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Enhanced silver gelling fiber dressing (OTC) may be used for the management of:

• Abrasions
• Lacerations;
• Minor cuts;
• Minor scalds and burns.

Extra enhanced silver gelling fiber dressing (Rx only) may be used for the management of:

• Partial thickness (superficial 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;

Enhanced silver gelling fiber dressing (OTC)/Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is a soft, conformable, sterile dressing composed of sodium carboxymethyl cellulose fibers, strengthening layer (polyester), 1.2% (w/w) ionic silver, and stitched with enhance fibers (polyester). This conformable dressing absorbs wound fluid and creates a soft gel, provides a moist wound healing environment, and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within the dressing. Based on in-vitro testing, the silver in the dressing inhibits bacterial growth in the dressing for up to seven days.

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Prescription Use:
LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.

OTC Use:
LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

LUOFUCON® Skin and Wound Cleanser is a clear, colorless solution with a mild odor. It helps in the mechanical removal of debris and foreign materials from the skin, wounds, or application sites. This product contains 0.1% w/w polyhexamethylene biguanide (PHMB) as a preservative, which helps inhibit the growth of microorganisms in the solution.

LUOFUCON® Skin and Wound Cleanser is available in various packaging forms, such as Spray, Mist, Squeeze, and Bottle models. They can be suited for different clinical situations.

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The Hemastyl Wound Gel is indicated for use as follows:

Hemastyl Wound Gel

Rx: Management of wounds such

• 1st degree burns and 2nd degree superficial burns
• stasis ulcers
• pressure ulcers
• diabetic ulcers
• lacerations
• abrasions
• skin tears
• surgical incision sites
• device insertion site wounds
• graft sites
• donor sites

OTC: Management of minor cuts, minor abrasions, minor lacerations and minor scalds.

Hemastyl™ Wound Dressing is a repeat use, amorphous hydrogel containing silver chloride (AgCl), cupric chloride (CuCl2) and ferric chloride (FeCl3) as preservatives and HA and fish collagen for use in the management of wounds.

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The Tegaderm™ Post-Op Transparent Antimicrobial Dressing is a waterproof, single use, sterile dressing with Chlorhexidine Gluconate (CHG), intended to be used on adult patients by healthcare professionals to cover and protect closed surgical incisions or laparoscopic incision and a percutaneous device(s) (e.g., sutures, staples, tissue adhesives).

Tegaderm™ Post-Op Transparent Antimicrobial Dressing includes a transparent adhesive dressing and an integrated transparent gel pad containing Chlorhexidine Gluconate (CHG) at a concentration of 1.2% (w/w). The transparent adhesive dressing provides a barrier against external contamination including fluids (waterproof), bacteria, mold and yeast, and is classified as a breached skin contact device intended for use on closed incisions.

In vitro testing (log reduction and barrier testing) demonstrates that the CHG gel pad in the Tegaderm™ Post-Op Transparent Antimicrobial Dressing has an antimicrobial effect against, gram-positive and gram-negative bacteria, yeast, and mold in the dressing. The gel pad absorbs fluid. Tegaderm™ Post-Op Transparent Antimicrobial Dressing is transparent, allowing for continual site observation, and is breathable, allowing moisture vapor exchange.

The device is sterile. Terminal sterilization is conducted with ethylene oxide.

As part of the Predetermined Change Control Plan, the Tegaderm™ Post-Op Transparent Antimicrobial Dressing design will be updated to include bodily fluid barrier protection. This product requirement will be tested per the ASTM Method F1670 Synthetic Blood Penetration standard.

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Dermalage for over-the-counter use is intended for cleansing wounds for the removal of foreign material, such as debris and dirt, from dermal wounds.

Dermalage is a liquid solution intended for cleansing wounds. The solution is applied by spraying directly onto the affected area until wet and then allowed to air dry. When sprayed, Dermalage moves across the wound bed by mechanical action to aid in the removal of foreign objects such as dirt and debris from granulating wounds. The Dermalage solution is provided in a bottle with a manual spray pump configuration.

Dermalage is a combination product that contains water, sodium laureth sulfate, sodium lauryl sulfoacetate, disodium laureth sulfosuccinate, cocamidopropyl betaine, sorbitol, Imidazolidinyl Urea, and sodium hydroxide. Imidazolidinyl Urea acts solely as a preservative to inhibit growth of microorganisms within the product before opening and between uses.

Dermalage is limited to use by a single patient for up to 24 hours.

The provided FDA 510(k) Clearance Letter for Dermalage (K243166) does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm effectiveness. The document focuses on demonstrating substantial equivalence to a predicate device (K103713 Elta Wound Cleanser) for its intended use as a wound cleanser through various safety and performance tests.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance in the context of cleaning wounds (e.g., a specific percentage of debris removal). Instead, it lists various safety and effectiveness tests:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on specific sample sizes for the performance tests (e.g., number of test subjects or samples for biocompatibility, shelf-life, or antimicrobial effectiveness). The data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The tests described (biocompatibility, shelf-life, antimicrobial effectiveness, etc.) are standard laboratory and ISO-based assessments, not typically requiring "experts to establish ground truth" in the same way an AI diagnostic device for image analysis would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments, which are not detailed in this document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the document. This type of study is relevant for AI-powered diagnostic or assistive devices where human-AI interaction is evaluated. Dermalage is a physical wound cleanser, not an AI or algorithmic device.

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

A standalone performance study for an algorithm was not mentioned as Dermalage is a liquid wound cleanser, not an algorithmic device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the performance and safety tests listed (biocompatibility, shelf-life, antimicrobial effectiveness), the "ground truth" would be established by the validated and standardized protocols of the respective ISO standards (10993 series) and USP monographs (e.g., USP <51>, USP <151>). These standards define the methods and criteria for determining cytotoxicity, irritation, sensitization, acute toxicity, pyrogenicity, and antimicrobial effectiveness.

8. The sample size for the training set

This information is not applicable as Dermalage is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

Summary:

The provided FDA 510(k) clearance letter pertains to a physical medical device (a wound cleanser), not an AI or software-as-a-medical-device (SaMD). Therefore, many of the questions related to AI device evaluation (sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not addressed or applicable in this context. The document focuses on demonstrating the substantial equivalence of Dermalage to a predicate wound cleanser through standard biocompatibility, chemical, and stability testing, confirming its safety and effectiveness for its intended use.

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Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Granudacyn® Wound Wash Solution is composed of water (H2O), hypochlorous acid (HOCl), sodium hypochlorite (NaOCl) and sodium chloride (NaCl). Pure water and pure sodium chloride are subjected to an electrolysis process to create the final solution.

The provided FDA 510(k) clearance letter for Granudacyn® Wound Irrigation Solution (K243415) does not contain information about acceptance criteria or a study that uses a device to meet acceptance criteria in the context of AI/ML or diagnostic performance.

This document pertains to a medical device that is a wound wash solution, not an AI-powered diagnostic device. The clearance is based on demonstrating substantial equivalence to a predicate device (Vashe® Wound Solution) through non-clinical testing of its physical and chemical properties and general effectiveness as a wound care product.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of device and regulatory submission presented.

The "Clinical Data Summary – Subject Device" section explicitly states: "Clinical Testing: Clinical data is not required." and "No clinical data was required to support substantial equivalence." This further confirms that no studies proving diagnostic accuracy or clinical effectiveness in a human cohort were conducted or needed for this clearance.

In summary, the provided text does not contain the information required to answer your specific questions related to AI/ML device performance and acceptance criteria.

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Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.

Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses.

Bonvadis® is multiple use and supplied in a 15 g aluminum tube.

The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing.

Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.

The provided FDA 510(k) clearance letter and summary for Bonvadis® do not contain any information regarding clinical performance studies, such as those involving human readers or expert panels, nor do they specify acceptance criteria for such studies.

The acceptance criteria mentioned in the document are primarily related to non-clinical performance tests proving the device's physical properties, safety, and functionality.

Here's the information that can be extracted or deduced from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical performance acceptance criteria or corresponding results are provided in the document, the table below focuses on the non-clinical tests mentioned. The document states that the results "meet the criteria" or "demonstrated that the device is as safe, effective, and performs as well as the predicate devices," implying successful completion of these tests against internal or regulatory standards, though specific numerical criteria are not detailed.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided for clinical performance. The document exclusively refers to non-clinical tests on the device itself (e.g., stability, physical properties, biocompatibility). There is no mention of a "test set" of patient data or images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As there are no clinical performance studies or test sets involving patient data, no experts were used to establish ground truth for such a purpose.

4. Adjudication method for the test set

Not applicable/Not provided. No adjudication method is mentioned as there were no clinical performance studies requiring expert review of data.

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/Not provided. This device is a topical wound dressing, not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.

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

Not applicable/Not provided. This device is a physical product (wound dressing), not a software algorithm.

7. The type of ground truth used

Not applicable/Not provided for clinical performance. For the non-clinical tests, the "ground truth" refers to established scientific and regulatory standards (e.g., USP monographs for microbial limits, pH, preservative efficacy) against which the device's physical and chemical properties were measured.

8. The sample size for the training set

Not applicable/Not provided. This refers to clinical or AI model training data, neither of which are mentioned or relevant to the non-clinical tests described for this wound dressing.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no mention of a training set for an AI model or clinical study, this information is not available.

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