(5 days)
The Threaded Lock Cannula is one of several needleless cannula components that are part of the InterLink® IV Access System that provide for continuous and intermittent IV Therapy, Vial Access, and Blood Draws. The system allows the user to make connections to any IV line using a mating injection site with a pre-slit septum safely without chance of needle stick injury to the user or patient. InterLink® Threaded Lock Cannula are specifically designed for use with InterLink® injection sites, identified by a white alert ring around the septum. Not compatible with conventional injection sites.
A product comparison between the modified InterLink® Threaded Lock Cannula and existing Threaded Lock Cannula is provided in the table below:
| Component/Characteristic | Threaded Lock (existing) | Threaded Lock (modified) |
|---|---|---|
| Cannula Body | Polypropylene | Polypropylene |
| Tip Shield (Cannula Stem) | Polyethylene | Polyethylene |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone |
| Sterilization Process | Radiation | Radiation |
The Threaded Lock Cannulae are equivalent in product function, design, and manufacturing process with the only difference being the addition of 'micro' helical thread molded internally between the existing double to provide additional surface contact with the mating threads of the luer thread. The micro thread provides additional security of the connection.
This document describes a 510(k) submission for the InterLink® Threaded Lock Cannula (modified), aiming to demonstrate its substantial equivalence to an existing predicate device, the BD/Baxter InterLink® Blunt Cannula. The document focuses on comparing the modified device to a previous version of the Threaded Lock Cannula and concludes with an FDA approval letter based on this equivalence.
However, the provided text does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or any similar quantitative measures. The core of this submission is to demonstrate functional, design, and material equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and reported device performance in the context of diagnostic or efficacy outcomes.
Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be directly answered from the provided text, as this type of information is typically found in performance testing reports for medical devices that aim to demonstrate efficacy or safety against measurable criteria.
Here's an analysis based on the information that is present:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document focuses on demonstrating substantial equivalence based on design, materials, sterilization, and intended use, rather than presenting specific quantitative performance criteria and the results of a study designed to meet those. The tables compare characteristics, not performance metrics against acceptance criteria.
2. Sample sized used for the test set and the data provenance
This information is not provided. The document does not describe a clinical or performance test set with a specific sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. As there's no described test set or ground truth establishment, this is not applicable.
4. Adjudication method for the test set
This information is not provided. As there's no described test set, this is not applicable.
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. This document describes a medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. No ground truth is established as there's no performance study described. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, which the modified device is being compared to.
8. The sample size for the training set
This information is not provided. This is not a machine learning or AI-based device, so the concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established
This information is not provided. As above, this is not relevant for this type of device submission.
Summary of what the document does provide regarding equivalence:
The document demonstrates substantial equivalence of the modified InterLink® Threaded Lock Cannula to an existing, unmodified predicate device through a direct comparison of physical and functional characteristics.
Comparison Table for Equivalence (from the text):
| Threaded Lock Cannula (modified) | Threaded Lock Cannula (existing) | |
|---|---|---|
| Intended Use | Used for needleless access to IV Sites connected to an injection site for continuous and intermittent IV Therapy. | Used for needleless access to IV Sites connected to an injection site for continuous and intermittent IV Therapy. |
| Incorporates Same Basic Design | Yes | Yes |
| Utilizes Same Operating Principle | Yes, lubricated and shielded cannula with standard female luer fitting hub. Injection site threads are enhanced with addition of 'micro' thread for added security for connection to mating injection site body. | Lubricated and shielded cannula with standard female luer fitting hub. Standard threads provide for attachment to mating injection site body. |
| Incorporates Same Material | Yes - Polypropylene Resin | Yes - Polypropylene Resin |
| Sterility | Sterile 10-6 SAL | Sterile 10-6 SAL |
| Sterilization Process | Gamma Radiation | Gamma Radiation |
| Toxicity | Non-Toxic | Non-Toxic |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Product Size | .915" x .500" Diameter | .915" x .500" Diameter |
The "study" in this context is the comparison and analysis of the modified device against the predicate device based on their technical specifications and intended use, as presented in the 510(k) submission. The FDA's letter (K011858) confirms that, based on this submission, they have determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The "acceptance criteria" can be implied as meeting the FDA's requirements for substantial equivalence, which primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. This is achieved by showing similar intended use, technological characteristics, and performance (in a broad, qualitative sense based on design and materials).
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.