(178 days)
Omnican fine is intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products.
The Omnican fine is a pen needle device that is a sterile, individually packaged, single use, hypodermic single lumen needle; intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Omnican fine is a double-ended needle consisting of a tri-beveled tip, hollow steel cannula, and needle hub packaged in a hard plastic sealed container. Specific versions contain an inner needle shield. The Omnican fine provides a fluid path from a drug container to subcutaneous tissue.
The provided text describes a 510(k) premarket notification for a medical device, specifically a hypodermic single lumen needle called "Omnican fine." The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials. Therefore, the "study" referred to will be a collection of non-clinical performance tests and comparisons.
Here's a breakdown of the acceptance criteria and the "study" details based on the document:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document outlines acceptance criteria indirectly through the "Summary of nonclinical performance tests" and lists the intended performance of the "Proposed Device Omnican fine."
| Feature/Test | Acceptance Criteria (Predicate/Omnican Fine) | Reported Device Performance (Omnican fine) |
|---|---|---|
| Functional Performance | ||
| Measurement of needle tube length: Injector end | 6.15 +0.5/-0.3 mm | 6.15 +0.5/-0.3 mm |
| Measurement of needle tube length: Patient End | 12 +1.1/-0.8 mm (for 12mm size) | |
| 8 +1.1/-0.8 mm (for 8mm size) | ||
| 6 +1.1/-0.8 mm (for 6mm size) | ||
| 4 + 1.25/-0.0 mm (for 4mm size) | 12 +1.1/-0.8 mm | |
| 8 +1.1/-0.8 mm | ||
| 6 +1.1/-0.8 mm | ||
| 4 + 1.25/-0.0 mm | ||
| Dislocation of measuring point at patient end | ≤ 1.1 mm (for 12mm needle) | |
| ≤ 0.9 mm (for 8mm needle) | ||
| ≤ 0.7 mm (for 6mm needle) | ||
| ≤ 0.6 mm (for 4mm needle) | Met criteria (implied by "Omnican fine met all established acceptance criteria") | |
| Bond between needle hub and needle tube | Withstand a 22 N force applied axially for 5 seconds. | Met criteria (implied by "Omnican fine met all established acceptance criteria") |
| Unscrewing torque of the needle |
§ 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).