(34 days)
The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and or institutional guidelines. The closure system has been found to maintain line patency throughout the labeled duration of use.
The Douglas Medical Products Maxcess Needlefree Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek\polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The Douglas Medical Products Maxcess Connector utilizes similar and equivalent designs, and materials, as currently legally marketed products.
This document is a 510(k) summary for a medical device (Maxcess Needlefree Connector). It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory submission does not typically include a study with acceptance criteria and device performance as would be expected for an AI/ML medical device.
Therefore, I cannot extract the requested information from the provided text because it describes a traditional hardware medical device and not a software/AI medical device. The information requested (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to the development and validation of AI/ML algorithms, which are not relevant to this type of device submission.
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Image /page/0/Picture/1 description: The image shows the logo for Douglas Medical Products. The logo consists of a geometric shape on the left, followed by the word "Douglas" in a large, stylized font. Below "Douglas" is the text "A SoloPak Company", and to the right of "Douglas" is the text "Medical Products" in a smaller font.
MAR 2 1 1996
January 26, 1996
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 Connector Common Name - Needleless Injection Port or Needlefree Injection Site Classification Name - Intravascular Administration Set
The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and or institutional guidelines. The closure system has been found to maintain line patency throughout the labeled duration of use.
The Douglas Medical Products Maxcess Needlefree Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek\polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The indicated use of the Maxcess Needlefree Connector is the same or the equivalent of the predicate device named in this submission. The named predicate device in this submission is the Clavem Connector currently marketed by ICU Medical, Inc. under 510(k) #K915571. The Douglas Medical Products Maxcess Needlefree Connector 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 Connector utilizes similar and equivalent designs, and materials, as currently legally marketed products, it is safe and effective when used as intended.
Sincerely,
Ron Hamilton
Ron Haselhorst Director of RAIQA 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.