(287 days)
The NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills.
The NEOSHIELD system also prevents microbial ingress for 3 days.
NeoShield is a needle free closed system drug transfer device (CSTD). Neoshield prevents transfer of environmental contaminants into the system and also prevents the escape of drug or vapor from the system.
The ability to prevent microbial ingress for up to 3 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.
The provide text is a 510(k) summary for a medical device called NEOSHIELD, an intravascular administration set. It does not describe a study involving humans or AI, but rather a set of non-clinical (bench) performance tests to demonstrate substantial equivalence to a predicate device.
Here's the information extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria (Implied by "No leak" or "Pass") | Reported Device Performance |
|---|---|---|
| Leaking Pressure of Pre-Slit Septum | No leak | No leak |
| Pressure Resistant Test (Liquid Tightness) | No leak | No leak |
| Pressure Resistant Test (Air tightness) | No leak | No leak |
| Pressure Resistant Test (Connecting Part of Closed System) | No leak | No leak |
| Airtight Connection | No leak | No leak |
| Leakproof Connections | No leak | No leak |
| Microbial Ingress Testing | No ingress for 3 days | No ingress for 3 days |
| Pyrogen test | Non-pyrogenic | Non-pyrogenic |
| Crack Test for drug compatibility | No cracks (except for N, N-dimethylacetamide, which is an exclusion) | No cracks except for N, N-dimethylacetamide |
| Sterility Testing (EO) (ISO 11135) | Sterile | Sterile |
| Shelf Life Testing | Sterility kept for 3 years | Sterility kept for 3 years |
| Biocompatibility Testing | All materials are biocompatible (Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systematic Toxicity (Acute), Haemocompatibility, Pyrogen, Particulate Matter) | All materials are biocompatible |
| Package Testing: Seal Strength/dye penetration testing | Pass/Pass | Pass/Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each non-clinical test. It states that "The following non-clinical tests were conducted," and then lists the tests and their results. The data provenance is from bench testing conducted by the manufacturer, JMS Co., Ltd / JMS Singapore Pte Ltd. This is a retrospective analysis of test results.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This was a non-clinical (bench) testing study, not a study involving human interpretation or expert ground truth establishment in the traditional sense of clinical studies. The "ground truth" for these tests is based on objective laboratory measurements against defined standards or pass/fail criteria.
4. Adjudication Method for the Test Set:
Not applicable, as this was non-clinical bench testing. The results are typically objectively measured against pre-defined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical performance and substantial equivalence to a predicate device, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device, NEOSHIELD, is an intravascular administration set (hardware), not an AI algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on objective physical and chemical measurements against established engineering and regulatory standards (e.g., "no leak," "sterile," "non-pyrogenic," "biocompatible").
8. The Sample Size for the Training Set:
Not applicable. As a hardware device, there is no "training set" in the context of an AI algorithm. The device's design and manufacturing processes are developed through engineering and testing, but not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.