(249 days)
The AMSafe® NeuFloTM Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.
The provided text is a 510(k) summary for the AMSafe® NeuFlo™ Needleless Connector. This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.
However, the provided text does not describe a study involving an AI/Machine Learning device, nor does it detail a study that proves a device meets acceptance criteria in the context of AI/ML performance metrics like sensitivity, specificity, or reader studies.
Instead, it details the acceptance criteria and results for a physical medical device. The criteria are based on compliance with established ISO standards and other tests to confirm physical, chemical, and biological performance. The "performance" described refers to the functionality and safety of the needleless connector itself, not AI model performance.
Therefore, I cannot fulfill the request as it pertains to AI/Machine Learning evaluation criteria, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or training set ground truth establishment in the context of an AI/ML device.
The document speaks to the following for the physical medical device:
1. A table of acceptance criteria and the reported device performance:
The document provides a table under "g) Summary of Non-clinical testing (Bench)" listing tests, methods, acceptance criteria, and conclusions (Pass/Fail).
| Test | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|
| Physical Performance test | |||
| Leakage Test | ISO8536-4 | ISO8536-4 | Pass |
| Luer adapter connection | ISO80369-7 | ISO80369-7 | Pass |
| Free Flow rate | ISO8536-4 | ISO8536-4 | Pass |
| Particulate contamination | ISO8536-4 | ISO8536-4 | Pass |
| Chemical performance test | |||
| Reducing matter | ISO8536-4 | ISO8536-4 | Pass |
| Metal ions | ISO8536-4 | ISO8536-4 | Pass |
| Titration acidity or alkalinity | ISO8536-4 | ISO8536-4 | Pass |
| Residue on evaporation | ISO8536-4 | ISO8536-4 | Pass |
| UV absorption of extract solution | ISO8536-4 | ISO8536-4 | Pass |
| EO residual test | ISO10993-7 | ≤10µg/g | Pass |
| Biological performance test | |||
| Sterility test | ISO8536-4 | ISO8536-4 | Pass |
| Pyrogenicity | ISO8536-4 | ISO8536-4 | Pass |
| Biocompatibility test | |||
| In vitro cytotoxicity test | ISO10993-5 | ISO10993-5 | Pass |
| Skin sensitization test 0.9% sodium chloride injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Skin sensitization test sesame oil extract | ISO10993-10 | ISO10993-10 | Pass |
| Intracutaneous reactivity test 0.9% sodium chloride injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Acute systemic toxicity test sesame oil extract | ISO10993-11 | ISO10993-11 | Pass |
| Pyrogen test 0.9% sodium chloride injection extract rabbit | ISO10993-11 | ISO10993-11 | Pass |
| Bacteria endotoxins test Gel-Clot technique | USP 43-NF | USP 43-NF | Pass |
| Subchronic systemic toxicity test | ISO10993-11 | ISO10993-11 | Pass |
| In Vitro hemolytic properties test | ISO10993-4 | ISO10993-4 | Pass |
For the other points (2-9), as explained, the document pertains to a physical medical device and its compliance with standards, not an AI/ML device performance study. Thus, no information is available regarding:
- Sample size used for the test set and data provenance (in an AI/ML context).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc. for an AI/ML model).
- Sample size for the training set.
- How the ground truth for the training set was established.
§ 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.