← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K963009 # DELTEC SUBCUTANEOUS INFUSION SET (K963009) _Sims Deltec, Inc. · FPA · Oct 18, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K963009 ## Device Facts - **Applicant:** Sims Deltec, Inc. - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Oct 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K963009 510(k) Summary of Safety and Effectiveness Date Prepared: May 20, 1996 OCT 18 1996 I. GENERAL INFORMATION Applicant's name and address: SIMS Deltec, Inc. 1265 Grey Fox Road St. Paul, MN 55112 Contact: David H. Short Manager, Regulatory Affairs (612)628-7214 II. PRODUCT INFORMATION Common/Usual Name: Subcutaneous Infusion Set Classification Name: Infusion Set Proprietary Name: Deltec Subcutaneous Infusion Set III. EQUIVALENCE DEVICE COMPARISON SIMS Deltec’s Subcutaneous Infusion Set and Micro Med’s 42” Winged Sub-Q Infusion Set. IV. DEVICE DESCRIPTION The Deltec Subcutaneous Infusion Set consists of a needle with attached wing, extension tubing and female luer. Page 1 of 2 {1} 510(k) Summary of Safety and Effectiveness Date Prepared: May 20, 1996 ## IV. DEVICE COMPARISON Provided in Table 1 is a feature comparison of commercially available subcutaneous infusion sets. Table 1. Comparison Chart | | Deltec Subcutaneous Infusion Set | Subcutaneous Infusion Set | Micro Med 42” Winged Sub-Q Infusion Set | | --- | --- | --- | --- | | MANUFACTURER | SIMS Deltec Inc. | SIMS Deltec Inc. | Micro Med, Inc. | | CONFIGURATION | | | | | needle length | ½ inch | ¾ inch | 0.475 inch | | needle angle | 90° | 30° | 90° | | gauge | 27 | 27 | 27 | | tubing length | 42 inches | 30 inches | 42 inches | | winged needle | yes | yes | yes | ## V. INTENDED USE The subject device is intended to facilitate subcutaneous infusion of fluids. ## VI. SUMMARY OF STUDIES A. Functional Testing The subject device is designed to meet certain functional requirements related to tubing to needle and luer to tubing bond strength. B. Clinical Studies Clinical studies were not deemed necessary. ## VII. CONCLUSION Based upon the information provided above, the Deltec Subcutaneous Infusion Set is suitable for its intended use. Page 2 of 2 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K963009](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K963009) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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