Search Results

The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the seff-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.

The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a NovoLog 3 mL PenFill® cartridge. The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected.

The provided document is a 510(k) Special Summary for the NovoPen Echo®, a reusable pen injector for insulin. It describes the device, its intended use, and the rationale for claiming substantial equivalence to predicate devices.

However, the document does not contain information about an AI/Algorithm-based diagnostic or prognostic device. Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details (test set, ground truth experts, adjudication, MRMC, standalone performance), or training set specifics as this type of information is not relevant to the described device.

The document states:

• "No clinical testing was provided or required." (Page 5)
• The performance testing was device verification tests to ensure compliance with ISO11608-1 "Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems." (Page 4)

Therefore, the requested details about an AI study (sample sizes, expert consensus, MRMC, training sets) are not applicable to the content of this 510(k) submission.

Ask a specific question about this device