← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K970800 # MAXCESS NEEDLEFREE - Y- SITE (100713) (K970800) _Solopak Medical Products, Inc. · FPA · Apr 2, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970800 ## Device Facts - **Applicant:** Solopak Medical Products, Inc. - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Apr 2, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The Douglas Medical Products Maxcess™ NeedleFree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times within the limits of CDC guidelines and/or institutional guidelines. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use. ## Device Story Intravascular administration set accessory; placed between primary solution source and patient vascular access device; provides unobstructed fluid flow; features needle-free side port for intermittent access; used in clinical settings; operated by healthcare professionals; maintains line patency; facilitates medication delivery or fluid administration; benefits patient by reducing needle-stick risk. ## Clinical Evidence Bench testing only. Materials tested per tripartite guidelines; sterility assurance level 10^-6 per AAMI guidelines; LAL testing per USP guidelines. ## Technological Characteristics Sterile, non-pyrogenic Y-site injection component. Materials tested per tripartite guidelines. Sterilized per AAMI guidelines to 10^-6 SAL. LAL tested per USP guidelines. Mechanical flow-through 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 - Maxcess™ NeedleFree Connector ([K960661](/device/K960661.md)) ## 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} K970800 March 19, 1997 Summary of Safety and Effectiveness SolePak® Medical Products APR - 3 1997 To Whom it may concern: This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92: Trade Name - Maxcess™ NeedleFree Y-Site Common Name - Y-Injection Site Classification Name - Intravascular Administration Set (accessory) The Douglas Medical Products Maxcess™ NeedleFree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times within the limits of CDC guidelines and/or institutional guidelines. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use. The Douglas Medical Products Maxcess™ NeedleFree Y-Site is a sterile, non-pyrogenic component packaged in a tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess™ NeedleFree Y-Site have been tested per tripartite guidelines and is safe for it's intended use. The indicated use of the Maxcess™ NeedleFree Y-Site is the same or equivalent to the predicate device named in this submission. The named predicate device in this submission is the Maxcess™ NeedleFree Connector currently marketed by Douglas Medical Products under 510(k) #K960661. The Douglas Medical Products Maxcess™ NeedleFree Y-Site is sterilized per AAMI guidelines to a $10^{-6}$ sterility assurance level. Each production lot is LAL tested per USP guidelines. Based on the fact that the Douglas Medical Products Maxcess™ NeedleFree Y-Site utilizes similar and equivalent designs, and materials, as current legally marketed products, it is safe and effective when used as intended. Sincerely, Elizabeth Loya, RN Regulatory Affairs Associate Douglas Medical Products 1845 Tonne Road, Elk Grove Village, Illinois 60007-5125 • Telephone: 847-806-0080 • Telefax: 847-806-0087 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970800](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970800) **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