(214 days)
Under the supervision of a healthcare professional, the Silver Hydrofiber® Wound Dressing Reinforced with Nylon may be used for the management of:
- 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 and full thickness);
- Wounds as an effective barrier to bacterial penetration of the dressing as this may help . reduce infection;
- Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; .
- Surgical wounds that heal by primary intention 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 t carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
- Management of painful wounds .
- . Infected wounds
Silver Hydrofiber® Reinforced with Nylon Wound Dressings is a soft, sterile, non-woven flat dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose), that is reinforced with nylon stitching and that contain 1.2% ionic silver which allows for an average 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 nonviable 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.
This document is a Premarket Notification (510(k)) for a medical device – a wound dressing. While it discusses the device's indications, substantial equivalence to a predicate device, and the general safety and effectiveness, it does not contain the specific details of a study that establishes acceptance criteria and then proves the device meets those criteria.
The document states:
"Extensive clinical testing, including controlled GCP studies, has been carried out with AQUACEL® Ag (the predicate). The results of these studies have consistently demonstrated that the products are safe and effective dressings in the treatment of a wide range of wound types. ... See 510(k) #K080383 for details."
And also:
"...extensive clinical investigations with Silver Hydrofiber® Dressings Reinforced with Nylon were not considered necessary to confirm the clinical safety and performance for all indications, however, a single study has been carried out in partial thickness burns, which is anticipated to be the major indication for this product..."
Therefore, I cannot provide the requested information in the format of a table detailing acceptance criteria and reported device performance from this document because it is not present. The document defers to a previous 510(k) (K080383) for the predicate device's studies and mentions a single study for the current device without providing its details.
To answer your request, I would need access to the K080383 submission and/or the details of the "single study...carried out in partial thickness burns" referenced in K090254.
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