(52 days)
The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis OTC Monitor's measurement capabilities. Data from the Genesis OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.
The Honeywell HomMed Genesis OTC Monitor System is a vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, and weight. The Genesis OTC Monitor has four serial ports available for external options. The Genesis OTC Monitor acquires vital signs data and displays it. The data can also be transmitted via the communication system to a central viewing station.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Honeywell HomMed Genesis OTC Monitor System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance in terms of vital signs measurement accuracy (noninvasive blood pressure, pulse rate, weight). Instead, it relies on compliance with general standards and demonstrating equivalence to a predicate device.
The reported device performance is described in terms of compliance with these standards and functional specifications.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Equivalence to Predicate Device | As safe, as effective, and performs as well as the HomMed Genesis Patient Monitor System (K040799) | "The results of these evaluations demonstrate the Genesis OTC Monitor is as safe, as effective and performs as well as the legally marketed predicate device, HomMed Genesis Patient Monitor." |
| Medical Electrical Safety | Compliance with EN 60601-1 | "Completed ... safety (operator and patient) ... testing demonstrate compliance with applicable standards." |
| EMC Compliance | Compliance with IEC 601-1-2 | "Completed EMC ... testing demonstrate compliance with applicable standards." |
| Biocompatibility | Compliance with ISO 10993-5,10-11 | "Biocompatibility testing performed." (Implied compliance) |
| Mechanical Durability | (No specific standard listed, but implied as a test category) | "Completed ... mechanical durability ... testing demonstrate compliance with applicable standards." |
| Electrical Performance | (No specific standard listed, but implied as a test category) | "Completed ... electrical ... testing demonstrate compliance with applicable standards." |
| Environmental Performance | (No specific standard listed, but implied as a test category for temperature/humidity) | "Completed ... temperature/humidity testing demonstrate compliance with applicable standards." |
| Overall Performance | Consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices; performs within specifications and functional requirements. | "The Honeywell HomMed Monitor System (Genesis OTC and its predicate Genesis) utilized within the environments for which it is marketed performs consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices." |
| "The test results demonstrated that the Genesis is in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any clinical or performance test set. It mentions "testing" but provides no details on the number of subjects or data points.
The data provenance is not explicitly stated as retrospective or prospective, or country of origin. The study described appears to be a series of engineering and compliance tests rather than a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" in this context appears to be defined by the technical standards (e.g., EN 60601-1, IEC 601-1-2, ISO 10993) and the performance of the predicate device, rather than expert consensus on medical measurements from a test set.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Since no clinical test set with human measurements requiring adjudication is described, there's no mention of adjudication methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence and compliance with technical standards, not on human reader performance with or without AI assistance. This device is a vital signs monitor, not typically an imaging-based AI diagnostic tool that would involve human readers interpreting AI output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The study described is essentially a standalone (device-only) performance evaluation against technical standards and comparison to a predicate device's specifications. The device's function is to measure vital signs, and its compliance is assessed independent of a human interpreting its readings in a "human-in-the-loop" clinical trial setting. The "OT" in "OTC" (Over-The-Counter) implies direct user interaction without a clinician interpreting the raw data in real-time.
7. Type of Ground Truth Used
The ground truth used in this submission appears to be:
- Compliance with established engineering and safety standards: EN 60601-1, IEC 601-1-2, ISO 10993-5,10-11, and FDA reviewer's guides for respiratory devices.
- Performance of the legally marketed predicate device: HomMed Genesis Patient Monitor System (K040799). The new device is deemed "as safe, as effective and performs as well as" the predicate.
8. Sample Size for the Training Set
The document does not mention a training set. This device likely uses traditional signal processing and measurement algorithms, not machine learning or AI that would require a distinct training set for model development.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, this information is not applicable.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).