← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K961049 # FLEX NEEDLE (K961049) _Lighthouse Medical, Inc. · FPA · Sep 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/K961049 ## Device Facts - **Applicant:** Lighthouse Medical, Inc. - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Sep 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The FlexNeedle™ allows transcutaneous cannulation of subdermally implanted venous access ports. ## Device Story FlexNeedle™; intravascular administration set for subdermally implanted venous access ports. Components: flexible catheter, hub with elastomeric septum and side port, sideleg tubing with luer infusion fitting, cap, pinch clamp, insertion stylet. Used by clinicians for port access; provides bloodstream access via hollow tube/luer fitting. Facilitates infusion/access; benefits patient by enabling reliable port utilization. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Flexible catheter, hub with elastomeric septum, sideleg tubing, luer infusion fitting, cap, pinch clamp, insertion stylet. Intravascular administration set 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 - Luther Medical Products L-CATH for Ports - Medex SureCath Port Access Catheter - SIMS Deltec Gripper ## 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} K 961049 10. 510(k) SUMMARY 10 (1) Lighthouse Medical, Inc. 100 Beaver St. Waltham, MA 02154 Contact Person: Jenna Andelman Date Summary Prepared: March 12, 1996 (2) Trade or Proprietary Name: FlexNeedle™ Common Name: Intravascular administration set Classified Name: Intravascular administration set (3) Predicates: Luther Medical Products L-CATH for Ports (K# unknown) Medex SureCath Port Access Catheter (K# unknown) SIMS Deltec Gripper (K# unknown). (4) Description of Device: The FlexNeedle™ is composed of a flexible catheter; a hub with elastomeric septum and side port; sideleg tubing with luer infusion fitting, cap, and pinch clamp; and an insertion stylet. (5) Intended Use: The FlexNeedle™ allows transcutaneous cannulation of subdermally implanted venous access ports. (6) The FlexNeedle™ has the same technological characteristics as the above predicate devices in that it is a hollow tube with a luer fitting intended to remain in a subcutaneous access port in order to provide access to the bloodstream. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K961049](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K961049) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com