(22 days)
The proposed device is intended for the subcutaneous injection of U-100 Insulin.
Kendall Monoject® Insulin Syringes are intended for subcutaneous injection of U-100 insulin.
These devices are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with a 30g x 5/16 inch needle.
The provided text describes the 510(k) summary for the Monoject® Insulin Syringe, which focuses on a design change involving a new, smaller gauge needle. The submission aims to demonstrate substantial equivalence to existing legally marketed devices.
However, the document does not contain the detailed information required to fill out the table and answer the study-related questions thoroughly. Specifically, it lacks:
- Explicit acceptance criteria with specific numerical targets. The document mentions conformance to ISO 8537:1991(E) but doesn't detail which specific parameters were tested against which criteria.
- Reported device performance in a quantifiable manner against predefined criteria.
- Descriptions of a study methodology that would include sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
- Details on the training set for an AI/algorithm, as this is a physical medical device (syringe with a needle), not an AI/software device.
- The type and establishment of ground truth in the context of an AI/algorithm, as it's not applicable here.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted or inferred based on the document's nature (510(k) for a physical device) and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific numerical criteria for physical and functional properties, e.g., plunger force, needle sharpness, dosage accuracy, sterility, material biocompatibility. (Not explicitly stated in the provided text, but implied by conformance to ISO 8537 and general medical device regulations.) | *Specific test results demonstrating compliance with the criteria, e.g., "Plunger force within X-Y range," "Needle penetration force |
§ 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).