(36 days)
The luer activated needleless injection site is designed for use with various SIMS Deltec, Inc. administration sets or syringes for fluid delivery.
The purpose of this submission is to offer an alternate injection site ("Luer Activated Needleless Injection Site") for use with various Deltec administration sets. The injection site is a valve and is accessed using needleless syringes or IV administration sets.
The provided document is a 510(k) summary for a medical device (a Luer Activated Needleless Injection Site). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical claim for an AI/ML device. Therefore, the requested information geared towards AI/ML device studies (such as the number of experts used for ground truth, adjudication methods, MRMC studies, training set size, etc.) is not applicable to this document.
However, I can extract the information that is relevant to the functional and biocompatibility testing mentioned in the summary.
Acceptance Criteria and Device Performance (Based on available information):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Specifications | "Functions according to specification" |
| Biocompatibility | "Meets the biocompatibility requirements" |
Study Details (as per the provided document):
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Sample size used for the test set and data provenance:
- The document does not specify sample sizes for either functional or biocompatibility testing.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These tests typically involve laboratory testing rather than patient data.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels. For functional and biocompatibility testing of a physical medical device, "ground truth" is established by adherence to predefined engineering specifications and regulatory standards.
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Adjudication method for the test set: Not applicable. This concept pertains to resolving discrepancies in expert labeling, which is not relevant for functional and biocompatibility testing.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical component, not an AI/ML diagnostic or assistive tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) study was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML context. For this device, "ground truth" for functional testing refers to meeting predefined engineering performance parameters, and for biocompatibility, it refers to compliance with established biological safety standards.
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The sample size for the training set: Not applicable. This device does not involve machine learning; therefore, a "training set" is not relevant.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device submission.
Summary of Studies from the Document:
- Functional Testing: "Functional specification testing was performed on the alternate injection site."
- Biocompatibility Testing: "Biocompatibility testing was conducted."
- Clinical Studies: "Clinical studies were not deemed necessary regarding the alternate injection site due to its similarity in materials, design and function to current commercially available injection sites."
The conclusion states: "The results of the testing indicated that the alternate injection site functions according to specification and it meets the biocompatibility requirements. Therefore, the alternate injection site is considered acceptable for human use."
§ 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.