DELTEC SUBCUTANEOUS INFUSION SET
Device Facts
| Record ID | K963009 |
|---|---|
| Device Name | DELTEC SUBCUTANEOUS INFUSION SET |
| Applicant | Sims Deltec, Inc. |
| Product Code | FPA · General Hospital |
| Decision Date | Oct 18, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The subject device is intended to facilitate subcutaneous infusion of fluids.
Device Story
Deltec Subcutaneous Infusion Set; consists of needle with attached wing, extension tubing, and female luer. Used to facilitate subcutaneous fluid infusion. Device connects to infusion pump or delivery system via luer; provides fluid path to subcutaneous tissue. Used in clinical or home settings; operated by clinicians or patients. Benefits include reliable fluid delivery access.
Clinical Evidence
No clinical data. Bench testing performed to verify functional requirements, specifically tubing-to-needle and luer-to-tubing bond strength.
Technological Characteristics
Subcutaneous infusion set; 27-gauge needle; 0.5-inch needle length; 90-degree needle angle; 42-inch extension tubing; female luer connector; winged needle design.
Indications for Use
Indicated for patients requiring subcutaneous infusion of fluids.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Micro Med 42” Winged Sub-Q Infusion Set
Related Devices
- K964455 — POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 · Medtronic Minimed · Jan 30, 1997
- K964456 — POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367 · Medtronic Minimed · Jan 30, 1997
- K140131 — SUB-Q SUBCUTANEOUS TISSUE INFUSION SET · Emed Technologies Corporation · Apr 3, 2014
- K021005 — SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE · Sterling Medivations, Inc. · Apr 25, 2002
- K020629 — SIMPLICITY SIMPLEX SOFT INFUSION SET · Sterling Medivations, Inc. · Apr 1, 2002
