(63 days)
This device is intended for injection or aspiration of fluids utilizing a Luer Lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
This device is intended for injection or aspiration of fluids utilizing a standard Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of needle hub and protective sheath with a living hinge. The needle cannula is pennanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the needle is engaged under the hook and contained within the sheath. The device is then immediately discarded into a sharps container.
This document describes a 510(k) premarket notification for a medical device called the Hypodermic Needle-Pro® EDGE™ Needle Protection Device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and a simulated clinical study.
Acceptance Criteria and Device Performance:
The document explicitly states that the bench testing and the simulated clinical study "did not raise any new issues with regards to safety or efficacy" and that the "proposed device was well received." This implies that the device met the acceptance criteria by demonstrating no new safety or efficacy concerns compared to the predicate devices. However, the document does not provide specific quantitative acceptance criteria or detailed reported device performance metrics in a tabular format as commonly seen in medical device studies with defined endpoints. Instead, it relies on a qualitative assessment of "no new issues."
Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical data from the provided text.
Study Details:
The information provided relates to two main types of studies: Non-Clinical Data (Bench Testing) and Clinical Data (Simulated Clinical Study).
Here's a breakdown based on the provided text:
1. Non-Clinical Data (Bench Testing):
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Bench testing was conducted comparing the proposed and predicate devices," implying a comparison with multiple units, but no specific sample size is given. Data provenance is not specified beyond being "bench testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench testing typically relies on standardized methods and measurements rather than expert consensus for ground truth.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No. This type of study is not relevant for bench testing of a hypodermic needle.
- Standalone performance: Yes, the bench testing assessed the device's technical characteristics and conformance to standards.
- Type of ground truth used: Conformance to established standards (ISO 594-1:1986(E), ISO 594-2:1998(E), ISO 7864:1993(E)) and guidance documents (Guidance on the Content of Premarket Notification [510(k)] submissions for hypodermic single lumen needles, Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features).
- Sample size for the training set: Not applicable for bench testing.
- How the ground truth for the training set was established: Not applicable.
2. Clinical Data (Simulated Clinical Study):
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "A simulated Clinical was conducted...with Smiths Medical's predicate device as the control." A specific number of participants or uses is not provided. Data provenance is not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. While it's a "simulated clinical," the specific method of evaluation or the involvement of experts for ground truth is not detailed. The phrase "the proposed device was well received" suggests user feedback was likely collected, but the role of 'experts' in establishing ground truth is not elaborated.
- Adjudication method: Not described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No. This type of study is typically for image-based diagnostic devices.
- Standalone performance: Yes, the "simulated clinical" assessed the device's performance, although the "control" implies a comparative aspect. The primary goal was to ensure no new safety or efficacy issues arose with the proposed device itself.
- Type of ground truth used: The "well received" comment suggests a subjective assessment of user satisfaction and absence of immediate issues. It's not a quantitative "ground truth" derived from pathology or specific outcomes data. The study aimed to ensure the device operated as intended and was acceptable in a simulated use environment compared to the predicate.
- Sample size for the training set: Not applicable. This was an evaluation of the device.
- How the ground truth for the training set was established: Not applicable.
§ 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).