(128 days)
This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
This device is consist of hub, cannula and protector and has difference hub color per each of gauges.
The provided text describes the IMC Hypodermic Needle and its substantial equivalence to a predicate device. It includes performance data for a single characteristic, "Hub/needle bond strength."
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | IMC Hypodermic Needle Performance |
|---|---|---|---|
| Hub/needle bond strength | ISO 7894 : 1993 | 16G-19G: >69N | Meets Standard Criteria |
| 20G: >54N | Meets Standard Criteria | ||
| 21G: >44N | Meets Standard Criteria | ||
| 22G: >40N | Meets Standard Criteria | ||
| 23G-24G: >34N | Meets Standard Criteria | ||
| 25G-30G: >22N | Meets Standard Criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for testing, nor its provenance (e.g., country of origin, retrospective or prospective). It simply states "Meets Standard Criteria" for the IMC Hypodermic Needle performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described device is a physical medical device (hypodermic needle) and the performance data pertains to a mechanical bond strength test, not an AI or diagnostic imaging device requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Mechanical testing does not involve human adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not applicable as the described device is a physical medical device, not an AI or diagnostic imaging system that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the described device is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance data (Hub/needle bond strength) is established by objective mechanical testing against the specified force thresholds outlined in the ISO 7894:1993 standard. This is a direct physical measurement, not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic devices.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device and does not involve AI or machine learning that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).