(31 days)
HeRO is intended to acquire, store, analyze, and report on ECG data collected from infants. HeRO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.
HeRO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HeRO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.
HeRO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The specialized HRV measurements produced by HeRO have not been approved by the FDA for any specific clinical diagnosis.
HeRO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.
HeRO Version 2.0 is comprised of off-the-shelf Personal Computers (PC's) and special-purpose hardware capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring devices. Data is acquired on a special-purpose Data Acquisition Device (DAD). It is stored and analyzed on a server, also called the Central Monitoring Station (CMS), located in a data closet or other suitable location. Results of the analyses are reported on a viewing station, or Remote Monitoring Station (RMS). The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.
Acceptance Criteria and Device Performance Study for HeRO Version 2.0
This submission describes the HeRO Version 2.0 HRV Analysis System, which is a substantial equivalence determination for an updated version of a previously approved device (HeRO, K021230). The focus of this 510(k) is on demonstrating the updated device maintains the same intended use, technology, and safety/efficacy profile as its predicate, rather than establishing new clinical performance metrics. Therefore, explicit "acceptance criteria" for novel clinical performance and a specific "study" proving these criteria are met are not presented in the traditional sense of a de novo device. Instead, the submission focuses on demonstrating equivalency to the predicate.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) (Special 510(k) for an updated device), the "acceptance criteria" are primarily centered around maintaining the performance, safety, and intended use of the predicate device. The "reported device performance" is then the assertion that HeRO Version 2.0 achieves this equivalence.
| Aspect | Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to the predicate device | "HeRO Version 2.0 has an identical intended use as the predicate (unmodified) device." The device is intended to acquire, store, analyze, and report on ECG data from infants in a hospital neonatal or pediatric ICU, specifically for analyzing variability in RR intervals (heart rate) to identify periods of transient decelerations and/or reduced baseline variability. It does not produce interpretations or diagnoses. |
| Safety and Efficacy | Raises no new questions of safety or efficacy compared to the predicate device. | "HeRO Version 2.0 raises no new questions of safety or efficacy when compared with the predicate device." Tested in accordance with UL 60601-1 and IEC 60601-1-2 (electrical safety and electromagnetic compatibility). Manufactured in accordance with 21CFR820 Quality System Regulations. |
| Technology | Maintains similar underlying technology and functionality for HRV analysis. | Microprocessor based system. "The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability." It is comprised of off-the-shelf PCs, special-purpose hardware, a Data Acquisition Device (DAD), a server (Central Monitoring Station), and viewing stations (Remote Monitoring Stations). |
| Functional Equivalence | Performs the same specialized HRV measurements as the predicate. | "The HRV measurements reported by HeRO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate." |
| Regulatory Compliance | Complies with general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). | Stated compliance with 21CFR820 Quality System Regulations. The FDA's letter confirms that the device is subject to these general controls. |
| Predicate Equivalence | Substantially equivalent to the predicate device (HeRO, K021230). | Concluded to be substantially equivalent to HeRO (K021230). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not detail any specific test set, its sample size, or data provenance used for a clinical performance study demonstrating the device's accuracy or effectiveness with patient data. This is typical for a Special 510(k) where the device is an update to an existing one, and the focus is on engineering changes and maintained performance, rather than new clinical claims. The "Test Summary" section refers to third-party testing for electrical safety and electromagnetic compatibility (UL 60601-1 and IEC 60601-1-2), not clinical performance with a patient data test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
As no clinical performance study with a test set of patient data is described, there is no information provided on experts or ground truth establishment for such a dataset.
4. Adjudication Method
Since no clinical performance study involving expert review of a test set is described, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The HeRO device is described as an "HRV Analysis System" that provides "specialized HRV measurements" and is not intended to "produce any interpretation of those measurements or any kind of diagnosis." This indicates it's an analytical tool, not a diagnostic aid requiring human interpretation in a comparative effectiveness study as typically understood for AI-assisted diagnostics.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study in terms of diagnostic accuracy or clinical utility using patient data. The device's function is to "acquire, store, analyze, and report on ECG data" by identifying "HRV patterns." The performance being demonstrated here is primarily related to its technical ability to compute these HRV measurements and its safety, not its standalone diagnostic accuracy for a specific condition.
7. Type of Ground Truth Used
As no clinical performance study on patient data is detailed, no specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned for establishing the accuracy of the device's HRV measurements in a clinical context.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is consistent with the nature of the submission not detailing a new algorithm development or extensive clinical validation study. The algorithm likely evolved from previous versions or established HRV analysis techniques, rather than being a de novo algorithm from a large training dataset for this specific submission.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information provided on how its ground truth might have been established.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).