(87 days)
This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.
This device is intended for injection or aspiration of fluids. 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 permanently 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 lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap", the needle protection sheath for needles equal to or less than 1" has one needle retaining hook (except 30g) and the sheath for needles longer than 1" has two hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure. An example is removal of the EDGE™ safety device from a blood sampling syringe. The EDGE™ safety device is then discarded into a sharps container.
The provided text describes a 510(k) submission for the Hypodermic Needle-Pro® EDGE™ Safety Device. However, the document does not contain explicit acceptance criteria and corresponding reported device performance in a table format. The study conducted is a "Simulated clinical use studies" for the device, and the document states that these studies "confirmed that the EDGE™ safety device could be used by phlebotomists with no substantial change to their technique and could be safely removed from the syringe after activation."
Based on the information provided in the document, here's a breakdown of the requested details:
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Table of acceptance criteria and the reported device performance:
Acceptance Criterion Reported Device Performance Device can be used by phlebotomists with no substantial change to their technique. Confirmed. Device can be safely removed from the syringe after activation. Confirmed. -
Sample size used for the test set and the data provenance:
The document does not specify the sample size for the "Simulated clinical use studies." It also does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Simulated clinical use studies." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide this information. It only states that the study involved "phlebotomists." -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method. -
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:
No MRMC study was described. This device is a physical medical device (hypodermic needle with safety feature), not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This question is not applicable as the device is a physical medical device, not an algorithm, and its use inherently involves human interaction. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established through observation and evaluation of the device's functionality during "simulated clinical use studies" by phlebotomists. This would imply an observational assessment of ease of use and safety during a simulated procedure. -
The sample size for the training set:
The document does not mention a "training set" as this is not a machine learning model. The clinical studies described are for validation of the device's performance. -
How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of medical device submission.
§ 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).