(59 days)
Sternal IO access is indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies
The EZ-MIO Sternal is very similar to the EZ-MIO, manual driver, previously cleared under 510(k) K052195. The two minor differences between the devices are in the driver and addition of a collar to the needle set. The predicate EZ-MIO consists of a proprietary pentagon shaft permanently attached to an ergonomically designed reusable driver. The EZ-MIO Sternal is single use and has a smaller driver permanently attached to the needle set. The second difference is the EZ-MIO Sternal has a permanently attached collar added to the same needle set used by the EZ-MIO. The collar is used to control depth of penetration. Both products utilize the same needle set and are designed to allow the user to manually insert a needle set consisting of a stylet and catheter through the cortex of a bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set, both systems function identically by allowing the user to remove a stylet 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). The needle set size used in the sternum is the identical needle set used by the predicate EZ-MIO (15G X 25mm). The EZ-MIO system is approved for use in the proximal tibia under 510(k) K052195. This submission requests an indication for use of the EZ-MIO Sternal in the sternum location already established by the predicate device Pyng F.A.S.T.1 (K970380).
This Premarket Notification [510(k)] for the Vidacare EZ-MIO Sternal device does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
This document is a 510(k) summary submitted to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not include:
- Acceptance criteria: Specific performance metrics with defined thresholds.
- Study details: Information about a clinical or other performance study designed to demonstrate the device meets acceptance criteria.
- Sample sizes (test, training): There's no mention of a test set or training set.
- Data provenance, ground truth establishment, expert qualifications, adjudication methods: These are all related to performance studies, which are not described here.
- MRMC comparative effectiveness study or standalone algorithm performance: These concepts are relevant to AI/algorithm-driven devices, which the EZ-MIO Sternal (an intraosseous infusion system) is not.
The document states: "The EZ-MIO Sternal has the exact same technology as the EZ-MIO cleared under 510(k) K052195. There have been no major changes to the design or components and therefore the comparison of technological characteristics such as target population, needle design, technique, sterility, biocompatibility and where it is used is identical."
This indicates that the submission relies on the established safety and effectiveness of the predicate devices rather than new performance studies specifically for the EZ-MIO Sternal. The primary purpose of this 510(k) is to extend the indications for use of an existing device concept to a new anatomical location (sternum) based on equivalence to another device already cleared for that location (PYNG Medical Corp. F.A.S.T. 1).
§ 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).