(241 days)
The LifeFlow™ Rapid Infusion Device is an intravenous administration set with Handle intended for rapid* delivery of fluids from a container into a patient's vascular system. The device is intended to deliver only crystalloid and colloid resuscitative fluids. These devices may be used for any pediation with consideration with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused and duration of therapy.
*Capable of rates greater than 150 mL/min through a 20G needle.
Each LifeFlow™ Rapid Infusion Device (LifeFlow™ Device) is a disposable, single-use device that includes an intravenous administration set (Tubing Set) and a Handle and is used to deliver up to 4 Liters of fluid from a container into a patient's vascular system rapidly through manual compression of the levered Handle.
The Tubing Set is sterile, compatible with standard IVs and IV fluid bags and comprised of various generic components, such as a check valve, tubing, syringe, bag spike, thumb clamp, Luer access device, and Luer connections. Each of the needleless components are 510(k) cleared.
The addition of a hand pressure pump, the Handle, provides the capability for rapidly delivering IV fluids. The end of the Tubing Set is placed into the Handle. The clear canopy, through which the graduations and contents of the syringe can be viewed during use, is closed. The Handle is manually compressed to actuate the syringe, which delivers fluid to the patient and then automatically refills when the Handle is released.
The provided text is a 510(k) summary for the LifeFlow™ Rapid Infusion Device and discusses its substantial equivalence to a predicate device. It does not describe an AI/ML powered device, nor does it contain the information required to analyze acceptance criteria and studies in the context of AI device performance.
Therefore, I cannot provide an answer based on the given sections of the document. The document pertains to a medical device's 510(k) submission, confirming its equivalence to a predicate device based on functional, biocompatibility, and sterilization testing, not AI/ML performance evaluation.
§ 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.