Search Results

The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are intended for the management of partial and full thickness wounds such as:

• first and second degree burns
• severe sunburns
• superficial injuries, cuts, abrasions and surgical wounds

The Keratec Wound Dressings may also be used under guidance of a health care professional in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:

• Pressure (stage I-IV) and venous stasis ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Donor sites and grafts

Keragel is intended for dry to moderately exuding wounds, Keraderm for low to highly exuding wounds and Kerafoam for moderately exuding wounds to highly exuding wounds.

The Keratec Wound Dressings are not intended to be used on third degree burns.

The Keratec Keragel, Kerafoam and Keraderm Wound Dressings (Keratec Wound Dressings) are designed as chronic wound treatment devices for dry to heavily exuding wounds. The Keratec Wound Dressings are sterile, single-use wound care dressings that include keratin proteins derived from sheep wool for use in moist wound management.

The primary mode of action of keratin containing dressings Keragel, Keraderm and Kerafoam is to absorb and interact with wound fluids to form a soft, hydrophilic keratin gel that facilitates a moist wound healing environment. The secondary mode of action is to provide the cells in the wound with a friendly structural framework that allows cellular migration where no framework exists.

Keragel is a gel dressing that provides moisture to dry wound beds by using water. emollients, and biocompatible thickeners in a similar manner to other hydrogels.

Kerafoam is a keratin film coated on a polyurethane foam substrate for use in multilayered advanced wound dressings. The keratin film is in matrix form with soluble keratin proteins. The Kerafoam product forms a gel when in contact with wound exudates. The Kerafoam provides the exudate management features of other advanced moist wound dressings.

Keraderm is open-celled foam derived from freeze-dried keratin protein. Keraderm is re-absorbed into the developing tissue without traumatic dressing changes. Keraderm provides a bio-absorbable "scaffold" for the rapid growth of new tissue in three dimensions. Keraderm is provided in an acellular form of keratin protein.

The Keratec Wound Dressings (Keratec Keragel, Kerafoam, and Keraderm) are wound care dressings containing keratin proteins from sheep wool, intended for moist wound management.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not include specific quantifiable acceptance criteria in a tabular format with corresponding reported device performance metrics. Instead, it relies on a comparison to predicate devices and a general statement of positive performance testing.

2. Sample Size Used for the Test Set and Data Provenance

The summary states that "Extensive bench, biocompatibility, animal and clinical testing have been performed." However, it does not specify the sample size for any of these test sets. The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned for these tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. The document does not detail how specific ground truths for "safety" or "efficacy" were established by experts for the performance testing.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1) for establishing ground truth in performance testing is not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a wound dressing, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The Keratec Wound Dressings are physical medical devices (dressings) and do not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The document broadly refers to "safety and efficacy" demonstrated through "bench, biocompatibility, animal and clinical testing." This implies that the ground truth for these tests would have been established through:

• Bench Testing: Engineering specifications, material properties, absorption rates (measurable parameters).
• Biocompatibility Testing: Standards-based biological response (e.g., cytotoxicity, sensitization, irritation).
• Animal Testing: Physiological responses, wound healing rates, tissue integration in animal models.
• Clinical Testing: Clinical outcomes related to wound healing, adverse event rates, patient comfort (likely adjudicated by healthcare professionals, though not explicitly stated).

8. The Sample Size for the Training Set

This question is not applicable as the Keratec Wound Dressings are not AI/ML devices that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the Keratec Wound Dressings are not AI/ML devices.

Ask a specific question about this device