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For Over-the-Counter Use, AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing may be used for:

• Abrasions
• Lacerations
• Minor cuts
• Minor scalds and burns

Under the supervision of a healthcare professional, AQUACEL® Ag Hydrofiber Dressing may be used for the management of:

• Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection
• Partial thickness (second degree) burns
• Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness)
• Surgical wounds left to heal by secondary intention such as dehisced surgical incisions
• Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular)
• Traumatic wounds
• Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites
• Oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
• Management of painful wounds
• Infected Wounds

For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for:

• Abrasions
• Lacerations
• Minor cuts
• Minor scalds and burns

Under the supervision of a healthcare professional, AQUACEL® Hydrofiber® Wound Dressing may be used for the management of:

• Leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers
• Surgical wounds (post-operative, donor sites, dermatological)
• Partial thickness (second degree) burns
• Traumatic or surgical wounds left to heal by secondary intention such as dehisced surgical incisions
• Surgical wounds that heal by primary intent, such as dermatological and surgical incisions (e.g., orthopedic and vascular)
• Traumatic wounds
• Local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites
• Management of painful wounds

AQUACEL® Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver which allows for a maximum of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection.

AQUACEL® Hydrofiber® Wound Dressings are soft, sterile, non-woven pad or ribbon dressings composed of hydrocolloid fibers (sodium carboxymethylcelulose) These conformable and highly absorbent dressings absorb wound fluids and create a soft sel which maintains a moist environment which supports the body's healing process.

Based on the provided text, the document is a 510(k) Summary for the AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing and AQUACEL® Hydrofiber® Wound Dressing. This type of regulatory submission demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a newly conducted study with detailed statistical analysis.

The document discusses clinical studies, but these are literature reviews of existing studies on the predicate device (AQUACEL® Hydrofiber® Wound Dressing) or similar Hydrofiber® technology, used to support the safety and effectiveness for new indications or the new device (AQUACEL® Ag). It does not present a new, dedicated study designed to explicitly meet pre-defined acceptance criteria for the current 510(k) submission in the way one might assess a high-tech diagnostic algorithm.

Therefore, many of the requested categories for a study proving device acceptance criteria cannot be directly answered from this regulatory summary. However, I can extract the relevant information that is present.

Here's a breakdown of what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria or target device performance values in a table format for a specific new study to demonstrate device capabilities against defined metrics. Instead, it relies on the established safety and effectiveness of the predicate device and the literature.

The "performance" is reported in terms of clinical outcomes from existing studies, showing the benefits of Hydrofiber® dressings.

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For Over The Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, minor cuts and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for wounds such as: leg ulcers, pressure ulcers (Stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree); management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

Aquacel Hydrofiber Wound Dressing is a non-absorbable wound dressing.

The provided text is a 510(k) premarket notification for the AQUACEL™ Hydrofiber™ Wound Dressing. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Instead, it states: "Data/information supporting the safety of Aquacel Hydrofiber Wound Dressing was presented in Premarket Notification K943258. All testing was performed in accordance with Good Laboratory Practice Regulations." This indicates that safety data was submitted previously and is referenced here, but the specifics of that data or any performance criteria are not included in this document.

Therefore, I cannot provide the requested information from the given text. The text focuses on regulatory approval based on substantial equivalence rather than detailed performance study results against specific acceptance criteria.

Ask a specific question about this device