(29 days)
None
No
The 510(k) summary describes a mechanical needle-free connector and does not mention any AI or ML components or functionalities.
No
The device is a needle-free Y-site connector intended for fluid delivery, not for treating a disease or condition. It facilitates fluid administration but does not provide therapeutic action itself.
No
The device is a needle-free Y-site used for fluid delivery, providing unobstructed flow between a fluid source and a patient's vascular access device. Its function is to facilitate the administration of fluids, not to diagnose a condition or disease.
No
The device description clearly indicates it is a physical, sterile, nonpyrogenic component made of materials, which is characteristic of a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for connecting fluid sources to a patient's vascular access device. This is a direct interaction with the patient's circulatory system for fluid delivery, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the physical components, materials, and packaging of a sterile, nonpyrogenic connector. It doesn't mention any reagents, assays, or components used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose, monitor, or screen for diseases or conditions.
Therefore, the Douglas Medical Products Maxcess™ NeedleFree Y-Site is a medical device used for fluid administration, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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