(200 days)
The EZ Huber Safety Infusion Set is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks.
The EZ Huber Safety Infusion Set is a single use, sterile and non-pyrogenic device intended for use as an accessory to deliver solutions and drugs into a patient's vascular implant port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks. When removing the EZ Huber Safety Infusion Set, the healthcare provider stabilizes the port by placing two fingers on the small wings of the EZ Huber Safety Infusion Set. The cannula is withdrawn by pulling on the large wings. As the cannula is withdrawn, the Huber needle housing (with small wings) slide over the cannula and lock over the cannula tip, rendering the cannula from being reused and preventing accidental needle sticks. A plastic shroud surrounds the cannula shaft between the large wings and the small wings/cannula tip. The shroud prevents exposure to any biohazardous materials on the cannula shaft.
Components will be assembled into standard configurations or configurations specified by the customer and packaged.
Types of components that may be contained in a set include:
- Huber Needle Housing
- Huber Needle Wing
- Tubing
- Clamps
- Y-Site Injection Ports
- Stopcock
This document is a 510(k) summary for a medical device called the "EZ Huber Safety Infusion Set." It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
There is no information in the provided text regarding acceptance criteria, device performance, or any studies (including multi-reader multi-case, standalone, or studies on human improvement with AI) related to the device's efficacy or comparison against established metrics.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification, and equivalent predicate device.
- Device Description: What the device is, its components, and how its safety feature (prevention of accidental needle sticks) works.
- Intended Use: Administering fluids to a patient's vascular system through an implanted port, with an active safety feature.
- Biocompatibility: Stating that materials are used in legally marketed devices under comparable conditions.
- FDA Communication: An FDA letter confirming the review of the 510(k) and a determination of substantial equivalence, allowing the device to be marketed.
Therefore, I cannot provide the requested information in the table format or answer specific questions about study design, sample sizes, ground truth, or expert qualifications because this data is not present in the provided text.
This type of submission for a medical device (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific performance metrics and acceptance criteria, as might be seen for novel technologies or PMA submissions.
§ 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.