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OTC Use: Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns. Prescription Use: Under the supervision of a healthcare professional. Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: Partial thickness (second degree) burns; Pressure ulcers (partial and full thickness); Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Diabetic foot ulcers; Surgical wounds that heal by primary intent such as dermatological and surgical incisions; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites: Traumatic wounds.

Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days. The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.

This document describes the Silver Gelling Fiber Dressing's acceptance criteria and how it was proven to meet them.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance metrics in a numerical sense; rather, it focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests and a comparison of characteristics. The performance is largely demonstrated by meeting established standards and showing comparable properties to the predicate.

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

• Biocompatibility Tests (ISO 10993 series): The document does not specify exact sample sizes for these in vitro and in vivo (systemic toxicity) tests. The standards themselves typically outline sample size requirements. Provenance is not explicitly stated but these are laboratory tests following international standards.
• Sterility & Packaging Integrity Tests (ASTM, USP): No specific sample sizes are mentioned, but these are standard laboratory tests. Provenance not specified.
• Antibacterial Activity (AATCC 100-2012): No specific sample size is mentioned in terms of the number of dressings tested, but it describes testing against "four gram-positive bacteria" and "four gram-negative bacteria." Provenance not specified but these are in vitro laboratory tests.
• Porcine Wound Healing Study: The document refers to "the test subjects (Silver Gelling Fiber Dressing, and a Control AQUACEL® Ag Hydrofiber Dressing)." It does not specify the number of porcine subjects used. This is an animal study, not human data. The provenance of the animals or the location of the study is not specified. All studies appear to be retrospective in the context of the 510(k) submission, meaning they were completed prior to the submission.

There is no test set of human subjects/patients for clinical performance evaluation mentioned in this submission. The "test set" for performance evaluation is primarily in vitro and animal models.

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

Not applicable. The study is for a medical dressing and focuses on non-clinical performance and substantial equivalence to a predicate device. There is no expert-established ground truth in the context of diagnostic or interpretive accuracy, as would be relevant for an AI/CADe device. The "ground truth" for the non-clinical tests is established by the methods outlined in international and national standards (e.g., cell viability in cytotoxicity tests, bacterial counts in antimicrobial tests).

4. Adjudication Method for the Test Set:

Not applicable, as there is no human-interpreted test set requiring adjudication in this context. The non-clinical tests directly measure physical, chemical, or biological properties against established standards or compare them to a control/predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not an AI/CADe device, and no MRMC study was conducted or is relevant for this type of medical dressing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is not an AI/algorithm-based device. The "device" is a physical wound dressing. The tests performed are "standalone" in the sense that they assess the intrinsic properties and performance of the dressing itself without human intervention in its function.

7. The Type of Ground Truth Used:

• Biocompatibility: Established by standardized methods measuring cellular response (cytotoxicity, irritation, sensitization) and systemic effects. For the porcine study, the ground truth was the wound healing characteristics observed in the animal model.
• Sterility & Packaging Integrity: Established by adherence to validated sterilization methodologies and standardized tests for seal strength and integrity, and bacterial endotoxins.
• Antibacterial Activity: Established by measuring the log-reduction of specific challenge organisms according to the AATCC 100-2012 standard.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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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.

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Under the supervision of a healthcare professional:

AQUACEL® Ag Surgical may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.

AQUACEL® Ag Surgical Dressing with Silver is a one piece post-operative dressing comprised of an inner (wound contact) non-woven pad which is held in place by two layers of skin-friendly hydrocolloid adhesive and an outer top layer of polyurethane film. The nonskin moraly if your over of and innic silver sitems and ionic silver stitchbonded with nylon and elastane yarn for dressing extensibility (so the ressing will stretch and be eiastane yairi for drossing oxiension (after limb movement the dressing will return to its original shape and size without the application of any additional force to the skin).

The one-piece dressing design provides ease of application and removal and provides a waterproof, bacterial, and viral barrier covering to the wound. The benefits provided by this waterproof, at the clinical need for improved management of surgical wounds which have wound drainage and are at risk of infection.

AQUACEL® Ag Surgical combines the absorbency/retention properties of AQUACEL® Ag AQUACEL Ag Surgical combines the absorbonomics of DuoDERM® Extra Thin adhesive.

AQUACEL® Ag Surgical dressing is a soft, sterile, non-woven pad composed of hydrocolloid fibers. 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.

The provided text describes the AQUACEL® Ag Surgical dressing and its substantial equivalence to a predicate device, AQUACEL® Ag Hydrofiber® Dressing (K080383). However, it does not contain acceptance criteria for device performance, nor details of a specific study to prove the device meets such criteria.

Instead, the documentation relies on the safety and effectiveness demonstrated by the predicate device (K080383) and a literature review.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided. The text mentions a "literature review" and "clinical data provided in previous 510(k)s" without specifying the sample size or provenance for this specific submission's evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no specific test set described for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 medical dressing, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for this device's evaluation, beyond relying on the "safety and effectiveness" demonstrated by the predicate and literature, which would imply clinical outcomes.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information regarding demonstration of effectiveness:

The submission states that:

• "Since AQUACEL® Ag Surgical dressing is based on the AQUACEL® Ag Hydrofiber® technology, the safety and effectiveness of AQUACEL® Ag Surgical has been demonstrated by the literature and clinical data provided in previous 510(k)s (i.e., K080383)."
• "In summary, a careful and thorough review of the literature suggests that Hydrofiber® dressings have been used safely and effectively in clinical trials for the management of-surgical incisions healing with primary intent."
• "All the studies which have been reviewed suggest that, compared to a standard dressing, using a dressing with AQUACEL® leads to less dressing changes."

This indicates that the device's effectiveness is primarily supported by:

• Substantial equivalence to the predicate device (AQUACEL® Ag Hydrofiber® Dressing, K080383).
• A literature review of Hydrofiber® dressings, highlighting their safe and effective use in clinical trials, particularly noting fewer dressing changes compared to standard dressings.

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