Ivex-Tpn Extension Filter Set
by Abbott Laboratories 510(k)
Active
510(k) K913308
Overview
The Ivex-Tpn Extension Filter Set is a Filter, Infusion Line designed to connect intravenous administration sets to total parenteral nutrition (TPN) systems. It incorporates a sterile filter to remove particulate matter from infusates, ensuring the delivery of clear fluids to patients while maintaining the integrity of the TPN formulation.
This device is intended for single-use in hospital settings and is supplied sterile. It is classified as a Class II medical device under FDA regulation 880.5440, with an FDA 510(k) clearance (K913308) granted in 1992. The set is compatible with standard TPN administration systems and must be handled aseptically to prevent contamination.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913308 | Date15 Jan 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0955-03
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
Specification
- 510(k) Number
- FDA Product Code
- FPB
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the primary purpose of the IVEX-TPN Extension Filter Set in a clinical setting?
The IVEX-TPN Extension Filter Set is designed to connect intravenous administration sets to total parenteral nutrition (TPN) systems. Its key function is to incorporate a sterile filter that removes particulate matter from infusates, ensuring that only clear fluids are delivered to patients while preserving the integrity of the TPN formulation. This helps prevent clogging or contamination of the TPN line.
Is the IVEX-TPN Extension Filter Set intended for reuse, or is it meant for single-use only?
The IVEX-TPN Extension Filter Set is explicitly intended for single-use in hospital settings. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical when administering TPN, a sterile and precise nutritional formulation.
How should the IVEX-TPN Extension Filter Set be stored before use, and what sterility guarantees does it provide?
The device is supplied sterile and must be handled aseptically to prevent contamination. While the exact storage instructions aren’t detailed in the data, the sterile packaging ensures it remains uncontaminated until use. Always follow manufacturer guidelines for storage conditions (e.g., protected from light, moisture, or extreme temperatures) to maintain sterility.
Are there different sizes or models of the IVEX-TPN Extension Filter Set, or is it available in a single configuration?
The provided data does not specify distinct sizes or models beyond its classification as a Filter, Infusion Line with a product code of FPB. However, the device is designed to be compatible with standard TPN administration systems, suggesting it may accommodate common infusion line diameters. For exact sizing or model variations, refer to Abbott Laboratories’ product documentation or consult their technical support.
What regulatory pathway was followed for the FDA clearance of the IVEX-TPN Extension Filter Set, and what does this mean for its use in hospitals?
The IVEX-TPN Extension Filter Set received FDA 510(k) clearance (K913308) under the Traditional 510(k) review pathway, with a decision dated January 15, 1992. This clearance confirms the device is substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under FDA regulation 880.5440. Hospitals can use it with confidence, as it meets FDA standards for safety and effectiveness in filtering particulate matter from TPN infusions.