(29 days)
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, nonpyrogenic 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.
I am sorry, but the provided text from "Ka70800" does not contain information about acceptance criteria, device performance, study design, or any of the other specific points requested in your prompt. The document is a "Summary of Safety and Effectiveness" for a medical device (Maxcess™ NeedleFree Y-Site) and primarily focuses on its intended use, materials, sterilization, and equivalence to a predicate device for 510(k) submission.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.
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Ka70800
Image /page/0/Picture/1 description: This image contains the text "Summary of Safety and Effectiveness" and "Medical Products". The image also contains the date March 19, 1997. The image also contains a logo for SolePak.
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, nonpyrogenic 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 quidelines to a 10 d 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 foya, RN
Elizabeth Lova. RN Requiatory Affairs Associate Douglas Medical Products
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.