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The Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and transfer of Repronex® (menotropins for injection, USP) and/or Bravelle® (urofollitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration.

The Vial Adapter component's physical design, description and performance are identical to that of the previously cleared predicate device, Q-Cap ™ Reconstitution 13mm Vial Adapter: K041654 Ko4166 H. Packaging and sterilization of the Vial Adapter are identical to that of the previously cleared predicate device, Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter: K044654 Ko41564. The clear polycarbonate component is General Electric Lexan® 144R. No color additives are present in this component. Ethylene oxide sterilization, ETO residual testing, and LAL Pyrogen testing support additional product safety.

Here's a summary of the acceptance criteria and the study details for the Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter, based on the provided text:

Acceptance Criteria and Device Performance

• FSH: Syringe (78.6 U/Vial), Q-Cap (79.8 U/Vial)
• LH: Syringe (77.1 U/Vial), Q-Cap (77.4 U/Vial)
  The results are virtually identical and within the experimental error range of the assay, demonstrating no substantial differences in biological activity. |
  | Physical Design, Description, and Performance (Vial Adapter Component) | Identical to the previously cleared predicate device, Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter (K041654 K041564). |
  | Packaging and Sterilization | Identical to the previously cleared predicate device, Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter (K041654 K041564). Ethylene oxide sterilization, ETO residual testing, and LAL Pyrogen testing support additional product safety. |
  | Non-Cytotoxicity of Materials | The clear polycarbonate component (General Electric Lexan® 144R) in contact with the drug was previously established as non-cytotoxic with other cleared Ferring fertility drugs. No color additives are present. |
  | No other safety issues | No other safety issues have been identified for the device component via the testing performed for this notification. |

Study Details

1. Sample size used for the test set and the data provenance:

   • The test set involved comparing the biological activity of Menopur® (FSH and LH) when prepared with the Q-Cap™ Vial Adapter versus a standard needle and syringe.
   • The exact sample size (number of vials, number of tests performed) for this specific biological activity comparison is not explicitly stated in the provided text.
   • The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be a prospective laboratory study conducted by the manufacturer or a contracted lab to generate data for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This was a laboratory assay for biological activity of a drug, not a diagnostic device requiring expert interpretation of images or patient data. Therefore, the concept of "experts establishing ground truth" in the typical sense (e.g., radiologists) does not apply.
   • The ground truth was established by the quantifiable results of the Menopur® Assay, performed in a lab environment. The qualifications of the personnel conducting the assay are not provided but would typically involve trained laboratory scientists.

3. Adjudication method for the test set:

   • Not applicable, as this was a quantitative biochemical assay, not a case-based interpretation requiring adjudication.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical accessory for drug reconstitution, not an AI-powered diagnostic tool, and therefore does not involve human readers interpreting data or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, this device is a physical vial adapter, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used was quantitative laboratory assay results for the Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) biological activities of Menopur®.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI algorithm requiring a training set. The "design and performance" were established based on the predicate device and physical/chemical testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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