(83 days)
For pediatric use: The PD-IO™ infusion system provides intraosseous access in proximal tibia, as an alternative to IV access during emergencies to pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg). For adult use: The EZ-IO™ Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies to adult patients (22 years of age or older, > 40 kq)
The EZ-MIO. Manual Driver consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The EZ-MIO, Manual Drivers are designed to allow the user to manually insert a needle set consisting of a stylet and catheter into the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set the manual driver is detached from the needle set leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied). There are two size needles that can be used with the EZ-MIO, Manual Driver, an adult size, 15g X 25mm, and pediatric size, 15g X 15mm.
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.
Instead, the document is a 510(k) premarket notification for the EZ-MIO Reusable Manual Driver, outlining:
- Summary: Submitter information, device name, date of preparation, and a description of the EZ-MIO Manual Driver.
- Predicate Device Comparison: A table listing predicate devices and a summary of technological characteristics compared for substantial equivalence.
- Indications for Use: Specific patient populations (pediatric and adult) and anatomical sites for which the device is intended.
- FDA Correspondence: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, human reader studies, or ground truth establishment. This type of information is usually found in performance testing reports, clinical studies, or verification and validation documents, which are not included in this 510(k) summary.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).