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The OnControl™ Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy in adult and pediatric patients age 2 and older.

The OnControl Bone Marrow Biopsy System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed procedure tray. The procedure tray contains 1 driver connector with sterile sleeve, 1 biopsy needle set with depth guide, an ejector rod and alignment quide. The OnControl Bone Marrow Biopsy System Needle Set consists of a cannula made of 304 stainless steel, with a beveled cutting tip and stylet. The needle sets are 11 gauge, 102 mm and 152 mm with an internal core capturing thread at the distal tip of the cannula. The proposed device will utilize identical needle sets (gauge, length and materials) as currently utilized in the predicate device K072045 The OnControl Bone Marrow Biopsy System by Vidacare®. The proposed device will also utilize the power rotary driver technology as used for the predicates K072045, The OnControl Bone Marrow Biopsy System by Vidacare® and K070759 Powered EZ-10® Pediatric Bone Marrow Aspiration System (new trade name, OnControl Bone Marrow Aspiration System). Upon activation, the power rotary driver assists the clinician in inserting the needle set through the cortex of the bone. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism. The inner stylet is used only to penetrate the cortex and is then removed. The standard Luer lock hub on the cannula permits attachment of a syringe for aspiration. The depth guide which slides up and down the cannula is moved to the desired depth marking. The power rotary driver is then reattached to the biopsy cannula and the driver is activated and advanced the desired depth to obtain the biopsy specimen and then withdrawn. The driver is then separated from the needle assembly for specimen removal. This submission requests the addition of the pediatric population, age 2 and older, as an expanded indication to previously cleared K072045. The OnControl Bone Marrow Biopsy System with the same Indication For Use, for bone marrow aspiration and biopsy utilizing the same insertion technique and devices as the predicate.

The EZ-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in 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 previously cleared with K132583 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 and medications 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 (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set catheter serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver 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 to ensure adequate needle length for proper placement within the medullary space. 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 the medullary space; the needle set will not always be inserted to the hub. After insertion of the needle set, the driver unit 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 medications and fluids. This submission requests the addition of the distal femur as an insertion site for the pediatric population utilizing the same insertion technique and devices previously cleared via 510(k) K132538, which includes the insertion sites of the proximal tibia, distal tibia and proximal humerus.