Search Results

For Over-the-Counter Use: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber 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; l AND/OR - 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; l - 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; - Painful wounds; - Infected wounds

AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber is a one piece wound dressing comprised of two layers of soft, sterile non-woven material. The non-woven pads are comprised of Hydrofiber™ dressing and ionic silver stitchbonded together with regenerated cellulose fibers and designed to provide additional absorbency and tensile strength properties. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment and supports the body's healing process.

Section 5 of the 510(k) summary for AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber (K121275) states that the safety and effectiveness of the device were demonstrated by literature and clinical data provided in previous 510(k)s, specifically referencing K080383 for AQUACEL™ Ag Hydrofiber™ Dressing. This indicates that the current submission relies on the substantial equivalence to a predicate device rather than presenting new primary study data to meet specific acceptance criteria. Therefore, the detailed information requested in the prompt related to a new study's acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not directly available in the provided text for this specific device (K121275).

Summary of Information from the Provided Text:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated as this submission relies on established equivalence to a predicate device. The performance is implied to be similar to the predicate.
• Sample size used for the test set and the data provenance: Not applicable, as no new test set study data is presented. The submission relies on existing literature and clinical data from the predicate device (K080383).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new test set study data is presented.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no new test set study data is presented.
• 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 device is a wound dressing, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a wound dressing, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly detailed for this submission, as it refers to "literature and clinical data" from a predicate device. For wound dressings, ground truth would typically relate to clinical outcomes such as healing rates, infection reduction, pain management, and tensile strength.
• The sample size for the training set: Not applicable, as no new training set data for an algorithm is relevant to this wound dressing submission.
• How the ground truth for the training set was established: Not applicable.

Conclusion based on the provided text:

The information indicates that the AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber device (K121275) was cleared based on its substantial equivalence to a previously cleared predicate device, AQUACEL™ Ag Hydrofiber™ Dressing (K080383). The claim is that the updated device is "largely based on the AQUACEL™ Ag Hydrofiber™ technology" and that "the safety and effectiveness... has been demonstrated by the literature and clinical data provided in previous 510(k)s (i.e., K080383)." Therefore, no new primary clinical study data or specific acceptance criteria for a new study are detailed in the provided K121275 summary to address the questions directly. The implicit acceptance criteria are that the new device performs similarly to or better than the predicate in terms of safety and effectiveness for wound management, as supported by existing data and literature.

Ask a specific question about this device