(82 days)
The Nipro Disposable Stopcocks are intended for use to change the direction of flow of fluids through a tubing set.
The subject devices can be classified as stopcocks as described in 21 CFR 880.5440. Among the types described here are: click - stop; 3W-R; 3W-L; and, NCN. Both slip tip and luer lock are included.
This document is a 510(k) premarket notification for a Class II medical device (Nipro Disposable Stopcocks) and does not contain the details of a study with acceptance criteria and reported device performance in the manner typically associated with clinical or standalone performance studies for more complex devices.
The approval is based on a determination of substantial equivalence to a previously marketed predicate device, not on a new performance study demonstrating the device meets specific numerical acceptance criteria.
Therefore, many of the requested fields cannot be directly extracted from this document as the information simply isn't present for a device of this type and regulatory pathway.
Here's a breakdown based on the provided text, indicating where information is present and where it is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified as numerical performance metrics for a specific study. The primary "acceptance criterion" for 510(k) is substantial equivalence to a predicate device. | "Performance tests demonstrated that the subject devices are safe and suitable for human use." This is a general statement, not specific numerical performance data against defined criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not mentioned.
- Data provenance: Not mentioned. Given the nature of a 510(k) for this type of device, performance tests would likely be in-vitro engineering tests (e.g., flow rate, pressure resistance, leak testing), not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device does not involve expert interpretation or ground truth establishment in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a physical medical device (stopcock), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for a device like a stopcock is its adherence to engineering specifications and performance within safe parameters, typically verified through physical and mechanical testing rather than clinical "ground truth" as defined for diagnostic systems.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI device that requires a training set.
§ 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.