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Professional Indications (Prescription Use):

Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers Intended to protect vascular access sites, intramuscular sites, and surgical incisions 1" and 20d degree burns Donor sites

The device is a silver ion-containing dressing in which the silver ion is in the form of a molecule of silver alginate. The silver alginate is interspersed in a matrix of calcium alginate and therefore all of the silver in the device is in the ionic state. The silver alginate in its composition prior to layering on a suitable backing is stirred in order to introduce a foam into the silver alginate composition, which foam will materially assist in absorbing exudates from an exudating wound.

The foam composition of the silver alginate gel as composed above has the advantage of absorbing a considerable amount of exudates where such wounds may be treated with this dressing. The layering of the composition as described above is performed on a polyester or polyurethane backing which absorbs excess exudate.

Please provide me with the specific section of the document that describes the acceptance criteria and study results. The provided text discusses the device description, intended use, comparison to predicate devices, and a general summary of preclinical performance studies and conclusions. However, it does not explicitly detail specific acceptance criteria values or present a table of device performance against these criteria as requested in your prompt.

Without that specific information, I cannot complete the table or the detailed breakdown of the study you've requested.

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Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1st and 2nd degree burns; donor sites

CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Calgitrol™ AG Silver Alginate Foam and Gel Foam Dressings). This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory approval letter, not a study report.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device