(104 days)
The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart 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 text describes a 510(k) premarket notification for the NovoPen Echo®, specifically to expand its approved use to include Fiasp® (insulin aspart injection) 3mL PenFill® cartridges. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K162602) rather than presenting a standalone study of the device's diagnostic or therapeutic performance in a clinical setting.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this regulatory document. This document is about a device's safety and performance in delivering a drug, not about its diagnostic accuracy or establishing a new therapeutic effect.
Here's the information that can be extracted or reasonably inferred from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Requirement) | Reported Device Performance |
|---|---|
| Meets requirements of ISO11608-1:2014 (Needle-based injection systems for medical use - Requirement and test methods - Part 1: Needle based injection systems) for dose accuracy with Fiasp® 3mL PenFill® cartridges. | "Dose accuracy performance test of the Fiasp® (insulin aspart injection) 3 mL PenFill® cartridges with NovoPen Echo® was performed which meets the requirements of ISO11608-1:2014." |
| Device in-use lifetime | 5 years, provided pen is taken into use within two years of production date. (Device informs user when end of life is reached via memory display). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for the dose accuracy performance test. ISO11608-1:2014 would specify the number of individual tests (e.g., number of pens tested, number of doses per pen) required for compliance. This document only states that the testing was performed and met the standard.
- Data Provenance: Not specified, but generally, such performance tests are conducted by the manufacturer (Novo Nordisk) in a controlled laboratory environment. It is not clinical data, so terms like "retrospective or prospective" or "country of origin of the data" are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The "ground truth" for a mechanical device's dose accuracy is typically established by precision measurement equipment (e.g., gravimetric or volumetric methods) in an engineering or metrology lab, not by human experts, and certainly not by medical experts for diagnostic purposes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human interpretation of diagnostic data where a consensus among experts is needed. For mechanical performance testing, the results are objectively measured.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device for insulin delivery, not an AI-assisted diagnostic tool or a system involving human readers/interpreters in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the sense of an algorithm for diagnosis or interpretation. The device itself operates mechanically. The "standalone" performance here refers to the device's ability to accurately deliver insulin doses, which was tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for device performance (dose accuracy) would be the precisely measured volume or weight of liquid dispensed, determined using calibrated laboratory equipment according to the methods outlined in ISO11608-1:2014.
8. The sample size for the training set
- Not applicable. The NovoPen Echo® is a mechanical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
- Not applicable for the reason above.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).