Search Results

FASTx™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

FASTx™ Sternal Intraosseous Device has been designed to provide an alternative to intravenous infusion access of the circulatory system. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum. The FASTx™ Sternal Intraosseous Device consists of an introducer handle with target foot which allows the user to target the recommended insertion site and place the infusion tube bone portal into the manubrium. On withdrawing the introducer handle, the infusion tube bone portal is left firmly placed in the manubrium, the infusion tube luer lock can be connected to a source such as an IV line or standard syringe for infusion of emergency drugs or fluids. The target foot separated from the handle is adhered to the skin over the insertion site providing protection; the infusion tube strain relief hook is clipped to the target foot for strain relief. The protective dome is placed over the target foot insertion site providing additional protection from external forces.

The provided document is a 510(k) summary for the FASTx™ Sternal Intraosseous Device, seeking substantial equivalence to a predicate device (FAST1® Intraosseous Infusion System cleared under K080865). This type of submission focuses on demonstrating equivalence rather than proving novel effectiveness through clinical studies with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria for a new device, a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document states that the FASTx™ Sternal Intraosseous Device has "the same intended use and similar technological characteristics as the predicate devices." It outlines the safety and effectiveness review based on:

• Bench tests, functional testing, and validation studies.
• The infusion needle tubing and portal tip being the same as the predicate device.
• Risk analysis conducted according to ISO 14971:2007.
• Biocompatibility testing according to ISO 10993-1.
• Sterilization validation study according to ISO 11137.
• Pyrogen study according to USP guidelines.
• Packaging validation according to ISO 11607.

These are standard regulatory assessments for demonstrating safety and performance equivalence to a legally marketed predicate device, not a study designed to establish novel acceptance criteria or compare performance against a specific clinical benchmark for a new, non-predicate-based claim.

Ask a specific question about this device