(8 days)
MiniMed Connect is intended to provide a secondary display of continuous glucose monitoring and/or insulin pump data on a suitable consumer electronic device to care partners and users of a MiniMed 530G system or Paradigm REAL-Time Revel system for the purpose of passive monitoring.
MiniMed Connect system is not intended to replace the real-time display of continuous glucose monitoring and/or insulin pump data on the primary display device (i.e. the sensor-augmented pump). All therapy decisions should be based on blood glucose measurements obtained from a blood glucose meter.
The MiniMed Connect is not intended to analyze or modify the continuous glucose monitor data and/or insulin pump data that it receives. Nor is it intended to control any function of the connecting continuous glucose monitor system and/or insulin pump. The MiniMed Connect is not intended to serve as a replacement for a primary display device for the continuous glucose monitoring system and/or insulin pump data. The MiniMed Connect is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.
MiniMed® Connect is a secondary display of continuous glucose monitor and/or insulin pump data on a suitable consumer electronic device for insulin pump patients and their care partners. This system is designed as an optional accessory to compatible sensor-augmented pump systems.
MiniMed® Connect consists of a MiniMed® Connect app (for a local secondary display), the CareLink® Connect module of CareLink® Personal (for a remote secondary display), and the MiniMed® Connect uploader (for data transmission to the local app).
The MiniMed® Connect uploader is a small, battery-powered, ambulatory device that is carried with the patient in near proximity to the insulin pump. Its rechargeable battery is charged as needed (approximately once a day) using a USB Charger that accompanies the device.
The MiniMed® Connect uploader receives continuous glucose monitor and/or insulin pump data from the sensor-augmented insulin pump using a proprietary 916.5 MHz RF, and then converts it into a 2.4 GHz Bluetooth Low Energy (BLE) format. This BLE formatted data can then be read by the MiniMed® Connect app installed on a compatible consumer electronics device with BLE capabilities.
The MiniMed® Connect app reads the BLE data transmission and displays it on the patient's compatible consumer electronic device. The MiniMed® Connect app then uploads the continuous glucose monitor and/or insulin pump data to CareLink® Connect, the remote monitoring module of CareLink® Personal. Authorized care partners can access CareLink® Connect to view the patient's continuous glucose monitor and/or insulin pump data through an Internet-enabled consumer electronic device for the purpose of passive monitoring.
Accessories associated with this system include:
- USB Charger (for charging the MiniMed® Connect uploader) .
I am sorry, but the provided text does not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for the MiniMed Connect device, which primarily focuses on establishing substantial equivalence to a predicate device.
Specifically, the text states under "PERFORMANCE DATA [807.92(b)] VII.":
"Results of the verification and validation testing indicate that the product meets established performance requirements, and is safe and effective for its intended use."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details about the sample size, data provenance, number of experts, their qualifications, or adjudication methods for a test set.
- Information about MRMC comparative effectiveness studies, effect sizes, or standalone algorithm performance.
- The type of ground truth used, training set sample size, or how ground truth for the training set was established.
The document confirms that verification and validation testing was done and that the device met performance requirements, but it does not elaborate on what those requirements were or present the results of such testing.
§ 862.1350 Continuous glucose monitor secondary alarm system.
(a)
Identification. A continuous glucose monitor (CGM) secondary alarm system is identified as a device intended to be used as a secondary alarm for a CGM to enable immediate awareness for potential clinical intervention to help assure patient safety.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special controls for this device are:(1) Devices being marketed must include appropriate measures to protect against unauthorized access to data and unauthorized modification of data.
(2) The labeling must prominently and conspicuously display a warning that states “Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system.”
(3) The labeling for the device must include a statement that reads “This device is not intended to replace self-monitoring practices as advised by a physician.”