(121 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) finsulin 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® (STJ) 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 PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] . 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-injector for the 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 pen-injector is intended for use with PenFill® 3 mL cartridge of NovoLog", 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] and a single-use, detachable and disposable pen needle (supplied separately by Novo Nordisk ).
The provided document is a 510(k) summary for the NovoPen Echo® device, specifically for a change in manufacturing location and minor updates to the device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a de novo study with novel acceptance criteria and reported device performance from a new efficacy trial.
Therefore, the document does not contain the detailed information necessary to fully address all points concerning acceptance criteria and study design as typically expected for a new device's efficacy study.
However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states that the device was evaluated against the requirements specified in ISO 11608-1:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems. This standard would define the acceptance criteria for performance aspects such as dosing accuracy, dose button force, and other functional parameters relevant to pen injectors.
While specific numerical acceptance criteria and reported performance values are not provided in this summary, the document states:
- "Device Verification Tests were run to verify all product requirements are still met and all changes work properly and complies with the requirements specified in ISO11608-1:2012"
- "Software verification and validation regression testing all static, unit, integration and system, tests as well as additional tests for the changes and related risk control measures was conducted and all tests passed."
- "In conclusion, the results of the testing demonstrate that NovoPen Echo® (STJ) is as safe and effective and performs as well as the predicate device."
- "The results of the testing to standards provide additional evidence that NovoPen Echo® (STJ) is substantially equivalent to the predicate device, NovoPen Echo® (DMD)."
Therefore, the implied acceptance criteria are compliance with ISO 11608-1:2012 and the reported device performance is that it met all product requirements and passed all tests, demonstrating substantial equivalence to the predicate device.
Without the full test reports, a detailed table with specific numerical criteria and results cannot be generated from this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the summary.
- Data Provenance: The tests were conducted to support the transfer of manufacturing from Denmark (DMD) to Tianjin, China (STJ), implying the testing was performed on devices produced at the new manufacturing site. The study is prospective in the sense that newly manufactured devices were tested to confirm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to the type of device (pen injector) and the nature of this submission (manufacturing change). Ground truth for a pen injector's functional performance would typically be established through engineering measurements and adherence to international standards, not through expert consensus on diagnostic images or similar expert review processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and submission. Adjudication methods are typically used in studies involving subjective interpretation (e.g., medical imaging) to resolve disagreements among human readers.
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. The NovoPen Echo® is a mechanical pen injector designed for patient self-injection, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is typically relevant for AI/software devices. The NovoPen Echo® is a mechanical device with a memory function and liquid crystal display; its "memory function" is described as a sensor detecting movement for display, not a complex algorithm performing diagnosis or analysis. The performance verified was related to the mechanical and display functionalities, meaning a form of "standalone" evaluation of the device's technical specifications was performed according to ISO standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is objective measurement against the specifications and requirements outlined in ISO 11608-1:2012 and potentially internal product requirements for dose accuracy, delivery force, functionality of the display, etc. This is based on engineering and physical measurement standards, not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is not an AI-driven learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable (as per point 8).
§ 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).