(36 days)
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 diluent from vials into an injection syringe for administration.
The device which is the subject of this Notification is a sterile, injection molded component, which will be included into Ferring Pharmaceutical's Repronex® and Bravelle® drug kits to assist in needle-free reconstitution of these lyophilized drugs for injection. The Vial Adapter component's physical design, description and performance are identical to that of a previously cleared device, Bioject Reconstitution Kit & Vial Connector (K010623). Packaging and sterilization of the Vial Adapter are identical to that of a previously cleared devices, Bioject Needle-Free Vial Adapter, (13mm); K963012.
This 510(k) summary describes a medical device, the Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter, and references its performance by comparing it to predicate devices. It does not contain a study report with specific acceptance criteria and reported device performance in the format of a table as requested, nor does it detail a standalone algorithm performance study or an MRMC study.
However, based on the provided text, here's an attempt to extract the relevant information, with some sections marked as "Not Applicable" or "Not Provided" due to the nature of the document.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily relies on the equivalency to predicate devices rather than presenting explicit performance metrics against predefined acceptance criteria for the new device. The performance is assessed by stating that the device is "identical" or that certain aspects "support product safety."
| Acceptance Criteria Category | Specific Criteria (Implicitly from the document) | Reported Device Performance |
|---|---|---|
| Physical Design | Identical to predicate device (K010623) | Confirmed as identical |
| Description | Identical to predicate device (K010623) | Confirmed as identical |
| Performance | Identical to predicate device (K010623) | Confirmed as identical |
| Packaging | Identical to predicate device (K963012) | Confirmed as identical |
| Sterilization | Identical to predicate device (K963012) | Confirmed as identical |
| Biocompatibility | Absence of cytotoxicity with polycarbonate (Lexan® 144R) and with specific fertility drugs (Repronex®, Bravelle®) | Demonstrated for both cytotoxicity and compatibility with specific drugs |
| Safety (Sterilization) | Acceptable ETO residual levels | ETO residual testing supports product safety |
| Safety (Pyrogenicity) | Absence of pyrogens | LAL Pyrogen testing supports product safety |
| Other Safety Issues | No other identified safety issues | No other safety issues identified |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly provided. The document relies on equivalence to previously cleared devices rather than new extensive testing for this 510(k) application.
- Data provenance: Not explicitly provided for new testing. The reference to predicate devices implies that past testing data from these devices (Bioject Reconstitution Kit & Vial Connector (K010623) and Bioject Needle-Free Vial Adapter (K963012)) would be the primary provenance. The document indicates that biocompatibility was "demonstrated" and that "testing support(s) product safety," implying some form of testing was performed, but details on sample size or provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a medical accessory, and the regulatory submission focuses on physical and biological safety/performance equivalence, not diagnostic accuracy requiring expert ground truth establishment in the traditional sense of image analysis or diagnostic algorithms.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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
- No. This is a medical device (vial adapter) and not an AI/software as a medical device (SaMD). Therefore, MRMC studies are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this type of device, "ground truth" relates more to material specifications, sterility, absence of extractables, and functionality (e.g., proper fit, ease of use, no leakage) as demonstrated by engineering and biological testing, rather than a diagnostic 'truth'. The document states that "biocompatibility...is demonstrated" and "testing support additional product safety," implying laboratory-based testing results served as the "ground truth" for these safety aspects.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.