(452 days)
The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis.
Data are securely transmitted via wireless connection from the device for storage, review, and further analysis.
The data from the device are intended as an aid to diagnosis, diseases management, and treatment.
The device is intended for use on users who are 18 years of age or older.
The device is not intended to output physiological measurements while the user undergoes significant motion or is active.
The device is not intended for critical care.
The BioButton System is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted from the BioButton for storage and analysis.
The BioButton System (the System), is an extension of the BioSticker System with the same/similar intended use. The System is intended to monitor physiological parameters of the patient/users for relatively long duration (up to 60 days with medical data collection). The System should now enable the connectivity with the BioButton sensor device (BBN) with the rest of the system components.
The BioButton System consists of a single-use wearable hardware sensor module to collect data from a patient and other Medical Device Data System (MDDS) components that enables remote transfer of collected data. See main components of the BioButton System. The main components of the BioButton System could include the following:
- BioButton Sensor -
- -BioButton adhesives (accessory)
- Data Exchange Hubs (MDDS) -
- -Cloud-based data platform (MDDS)
The BioButton System is used to collect physiological information from a patient using the BioButton Sensor for a set duration (as defined by different use cases) in home and healthcare settings. Physiological data is collected continuously while the patient is at rest¹. The medical physiological data collected includes:
- . Heart rate at rest,
- . Respiratory rate at rest, and
- Skin temperature
¹ "At Rest" means the device will not output measurement data to the user undergoes significant motion or is active.
There are other wellness parameters that can be collected by the device that include: activity level, body position, sleep, and step and gait analysis. These wellness data types are not discussed in detail the requlatory submission since they do not meet the definition of medical device.
Upon completion of a physiological data collection period, the data offload is conducted via wireless Bluetooth connection using the Offload Software. The data offloading is performed and qualified personnel. Also using the Offload Software, a report will be generated to be viewed by a healthcare professional. The report is not intended to be viewed by the patient.
The provided text describes the BioButton System, a remote monitoring wearable device, and its acceptance criteria as part of a 510(k) submission to the FDA. The information focuses on demonstrating substantial equivalence to a predicate device (BioSticker System K191614).
Here's a breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for performance are clearly stated in the "Performance / Effectiveness" section (page 8).
| Comparison Items | Acceptance Criteria (BioButton System) | Reported Device Performance (BioButton System) |
|---|---|---|
| Heart Rate Range | 40-125 Beats per Minute | 40-125 Beats per Minute (stated as "Same" as predicate, implying it meets this range) |
| Heart Rate Accuracy | Mean absolute error of less than 5 Beats per minute ( |
§ 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).