(22 days)
This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.
This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device is an integral component of the device as it comes pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the needle bevel by swiveling the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a onehanded technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately be disposed into a sharps container. This device is not designed for use with a luer lock syringe. The device is supplied with 25G, 26G, 27G needles both with and without a syringe.
The provided text, a 510(k) summary for the "Hypodermic Needle-Pro® Needle with Needle Protection Device" and "Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device," does not include specific acceptance criteria or an analytical study detailing device performance against such criteria.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (K923127 Needle-Pro™ Cartridge) through non-clinical bench testing.
Here's an analysis of the information available in the document:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria for specific performance metrics. It makes a general claim:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined, but implied to be "equal or greater ability to resist static and dynamic forces, as compared to the predicate devices, while testing for needle disengagement." | "The bench test data submitted demonstrates that the proposed device has an equal or greater ability to resist static and dynamic forces, as compared to the predicate devices, while testing for needle disengagement." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Bench test (non-clinical) data. The country of origin is not specified, but the applicant company, SIMS Portex Inc., is based in Keene, NH, USA. The data is prospective in the sense that it was generated for the purpose of this submission, but it's not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the study was non-clinical bench testing comparing the device to a predicate, not assessing a diagnostic or predictive performance against a "ground truth" established by experts.
4. Adjudication method for the test set:
This is not applicable as the study was non-clinical bench testing, not involving human interpretation or adjudication.
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:
This is not applicable. The device is a medical product (hypodermic needle and syringe), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical product, not an algorithm.
7. The type of ground truth used:
This is not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for the non-clinical testing would be the established performance characteristics of the predicate device regarding its resistance to forces and needle disengagement. The goal was to prove the new device performed at least as well.
8. The sample size for the training set:
This is not applicable. There is no "training set" in the context of this 510(k) submission as it concerns a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
§ 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).