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510(k) Data Aggregation
K Number
K111509Device Name
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
Manufacturer
Date Cleared
2011-11-09
(161 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
SWEETSPOT DIABETES CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SweetSpot Diabetes Data Management Service is intended for use in clinical settings by both patients and healthcare professionals, to assist in the review, analysis, and evaluation of blood glucose test results by the clinician to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data interface capabilities.
Device Description
The SweetSpot Service allows patients or healthcare professionals to download data from blood glucose meters (BGM) and generates a report from the downloaded data. which is delivered to the healthcare professional for use in patient management. The Service is comprised of three different types of data retrieval stations, a Fetch Utility, a data processing and storage platform, report generation software, and an information delivery service.
The first type of data retrieval station is a Front-Office Kiosk - a dedicated off-the-shelf computer that a patient uses to download the data from their devices (if they download from multiple devices the Service will consolidate that data into a single report). A device-specific cable is required to connect the BGM to the Kiosk for data download. Once the data is downloaded, it is processed into a report and delivered according to the specific clinic's needs and workflow.
The second type of data retrieval station is a Back-Office Kiosk - a dedicated off-theshelf computer that healthcare professionals use to download patient devices and/or monitor reports. This kiosk is also configured for the workflow needs of the clinic.
The third type of data retrieval station is a Back-Office Web Application – a standalone application used by healthcare professionals that does not require a dedicated computer. Each customer uses a specific instance of the web application through a unique URL. This launches a proprietary web application configured for that specific clinic's needs and workflows.
The SweetSpot Fetch Utility retrieves data from various BGM manufacturers' devices and includes device drivers for multiple manufacturers. The Fetch Utility is centrally updated and maintained. When any version of the SweetSpot Services retrieval stations - in any setting - is directed to perform data retrieval, the Service ensures the most upto-date version of the Fetch Utility is used.
The SweetSpot Service is primarily web-based and is delivered using a software-as-aservice (SaaS) model. All data storage and processing takes place on remotely hosted virtualized computing resources on the Internet, often referred to as "cloud computing".
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