(8 days)
The over the counter Medi-Jector Choice Needle-Free Insulin Delivery System is intended for the subcutaneous injection of U-100 insulin. The injector is labeled as suitable for administration of 2 to 50 insulin units in a 0.5 unit increment.
Needle-Free Insulin Delivery System
This submission is for a labeling change only, specifically to allow the Medi-Jector Choice Needle-Free Insulin Delivery System to be sold over the counter. No new studies were performed or are included in this document to demonstrate device performance against acceptance criteria.
Therefore, I cannot provide information on acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are typically associated with studies demonstrating device efficacy or safety, which are absent in this submission.
The document explicitly states:
- "Summary of Nonclinical Tests: None were performed in support of this submission. This request is for a labeling change only." (Section D, Page 0)
This implies that the device's performance characteristics were previously established and deemed acceptable under its prior 510(k) clearance (K962956), and this submission does not involve re-evaluating those performance aspects.
§ 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).