(135 days)
The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only.
The Promepla Intravascular administration and extension sets contain components that are commonly found in this category of IV sets. The IV Administration (pump tube) Set belongs to a full line of intravenous fluid delivery sets. It is an infusion set intended to deliver fluids, medications, blood and blood products, using continuous or intermittent delivery through clinically acceptable routes of administration (e.g. intravenous, intra-arterial, subcutaneous, epidural, enteral or irrigation of fluid spaces). An optional component, a flow controller allows the use with a peristaltic pump. The Extension Set device is a triple lumen peripheral set with two detachable long lines, belonging to a family of extension tubing sets. This device uses a main gravity drip line, plus the two long extension limbs. It is a connector system, which has anti free-flow valves and line clamps, which are common in intravascular extension sets on the market. The extension set allows IV fluids to be given simultaneously by way of the same connector. Both the IV Administration Set and Extension Set are provided sterile (by Eto) and are for single use only. They are intended only for use by trained professionals in a clinic or hospital environment.
This 510(k) submission (K071421) for the Promepla Intravascular Administration Set and Extension Set describes a conventional predicate device comparison and does not involve a study to prove the device meets acceptance criteria for an AI/ML powered device. The document is for a medical device that administers fluids and is not an AI/ML powered device.
Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert involvement, and MRMC studies for AI/ML devices is not applicable to this submission.
The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, materials, and conducted bench testing (implied, though not detailed in the provided snippets).
The relevant sections from the input that are applicable are:
- Device Trade Name: Promepla Intravascular Administration Set and Extension Set
- Intended Use: "The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only."
- Comparison to Predicate Devices: "Based upon the intended use, design, materials, and the testing conducted, it can be concluded the Promepla Intravascular Administration Set and Extension Set are substantially equivalent to the predicate devices."
Since this is a traditional 510(k) for a non-AI/ML device, the detailed questions about AI/ML specific study design are 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.