(26 days)
The addEASE 20 mm Binary Connector with 17 Ga. Needle is a double ended transfer device intended for use in a pharmacy setting to connect a B. Braun 250mL Excel® IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
The addEASE 20 mm Binary Connector with 17 Ga. needle is a double ended transfer device intended to connect a B. Braun 250 mL Excel® IV solution bag to a 20 mm drug vial. The device contains a bag spike on one end and a vial spike on the other end. The vial spike is composed of polycarbonate and the bag spike is composed of a 17 Ga. stainless steel needle. The device contains a plunger which keeps the contents of the connected containers separate until the plunger is purposely deployed and the contents of the bag and vial are mixed. The bag spike and vial spike are protected with caps that maintain the sterility of the device until the caps are removed prior to use.
The provided documentation is a 510(k) Premarket Notification for the addEASE 20mm Binary Connector with 17 Ga. Needle. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria.
Therefore, the information required to fully answer your questions regarding acceptance criteria, study details, and ground truth establishment is not available within this document. This submission primarily focuses on the device's design, intended use, and its similarities to a previously cleared predicate device.
However, I can extract the available information and highlight what is missing:
1. Table of acceptance criteria and the reported device performance
The document states: "Design verification testing has been completed and all specifications have been met." However, the specific acceptance criteria and the detailed performance results are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "All specifications have been met." |
| (e.g., Sterility, Leakage, Flow rates, Compatibility with specific vials/bags, etc.) | (Specific quantitative results are not provided in this document) |
2. Sample size used for the test set and the data provenance
The document mentions "Design verification testing," but does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve expert-established ground truth. No experts for ground truth establishment are mentioned.
4. Adjudication method for the test set
This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve adjudication for ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the document describes a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
This information is not applicable as the document describes a physical medical device. The "ground truth" for such a device would be based on engineering specifications, material properties, and functional testing rather than expert consensus or pathology.
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device, not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a physical medical device.
Summary of the study conducted (as per the document):
The only study mentioned is "Design verification testing." The purpose of this testing was to demonstrate that the modified device (with the 17 Ga. needle) did not introduce new safety or effectiveness issues compared to the predicate device.
- Study Objective: To demonstrate that the addition of a 17 Ga. needle to the addEASE 20mm Binary Connector does not significantly impact the fundamental technology and does not raise new issues of safety or effectiveness compared to the predicate device (Add-A-Vial II, K900865).
- Methodology: "Design verification testing has been completed." The specific tests performed are not detailed, but would typically include tests related to mechanical integrity, sterility, leakage, function (e.g., successful transfer of fluids), and material compatibility.
- Results: "all specifications have been met." It further states that "The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness."
In conclusion, this 510(k) summary provides evidence of design verification testing to support substantial equivalence but does not offer the detailed performance metrics, sample sizes, or ground truth methodologies that would be typical for an AI/ML-based device submission.
§ 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.