(72 days)
The needles are intended for general purpose fluid injection/aspiration, infusion, venupucture to obtain blood collection and insulin injection.
This change in needle lubricant carrier is across the BD product lines.
This document describes a 510(k) premarket notification for a change in the formulation of the lubricant carrier for BD needle products. The primary goal of the submission is to demonstrate that the modified devices are substantially equivalent to their predicate devices, meaning they have the same intended use and performance characteristics, despite the change in lubricant carrier.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or measurable format for specific performance metrics. Instead, the entire submission hinges on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it remains identical to the predicate.
| Element of Comparison | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Intended Use | Must be identical to predicate devices. | Identical to predicate devices. |
| Sterility | Sterile fluid path, identical to predicate devices. | Sterile fluid path, identical. |
| Sterilization | Gamma or EtO, unchanged from predicate devices. | Gamma or EtO, unchanged. |
| Design | Unchanged from predicate devices. | Unchanged. |
| Needle Material | Unchanged from predicate devices. | Unchanged. |
| Packaging | Unchanged from predicate devices. | Unchanged. |
| Silicone Proportions | Unchanged from predicate devices. | Unchanged. |
| Labeling | Unchanged from predicate devices. | Unchanged. |
| Product Claims | Unchanged from predicate devices. | Unchanged. |
| Performance | Unaffected by lubricant carrier change, equivalent to predicate. | Unaffected, equivalent. |
| Physical/Mechanical/Biological Specifications | Unaffected by lubricant carrier change, equivalent to predicate. | Unaffected, equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a test set sample size or the data provenance (e.g., country of origin, retrospective/prospective). This submission is for a material change (lubricant carrier) where the argument for substantial equivalence relies on the fact that the carrier evaporates, leaving the same silicone lubricant in the same proportions as the predicate device. Therefore, new extensive performance testing of physical/mechanical/biological specifications might have been conducted by the manufacturer but is not detailed as a "test set" in this summary. The focus is on the impact of the carrier change, which is argued to be negligible on the final product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. Given the nature of the submission (change in excipient/carrier), it's unlikely that "ground truth" in the sense of expert consensus on diagnostic interpretations (as would be the case for imaging AI) was required or established. The ground truth here is the established performance and safety of the predicate devices.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. There's no mention of a "test set" requiring adjudication in the context of this submission. The evaluation is based on a comparison to predicate devices and the scientific rationale that the carrier's evaporation renders its change inconsequential to the final product's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices, particularly AI-driven ones where human readers' performance is being evaluated with and without AI assistance. This submission is for a medical device (needles, syringes) with a material change to a non-active component, not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance study (in the context of an algorithm) was not done. This submission is for a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the established performance and safety profiles of the predicate devices. The entire argument for substantial equivalence rests on the modified devices being equivalent to these already-cleared, safe, and effective predicates. The claim is that the change in the lubricant carrier does not alter these established characteristics.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. There is no "training set" in the context of an AI algorithm for this type of submission.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. As there is no training set for an AI algorithm, there is no ground truth establishment for it.
§ 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).