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Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns. They are also intended to help control minor bleeding.

These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist wound environment.

The provided text does not contain any information about acceptance criteria, device performance, or any studies with specific metrics.

The document is a 510(k) submission for the "Al-Gen Calcium Alginate Dressing," focusing on establishing substantial equivalence to a predicate device (K953781). The "Testing Summary" section explicitly states: "Biocompatibility test results presented in 510(k) K953781 remains current, no changes to raw materials or components which would require the submission of new toxicity data." This indicates that no new testing was performed or reported for this specific 510(k) submission to demonstrate performance against new acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on prior biocompatibility data and substantial equivalence, not on a new performance study with specific acceptance criteria.

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Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:

• Pressure ulcers Arterial Ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
  Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.

These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.

This document is a 510(k) summary for the 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing. It states that substantial equivalence was provided in previous 510(k) applications (K953781 and K980989) and that biocompatibility test results were also presented in those previous applications. Therefore, there is no new study or acceptance criteria information in the provided text to describe.

The letter explicitly states: "The 510(k) submission was not re-reviewed." (Page 0, K982638, Jun 11, 2023 letter) and "This letter corrects our substantially equivalent letter of August 21, 1998." (Page 1, K982638, Mar 1 9 2007 letter). This indicates that the current document is an administrative update and a correction to previous approvals, not a new submission with new performance studies.

Hence, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details. This information would have been contained in the original 510(k) submissions (K953781 and K980989) which are not provided here.

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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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