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Chemfort™ is a Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, reconstitution, compounding and administration, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
Chemfort™ prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

The Chemfort™ Closed System Transfer Device (CSTD) is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion container. The Chemfort™ CSTD prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.

The components of the Chemfort™ CSTD system are:

• . Vial Adaptor 20 mm with 13 mm Vial Converter
• Vial Adaptor 28 mm
• Vial Adaptor 32 mm
• Syringe Adaptor
• Syringe Adaptor Lock
• Luer Lock Adaptor
• Bag Adaptor SP

Each of the Chemfort™ system components is available separately.

The acceptance criteria for the Chemfort™ Closed System Transfer Device (CSTD) and the study that proves it meets these criteria are detailed through various non-clinical performance tests. The device aims to mechanically prohibit the release of drugs (including antineoplastic and hazardous drugs) in vapor, aerosol, or liquid form during preparation, compounding, and administration, thereby minimizing exposure to hazardous drugs. It also prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted to demonstrate equivalence with the predicate device (TEVADAPTOR®) and to support the new indication concerning microbial ingress. While specific quantitative acceptance criteria are not explicitly detailed in the provided text for each test, the general reporting indicates that the device "successfully passed" or "has been carried out" with tests demonstrating equivalence or functionality. The conclusion states that the device "does not raise new types of safety and effectiveness questions" and is "substantially equivalent" to the predicate.

Here's a table summarizing the tests and the reported performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes used for each test. It generally refers to "bench testing" and "biocompatibility tests" being "carried out on the Chemfort™ system components." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that it's bench testing for a medical device submission, it would typically be prospective testing conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the use of experts or their qualifications for establishing ground truth for the test set. All mentioned studies are non-clinical bench tests performed according to recognized standards (e.g., ISO, USP, ASTM). These types of tests typically rely on standardized protocols and quantitative measurements rather than expert consensus on subjective evaluations.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. This is consistent with non-clinical performance testing where results are objective measurements against predefined specifications, rather than subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI/radiology devices where human interpretation is a key component. The Chemfort™ CSTD is a mechanical device, and its performance is evaluated through bench testing against physical and chemical criteria.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study for an algorithm was not conducted as the Chemfort™ CSTD is a mechanical medical device, not an AI/software device. The performance data presented are for the device itself.

7. Type of Ground Truth Used:

The ground truth for the device's performance is based on objective measurements and results from standardized non-clinical bench tests. These tests evaluate physical properties, chemical integrity, microbial barrier efficacy, and other performance characteristics against established industry standards (e.g., ISO, USP, ASTM) and the specifications of the predicate device. For example, "microbial ingress tests (7 days)" would confirm the device's ability to prevent contamination, which is a measurable outcome.

8. Sample Size for the Training Set:

This question is not applicable. The Chemfort™ CSTD is a mechanical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable, as there is no training set for a mechanical device.

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