PUMA-G Pediatric System

The PUMA-G Pediatric System is a medical device that aids in placing gastrostomy (feeding) tubes in children by using magnetic attraction to affix the stomach to the anterior abdominal wall. It contains a balloon catheter with an internal magnet, a guidewire, and an external magnet; ultrasound visualization is used to guide needle placement and tube insertion.

The device uses the same mechanical mechanism (magnetic attraction) as the predicate, achieves stomach-to-abdominal wall coaptation in less than 10 minutes, uses ISO 10993-compatible materials, is sterilized by ethylene oxide per ISO 11135, and requires the same procedural approach (orogastric placement, over-the-wire/pull tubes, ultrasound visualization).

ASTM F2528-06 (balloon performance), ISO 10993 (biocompatibility), ISO 11135 (sterilization validation), and unspecified functional testing and magnetic force characterization.

The PUMA-G Pediatric System is substantially equivalent to the predicate PUMA-G System because both devices share identical intended use (aiding gastrostomy placement), the same fundamental magnetic mechanism and technical approach, equivalent performance across all tested parameters (biocompatibility, sterilization, magnetic function), and comparable clinical results demonstrating safe and effective gastrostomy completion. The only material difference—limitation to pediatric patients weighing ≥15 kg with abdominal wall thickness 0.6–3.0 cm—reflects the clinical study population rather than a change in technology or mechanism of action.