(103 days)
The Epicardia Anywhere is indicated as a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.
The Epicardia Anywhere System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail and clinicallysignificant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.
This document is a 510(k) summary for the Epicardia Anywhere device, primarily comparing it to a predicate device, the Epicardia 5000. It focuses on demonstrating substantial equivalence based on technological characteristics and indications for use, rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial.
Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets those criteria (e.g., sample size for test sets, number of experts, MRMC studies, ground truth establishment) is not detailed in this submission. The submission explicitly states "CLINICAL TESTING: Not Applicable."
However, I can extract the relevant information provided and frame it within the context of required testing for substantial equivalence.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a table with explicit performance-based acceptance criteria related to clinical accuracy (e.g., sensitivity, specificity for arrhythmia detection) and corresponding reported performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the technological characteristics and indications for use of the subject device (Epicardia Anywhere) are the same or substantially equivalent to the predicate device (Epicardia 5000) and that applicable non-clinical standards were met.
The comparison table provided in the document serves as the basis for demonstrating equivalence in technological characteristics.
| Feature | PREDICATE DEVICE Epicardia 5000 (K090834) | SUBJECT DEVICE Epicardia Anywhere | Substantially Equivalent (SE) Determination | Implied Acceptance Criterion | Reported Device Performance (vs. Predicate) |
|---|---|---|---|---|---|
| ECG Analysis | Yes (Diogenes) | Yes (Diogenes) | Identical/SE | ECG analysis algorithm (Diogenes) must be capable of processing and classifying ECG events similarly to the predicate. | Same Diogenes version as predicate. |
| User Interface | Personal Computer (Windows) | Personal Computer (Windows) | Identical/SE | User interaction and display of information should be consistent with predicate. | Same Windows-based PC interface. |
| PC Interface | TCP/IP, Trans Telephonic, Cellular, Direct, USB, File | TCP/IP, Trans Telephonic, Cellular, Direct, USB, File | Identical/SE | Device must support the same methods for data transfer and communication as the predicate. | Uses the same interface options. |
| Operating System | Microsoft Windows | Microsoft Windows | Identical/SE | Must operate within a standard, consistent software environment. | Same Microsoft Windows based application. |
| Location of Server | Desktop | Azure-cloud based | Different/SE | Cloud-based server must not introduce new safety/effectiveness issues and maintain functionality. | Functionality retained; no new safety/effectiveness issues introduced. Hazard analysis confirmed SE. |
| EC38 Type | Type 3 | Not Applicable | Different/SE | (Not applicable for software-only system, demonstrating it doesn't need this spec if it's solely software.) | Solely a software system, so EC38 is not applicable. |
| Unique Patient ID | Limited | Unlimited | Different/SE | Expanded patient ID capability should not negatively impact device function or data integrity. | Expanded from limited to unlimited. |
| Processor | 16 BIT | 64 BIT | SE | Processor upgrade should improve performance without negatively impacting existing functionalities or safety. | Server side software changed from 16 bit to 64 bit. |
| Consecutive ECG (Workflow) | 24-Hours to 30-Day | 24-Hours to 30-Day | Identical/SE | Must support the same monitoring durations and workflow as the predicate. | Presents consecutive ECG of 24 hours to 30 days in workflow, same as predicate. |
| Indications for Use | "Indications for Use" (implied, predicate features) | "Indications for Use" (explicitly stated) | Same (with minor additions) | Indications for Use must be the same or very similar, demonstrating the same purpose and clinical application. | Same, with exception of adding required age designation and prescription notation. |
Implied Acceptance Criteria for Non-Clinical Testing:
The document lists national and international standards utilized for testing, implying that compliance with these standards serves as "acceptance criteria" for safety and effectiveness:
- ANSI/AAMI EC57:1998/(R)2008 Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms
- AAMI / ANSI / ISO 14971:2007/(R)2010 Medical devices - Application of risk management to medical devices
- AAMI / ANSI / IEC 62366:2007/(R)2013 Medical Devices - Application of Usability Engineering to Medical Devices
Reported Performance (in relation to these standards):
"None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Epicardia Anywhere testing met all relevant requirements of the aforementioned tests and therefore, the subject device does not introduce any new issue of safety or effectiveness and is substantially equivalent to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified, as clinical testing was "Not Applicable." The document refers to "testing" against standards (e.g., ANSI/AAMI EC57 for algorithms), which typically involves well-defined datasets (e.g., standard ECG databases like MIT-BIH Arrhythmia Database). However, the specific size or characteristics of the datasets used for general "testing" are not detailed in this 510(k) summary.
- Data Provenance: Not specified. Again, clinical data was not used. For "testing" against standards, common practice would be to use publicly available and well-characterized ECG databases.
- Retrospective/Prospective: Not applicable, as no clinical testing was performed or reported.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable, as no clinical test set requiring expert ground truth for performance evaluation was involved. The 510(k) relies on the substantial equivalence to a predicate, utilizing the same core algorithm (Diogenes) which would have been validated previously.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring adjudication was involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states "CLINICAL TESTING: Not Applicable." The rationale is that "No new issues of safety or effectiveness are introduced by using this device" (due to primarily being a cloud-based server change and retaining core functionality).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies that the core ECG analysis algorithm, "Diogenes," was part of the testing implicitly. It states "The ECG analysis, Diogenes, remains the same. The version of Diogenes in the subject device is the same version of Diogenes in the predicate, Epicardia 5000."
- Furthermore, ANSI/AAMI EC57:1998/(R)2008 is listed as a standard used for testing. This standard is specifically "Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms," which implies an assessment of the algorithm's performance in a standalone manner. However, the results of this testing (e.g., specific performance metrics) are not provided in the summary, only the statement that the testing "met all relevant requirements."
7. The Type of Ground Truth Used
- For the non-clinical testing of the Diogenes algorithm (implied by the use of ANSI/AAMI EC57), the ground truth for such algorithms is typically established from standardized ECG databases (e.g., MIT-BIH Arrhythmia Database) where expert annotations have already designated arrhythmias and other cardiac events. The submission does not specify which databases were used.
8. The Sample Size for the Training Set
- Not specified. The document focuses on demonstrating equivalence to an existing device rather than a de novo development of a new algorithm where training set details would be critical. The "Diogenes" algorithm is pre-existing; its training set details would have been established during its original development and validation.
9. How the Ground Truth for the Training Set was Established
- Not specified. This relates to the development of the "Diogenes" algorithm itself, which is a component of both the predicate and subject devices. Ground truth for arrhythmia detection algorithms is typically established by expert cardiovascular specialists (e.g., cardiologists, electrophysiologists) manually annotating ECG waveforms. These annotations are then used to train and validate the algorithm.
In summary: This 510(k) summary for Epicardia Anywhere is a "software modification" submission, where the primary justification for substantial equivalence is that the device uses the same core algorithm ("Diogenes") and maintains the same indications for use as a previously cleared predicate device. The changes are primarily in the deployment environment (cloud vs. desktop server) and underlying infrastructure (64-bit processor, unlimited patient IDs). Due to this nature, the FDA's review relies on non-clinical testing demonstrating that these changes do not introduce new safety or effectiveness issues, rather than requiring a new clinical performance study with human readers or specific statistical acceptance criteria for accuracy metrics.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.