(91 days)
U&U Sterile Hypodermic Needles is intended for use with syringes and injection devices for general purpose fluid injection/ aspiration.
The U&U Sterile Hypodermic Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The U&U Sterile Hypodernic Needle are offered in various gauge sizes and needle lengths. The U&U Sterlie Hypodermic Needle is sterilized by EtO gas. The U&U Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use.
The provided text describes a 510(k) submission for a medical device, the U&U Sterile Hypodermic Needle. This submission focuses on demonstrating substantial equivalence to a predicate device, the BD Hypoint™ Hypodermic Needle (K070440).
However, the provided document does not describe a study involving an algorithm or AI. It is a regulatory submission for a physical medical device (a hypodermic needle). Therefore, many of the requested categories related to algorithm performance, training, and ground truth are not applicable.
Here's the information that is available based on the provided text, with a clear indication of what is not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the comparison to the predicate device and adherence to international standards. The "reported device performance" is essentially that it conforms to these standards and exhibits similar technological characteristics to the predicate.
| Element of Comparison | Predicate Device (Acceptance Criteria) | Submitted Device (Reported Performance) |
|---|---|---|
| Intended Use | Fluid injection/aspiration | Fluid injection/aspiration |
| Principle of Operation | Normal | Normal |
| Needle Gauge/Length | Various Sizes | Various Sizes |
| Lubricant for Needle | Silicone Oil | Silicone Oil |
| Adhesive | Epoxy Resin | UV Glue |
| Needle Hub Colors | Various Colors | Various Colors |
| Tip configuration | Bevel | Bevel |
| Needle Hub Material | PP | PP |
| Needle Material | Stainless Steel | Stainless Steel |
| Needle Cover Material | PE | PP |
| Performances | Conforms to ISO7864 | Conforms to ISO7864 |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meets 21 CFR Part 801 | Meets 21 CFR Part 801 |
(Note: The 'Acceptance Criteria' column above represents what the predicate device achieves, which the submitted device aims to be substantially equivalent to or meet similar standards for.)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document is for a physical hypodermic needle, not an algorithm. There is no "test set" in the context of an algorithm's performance data. The device itself undergoes various testing (e.g., performance, biocompatibility) to meet ISO standards, but the specifics of sample sizes for these tests are not detailed in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "ground truth" to be established by experts for an algorithm in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No algorithm performance data is being adjudicated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm. The device, a hypodermic needle, is a standalone physical product.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. This is not an algorithm. For the physical device, compliance with established performance standards (ISO7864) and biocompatibility standards (ISO10993) serves as the "ground truth" for its safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This is not an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This is not an algorithm.
§ 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).