(146 days)
The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.
The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gland/Center Post Assembly, as described below:
The Gland is a valve/gasket which provides a seal against the syringe/luer connector when the device is being utilized. The Gland incorporates a slit to accept the syringe/luer connector. The Gland is also the swabbable surface of the Capless Luer Activated Valve. The valve can be easily swabbed per hospital protocol before each connection.
The Center Post mechanically supports the Gland and serves as the primary high pressure seal to keep the fluid path closed during the resting state.
The Gland and the Center Post are mechanically press-fit together to form the Gland/Center Post Assembly.
In the resting state, the Center Post is flush with the walls of the Gland Housing, ensuring that there is no fluid path. As the device is activated by a syringe/male luer connector, the flexible Gland is forced open and the Center Post is pushed down. As the Center Post is forced further down into the Gland Housing, the fluid path is established.
The provided text describes a 510(k) submission for a medical device, the "NP Medical Capless Luer Activated Valve." However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria and the results of a study that quantifies device performance against those criteria. The submission states that performance requirements were met but does not provide the specific metrics or values.
Here's a breakdown of the available information based on your requested points:
1. A table of acceptance criteria and the reported device performance
The document mentions that mechanical, biocompatibility, and microbial challenge testing were performed and that the device "meets their performance requirements" or "passed all" tests. However, it does not specify the exact acceptance criteria or the quantitative results achieved. Without specific numerical values for acceptance criteria and device performance from the document, a table cannot be constructed with the requested level of detail.
Illustrative Table (Based on available qualitative information):
| Acceptance Criterion (Hypothetical - Not explicitly stated in document) | Reported Device Performance (As stated in document) |
|---|---|
| Mechanical Integrity: Maintain structural integrity under anticipated forces (e.g., pressure, luer connection cycles). | "The results of the Mechanical Testing demonstrate that the NP Medical Capless Luer Activated Valves meet their performance requirements." |
| Biocompatibility: Absence of adverse biological reactions (e.g., cytotoxicity, sensitization, irritation). | "Full biocompatibility testing has been performed ... The materials passed all of the biocompatibility tests." |
| Microbial Barrier/Sterility Maintenance: Prevent microbial ingress into the fluid pathway under specified challenge conditions. | "The results of the testing demonstrate that, in response to excessive microbial challenge conditions, the sterility of the fluid pathway was maintained." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the tests (Mechanical, Biocompatibility, Microbial Challenge). It also does not explicitly state the provenance of the data (country of origin, retrospective or prospective). Given that NP Medical, Inc. is located in Clinton, MA, and the submission is to the FDA, it is highly probable the testing was conducted in the USA by or for the manufacturer. The testing described (mechanical, biocompatibility, microbial challenge) is typically prospective and laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not available in the provided document. The device is a physical medical device (a luer activated valve), not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The performance is assessed through laboratory testing (mechanical, chemical, microbial) rather than interpretation by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not available in the provided document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human expert assessment where there might be disagreement in interpretations (e.g., in radiology studies). This submission describes laboratory-based engineering and biological tests for a physical device, not an interpretive process.
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 information is not applicable and therefore not available in the provided document. An MRMC study is relevant for evaluating diagnostic tools, often AI-powered, where human readers interpret patient cases. The Capless Luer Activated Valve is a physical device for fluid delivery, not a diagnostic tool, and involves no "human readers" in its intended function or performance testing described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not available in the provided document. "Standalone performance" in this context usually refers to the performance of an AI algorithm alone. The NP Medical Capless Luer Activated Valve is a physical medical device, not an algorithm. Its performance is inherent in its physical and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be defined by engineering specifications and established test methods (e.g., pressure resistance, flow rates, number of activation cycles without failure). For biocompatibility, the "ground truth" is determined by standardized biological assays according to ISO 10993. For microbial challenge testing, the "ground truth" is the absence of microbial growth in the fluid pathway after being subjected to a known microbial load, following established microbiological testing protocols.
8. The sample size for the training set
This information is not applicable and therefore not available in the provided document. "Training set" refers to data used to train machine learning models. As this is a physical medical device, there is no "training set" in the context of AI. The device's design and manufacturing rely on engineering principles and material science, not machine learning.
9. How the ground truth for the training set was established
This information is not applicable and therefore not available in the provided document. As there is no AI training set for this physical device, there is no ground truth to be established for it.
§ 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.