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.

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.

Device Description

McKesson Radiology, a Picture Archiving and Communication System (PACS), consists of configurable software-only applications that receive, transmit. store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information to aid in the day-to-day operations and workflow of clinicians and healthcare practitioners. It includes the primary diagnostic viewer McKesson Radiology Station, clinical-reference viewers, workflow tools and administrative tools. Although the primary McKesson Radiology functionalities, such as DICOM study acquisition, storage, and archival, are intended to be installed and used within a hospital or health care facility environment, the viewing, reporting and administrative functions are intended for use both inside and outside of these settings by qualified healthcare practitioners.

AI/ML Overview

The provided text describes a 510(k) premarket notification for McKesson Radiology, a Picture Archiving and Communication System (PACS). The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance data for a new, novel device feature.

Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable or not present in the provided text. The McKesson Radiology device is primarily a software system for managing and displaying medical images, not a diagnostic algorithm with performance metrics like sensitivity and specificity against a ground truth.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria (e.g., minimum diagnostic accuracy, latency) and corresponding reported performance metrics are detailed in the document. The performance data section broadly states:

Acceptance Criteria (Implicit)	Reported Device Performance
Meet all specifications	"McKesson Radiology functioned as intended"
Perform as intended	"McKesson Radiology functioned as intended"
Compliance with ISO 13485:2003, IEC 62304:2006, ISO 14971:2007/EN 14971:2012	"Performance testing was conducted to verify compliance..."
Substantial Equivalence	"observed results demonstrate substantial equivalence with the predicate devices."

2. Sample size used for the test set and the data provenance:

Not explicitly stated. The document mentions "Verification and validation testing" and "Performance testing" but does not provide details on the specific data sets used for these tests, their sample sizes, or their provenance (e.g., country of origin, retrospective/prospective).
Likely internal testing data: Given the nature of a PACS system, the testing would focus on functional correctness, system integration, DICOM compliance, and user interface validity, rather than clinical diagnostic accuracy per se. This would typically involve internal test cases and possibly simulated clinical scenarios.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not stated. As this is a PACS system for managing and displaying images, the concept of "ground truth" as it relates to expert diagnosis of medical conditions in a test set is not directly relevant for demonstrating its primary functionality.
The validation would likely involve experts in software testing, medical imaging informatics, and potentially medical professionals (radiologists, technologists) to verify usability and correct display of images, but not to establish a diagnostic ground truth for algorithmic performance.

4. Adjudication method for the test set:

Not applicable/Not stated. No information is provided regarding an adjudication method, as the testing described is not a clinical study involving diagnostic interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study is not mentioned. This type of study is typically conducted for AI-powered diagnostic aids, which McKesson Radiology is not described as. The document focuses on the system's ability to "receive, transmit, store, archive, retrieve, manage, display, print and process digital medical images."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. TheMcKesson Radiology is a PACS, an infrastructure for image management and display, not a standalone diagnostic algorithm. Its function is to facilitate human interpretation, not to provide automated diagnoses without human interaction.

7. The type of ground truth used:

Not applicable/Implicitly functional correctness. The "ground truth" for this device would be its adherence to technical specifications, DICOM standards, and the correct rendering and management of medical images. It's not a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set:

Not applicable. McKesson Radiology is described as software for image and information management, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As no training set is relevant for this type of device, no ground truth for a training set was established.

Summary

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JUL 02 2014

MCKESSO!

Empowering Healthcare

510(k) SUMMARY McKesson Medical Imaging Company's McKesson Radiology 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: 604-821-6338 Fax: 604-279-5468 E-mail: Gilbert.Wong@McKesson.com

Date Prepared:

March 31, 2014

Proprietary Name: Common/Usual Name: Classification Name: Classification Regulation: Classification Product Code: Device Class: Classification Panel: Predicate Devices:

McKesson Radiology™M PACS Picture Archiving Communications System 21 CFR 892.2050 LLZ Class II Radiology Devices Horizon Medical Imaging (K043146) Fuji Synapse Workstation Software (K051553)

Intended Use / Indications for Use

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NEKESSON

Empowering Healthcare

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 was performed on McKesson Radiology to ensure it met all specifications. The device was further validated to ensure that it performs as intended. 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. In all instances, McKesson Radiology functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices.

Substantial Equivalence

McKesson Radiology is substantially equivalent to the identified predicate devices which include the cleared Horizon Medical Imaging device (K043146) and the Fuji Synapse Workstation Software (K051553), as well as other similar, if not identical, legally commercially available devices in U.S. Interstate commerce. Specifically, McKesson Radiology has the same general intended use and similar indications for use,

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K140969
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technological characteristics and principles of operation compared to these previously cleared predicate devices.

The minor technological differences between McKesson Radiology and its predicate devices raise no new issues of safety or effectiveness. Thus, McKesson Radiology is substantially equivalent to previously-cleared predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 2, 2014

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

Re: K140909

Trade/Device Name: McKesson Radiology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 24, 2014 Received: June 27, 2014

Dear Mr. Sumner:

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 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.

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Page 2-Mr. Sumner

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,

Michael D. O'Hara for

Janine M. Morris 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140909

Device Name McKesson Radiology™

Indications for Use (Describe)

McKesson Radiology™ is medical image and information management software that is intended to receive, transmit, store, archive, retrieve, manage, 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 modalitics.

Lossy compressed manmographic images and digitized film serven 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 healtheare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara

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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).