(12 days)
Baxter's Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.
The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing port cap on a number of currently marketed Baxter devices such as sets, stopcocks and manifolds. It will also be sold individually as a replacement cap to cover an open luer port after it has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male luer lock connection on one end and a female luer lock connection on the other end.
Here's an analysis of the provided text regarding the "Dual Luer Lock Cap" and its acceptance criteria and supporting study, formatted as requested.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements (unspecified) | "meets or exceed all functional requirements" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set. It mentions "functional testing" was performed, and "data have been generated," but no numbers are provided for the quantity of devices tested.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a medical device accessory, it is almost certainly a prospective test conducted by the manufacturer for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not detailed in the provided text. For a device like a luer lock cap, "ground truth" would likely be established by engineering specifications and objective measurements against those specs, rather than expert interpretation (e.g., radiologist consensus).
4. Adjudication Method for the Test Set
This information is not detailed in the provided text. Since the acceptance criteria are functional, adjudication would likely involve comparing test results directly to predefined objective standards, rather than a consensus method among human adjudicators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging AI systems where human readers interpret medical images. The "Dual Luer Lock Cap" is a mechanical medical device, not a diagnostic tool that involves human interpretation of data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was effectively performed, although the term "algorithm" is not applicable here. The device's functional performance was evaluated independently without human intervention influencing the functional outcome itself. The tests would assess properties like seal integrity, connection strength, and material properties.
7. Type of Ground Truth Used
The ground truth used for this device would be based on engineering specifications and objective functional requirements. This includes standards for luer connectivity, sealing capability, material compatibility, and sterilization. The specific details of these functional requirements are not itemized in the summary, but it's implied that the device was tested against such standards.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are used for machine learning algorithms. The "Dual Luer Lock Cap" is a physical medical device, not an AI or software product.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for this physical device, this question is not applicable.
§ 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.