(62 days)
The IMM Hypodermic Needle Set is to be used for sampling blood from or infusing fluid into body system underneath the skin.
The IMM™ Hypodermic Needle Set consists of a conventional stainless steel needle, needle hub, extension tubing, clamp, and standard female 6% luer conical fitting for connection to a device contains a male luer fitting.
The provided text describes the 510(k) premarket notification for the IMM Hypodermic Needle Set. It details the device, its intended use, and a summary of performance. However, this document does not describe a study involving AI or machine learning.
Instead, it refers to:
- Functional and performance tests demonstrating compliance with voluntary standards (ISO 594, ISO 7864).
- Biocompatibility tests meeting requirements per ISO 10993.
Therefore, many of the requested categories related to AI studies (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance with AI, etc.) cannot be answered from the provided text.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance (Non-AI Study)
| Acceptance Criteria Category | Specific Standard/Requirement Met | Reported Device Performance |
|---|---|---|
| Functional & Performance | ISO 594 (Luer conical fittings) | Meets specific requirements |
| ISO 7864 (Sterile hypodermic needles for single use) | Meets specific requirements | |
| Biocompatibility | ISO 10993 ("Limited exposure, indirect blood path, external communicating device") | Meets requirements |
Information Not Applicable/Available for an AI Study:
Since this is a submission for a traditional medical device (hypodermic needle set) and not an AI/ML powered device, the following points are not applicable or cannot be answered from the provided document:
- Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated against engineering and biological standards, not a clinical test set in the context of AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI study. The "ground truth" here involved physical and chemical properties assessed against established international standards.
- The sample size for the training set: Not applicable. There is no training set for an AI model.
- How the ground truth for the training set was established: Not applicable. There is no training set for an AI model.
§ 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.