices (also commonly referred to as "slabbing").

Unlike the predicate device(s), however, similar to other mammography image viewing and reporting devices legally marketed in U.S. interstate commerce, including McKesson Radiology (K140909), Mammography Plus also provides the following functionalities:

The display of BI-RADS® (Breast Imaging-Reporting and Data System) . Assessment Categories obtained from prior patient mammography and other breast imaging reports,
. The ability to automatically dim auxiliary monitors, and
Web-enabled communication functionality for imaging study and patient records ● access.

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Empowering Healthcare

None of the additional functionalities raise any new issues of safety and/ or effectiveness.

Thus, Mammography Plus is substantially equivalent to previously-cleared predicate devices.

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).