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510(k) Data Aggregation
K Number
K173510Device Name
BioStamp nPoint
Manufacturer
Date Cleared
2018-05-08
(176 days)
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
MC10 Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BioStamp nPoint is a wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and professional healthcare settings during research studies. These physiological data include heart rate variability, respiration rate, activity (including step count and activity classification), and posture (body position relative to gravity). The system is also intended for measurement of surface electromyography, and to monitor limb or body living and sleep. Data are transmitted wirelessly from the Sensors for storage and analysis.
The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The BioStamp nPoint system are only intended for use by researchers and healthcare professionals for research applications, including at the discretion of a qualified healthcare professional as an aid to diagnosis and treatment in the context of clinical research and product development. The device is not intended for use on critical care patients, and is not a real time or remote diagnostic device.
Device Description
The BioStamp nPoint system is a wireless remote monitoring platform intended for use by healthcare professionals and researchers for the continuous collection of physiological data in home and healthcare settings. The system is designed only for data collection during research studies.
The BioStamp nPoint system centers on body-worn Wearable Sensor Patches (WSPs) and can be used in both clinic and home settings for up to 24 hours. Study facilitators (either researchers or physicians) set up data collection studies using a web-based study configuration tool, called the Investigator Portal. For supervised uses, the BioStamp nPoint system includes a Tablet with Investigator Application that study facilitators use to connect to and configure WSPs. When used at home, study subjects interact with the system through the Mobile Phone Link Application. The Link Hub is used to charge and synchronize data from the Wearable Sensor Patches. The BioStamp nPoint system includes an algorithm package that delivers processed metrics on general activity classification, heart rate, heart rate variability, posture, sleep, and respiration during sleep. The BioStamp nPoint system is intended for use on general care patients who are 18 years of age or older and is not intended for use on critical care patients.
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