(154 days)
Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. Non Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.
Sterile, single use non-pyrogenic intravenous administration extension set comprised of 7 inch tubing bonded to a male luer on one end and a female luer on the other end with a clamp in between. A swabable, needle-free port is connected to the female luer. This device is not made with the plasticizer Diethylhexylphthalate (DEHP).
The provided text describes information for the Q2® Low Pressure Power Injection Extension Set, which is a medical device, and does not contain information about an AI/ML powered device. Therefore, I cannot extract information pertaining to AI/ML acceptance criteria or studies.
However, I can provide available information regarding the device's performance as described in the document in a table format:
1. A table of acceptance criteria and the reported device performance
| Test Parameter | Acceptance Criteria / Predicate Performance | Reported Device Performance (Q2 Low Pressure Power Injection Extension Set) |
|---|---|---|
| Particulate Testing | Per ISO 8536-4:2010 | Successfully demonstrated device performs as intended and meets manufacturer specification. |
| Simulated Shipping | (Not explicitly stated but implied to meet functional requirements) | Successfully demonstrated device performs as intended and meets manufacturer specification. |
| Package Burst | (Not explicitly stated but implied to meet functional requirements) | Successfully demonstrated device performs as intended and meets manufacturer specification. |
| Priming Volume | Predicate: |
§ 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.