(205 days)
Under the supervision of a healthcare professional:
AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, adhesive and non adhesive may be used for the management of both chronic and acute wounds, such as:
- Partial thickness (second degree) burns; -
- Diabetic foot ulcers, leg ulcers, (venous stasis ulcers and leg ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
- Surgical wounds -
- Traumatic wounds; -
- Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
- Abrasions;
- Lacerations;
- Minor Cuts;
- Minor scalds and burns.
AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is a soft, sterile foam wound dressing comprised of a waterproof outer polyurethane film and a multi-layered absorbent pad, with the adhesive dressing having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of silver Hydrofiber™ (sodium carboxymethylcellulose). The dressing's Hydrofiber™ wound contact layer contains 1.2% w/w ionic silver. The silver in the dressing kills a broad spectrum of wound bacteria held in the dressing. 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) without damaging healthy tissue. The outer film layer provides a waterproof viral and bacterial barrier which protects the wound from external contaminants. The film also helps manage the moisture vapor transmission of the exudates absorbed by the dressing AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive may be used as a primary or secondary dressing. It may be used alone or in combination with other wound care products. The adhesive dressing has a silicone border which provides secure, skin friendly adhesion. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment. The moist wound environment is known to support the body's healing process.
This document describes a medical device, the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and statistical analysis for a device performance study is not present in this submission.
The document primarily focuses on establishing "substantial equivalence" to legally marketed predicate devices, a regulatory pathway where direct clinical performance trials demonstrating specific acceptance criteria are often not required if the new device's technological characteristics and intended use are similar to established predicates.
Here's a breakdown of the available information based on your request, highlighting what is missing due to the nature of this 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission is a 510(k) summary for a wound dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific performance against quantitative acceptance criteria from a standalone study. The document states:
- "The predicate AQUACEL Dressings in clinical studies shown to be successfully used in the management of chronic wounds." (This refers to predicate devices, not the subject device's own study.)
- "The subject device's technological characteristics are similar to the other AQUACEL predicate devices."
- "The AQUACEL foam devices contain a polyurethane film which on the bench testing is shown to provide bacterial, viral and waterproof properties." (This is a mention of bench testing but no specific acceptance criteria or performance numbers are given).
2. Sample size used for the test set and the data provenance
No test set for evaluating the performance of the subject device against specific criteria is described in this document. The submission references past clinical studies on predicate devices but does not detail a test set for the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as no such test set or ground truth establishment is described for the subject device's performance evaluation.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is a wound dressing, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a wound dressing.
7. The type of ground truth used
Not applicable, as no ground truth for performance evaluation of the subject device is described. The "ground truth" for the 510(k) submission is the pre-existing regulatory clearance and established safety/effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This is a wound dressing, and no machine learning model or training set is mentioned.
9. How the ground truth for the training set was established
Not applicable.
Summary of what is present in the document relevant to its regulatory submission:
The document serves as a 510(k) premarket notification, aiming to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.
- Predicate Devices:
- Argument for Substantial Equivalence: The applicant argues that the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is substantially equivalent due to:
- Similar technological characteristics to other AQUACEL predicate devices.
- The use of a polyurethane film (in AQUACEL foam devices) demonstrated in bench testing to provide bacterial, viral, and waterproof properties.
- Predicate AQUACEL Dressings having been successfully used in clinical studies for chronic wounds.
- Intended Use/Indications: The device is indicated for the management of various acute and chronic wounds, including partial thickness burns, diabetic foot ulcers, pressure ulcers, surgical wounds, traumatic wounds, and minor cuts/abrasions. This is consistent with the indications for the predicate devices.
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