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PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as press, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.

PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a prefilled syringe. PuraDerm Gel is comprised of 2.5% (w/v) of a synthetic repeating peptide (acetyl-[arginyl-alany]-asparty]-alany] 4-amide tetrahydrochloride in sterile water for injection. The peptide is synthesized by standard solid-phase chemistry with no raw materials of animal or cellular origin.

The PuraDerm Gel solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel.

PuraDerm Gel forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of nanofibrils formed from individual peptide monomers. These fibrils are 10-20 nm in diameter and are interwoven to create an ordered structure with 50-100 nm pore sizes. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM").

The gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip.

The provided FDA 510(k) document for PuraDerm Gel (K193085) does not describe an acceptance criterion or a study that proves the device meets an acceptance criterion.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that does not require premarket approval. This is achieved by showing that the device has the same intended use and the same technological characteristics as the predicate, or that differences in technological characteristics do not raise different questions of safety and effectiveness.

Here's why the requested information isn't present:

• No new performance data: The document explicitly states: "Because there is no change to the device, source material, or manufacturing compared to the predicate K143058, the existing biocompatibility, sterilization, and shelf life information from K143058 fully applies. GLP pyrogenicity testing showed that the device is considered to be nonpyrogenic. New performance testing was not necessary to support the additional indications or the updates to the IFU."
• Focus on equivalence: The entire "Substantial Equivalence Discussion" (Section 6) and "Conclusions" (Section 8) are dedicated to comparing the proposed device with the predicates based on their characteristics and indications for use, rather than presenting results from a new performance study against defined acceptance criteria.

Therefore, I cannot populate the requested table and details because the provided text explicitly states that new performance testing was not done and thus no acceptance criteria or study results for K193085 are discussed.

The document essentially leverages the prior clearance (K143058) for its technical characteristics and expands its indications based on equivalence to another predicate (K991202) for those specific indications.

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