(133 days)
Horizon 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.
Horizon Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and may be part of a larger PACS configuration.
Horizon Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.
Horizon 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.
The provided 510(k) summary for McKesson Israel Ltd.'s Horizon Cardiology™ does not contain specific acceptance criteria or a study that evaluates the device against such criteria in terms of clinical performance or accuracy beyond confirming its intended functionality.
Instead, the submission focuses on substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation. The "Performance Data" section states that "Verification and validation testing was performed on Horizon Cardiology™ to ensure it met all specifications. The device was further validated to ensure that it performs as intended. In all instances, Horizon Cardiology™ functioned as intended and the results observed demonstrate substantial equivalence with the predicate devices." This suggests internal testing for functionality and specifications, but no detailed clinical performance study with defined acceptance criteria is presented.
Therefore, the requested information cannot be fully extracted from the provided text. However, based on the information given, here's what can be inferred and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of the provided document. The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a specific diagnostic task). The "performance" discussed broadly refers to the device functioning as intended in comparison to predicate devices, not against specific, measurable clinical outcomes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document for clinical performance. The criteria are implicitly related to the functional specifications and intended use being equivalent to predicate devices. | "In all instances, Horizon Cardiology™ functioned as intended and the results observed demonstrate substantial equivalence with the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
Not specified. The document mentions "Verification and validation testing" but does not detail the nature of this testing, the size of any test sets (clinical or technical), or the provenance (country of origin, retrospective/prospective) of any data used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable/Not specified. Since no clinical performance study with a test set and ground truth establishment is described, this information is not present.
4. Adjudication Method for the Test Set
Not applicable/Not specified. As no clinical performance study with a test set is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
No. The device is described as an image and information system for import, export, storage, archival, review, analysis, quantification, reporting, and database management. It's a system to support cardiovascular imaging workflows, not a standalone AI algorithm designed for automated diagnostic tasks. Therefore, a standalone performance study in the sense of an "algorithm only" evaluation is not relevant or described.
7. Type of Ground Truth Used
Not applicable/Not specified. Without a clinical performance study, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" for the device's functionality would likely be adherence to technical specifications and successful execution of its stated features.
8. Sample Size for the Training Set
Not applicable/Not specified. As this is not presented as an AI/machine learning diagnostic device in the sense of a predictive algorithm, there is no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. Similar to the above, without a training set for an AI algorithm, there is no information on how its ground truth would be established.
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Horizon Cardiology 510(k)
JAN 3 0 2012
Empowering Healthcare
510(k) SUMMARY
McKesson Israel Ltd.'s Horizon Cardiology™
McKesson Israel Ltd. 4 HaNechoshet Street Tel Aviv Israel 69710
Contact Person: Tomer Levy, VP Engineering Phone: +972 (0)3 7698000 Facsimile: +972 (0)3 6478593
Date Prepared: January 4, 2012 Horizon CardiologyTM Name of the device:
Common or Usual Name: Imaging Processing System
892.2050
LLZ
II
Classification Name:
Product code:
Device Class:
Predicate Device:
Philips's Xcelera (K061995)
Medcon Ltd. TCS(K974679)
GE Medical Systems Information Technologies' Centricity (K063628)
Picture archiving and communications system, 21 C.F.R. §
Intended Use / Indications for Use
Horizon 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.
Horizon Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and may be part of a larger PACS configuration.
Horizon Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.
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Image /page/1/Picture/0 description: The image shows the McKesson logo. The logo is in black and consists of the word "McKesson" in a bold, sans-serif font. Below the logo is the tagline "Empowering Healthcare" in a smaller, italicized font. The logo is simple and modern, and the tagline conveys the company's mission.
Horizon Cardiology 510(k)
Technological Characteristics
Horizon 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.
Performance Data
Verification and validation testing was performed on Horizon Cardiology™ to ensure it met all specifications. The device was further validated to ensure that it performs as intended. In all instances, Horizon Cardiology™ functioned as intended and the results observed demonstrate substantial equivalence with the predicate devices.
Substantial Equivalence
Horizon Cardiology™ is substantially equivalent to Medcon Ltd.'s TCS. as well as Philip's Xcelera, and GE Medical Systems Information Technologies' Centricity. Horizon Cardiology™ has the same intended uses and similar indications, technological characteristics. and principles of operation as the predicate devices. All of the products are generally intended to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital medical images. In addition, the products have very similar indications for use.
The products also feature identical or very similar Client and Server operating systems, industry standards for system and network connectivity and communication (LAN, WAN. TCP/IP), image communication (DICOM), data exchange (HL7, PDF), file storage and management, and database engines. Moreover, all of the products feature structured templates for reporting on selected types of imaging. The minor technological differences between Horizon Cardiology™ and its predicate devices raise no new issues of safety or effectiveness. Thus. Horizon Cardiology™ is substantially equivalent.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal on the left side, containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus. The symbol is composed of three curved lines that converge at the top and bottom. The logo is black and white.
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
McKesson Israel Ltd. % Mr. Tomer Levy VP Engineering McKesson Israel Ltd. MD 605 Hanechoshet 4, 69710 TEL AVIV ISRAEL
JAN 3 0 2012
Re: K112720
Trade/Device Name: Horizon CardiologyTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: January 4, 2012 Received: January 4, 2012
Dear Mr. Levy:
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 (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 Pastel
Mary S. Pastel. Sc.D. 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
510(k) Number (if known): K112720
Device Name: Horizon CardiologyTM
Indications for Use:
Horizon 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.
Horizon Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and may be part of a larger PACS configuration.
Horizon Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Pastel
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K112720
Page 1 of
§ 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).