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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 for storage, review, analysis, and display.

The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters.

The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older.

The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active.

The Device is not intended for critical care.

The BioButton System (the "Device") 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 Device for storage and analysis.

The Device is an extension of the Predicate Device (K212957) with the same intended use. The Device consists of a multiple-use and rechargeable 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. The main components of the Device include the following:

1. A wearable sensor to collect data from a patient
2. A device-based Medical Device Data System (MDDS) data gateway to transfer data from the wearable sensor to the cloud
3. A cloud-based Medical Device Data System (MDDS) for data storage and transmission
4. A cloud-based system for configuration of the wearable sensor and data analysis
5. A cloud-based system for healthcare professionals to view patient information

The Device is used to collect physiological information from a patient using the 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 rest. The medical physiological data collected includes:

• Heart rate at rest,
• Respiratory rate at rest, and
• Skin temperature

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 regulatory 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. The Device also provides a web display for healthcare professionals to view patient information.

The provided text is a 510(k) summary for the BioButton System, a remote monitoring wearable device. It describes the device, its intended use, and comparisons to a predicate device, along with performance testing conducted to support substantial equivalence.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides the following performance specifications for the BioButton System:

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