(265 days)
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
The Advocate Insulin Pen Needle consists of a polypropylene 'outer cap' enclosure. This polypropylene cap contains an opening at one end to allow the needle or cannula to exit. The other end of the outer cap is the 'hub' that can be connected to various pens. Contained within the outer cap is the cannula assembly made up of the stainless steel cannula that is contained within an 'inner cap' polypropylene shell that is located on top of the hub. Medical grade blister paper covers and seals the hub. The Advocate Insulin Pen Needles when sealed with the blister paper are EO sterilized and provide a sterile fluid path during use. The Advocate Insulin Pen Needles when connected to the pen injector, is intended for subcutaneous injection of insulin.
The requested information regarding acceptance criteria and study details for the Advocate Insulin Pen Needles, based on the provided FDA 510(k) summary, is presented below.
Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with human readers or AI performance metrics. Therefore, several sections of your request related to AI, human reader improvement, and training set details are not applicable or cannot be extracted from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Normative References/Description | Acceptance Criteria (Implied by "All pre-determined acceptance criteria were met") | Reported Device Performance |
|---|---|---|---|
| Accelerated Shelf Life | ASTM F 1980-07, ISO 11607-1, ISO 11608-2, ASTM F 1929, ASTM F88 | Meet requirements of the referenced standards (e.g., maintain sterility, package integrity, and functional performance over simulated shelf life). | All pre-determined acceptance criteria were met. |
| EO Sterilization Validation | Validation process used a standard half-cycle method to demonstrate the efficacy of the EO sterilization process. | Efficacy of EO sterilization process demonstrated. | All pre-determined acceptance criteria were met. |
| EO Residual | Sterilant residual limit for limited exposure met of EO |
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).