(365 days)
The Velano ExT™ Extension Set with needle-free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.
The Velano ExT™ Extension Set is a sterile, single use, non-pyrogenic intravenous administration extension set comprised of an approximate 5" inch tube bonded to a T-connection port on one end and a female luer on the other end with a clamp in between. The T-connection port has a swabable, needle-free port on one side and a locking male luer on the other side. The device contains and integrated stabilizer under the swabable needle-free port. This component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano ExT™ Extension Set is compatible with Velano Vascular PIVOT™ devices.
The provided text is a 510(k) premarket notification for a medical device called the "Velano ExT™ Extension Set". This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on a clinical trial or algorithm performance study as you might find for an AI/ML medical device.
Therefore, the document does not contain the information required to answer questions 1 through 9, as it does not describe an acceptance criteria table, a study proving the device meets these criteria, or details regarding algorithm performance, ground truth establishment, or expert reviews.
The document details the following regarding the device and its testing:
- Device Name: Velano ExT™ Extension Set
- Intended Use: Administration of intravenous fluids, and use with low-pressure power injectors up to 325 psi and a maximum flow rate of 10 mL/second.
- Predicate Device: Velano Vascular Q2® Low Power Injector Extension Set (K182897)
- Functional and Safety Testing Performed: This section lists various tests conducted to verify the device's design meets functional and performance requirements. These tests are physical and mechanical in nature, not related to an algorithm's diagnostic performance.
- Visual inspection
- Simulated shipping
- Priming volume
- Microbial ingress
- Particulate
- Backpressure leak under normal use and power injection
- Flow rate for normal use and power injection
- Spin collar height and spin collar angle
- Simulated use
- Tubing bond strength
- Multiple Engagement
- Continuous Engagement
- Activation Force
- Tubing kink resistance
- Standards Applied: The document lists several ISO, USP, ASTM, and AAMI standards related to medical device sterilization, biological evaluation, particulate matter, packaging, and accelerated aging.
In summary, this document is a regulatory submission for a physical medical device (an extension set), not an AI/ML-driven device. Thus, the concepts of acceptance criteria for algorithm performance, test set size, expert adjudication, MRMC studies, standalone algorithm performance, or training set details are not applicable or present in this document.
§ 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.