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The EZ-10 Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-IO Intraosseous Infusion System including previously cleared K091140 EZ-MIO Distal Tibia, EZ-10 Distal Tibia; EZ-10 (formerly Vidaport) Intraosseous Infusion System ; EZ-IO Humeral Head and K101026 Powered PD IO Infusion System; EZ-IO Humeral Head; Powered PD-IO is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids for vascular access. All system materials are medical grade. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (3-39 kg); 25 mm (40 kg or over) and 45 mm (40 kg or over). Black lines on the needle set catheter serve as depth markers. The needle sets connect to the driver/drill/ manual handle shaft with a magnetic disc. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. The EZ-MIO consists of a manual handle device which is primarily used by the armed forces. Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver or manual handle with needle set attached the needle set is pressed through the soft tissue to the outer cortex of the bone. Depth markers on the catheter must be visible prior to powering driver or manually inserting the needle set to ensure placement within the medullary space. If using the powered driver clinicians then squeeze the driver trigger and apply moderate, steady pressure. Trigger is released when a sudden "give" or "pop" is felt, which indicates entry into medullary space; the catheter will not always be inserted to the hub. If using the manual handle, clinicians apply downward pressure and rotation through the bone until a change in pressure is felt as a "give" or "pop" or desired depth is reached. For both methods after insertion of the needle set, the driver unit 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 medications and fluids. This submission requests a label change only to the 25 mm needle set from "40 kg or over" to" 3 kg or over" utilizing the same technique and devices previously cleared via 510(k)s K091140 and K101026.

Sternal IO Access is indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies.

The T.A.L.O.N.™ (Tactically Advanced Lifesaving IntraOsseous Needle) by Vidacare® has the same indications as the EZ-MIO Sternal, previously cleared by K063567. Both devices are for the purpose of obtaining vascular access during emergencies; both devices utilize a 15g 304 stainless steel manual needle set with a stylet and catheter that is manually inserted through the cortex of bone to the desired set depth within the medullary space to facilitate the infusion of medications and fluids.

The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.

The OnControl Bone Access and Bone Biopsy System by Vidacare consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve. 1 beveled needle set and 2 sharps protectors. The OnControl Bone Access System Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the OnControl Bone Access System (cleared via K112468, The OnControl Bone Access System by Vidacare®) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K112468, The OnControl Bone Access System by Vidacare®. Under fluoroscopic imaging quidance, activation of the driver assists the clinician to insert the needle set through the cortex of the bone, into the vertebral body or area of lesion. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn. The driver is then separated from the needle assembly for specimen removal.

The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The Humeral Head EZ-IO provides vascular access when standard venous access is not possible. Humeral head IO access is indicated in pediatrics in emergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24 hours. The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in pediatric patients (approximate weight range: 3kg-39kg).

This submission seeks to extend the indications for use for the Powered PD-IO Intraosseous Infusion System (K051992); EZ-IO Humeral Head (K052408) and Powered PD-IO (K063142) for emergent, urgent and medically necessary intraosseous vascular access for the delivery of drugs and fluids to pediatric patients. Vidacare manufactures all of these products. The expansion of indications for these products requires no new technology to facilitate the safe application of the product. There have been no changes to the design or components of the devices cleared under 510(k) K051992, K052408, K063142 and therefore the comparison of technological characteristics listed below are identical.

EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only. EZ-IO Humeral Head: The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia. The VidaPort provides intraosseous access in the proximal tibia. The EZ-IO Humeral Head provides intraosseous access in the Humeral Head. These devices are used when intravenous access is difficult or impossible to obtain.

The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.

The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.

The OnControl™ Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy.

The OnControl™ Bone Marrow Biopsy System consists of a reusable battery powered driver (similar to the one cleared for bone marrow aspiration in adults via K062833) connected to a disposable bone marrow biopsy needle set. The 11 gauge, 152mm cannula is identical in gauge and length to the predicate InterV® TrapLok, cleared via K043523. The BioAccess Bone Marrow Harvest System is an FDAcleared powered biopsy device (K953064), which has a battery power source similar to Vidacare's product. Upon activation, the driver assists the clinician to insert a biopsy needle set through the cortex of the bone. The driver is then separated from the hub of the biopsy needle set by retracting the collar on the driver - coupler. The trocar/stylet is then removed from the needle set leaving な an 11-gauge biopsy cannula firmly seated in the bone. A standard Luer lock (part of the 11 gauge cannula) then permits attachment of a standard syringe for aspiration of bone marrow. The driver/coupler is then reattached to the biopsy cannula and the power driver is activated. The biopsy cannula is advanced to the desired depth in the medullary cavity for capturing adequate bone marrow biopsy samples. The entire needle assembly is then withdrawn from the patient using power to facilitate removal. At this point the driver is separated from the biopsy needle assembly; the specimen is removed from the biopsy cannula by attaching an alignment guide to the cutting end of the biopsy cannula and pushing out the bone specimen with an ejector rod. The cannula length is 152mm (6"), which is identical to the predicate InterV® TrapLok, K043523.

For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.

The Powered EZ-IO® Pediatric Bone Marrow Aspiration System consists of a reusable battery powered driver [previously cleared for aspiration in adults via 510(k) K062833], and a 25mm intraosseous (IO) device fcleared under 510(k) K032885] connected to a disposable, single use intraosseous aspiration needle set assembly. Upon activation, the drill assists the operator with needle set insertion into the bone. The driver is then separated from the hub of the needle set assembly, leaving the needle set securely seated in the bone. The trocar/stylet is then removed from the needle set leaving the 15 gauge catheter. A standard Luer lock (part of the catheter hub) then permits attachment of standard syringe for aspirating bone marrow samples. The needle set is 25mm in length [previously cleared for IO use in adults via 510(k] number K032885). This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications.

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).

The Manual PD-IO, and Powered PD-IO provide intraosseous access in the distal tibia of pediatric patients as an alternative to IV access during emergencies.

The Manual PD-IO consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The manual driver is designed to allow the user to manually insert a needle set consisting of a stylet and catheter through 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 into the bone, the manual driver is detached from the needle set, leaving the stylet and catheter 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). The Powered PD-IO consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill supplies power to the needle set in order to penetrate through the cortex of the bone to a desired depth within the bone marrow. After insertion of the needle set, the power driver is detached from the needle set, leaving the stylet and catheter 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).