Search Results

RELiZORB is indicated for use in pediatric (ages 1 year and above) and adults patients to hydrolyze fats in enteral formula.

RELiZORB® is a point-of-care device designed to fit in-line with currently used enteral feeding circuits. RELiZORB functions to hydrolyze (break down) fats present in enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This breakdown of fats by RELiZORB is intended to mimic the function of the enzyme pancreatic lipase. RELiZORB is comprised of a cylindrical, hollow cartridge with a single inlet port and a single outlet port connection. Inside the cartridge, there are small white acrylic beads. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipase-bead complex, iLipase® (immobilized lipase), is retained within the cartridge during use by filters on both ends of the cartridge. The fat in enteral formulas is hydrolyzed when it comes in contact with iLipase as the formula passes through the cartridge.

The provided text is a 510(k) summary for the RELiZORB device. It details various aspects of the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain a typical acceptance criteria table with reported device performance metrics in the format usually associated with diagnostic device evaluation (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on extending the Indications for Use for the RELiZORB device to include pediatric patients aged 1 year and above, compared to the previous indication of 2 years and above. The "acceptance criteria" in this context are primarily related to demonstrating that this change in indication does not introduce new safety or effectiveness concerns, and that the device remains substantially equivalent to the predicate.

Here's an analysis of the "acceptance criteria" and the study that supports the change, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with specific performance metrics (like sensitivity, specificity, or AUC) as one might expect for a diagnostic AI/ML device. Instead, the acceptance criteria for extending the age indication are implicitly:

• Safety: The device is safe for use in pediatric patients aged 1 to

Ask a specific question about this device