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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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OTC:

PuraDerm is used for the management of minor cuts, minor abrasions, minor wounds and minor burns (1st degree burns).

Rx:

Under the supervision of a health care professional PuraDerm is used for the management of partial and full-thickness wounds, such as pressure ulcers, diabetic ulcers, and surgical wounds.

PuraDerm™ Gel is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraDerm forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.

PuraDerm is completely non-animal and non-plant derived, and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraDerm can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.

The provided text describes the 510(k) premarket notification for the PuraDerm Gel, which is a wound dressing. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance-based acceptance criteria through an AI study.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria (especially related to AI performance, human-in-the-loop, MRMC studies, ground truth establishment for AI models, etc.) is not present in the provided document.

The document details:

• Device Description: PuraDerm Gel (a sterile gel of synthetic peptide and sterile water).
• Intended Use: Management of minor cuts, abrasions, minor burns (OTC), and management of partial and full-thickness wounds (Rx).
• Comparison to Predicate Devices: DuoDerm® Hydroactive® Gel and Woun'Dres® Collagen Hydrogel. The comparison focuses on presentation, function, and indication for use, highlighting similar material properties and hydration function.
• Performance Data: This section mentions non-clinical performance testing, specifically in vivo performance testing in an established porcine wound healing model and biocompatibility testing. It states that DuoDerm was used as the control device in the animal study.
• Statement of Substantial Equivalence: Concludes that PuraDerm is as safe, as effective, and performs as well as the proposed predicate(s) based on benchtop and animal testing.

There is no mention of:

• Acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) for an AI device.
• An AI component or algorithm within the PuraDerm Gel device.
• Test sets, training sets, or data provenance relevant to AI model development or validation.
• Experts establishing ground truth for AI model testing.
• Adjudication methods for AI model ground truth.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement with AI assistance.
• Standalone AI performance or human-in-the-loop performance studies.
• Ground truth types (pathology, outcomes data, etc.) in the context of AI.

In summary, the provided text does not contain the information requested in the prompt because it pertains to a traditional medical device (wound dressing) submission focused on substantial equivalence to existing predicate devices, not an AI/ML-enabled device.

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