Search Results

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 The entire needle assembly is then withdrawn from the patient using power to facilitate removal.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.

The provided text is a 510(k) summary for the OnControl™ Bone Marrow Biopsy System. It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain information about acceptance criteria or a specific study that proves the device meets those criteria.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific clinical study in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information from the given text.

The document states:

• "The predicates and the OnControl™ Bone Marrow Biopsy System were compared in the following areas and found to have similar technological characteristics and to be equivalent."
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the review focused on demonstrating equivalence in design, indications for use, and technological characteristics to existing devices, not on meeting new, specified performance criteria through a dedicated study.

Ask a specific question about this device