(255 days)
The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters, (e.g., syringes or sets) to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.
The subject of this submission is a luer access injection site which will be marketed as a stand-alone device for use as a heparin lock and will also be incorporated into currently marketed solution sets. The proposed injection site consists of a pre-slit synthetic polyisoprene septum and a polyester housing.
This submission describes a medical device, a Luer Access Injection Site, and its equivalence to a predicate device. It is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence, not necessarily on detailing rigorous clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) might.
Based on the provided text, here's a breakdown of the requested information, noting what is available and what is not available in this specific document:
Description of the Acceptance Criteria and Study to Prove Device Meets Criteria
The document reports that "Performance testing of the proposed luer access injection site has been conducted including microbiological evaluations. A description of the testing along with test results has been provided. All data indicate that the proposed device meets or exceeds all functional and microbiological requirements and thus support its suitability for use." However, the specific acceptance criteria and detailed study results are not provided in this summary. The submission focuses on substantial equivalence to a predicate device, the ICU Medical Inc. Clave™ Needleless Connector.
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that testing was conducted and met requirements, but does not enumerate the specific criteria or the quantitative results against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document mentions "performance testing" and "microbiological evaluations" were conducted, but does not specify sample sizes or the origin of the data. Given the nature of a 510(k) for a device like this, it's highly likely the testing was conducted in a laboratory setting, not with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications
Not applicable/Not available for this type of device and submission. The testing described (functional and microbiological) would involve laboratory measurements and standards, not human expert interpretation of data or images.
4. Adjudication Method for the Test Set
Not applicable/Not available. As mentioned above, the testing for this type of device does not involve human expert adjudication in the context of clinical interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, not done or not reported. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). The Luer Access Injection Site is a physical medical device for fluid administration and blood sampling, and its evaluation focuses on functional performance and microbiological integrity, not human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance assessment was done. The document describes "performance testing" and "microbiological evaluations" conducted on the device itself. This refers to the device's inherent function, independent of a human operator's interpretative skills.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" would be established by validated laboratory methodologies and industry standards for functional performance (e.g., fluid flow, resealing efficacy, luer compatibility) and microbiological integrity (e.g., sterility, microbial ingress prevention). The document mentions "functional and microbiological requirements," implying a comparison against established benchmarks for these types of devices.
8. The Sample Size for the Training Set
Not applicable/Not available. This device is a physical medical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve engineering specifications and quality control, but not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.
§ 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.