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Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound.

The following Indications are for Prescription Use or under the direction of a health care professional:

• Venous ulcers
• Diabctic ulcers
• Pressure ulcers
• Ancrial ulcers
• Superficial burns
• Abrasions and laccrations
• Donor sites
• Postoperative wounds

The following Indications are for Over-the-Counter Usc:

• Abrasions
• Minor Burns
• Minor Cuts
• Minor Laccrations

Dermaphylyx Calcium Alginate Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of calcium alginate fibers fabricated into a felt or rope configuration.

Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a gel/fiber mat which provides an environment conducive to moist wound healing. The formation of the gel/fiber mat facilitates trauma free removal from the wound.

This document is a 510(k) summary for the Dermaphylyx Calcium Alginate Wound Dressing, submitted by Dermaphylyx, Inc. The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not contain information regarding acceptance criteria, study performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to the acceptance criteria for an AI/ML device.

The provided text describes a medical device (wound dressing) and aims to establish its substantial equivalence to existing devices based on its description, intended use, and general characteristics. It is not an AI/ML device, and therefore, the requested information (acceptance criteria, study performance characteristics, sample sizes, etc.) related to AI/ML device validation does not apply to this submission.

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Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding.

The following Indications are for Prescription Use or under the direction of a health care professional:

• Venous ulcers
• Diabctic ulcers
• Pressure ulcers
• Arterial ulcers
• Superficial burns
• Abrasions and lacerations
• Donor sites
• Postoperative wounds

The following Indications are for Over-the-Counter Use:

• Abrasions
• Minor Burns
• Minor Cuts
• Minor Lacerations

Dermaphylyx Calcium Alginate Wound Dressings consist of calcium alginate fibers fabricated into felt and rope configurations. Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound cxudate. During the absorption of exudate the dressing forms a gel/liber mat. The formation of the gel/fiber mat may help facilitate removal from the wound.

This document is a 510(k) premarket notification for the Dermaphylyx Calcium Alginate Wound Dressing. It declares substantial equivalence (SE) to previously marketed devices and does not contain detailed information about a study proving the device meets specific acceptance criteria with performance metrics.

Therefore, I cannot provide the requested information. This document is focused on obtaining regulatory clearance by demonstrating substantial equivalence, not on presenting results from a performance study against predefined acceptance criteria.

Specifically, there is no mention of:

• Quantitative acceptance criteria for device performance.
• A study design (sample size, data provenance, ground truth establishment, expert involvement, adjudication methods, MRMC studies, standalone performance).
• Any reported device performance against such criteria.

The 510(k) summary states that "Dermaphylyx Calcium Alginate Wound Dressings are substantially equivalent to Innovative Technologies Calcium Alginate Wound Dressings (Innovative Technologies Group, Ltd.) and Kaltostat® Calcium Alginate Wound Dressings (Calgon Vestal Laboratories)." This substantial equivalence claim is the basis for regulatory approval, not a separate performance study with acceptance criteria as typically found for software or diagnostic devices.

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