(575 days)
The Diana ChemoLock Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.
Diana ChemoLock Transfer Set is intended for use with the Diana Compounding System. It is a disposable, single use ancillary device for Pharmacy Compounding Devices (PCD).
The transfer set is comprised of multiple components bonded together to form a single device. These components include the following: stopcock, tubing, ChemoLock, syringe, and cassette handle. When placed in the Diana Compounding System, the Diana ChemoLock Transfer Set allows the transfer of fluids from one container to the other container for reconstitution of lyophilized drug or transfer of stock drug solution to prepare medications.
The purpose of this submission is to release a new closed system transfer device (CSTD) drug transfer set to be used with Diana Pharmacy Compounding System
The provided text describes a 510(k) premarket notification for the Diana ChemoLock Transfer Set, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and performance data for a standalone AI/algorithm device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text. The document details various functional and safety tests performed on the device to ensure its performance and safety, but these are not presented as "acceptance criteria" in the context of an AI/algorithmic performance study.
Here's what can be extracted, framed as general performance data rather than specific acceptance criteria for an AI/algorithm:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list acceptance criteria in a tabular format with corresponding reported performance for AI/algorithmic measures. Instead, it lists various performance tests conducted.
| Test Category | Description of Test Conducted |
|---|---|
| Functional Testing | Demonstrated functionality of ChemoLock, stopcock, tubing, syringe, and cassette handle. Included: Fluid Flow, Accuracy Testing, Positive Pressure, Chemical Compatibility, Internal Seal Integrity, Stopcock Handle Torque, Component Bond Strength Testing, Visual Inspection. (Follows FDA guidance "Intravascular Administration Sets Premarket Notification Submissions [510(k)]") |
| Packaging Integrity and Shelf Life | Conducted according to ASTM D4169, ASTM F1980, ASTM F2096, and ASTM F88 standards. |
| Biocompatibility | Evaluated according to FDA Guidance and ISO 10993-1. Included: Hemocompatibility, Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity. |
| Microbial Ingress Testing | Demonstrated that the needless access site maintains physical integrity and prohibits environmental contaminant transfer after access. (Consistent with FDA guidance "Intravascular Administration Sets Premarket Notification Submissions [510(k)]") |
| Emission, Dry Disconnection, and CSTD Hazardous Drug Exposure Evaluation | Performed to validate no escape of drug from the device outside the closed system. |
| Particulates | Testing performed following USP (method 1) to demonstrate particulate levels meet USP 788 requirements. |
| Sterility Testing | E-beam sterilization process validation conducted according to ISO 11137-1 and ISO 11137-2. Bacterial endotoxin testing conducted based on AAMI ST72 and USP , and followed FDA Guidance for Industry - Pyrogen and Endotoxins Testing: Questions and Answers. Achieved Sterility Assurance Level (SAL) of 10-6. |
2. Sample size used for the test set and the data provenance: Not applicable. The document describes physical and chemical testing, not a test set for an AI/algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to AI/algorithm validation, not to the functional testing of a transfer set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to AI/algorithm validation.
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: Not applicable. This device is a drug transfer set, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The testing described relies on established engineering and medical device standards (e.g., ASTM, ISO, USP, FDA guidance), rather than ground truth in the context of an AI model.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable. This device does not involve a training set for an AI/algorithm.
In summary, the provided document is a 510(k) submission for a physical medical device, not for an AI/algorithmic device. Therefore, the questions related to AI/algorithm performance and validation are not addressed within this text. The "performance data" section outlines various physical, chemical, and biological tests conducted to demonstrate the device's safety and functionality in accordance with relevant standards.
§ 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.