(194 days)
The Spiros is a single use, sterile, non-pyrogenic, swab-able, bidirectional valve device intended for use as an accessory to an Intravascular Administration Set. The Spiros provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).
The Spinning Spiros is a closed connector which is compatible with and used to access, standard female luers and known needle-free connectors. The Spinning Spiros is a passively closed design which will prevent the leakage of fluid or ingress of air when in the inactivated (resting) state. When activated the luer is an open twoway conduit for fluid flow. The Spinning Spiros is an accessory to an IV administration device including tubing sets and syringes, such that an integral female luer is used to connect to such devices.
The provided text describes a 510(k) summary for the "Spinning Spiros" device. This is a regulatory submission for a medical device seeking clearance based on substantial equivalence to a predicate device, not typically a study reporting detailed performance metrics and acceptance criteria in the way a clinical trial or a formal performance study would.
Therefore, the information requested in your prompt (especially regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not present in the provided document. This type of regulatory document focuses on demonstrating equivalence to an already marketed device rather than presenting novel performance study data in detail.
However, based on the snippet: "ICU Medical Spinning Spiros closed male luer device has been tested post sterilization and passed all acceptance criteria. The Spinning Spiros closed mate luer meets the functional claims and intended use as described in the product labeling and is safe and effective in terms of substantial equivalence as the predicate device described in this document," we can infer the general nature of the acceptance criteria and the study's conclusion, even if the specifics are not given.
Here's a breakdown of what can be extracted and what is missing based on your prompt:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Functional equivalence to predicate device (K070532 - Spiros) | "The Spinning Spiros... is equivalent to the predicate device because it does not modify the claim." |
| Prevention of fluid leakage in inactivated state | "The Spinning Spiros is a passively closed design which will prevent the leakage of fluid..." |
| Prevention of air ingress in inactivated state | "The Spinning Spiros is a passively closed design which will prevent... ingress of air when in the inactivated (resting) state." |
| Open two-way conduit for fluid flow when activated | "When activated the luer is an open two-way conduit for fluid flow." |
| Compatibility with standard female luers and needle-free connectors | "The Spinning Spiros is a closed connector which is compatible with and used to access, standard female luers and known needle-free connectors." |
| Single use | "The Spiros is a single use..." |
| Sterile | "The Spiros is a... sterile..." |
| Non-pyrogenic | "The Spiros is a... non-pyrogenic..." |
| Swab-able | "The Spiros is a... swab-able..." |
| Bi-directional valve function | "The Spiros is a... bidirectional valve device..." |
| Mechanical integrity post-sterilization | "ICU Medical Spinning Spiros closed male luer device has been tested post sterilization and passed all acceptance criteria." |
| Safety and effectiveness | "The Spinning Spiros closed mate luer... is safe and effective in terms of substantial equivalence..." |
| No accidental back-off from syringe | "The spin collar adds the feature that the Spinning Spiros won't accidentally back off of a syringe." |
Missing Information (Not Available in the Provided Text):
- Sample size used for the test set and the data provenance: This information is not provided. The document states "has been tested," but no specifics on sample size or whether it was internal company testing, external, etc., are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. This device is not one that typically requires expert interpretation for "ground truth" in the way an imaging AI model would. It relates to functional and material testing.
- Adjudication method: Not applicable or not provided.
- 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. This is a physical medical device, not an algorithm.
- The type of ground truth used: For a physical device like this, "ground truth" would be established by physical measurements, functional tests (e.g., flow rate, leak tests, force to connect/disconnect), material testing, and sterilization validation, all performed against engineering specifications and relevant ISO/ASTM standards. The document only generically states "passed all acceptance criteria" and "meets the functional claims."
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (Inferred from the document):
The "study" referenced is likely a series of internal verification and validation tests (V&V) conducted by ICU Medical, Inc. on the Spinning Spiros device. These tests would have been designed to ensure the device met its design specifications and functional requirements, and to demonstrate substantial equivalence to the predicate device (Spiros, K070532). The tests would have included evaluating the device's mechanical integrity (especially after sterilization), fluidic properties (leakage, flow), compatibility with standard luers, and the specific feature of the spinning collar preventing accidental disconnection. The conclusion of these internal studies was that the device met all acceptance criteria, functional claims, and intended uses, deeming it safe and effective and substantially equivalent to its predicate. The specifics of these tests (e.g., protocols, sample sizes, detailed results) are typically found in the full 510(k) submission, not in the publicly available summary.
§ 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.