Horizon Cardiology™ ECG Management is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.

Horizon Cardiology™ ECG Management allows analysis of resting ECGs and provides preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management can also provide a serial comparison of resting ECG data to facilitate review of a patient's current ECG with previous ECGs of the same patient.

Horizon Cardiology™ ECG Management is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators in a hospital or facility providing patient care. Horizon Cardiology ECG Management is not intended for real-time monitoring.

Device Description

Horizon Cardiology™ ECG Management is a standard ECG management system for importing ECG waveform data, reviewing, performing measurements, diagnosis and comparison of ECG procedures and storing them for future review and management.

Horizon Cardiology™ ECG Management functions as a non-real time system. It receives ECG procedure files after the cessation of the ECG procedure, which can originate from any one of a variety of manufacturer's cardiographs, Stress ECG machines, Holter recording devices or Holter analysis and review stations. Horizon Cardiology™ ECG Management acquires the ECG waveforms through a network connection or via a diskette, and normalizes them to a common format. If the ECG cart has made an ECG procedure analysis, Horizon Cardiology™ ECG Management presents it and utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison without changing the raw waveform data.

Horizon Cardiology™ ECG Management acquires the Stress and Holter ECG files in PDF format through a network connection, modem or via a portable media (diskette, SD card, etc.) or wireless device and stores them in their original format without changing the file.

Horizon Cardiology™ ECG Management uses an intuitive interface, which provides tools to edit measurements and procedure diagnoses and enables the physician to seamlessly review numerous ECG procedures. Horizon Cardiology™ ECG Management complies with HL7 standards for export to the Hospital Information System (HIS) to provide billing information. Horizon Cardiology7™ ECG Management supports final ECG report distribution by printing, faxing, e-mailing and automatic export to other systems. The Horizon Cardiology™ ECG Management database complies with the requirements of HIPAA through robust password security, record access security and file allocation in a secure and managed server.

Horizon Cardiology™ ECG Management allows access to ECG records from web-enabled PC's throughout a network and enables authorized clinical users to access the system from remote locations.

AI/ML Overview

The provided text describes McKesson Israel Ltd.'s Horizon Cardiology™ ECG Management system. It is a software application designed to import, display, store, analyze, distribute, and manage information related to ECG procedures. The analysis component uses the Glasgow University Interpretive Algorithm.

However, the provided document does not contain acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy, or reader improvement). It states that "Verification and validation testing was performed on Horizon Cardiology™ ECG Management to ensure it met all specifications. The device was further validated to ensure that it performs as intended. In all instances, Horizon Cardiology™ ECG Management functioned as intended and the results observed demonstrate substantial equivalence with the predicate devices."

This indicates that the study focused on demonstrating substantial equivalence to predicate devices (Medcon Ltd.'s Horizon Cardiology ECG (K061905) and GE Healthcare's GE MUSE® Cardiology Information System (K110132)). Substantial equivalence claims generally rely on demonstrating that the new device has the same intended use, similar technological characteristics, and principles of operation, and does not raise new issues of safety or effectiveness. This is often achieved through comparative analysis of features and functionality rather than rigorous statistical performance testing against predefined criteria for diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria and specific study designs are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of specific performance metrics (e.g., sensitivity, specificity, agreement rates) in the document.	"In all instances, Horizon Cardiology™ ECG Management 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

Test Set Sample Size: Not specified.
Data Provenance (country of origin, retrospective/prospective): Not specified.

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

Not specified. The document states the system "provides preliminary data for editing and confirmation by an over-reading physician," implying physician review but not detailing its role in establishing formal ground truth for validation.

4. Adjudication Method for the Test Set

Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Was an MRMC study done? No, an MRMC study focused on comparing human readers with and without AI assistance is not described. The validation focuses on the system itself and its equivalence to predicate devices.
Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as no such study is described.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

Was a standalone study done? The document indicates that the device performs its own measurements, diagnosis, and serial comparison using the Glasgow University Interpretive Algorithm. It "provides preliminary data for editing and confirmation by an over-reading physician." This implies a standalone diagnostic output that is then subject to physician review. However, the document does not present specific performance metrics for this standalone output against a ground truth. The "performance data" section focuses on meeting specifications and substantial equivalence rather than diagnostic accuracy.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated for performance evaluation. For the system's intended use, the "over-reading physician" is expected to confirm or edit the preliminary analysis, suggesting physician consensus or final readings as the de facto clinical ground truth. However, for the validation study, the specific method of establishing ground truth for performance metrics is absent.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The document describes a system that utilizes the Glasgow University Interpretive Algorithm, an established algorithm, rather than a de novo machine learning model trained on a specific dataset. Therefore, there isn't a "training set" in the context of training a novel AI algorithm.

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

How Ground Truth for Training Set was Established: Not applicable, as the device uses an established algorithm rather than a newly trained AI model.

Summary

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K113515

Empowering Healthcare

510(k) SUMMARY

McKesson Israel Ltd.'s Horizon Cardiology™ ECG Management

McKesson Israel Ltd.
----------------------	--

4 HaNechoshet Street

Tel Aviv

Israel

69710

Contact Person: Tomer Levy, VP Engineering

+972 (0)3 7698000 Phone: +972 (0)3 6478593 Facsimile:

Date Prepared:	15 November 2011
Name of the device	Horizon Cardiology™ ECG Management
Common Name:	Programmable diagnostic computer
Classification Name:	Computer, Diagnostic, Programmable, 21 C.F.R. § 870.1425
Product code:	DQK
Device Class:	Class II
Predicate Device:	Medcon Ltd., Horizon Cardiology ECG (K061905), GE Healthcare, GE MUSE® Cardiology Information System (K110132)

Intended Use / Indications for Use

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Technological Characteristics

Horizon Cardiology™ ECG Management allows access to ECG records from web-enabled PC's throughout a network and enables authorized clinical users to access the system from remote locations.

Performance Data

Verification and validation testing was performed on Horizon Cardiology™ ECG Management to ensure it met all specifications. The device was further validated to ensure that it performs as intended. In all instances, Horizon Cardiology™ ECG Management functioned as intended and the results observed demonstrate substantial equivalence with the predicate devices.

Substantial Equivalence

Horizon Cardiology™ ECG Management is substantially equivalent to Medcon Ltd.'s Horizon Cardiology ECG (K061905), as well as GE Medical Systems Information Technologies, Inc. 's MUSE® Cardiology Information System (K110132). Horizon Cardiology™ ECG Management 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, storage, archival, review, analysis, quantification, reporting and database management of cardiology data and reports. In addition, the products have very similar indications for use.

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Image /page/2/Picture/1 description: The image shows the McKesson logo. The logo consists of the word "MCKESSON" in bold, black letters. Below the word "MCKESSON" is the tagline "Empowering Healthcare" in a smaller, italicized font.

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 (DatamedFT™, DICOM), data exchange (HL7 and PDF), file storage and management (disk based and SAN/NAS), 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™ ECG Management and its predicate devices raise no new issues of safety or effectiveness. Thus, Horizon Cardiology™ ECG Management is substantially equivalent to previously-cleared predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is an abstract image of an eagle in flight, depicted with stylized lines.

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

MAR 1 6 2012

McKesson Israel Ltd. c/o Mr. Tomer Levy VP Engineering 4 HaNechoshet Street Tel Aviv Israel 69710

Re: K113515

Trade Name: Horizon Cardiology ECG Management Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: February 27, 2012 Received: February 27, 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. 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.

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Page 2 - Mr. Tomer Levy

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Horizon CardiologyTM ECG Management

Indications for Use:

Horizon Cardiology™ ECG Management allows analysis or reanalysis of resting ECGs and provides preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management can also provide a serial comparison of resting ECG data to facilitate review of a patient's current ECG with previous ECGs of the same patient.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Page 1 of 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	113515

Proprietary to McKesson

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).