(21 days)
The Safe-Connect™ Drug Dispensing Spike is a sterile, non-pyrogenic, single use device to be used in dispensing drugs from drug containers. The device is to be used by a trained healthcare professional using Aseptic Techniques for the addition of liquid diluents to powdered drug products for reconstitution, addition of liquids to concentrated liquid drugs for dilution, and/or the withdrawal of the reconstituted and liquid drug products from drug containers by the use of a standard luer tapered syringe. The device is indicated to allow for multiple accesses and withdrawals from the same drug container using standard hospital disinfectant solutions and procedures without the requirement of using a sterile cap to maintain fluid path integrity. The Safe-Connect™ Drug Dispensing Spike may aid in the prevention of needle stick injuries.
The Safe-Connect™ Drug Dispensing Spike is a sterile, single use, needle-less access spike for use in general administration of fluids.
The provided text describes the Safe Connect™ Drug Dispensing Spike and its substantial equivalence to a predicate device, the Safe Connect™ Vial Dispensing Spike. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or most of the other requested details regarding sample sizes, ground truth establishment, or multi-reader multi-case studies.
Based on the provided text, here is what can be inferred or stated:
Acceptance Criteria and Reported Device Performance
The submission focuses on substantial equivalence rather than meeting specific performance acceptance criteria. The "Summary of Testing" section is very brief and general.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in the document) | "All materials used in the fabrication of this Drug Dispensing Spike were evaluated with the original and proposed designs through biocompatibility testing. The proposed devices will perform in an equivalent manner to the predicate devices." (This implies the performance objective was to be equivalent to the predicate, but specific metrics are not provided.) |
Study Details
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- 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 device is a physical medical device (drug dispensing spike), not an AI-powered diagnostic or interpretive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified. The summary only mentions "biocompatibility testing."
- The sample size for the training set: Not applicable (not an AI/learning algorithm).
- How the ground truth for the training set was established: Not applicable.
§ 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.