(162 days)
Aidera Diasend is indicated for use by individuals or healthcare professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.
Diasend is a system for transmitting data from patients' home monitoring devices and consists of a transmitter, a server database and a website available for the care provider and the patient. The software transmitter is a Diasend software concept developed by Aidera that may run on a computer device, e.g. desktop computer, laptop or mobile phone, designed to transmit data to the Diasend server database. Current implementation is on Windows XP.
This section describes the acceptance criteria and study proving the device meets criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with applicable EMC and FCC requirements and standards | The Diasend transmitter is tested and found to comply with applicable EMC and FCC requirements and standards. |
Study Details:
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Sample Size and Data Provenance: Not applicable. The "study" mentioned here refers to compliance testing for electromagnetic compatibility (EMC) and Federal Communications Commission (FCC) requirements, not a clinical performance study with patient data.
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Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the conventional sense of expert consensus on medical findings, is not relevant for EMC/FCC compliance testing.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was conducted or is relevant for this type of device (a data transmission system).
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Standalone Performance Study: Yes, a standalone "study" (compliance testing) was performed to ensure the device meets regulatory standards for electromagnetic compatibility and radio frequency interference.
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Type of Ground Truth Used: The "ground truth" for this type of testing is defined by the technical specifications and limits set by EMC and FCC standards. The device's performance is compared against these engineering and regulatory benchmarks.
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Sample Size for Training Set: Not applicable. There is no machine learning component or training set involved in the compliance testing described.
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How Ground Truth for Training Set was Established: Not applicable.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).