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.
| Performance Metric (Based on Literature Review) | Reported Device Performance (AQUACEL® / AQUACEL® Ag) | Comparator | Statistical Significance / Effect Size |
|---|---|---|---|
| Likelihood of no wound complications | 5.8 times more likely to result in no complications | Control | 95% CI 2.8-12.5; p |
N/A