(232 days)
The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to patient through a cannula placed in the vein or artery.
The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory of an intravascular infusion device to connect a cannula placed in a vein or artery to infuse patients, including adults and pediatrics. The Needle Free Connector can be divided into two versions according to whether it has a protective cap or not. The Needle free connector with protective cap is composed of Body, Core, Polyester Shell or ABS Shell, and Protective Cap. The Needle free connector without protective cap is composed of Body, Core, Polyester Shell, or ABS Shell, or PC shell. The body is made from polycarbonate, the core made from silicone, the protective cap made from ABS. The PC shell of the device is clear with visible liquid pathway. The device is sterilized by EO gas and the sterilization process is validated. It is a luer activated device that eliminates the risk of needle-stick injuries and can be used for a maximum of 7 days following initial connection and 600 activations. It may be used with power injection procedure to a maximum pressure of 350psi.
This document is a 510(k) Pre-market Notification for a medical device called a "Needle Free Connector." It details the device's characteristics and compares them to a legally marketed predicate device to demonstrate substantial equivalence, rather than establishing acceptance criteria for an AI/ML powered device and proving those criteria were met through a study.
Therefore, the provided document does not contain the information required to answer the questions. The document describes the characteristics of a physical medical device (Needle Free Connector) and its substantial equivalence to a predicate device, focusing on mechanical, biological, and sterility performance rather than the performance of an AI/ML algorithm.
The questions in the prompt are specific to the study and acceptance criteria of an AI/ML-powered device, which is not what this FDA submission describes.
To reiterate which questions cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: The document lists characteristics and performance metrics, but these are for a physical connector, not an AI/ML device. There are no specific AI/ML acceptance criteria defined.
- Sample sized used for the test set and the data provenance: Not applicable, as this is not an AI/ML study involving test sets of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: 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.