Search Results

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.

2. Sample Size Used for the Test Set and Data Provenance

The "test set" here refers to the patient cohorts involved in the summarized clinical trials, which are part of a literature review rather than a new standalone validation study for this 510(k).

• Study 1 (Ravenscroft et al.): 183 patients (85 patients randomized to AQUACEL® / Tegaderm™, 98 patients to control).
• Study 2 (Abuzakuk et al.): 61 patients (30 patients allocated to AQUACEL® hydrofiber dressing group, 31 patients to control group).
• Study 3 (Harle et al.): 100 hip replacement patients (50 patients randomized to AQUACEL® hydrofiber dressing, 50 patients to control).

Data Provenance: The studies are clinical trials, implying prospective data collection. The countries of origin are not explicitly stated, but the journal publications cited (Ann R Coll Surg Engl; Int Wound J; Journal of Orthopedic Nursing) suggest an international origin, likely including the UK (Ann R Coll Surg Engl), given the author names.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable in the context of wound care dressing clinical trials. "Ground truth" in this scenario would typically be established by clinical assessments made by healthcare professionals (e.g., surgeons, nurses) managing the patients in the trials, following established medical protocols for wound assessment and treatment. The document does not specify the number or qualifications of clinicians involved in making these assessments for the referenced studies.

4. Adjudication Method for the Test Set

The document describes the studies as "randomized controlled trials." This implies a systematic approach to patient assignment, but it does not specify any particular adjudication method (e.g., 2+1, 3+1) for evaluating outcomes. Outcomes were likely assessed by treating clinicians or independent researchers involved in the respective studies based on clinical measures (e.g., wound complications, pain scores, dressing change frequency).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a wound dressing, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical wound dressing and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth or clinical endpoints for the summarized studies were based on outcomes data directly observed in patients, such as:

• Wound complications (e.g., presence/absence of complications)
• Patient-reported pain scores
• Frequency of dressing changes
• Observations of blister formation, hematoma, and edema

These are clinical outcomes directly measured or observed in patients during the course of their treatment.

8. The Sample Size for the Training Set

This question is not applicable. The device is a wound dressing, not a machine learning algorithm that requires a training set. The clinical data summarized are for demonstrating safety and effectiveness for regulatory clearance, not for training an AI model.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for a wound dressing.

Ask a specific question about this device