FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Cord Wrap with Needle Resheather comprises a reel for storing electric cords at a pole-type infusion stand. The stand provides a pole stanchion that extends a number of feet and supports an infusion pump and/or bags or bottles of liquid infusants. The Cord Wrap is constructed to conveniently store the electric cord of the infusion pump at the pole during and between use. The cord is coiled about an elongated spool which is retained on the pole via a clamp assembly. The clamp assembly includes a hand wheel and threaded hook arm. The hook arm mounts about the pole, and upon tightening of the hand wheel the hook arm is drawn tight to the infusion stand. Two protrusions are aligned to the hook arm and form a channel space where the infusion stand can nest. The Cord Wrap with Needle Resheather is thereby prevented from rotating about the pole. The position of the Cord Wrap with Needle Resheather along the infusion stand can be varied by loosening the hand wheel and moving the Cord Wrap with Needle Resheather either up or down the infusion stand and retightening the hand wheel. Protruding from the Cord Wrap with Needle Resheather is a needle holder which contains five cavities to receive and retain several cover pieces of needle storage containers. The five cavities are constructed to receive and hold the cover piece. This permits the staff member to de-couple the needle body from the cover with a single hand. The Cord Wrap, hand wheel, and Needle Resheather are molded from a resin Acrylonitrile-Butadiene-Styrene (ABS). The Needle Resheather is glued to the Cord Wrap with Loctite® 494 adhesive. The threaded hook arm is made of stainless steel. The Cord Wrap with Needle Resheather is packaged assembled in polyethylene bags.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Cord Wrap with Needle Resheather (Model CN-34)". This submission aims to demonstrate substantial equivalence to a predicate device, the Ferguson Medical I.V. Hanger Bag or Holder (K883133).

Crucially, the acceptance criteria and a study to prove the device meets these criteria are NOT present in the provided text.

Here's why and what information would typically be expected for such a request:

Substantial Equivalence: The 510(k) pathway relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device. This is often achieved by showing that the new device has the same intended use and the same technological characteristics as the predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
No Performance Metrics: The text describes the device's function and components but does not provide any quantitative performance metrics, safety thresholds, or effectiveness targets.
No Study Details: There is no mention of any formal studies (clinical or non-clinical) undertaken to evaluate the Cord Wrap with Needle Resheather against specific criteria. The submission relies solely on comparing its features to those of the predicate device.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
Sample size used for the test set and the data provenance: No test set or data are mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment are discussed.
Adjudication method: Not applicable as there's no test set or expert review.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. This device is not an AI/imaging device where such a study would typically be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical accessory, not an algorithm.
The type of ground truth used: Not applicable as no ground truth is established or used for performance evaluation.
The sample size for the training set: Not applicable as this is a physical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

What the document does describe is:

Device Name: Cord Wrap with Needle Resheather (Model CN-34)
Intended Use (implicit): Accessory to infusion stands for cord storage and single-handed needle cap removal.
Predicate Device: Ferguson Medical I.V. Hanger Bag or Holder (K883133)
Device Description: A reel for storing electric cords, clamps to an infusion pole, and contains five cavities to receive needle storage container covers. Made of ABS plastic, stainless steel hook arm, and assembled with Loctite 494 adhesive.
Mechanism of Action: Cord coiling, pole clamping, channel space for stability, and cavities to hold needle covers.
Key Safety Note: Explicitly states, "The Cord Wrap with Needle Resheather is NOT a SHARPS RECEPTACLE."

In a 510(k) submission, the "acceptance criteria" are often inherent in the demonstration of substantial equivalence. For a simple accessory like this, the lack of new technological characteristics and the demonstration that it performs its intended function similarly to the predicate would be the primary "proof" for regulatory acceptance. There wouldn't typically be a detailed clinical study with performance metrics for such a device.

Summary

Regulation Number and Section

§ 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).