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FASTResponder™ 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.

FASTRESPONDER™ 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 FASTRESPONDER™ 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.

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 FAST1™ Intraosseous Infusion System 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.

The FASTI™ Intraosseous Infusion System has been designed to provide alternative access of the circulatory system to intravenous infusion. 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 FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult patients requiring vascular administration of drugs or fluids to facilitate emergency resuscitation

The modified FASTI™ Intraosseous Infusion System is very similar to the FAST1™ Intraosseous Infusion System previously cleared under 510(k) K970380. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the sternum of the patient, the target/strain-relief patch, protector dome and sharps plug. The minor difference is that the infusion tube of the modified FAST1™ Intraosseous Infusion System can be removed from the patient's sternum by directly pulling on the infusion tubing, whereas the predicate device utilizes a remover tool to remove the infusion tube from the patient's sternum. Both products are single use, hand-held, manually operated passive devices, (it has no internal energy source). Both products have an infusion tube with a sharp stainless steel tip, a flexible shaft and a standard Luer connector. For both products the user grasps an introducer handle attached to the infusion needle, and pushes the needle tip through the skin and overlying tissue into the sternum of the subject. Fluids or drugs are delivered through the needle to the marrow space of the sternum, and flow out the emissary veins of the sternum into the venous circulation. Both devices use the same pusher handle and method to insert the infusion needle to the correct penetration depth in the sternum; a mechanism inside the introducer handle disconnects the handle from the infusion needle, preventing the user from pushing the needle any further. The principal of the mechanism is identical for both devices in that it detects the position of the anterior surface of the cortical bone of the sternum, and relates the position of the tip of the infusion needle to the surface of the cortical bone. Both devices utilize the same adhesive patch which is applied to the top of the patient's chest which the user aligns with the supra-sternal notch of the patient. The position of the recommended insertion site is the same for both devices and is marked on the patch to aid in land marking. Also, the same patch and an associated cover for both devices provide protection and strain-relief to the site and the installed Infusion Tube.

The F.A.S.T. 1™ Intraosseous Infusion System is intended for intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids.

The F.A.S.T. 1™ Intraosseous Infusion System has been designed to provide a means, as an alternative to intravenous infusion, for facilitating emergency resuscitation of adults through the administration of fluids and drugs. The F.A.S.T. 1™ Intraosseous Infusion System has been designed for use on the adult sternum. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the skin into the sternum of the patient, the target / strain-relief patch, and a protector dome. There is also an infusion tube removal tool.