(177 days)
This product is indicated for use with Saizen® [somatropin (rDNAorigin) for injection] for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Clicker™ Needle-Free Self-Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. This submission changes the labeling of the Vitajet 3, (Innova) (K962625) to allow the device to be used for needle-free subcutaneous administration of Saizen® [somatropin (rDNAorigin) for injection]. There are no other significant changes to the Vitajet 3 (Innova) in device design or function.
Here's a summary of the acceptance criteria and study details for the Bioject Clicker™ Needle-Free Self-Injection Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pharmacokinetic Equivalence (Adults) | |
| AUC (Area Under the Curve) 90% Confidence Interval (CI) for Test/Reference Ratio | (0.95, 1.12), falling within the (80%, 125%) required interval. |
| Cmax (Maximum Concentration) 90% Confidence Interval (CI) for Test/Reference Ratio | (0.81, 1.20), falling within the (80%, 125%) required interval. |
| tmax (Time to Maximum Concentration) | Not statistically different between needle and needle-free. |
| t1/2 (Half-life) | Assessed for assumptions, no significant difference. |
| Pharmacodynamic Equivalence (Adults) | |
| Serum IGF-1 levels (24 hours) | Very similar to needle injection. |
| User Experience (Adults) | |
| Pain | Trend toward less pain with jet-injector (p = 0.093). |
| Ease of Use | Highly significant preference for jet-injector (p = 0.017). |
| Convenience | Highly significant preference for jet-injector (p = 0.004). |
| Pleasantness | Highly significant preference for jet-injector (p = 0.011). |
| Less Apprehension | Highly significant preference for jet-injector (p = 0.0110). |
| Overall Preference | Highly significant preference for jet-injector (p = 0.053). |
| User Experience (Children) | |
| Pain | Highly significant difference favoring needle-free (p |
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).