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Innovative Technologies Alginate / Zinc Wound Dressings may be used for the management of moderate to heavily exuding partial to full thickness wounds such as:

• Pressure Ulcers .
• Arterial Ulcers .. ●
• . Venous Ulcers
• . Diabetic Ulcers
• . l st & 2nd Degree Burns
• Donor Sites .
• . Trauma Wounds
• Dermal Lesions

Innovative Technologies' Alginate / Zinc Wound Dressings is a combination of two products with existing 510(k)s: Dermagran™ Zinc-Saline Wet Dressing manufactured by Derma Sciences, 510(k) #K913344 and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing, 510(k) #K953781. Innovative Technologies' Alginate / Zinc Wound Dressings is a highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The non-woven Alginate / Zinc fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an dispersable, gelatinous, mass providing for a moist healing environment. The gel may easily be rinsed away from the wound, reducing the potential for delicate peri-wound fissue damage during dressing changes.

The provided document, K973283, is a 510(k) premarket notification for a medical device (Innovative Technologies' Alginate / Zinc Wound Dressing). This type of submission focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than conducting a full clinical study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance in the way you've outlined (including a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.

The document primarily details:

• Device Description: Innovative Technologies' Alginate / Zinc Wound Dressing is a combination of two existing 510(k) products. It's a sterile, primary wound dressing for moderate to heavily exuding partial to full thickness wounds, forming a gel with wound exudate.
• Predicate Devices: Dermagran™ Zinc-Saline Wet Dressing (K913344) and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing (K953781).
• Comparative Features Table: This table compares the new device with the predicate devices across characteristics like material, non-therapeutic additives, surface, integrity, indications, packaging, and sterilization method. This comparison is the core of demonstrating substantial equivalence, showing that the new device is "similar in design, composition and function" to the predicates.
• Safety and Effectiveness: "Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products." This refers to the predicate devices, implying that the new combination product inherits this safety and effectiveness.
• FDA Determination: The FDA determined the device is substantially equivalent to pre-amendment devices and can be marketed, subject to certain labeling limitations (e.g., not for third-degree burns, no claims of accelerating healing, no long-term dressing claims, not a treatment/cure).
• Indications for Use: The FDA-cleared indications for the Alginate / Zinc Wound Dressing are for the management of moderate to heavily exuding partial to full thickness wounds such as Pressure Ulcers, Arterial Ulcers, Venous Ulcers, Diabetic Ulcers, 1st & 2nd Degree Burns, Donor Sites, Trauma Wounds, and Dermal Lesions.

In summary, this document is a 510(k) notification, which establishes substantial equivalence rather than presenting a performance study against predefined acceptance criteria.

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