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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.

For Bone Marrow Aspiration of the Iliac Crest.

The Powered EZ-IO Bone Marrow Aspiration System consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired depth within the bone marrow. The driver then is separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringe for aspiration. The needle is 15 gauge and 60mm long.

The Barrett's Cytology Device is intended to collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus.

The Barrett's Cytology Device is a catheter that is advanced into the esophagus much like a gastric lavage catheter. The catheter with the aid of common intubation techniques is further advanced into the stomach. The placement into the stomach is confirmed by the use of a distal inflatable balloon which is used to identify the lower esophageal sphincter (LES). Identification of the LES is required because the target sample location is typically the distal esophagus. Once the LES is identified an external slide disc on the catheter is used to mark the length of the patient's esophagus from the dental arches. At this time the balloon will be deflated and the catheter withdrawn away from the LES into the esophagus using the slide disc and catheter markings for distance reference as to how far back the catheter is to be withdrawn. When the catheter is withdrawn to the desired location to sample a cytology brush contained within the catheter is deployed out the distal end of catheter and the cytologic brushing commences. Once the brushing of the esophagus is completed the brush is withdrawn back inside the catheter to contain the cell harvest within the catheter lumen. The entire catheter is withdrawn from the patient and the cytology brush is again deployed to prepare microscopic slides for analysis.