(151 days)
McKesson Cardiology ECG Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or retrieved by the Horizon Cardiology ECG Management device. The McKesson Cardiology ECG Mobile software application is intended to be used from a mobile device to perform the following:
- View ECG test results, such as waveforms, synopsis measurements and diagnosis statements, as well as other relevant current or historical patient information originally stored, analyzed or retrieved by the Horizon Cardiology ECG Management device.
- View the ECG lead traces using different display settings.
- . Compare the results of current ECG tests with any previous ECG test results stored on the Horizon Cardiology ECG Management device.
- . Perform ECG-related measurements and edit synopsis measurement values stored on the Horizon Cardiology ECG Management device.
- Enter new diagnosis statements and/or modify diagnosis records stored on the Horizon . Cardioloģy ECG Management device.
- . Confirm ECG procedures and results.
- . Communicate information with the Horizon Cardiology ECG Management device such as login credentials and user settings.
The McKesson Cardiology ECG Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators.
The McKesson Cardiology ECG Mobile application is not intended for real-time monitoring.
McKesson Cardiology ECG Mobile provides secure access to ECG records and related information contained on the Horizon Cardiology ECG Management device. The McKesson Cardiology ECG Mobile software functions as an accessory to the Horizon Cardiology ECG Management device, and requires a WiFi or cellular connection to a pre-installed and properly configured Horizon Cardiology ECG Management device. Through providing remote access to the ECG data stored on the McKesson Cardiology ECG Management device, the user is able to review current and previous ECG tests results, perform measurements on the ECG waveforms, and edit and confirm the ECG test results. McKesson Cardiology ECG Mobile does not store ECG or patient related information on the mobile device, does not directly communicate with cardiographs or other waveform acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data. The device does not allow modification of the original ECG traces (waveforms) stored on the Horizon Cardiology ECG Management device.
The McKesson Cardiology ECG Mobile application is not intended to replace the functionalities provided by the Horizon Cardiology ECG Management desktop client but to extend those to make selected functionalities described above available via mobile devices.
The McKesson Cardiology ECG Mobile functions as a non-real time system and is not intended for real time monitoring.
McKesson Cardiology ECG Mobile can be used both inside of medical facilities except in areas where cellular phone or wireless device use is prohibited.
McKesson Cardiology ECG Mobile is intended to operate on Apple®iPad running iOS mobile operating system from Apple Inc.
This 510(k) summary describes the McKesson Cardiology™ ECG Mobile, a software application designed to provide remote access to ECG data and related patient information from a mobile device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly define quantitative acceptance criteria for the McKesson Cardiology™ ECG Mobile. Instead, the performance data focuses on qualitative outcomes and ensuring the device functions as intended and is substantially equivalent to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Met all design specifications and requirements | "McKesson Cardiology™ ECG Mobile met all design specifications and requirements." |
| Operability with the predicate Horizon Cardiology ECG Management device | "Unit and system level testing included assurance of operability with the predicate Horizon Cardiology ECG Management device." |
| User accuracy qualification of ECG waveform and related information representation | "User accuracy qualification of ECG waveform and related information representation in a simulated user test environment." |
| Display and measurements acquisition capabilities verified in clinical qualification | "Clinical Qualification testing performed verified the McKesson Cardiology ECG Mobile display and measurements acquisition capabilities." |
| Adequate user readability and image quality on a small screen | "Testing was performed to ensure adequate user readability and image quality on a small screen." |
| Users with varying qualifications could use the device (Human Factors) | "Testing was performed to ensure... that users with varying qualifications could use the device." |
| Functions as intended by design requirements | "In all instances, the McKesson Cardiology™ ECG Mobile functioned as intended by the design requirements." |
| Substantial equivalence to predicate devices | "The observed results demonstrated substantial equivalence with the predicate devices." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Clinical Qualification Testing: Sample cases were "selected by a clinician based on technical characteristics and relevancy to the intended function." The exact number of samples is not specified.
- Usability Testing (Human Factors): Conducted by "three (3) U.S. medical facilities." The number of individual users involved in this testing is not specified, but it implies a prospective approach within the US.
- Data Provenance: The usability testing was conducted in "U.S. medical facilities," indicating prospective data collection from the US. The origin of the sample cases for clinical qualification is not explicitly stated but implies relevance to clinical practice.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Clinical Qualification Testing: "Sample cases selected by a clinician." The number of clinicians is not specified. Their qualifications are not explicitly detailed beyond being a "clinician."
- Usability Testing: The document mentions "users with varying qualifications" without specifying if these users were deemed "experts" for ground truth establishment. The focus of usability testing is on human factors and device interaction rather than establishing medical ground truth.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "clinical qualification" involved a clinician selecting sample cases and assessing the device's display and measurement capabilities against "the original data as presented by Horizon Cardiology ECG Management." This suggests a direct comparison against a reference system rather than a consensus-based adjudication among multiple experts.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader, multi-case (MRMC) comparative effectiveness study is mentioned. The device is purely for viewing and editing existing ECG data, not for independent diagnostic interpretation or AI-assisted interpretation, therefore, comparing human readers with and without AI assistance is not applicable to its intended use.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a software application for viewing and editing ECG data previously stored and analyzed by another device (Horizon Cardiology ECG Management). It "does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data." Therefore, a standalone performance study of an algorithm without human-in-the-loop performance is not applicable to this device, as it does not contain such algorithms.
7. Type of Ground Truth Used
The ground truth used for performance assessment (specifically clinical qualification) was "the original data as presented by Horizon Cardiology ECG Management." This implies that the Horizon Cardiology ECG Management system serves as the reference standard for waveforms and data representation.
8. Sample Size for the Training Set
The document does not mention a "training set" as the device does not employ machine learning or AI algorithms that would require such data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).