(49 days)
This device is intended to be used as a needless injection port that can be attre hed to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.
The Filtertek NFC Needlefree Connector is a one-piece design. luer interfacing injection port. It is sterile, nonpyroqenic and packaged in a Tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use.
This document is a 510(k) summary for the "Filtertek NFC Needlefree Connector". It outlines the device's intended use and claims substantial equivalence to existing devices.
Here's an analysis based on the provided text, focusing on the requested acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from predicates and general device safety) | Reported Device Performance (from text) |
|---|---|
| Maintain line patency throughout labeled duration of use | "The closure has been tested and has been found to maintain line patency throughout the labeled duration of use." |
| Sterile and nonpyrogenic | "It is sterile, nonpyrogenic..." |
| Materials safe for intended use | "The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use." |
| Sterilization Assurance Level (SAL) of 10^-6 | "The Filtertek NFC Needlefree Connector is sterilized per AAMI quidelines to a 10-6 sterility assurance level." |
| Absence of bacterial endotoxins | "Each production lot is LAL tested per USP guidelines." |
| Substantially equivalent to predicate devices | "The indicated use of the NFC Needlefree Connector is the same or the equivalent of the predicate device named in this submission." |
2. Sample size used for the test set and the data provenance
The document does not explicitly mention a test set sample size or specific data provenance (e.g., country of origin, retrospective/prospective) for validating the performance criteria. The statements regarding performance are general assertions without specific study details.
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 in the document. The filing focuses on substantial equivalence based on design, materials, and established testing guidelines rather than clinical expert evaluation for establishing ground truth for a new, independent test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of the device (a needlefree connector) and the type of submission (510(k) for substantial equivalence), a formal adjudication process akin to imaging algorithm validation is not detailed.
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
No. This document describes a medical device (a needlefree connector), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This device is a physical medical component, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's safety and effectiveness is primarily based on:
- Compliance with established industry guidelines and standards: e.g., AAMI guidelines for sterilization, USP guidelines for LAL testing, tripartite guidelines for material safety.
- Demonstrated performance in laboratory tests: "The closure has been tested and has been found to maintain line patency..."
- Substantial equivalence to legally marketed predicate devices: The document repeatedly asserts equivalence to existing devices (Douglas Medical Products Maxcess™ Connector and ICU Medical, Inc Clave™ Connector). The "ground truth" for the predicate devices' safety and effectiveness would have been established through their own regulatory pathways.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. (See point 8).
Summary of Study Type:
This 510(k) filing presents a declaration of substantial equivalence rather than a detailed report of a single, comprehensive clinical or performance study. The "study" here refers to the collection of evidence demonstrating that the device meets safety and effectiveness criteria through adherence to established standards and comparison to predicate devices. The evidence includes:
- Material testing: "tested per tripartite guidelines."
- Functionality testing: "closure has been tested and has been found to maintain line patency."
- Sterilization validation: "sterilized per AAMI quidelines to a 10-6 sterility assurance level."
- Endotoxin testing: "LAL tested per USP guidelines."
These tests and validations are typically performed to demonstrate that the new device performs as expected and is as safe and effective as its predicate counterparts. Specific numerical results, sample sizes for these tests, or expert involvement beyond standard regulatory review are not detailed in this summary.
§ 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.