(89 days)
The Pen Injector is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The Pen Injector uses HUMALOG (insulin lispro) injection (U-100) available in 3 mL cartridges, and a single use detachable and disposable insulin pen needle (supplied separately, needle sizes including: 32G4mm, 31G4mm, 31G5mm, and 31G6mm).
The Pen Injector is a reusable mechanical pen-injector capable of injecting a dose of up to 80 units of insulin, in 1 unit increments. The Pen Injector consists of a pen injector body, a push block, a injection button, a dose display window, a dose adjustment knob, a reservoir and a pen injector cap. The intended dose is mechanically set by rotating a dose adjustment knob. The insulin is injected by depressing the knob which mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The Pen Injector is intended for single user and provided for non-sterile.
The provided document describes the FDA 510(k) clearance for the Wuxi NEST Biotechnology Co., Ltd. Pen Injector (K240774). The acceptance criteria and supporting studies are primarily focused on performance testing to demonstrate substantial equivalence to the predicate device, NovoPen Echo® (K182387).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Requirement/Standard | Reported Device Performance (Pen Injector K240774) |
|---|---|---|
| Dose Accuracy | ISO 11608-1:2022 | Meets ISO 11608-1:2022 requirements |
| Injection Force | ISO 11608-1:2022 | Meets ISO 11608-1:2022 requirements |
| Injection Time | ISO 11608-1:2022 | Meets ISO 11608-1:2022 requirements |
| Biocompatibility - Cytotoxicity | ISO 10993-5:2009 | Meets requirements |
| Biocompatibility - Skin Sensitization | ISO 10993-10:2021 | Meets requirements |
| Biocompatibility - Irritation | ISO 10993-23:2021 | Meets requirements |
| Compatible with 3mL HUMALOG (insulin lispro) U-100 cartridges | Demonstrated compatibility | Compatible |
| Compatible with specified pen needles | Demonstrated compatibility | Compatible (listed sizes: 32G4mm, 31G4mm, 31G5mm, 31G6mm) |
| Shelf Life | 5 years (verified by accelerated aging) | 5 years |
| Service Life (reuse cycles) | 3,000 times | 3,000 times |
| Transportation Resistance | ASTM D4169:2022 | Functions as intended after transportation |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of devices, cartridges, or test repetitions) used for each individual performance test (dose accuracy, injection force, injection time, biocompatibility, shelf life, service life, transportation). It generally states that "corresponding performance tests were conducted" or "aging studies have been conducted."
The provenance of the data is from Wuxi NEST Biotechnology Co., Ltd. in China, and the studies are prospective in nature, conducted specifically to demonstrate the performance of the Pen Injector for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the reported studies. The performance tests rely on objective measurements against established international standards (ISO, ASTM) and not on human expert interpretation or ground truth establishment in a medical context.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on direct physical and chemical measurements against pre-defined thresholds from international standards.
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 device is a mechanical pen injector, not an AI-powered diagnostic or imaging device, so MRMC studies or human reader performance with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the core performance testing of the device (dose accuracy, injection force, etc.) which demonstrates the standalone capabilities of the Pen Injector mechanism without human-in-the-loop performance evaluation in a clinical setting. The tests confirm the device's inherent mechanical functionalities meet the specified standards.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests outlined is defined by:
- International Standards: ISO 11608-1:2022 (for injection system performance), ISO 10993 series (for biocompatibility), ASTM F1980-16 (for accelerated aging/shelf life), and ASTM D4169:2022 (for transportation).
- Device Specifications: The inherent design parameters and intended performance of the Pen Injector (e.g., maximum dose, dial increments, service life).
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical medical device, not an AI/machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is involved for this type of device.
§ 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).