(30 days)
Not Found
No
The summary describes an image and information management system with standard features for viewing, storing, and reporting. There is no mention of AI, ML, or any features that would typically utilize these technologies for analysis or interpretation. The new features listed are related to user interface, data management, and interoperability.
No
The device is an image and information system intended to assist professionals in viewing and interpreting images for diagnosis and treatment, not to provide therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease." This directly indicates its role in the diagnostic process.
No
The device description explicitly lists hardware components like "database server; web server; application server: image and document storage server and media; long-term archive and disaster recovery media; and client application workstation." While software is a key part, it is integrated with and relies on these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that McKesson Cardiology™ is an image processing system designed for the import, export, storage, archival, review, analysis, quantification, reporting, and database management of digital cardiovascular images and information.
- Intended Use: The intended use is to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. This focuses on interpreting visual data, not analyzing biological samples.
- No Mention of Biological Samples: The text does not mention the analysis of any biological samples from the human body.
Therefore, McKesson Cardiology™ falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
McKesson Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources.
McKesson Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration. McKesson Cardiology™ offers support for third-party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.
McKesson Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
McKesson Cardiology™ is an image processing system. The device consists of the following components and accessories: software application: database server; web server; application server: image and document storage server and media: long-term archive and disaster recovery media; and client application workstation.
New additional features and functionalities in this version and subject of this submission include:
-
MC-D (distributed web client application) patient list was redesigned as a browser based procedure list application
-
Procedure priority indication new display of procedure priority level
-
MRN aggregation option to review aggregated list of all patient procedures in MC-D for patients with multiple procedures from different facilities
-
VNA Interoperability Imaging Object Change Management (IOCM)
-
Vascular report redesigned as a browser based module
-
Multi-facility Support
-
New platform qualifications
-
EMR integration enhancements
-
-Added security, privacy and cybersecurity enhancements
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multimodality image
Anatomical Site
cardiac and vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing was performed on McKesson Cardiology to ensure it met all specifications. In addition, usability testing was performed, where applicable. 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 62304:2015 and ISO 14971:2007, FDA Guidelines for Cybersecurity and Interoperability. Furthermore, DICOM conformance testing was performed to verify compliance with NEMA 3.1-3.20 (2016) standards. No clinical studies were necessary to support substantial equivalence. In all instances, McKesson Cardiology functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 24, 2018
Change Healthcare Israel Ltd. % Mr. Paul Sumner Sr. Director, Compliance & Regulatory Affairs Change Healthcare Technologies LLC 5995 Windward Parkway ALPHARETTA GA 30005
Re: K181080
Trade/Device Name: McKesson Cardiology™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 12, 2018 Received: April 24, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jo Delfino
for
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181080
Device Name McKesson Cardiology™
Indications for Use (Describe)
McKesson Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources.
McKesson Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration. McKesson Cardiology™ offers support for third-party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.
McKesson Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.
| 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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3
510(k) SUMMARY Change Healthcare Israel Ltd.'s McKesson Cardiology
Change Healthcare Israel Ltd. 26 HaRokmim St.Azriel Center, Building A Holon, 5885849, Israel
Contact Person: Nadia Marchant,
Executive Director, Quality Assurance & Regulatory Affairs Change Healthcare Canada Company 10711 Cambie Road Richmond, BC Canada V6X 3G5 Phone: 604 279 5422 Fax: 604 279 5468 E-mail: Nadia.Marchant@McKesson.com
Date Prepared: April 08, 2018
| Name of the device: | McKesson Cardiology™ |
|---|---|
| Common or Usual Name: | Imaging Processing System |
| Classification Name: | Picture archiving and communications system |
| Classification Regulation | 21 C.F.R. § 892.2050 |
| Product code: | LLZ |
| Device Class: | Class II |
| Predicate Device: | Change Healthcare Israel Ltd.'s McKesson Cardiology™ (K151850) |
Intended Use / Indications for Use
McKesson Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources.
McKesson Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration.
McKesson Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.
McKesson Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.
4
The version of McKesson Cardiology which is the subject of this 510K notification, includes new additional features and enhanced functionality compared to the cleared version. These changes were introduced in the product in order to improve overall user experience and workflow. The changes introduced do not adversely affect or raise any new issues of safety or effectiveness in the product.
Technological Characteristics
McKesson Cardiology™ is an image processing system. The device consists of the following components and accessories: software application: database server; web server; application server: image and document storage server and media: long-term archive and disaster recovery media; and client application workstation.
New additional features and functionalities in this version and subject of this submission include:
-
MC-D (distributed web client application) patient list was redesigned as a browser based procedure list application
-
Procedure priority indication new display of procedure priority level
-
MRN aggregation option to review aggregated list of all patient procedures in MC-D for patients with multiple procedures from different facilities
-
VNA Interoperability Imaging Object Change Management (IOCM)
-
Vascular report redesigned as a browser based module
-
Multi-facility Support
-
New platform qualifications
-
EMR integration enhancements
-
-Added security, privacy and cybersecurity enhancements
Performance Data
Verification and validation testing was performed on McKesson Cardiology to ensure it met all specifications. In addition, usability testing was performed, where applicable. 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 62304:2015 and ISO 14971:2007, FDA Guidelines for Cybersecurity and Interoperability. Furthermore, DICOM conformance testing was performed to verify compliance with NEMA 3.1-3.20 (2016) standards. No clinical studies were necessary to support substantial equivalence. In all instances, McKesson Cardiology functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices.
5
Substantial Equivalence
McKesson Cardiology™, the subject of this submission, is substantially equivalent to Change Healthcare Israel's Ltd.'s previously cleared McKesson Cardiology™ (K151850). McKesson Cardiology™ has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate device.
The minor technological differences between McKesson Cardiology™ and its predicate device raise no new issues of safety or effectiveness. Thus, McKesson Cardiology™ is substantially equivalent to the previously cleared predicate device.