(146 days)
The Honeywell HomMed Genesis Touch™ Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs include noninvasive blood pressure. pulse oximetry, pulse rate, weight, temperature, blood sugar, prothrombin time/international normalized ratio (PT/INR), peak expiratory flow (PEF) and forced expiratory volume (FEV1). The Genesis Touch Retrospective Physiological Monitoring System collects; displays and transmits vital signs measurements from commercially available medical devices designed for home use. Collected measurement data from the Genesis Touch System can then be transmitted via a communication module to a central viewing station where the data can be viewed and analyzed by a healthcare professional.
The Genesis Touch Retrospective Physiological Monitoring System is intended for home use by patients and caregivers or in a healthcare related environment by healthcare providers.
The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring and does not have auditory or visual alarms for out-oflimit parameters.
The modified Honeywell HomMed Genesis Touch™ Retrospective Physiological Monitoring System (Genesis Touch 10 System) is a vital signs monitoring station.
The modified Genesis Touch System is a proprietary software application running on a dedicated software/commercially available tablet platform with touch screen; Wi-Fi, Bluetooth and video capability.
The modified Genesis Touch System uses text and voice prompts to collect users' vital signs information from paired Bluetooth noninvasive medical device peripherals, such as blood pressure, pulse oximetry, pulse rate, weight, temperature, blood sugar, and allows for manual entry of blood sugar, prothrombin time/international normalized ratio (PT/INR), peak expiratory flow (PEF) and forced expiratory volume (FEV1). The encrypted data is automatically or at the user's discretion, forwarded to a remote central monitoring station (Honeywell HomMed LifeStream Management Suite) for retrospective review by healthcare providers.
LifeStream Management Suite, a Windows-based application interface is used by the healthcare provider for the remote configuration of all the Genesis monitors, triaging of patient data, trending of clinical information, and the opportunity to provide preventative patient care.
The modified Genesis Touch System also asks the user disease specific symptom management questions and provides reminder information, just like the predicates Genesis DM and Genesis Touch System. Both the modified Genesis Touch System and predicate Genesis Touch System, offer animated video instructions and optional one-touch, video-based communication in addition to traditional telemonitoring.
The modified Genesis Touch monitor expands the user population to include patients and caregivers willing and capable of managing its use. The modified Genesis Touch System is a touch screen tablet with a consumer-based Android platform like the predicate Genesis Touch System. This type of user interface is easily usable by a wider age and acuity range. The user population of the predicate monitors, Genesis Touch System and Genesis DM Monitor are designated for use with adult and pediatric patients over twelve years of age. The expanded user population of the modified Genesis Touch System is presented in order to compliment the user population of interfaced peripheral medical devices which do not limit the user population to being over twelve years of age. This modification does not change the intended use of the modified Genesis Touch System as a communication hub that collects; displays and transmits vital signs data from noninvasive medical device peripherals via a communication module to a central viewing station for retrospective review by a healthcare professional. This modification does not affect the safety and effectiveness of the Genesis Touch System when used as labeled.
The provided document describes the Honeywell HomMed Genesis Touch System, a retrospective physiological monitoring system. It contains information about its indications for use, technological characteristics, and performance data from non-clinical testing. However, it does not include the specific details required to fully address your request in the format you provided.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance with specific metrics (e.g., accuracy, precision for each vital sign).
- Details on sample sizes used for a test set or training set for performance evaluation related to specific vital sign measurement accuracy. The document mentions "risk-based verification and validation testing," but not in terms of ground truth comparison.
- Data provenance (country of origin, retrospective/prospective) for any test or training sets.
- Number of experts or their qualifications, or adjudication methods for establishing ground truth.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Details on a standalone (algorithm only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data) for specific physiological measurements.
- How ground truth for a training set was established.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Honeywell HomMed Genesis DM Pro BP and Honeywell HomMed Genesis Touch System). The "Performance (Non-clinical) Data" section describes software verification and validation, ensuring the system met performance and functional specifications for usability, interoperability, data transfer, accuracy display and transmission, system reliability, and serviceability. This refers more to the functionality of the device as a data collection and transmission hub rather than the intrinsic accuracy of measuring vital signs against a gold standard. The device collects vital signs from commercially available peripheral medical devices; it does not itself primarily measure the vital signs.
Therefore, I cannot provide a detailed answer to your request as the necessary information regarding acceptance criteria, specific performance metrics against ground truth, and study design elements like sample sizes, expert qualifications, and ground truth establishment methods are not present in the provided text.
§ 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).