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BIONECT® Hydrogel Foam provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT® Hydrogel Foam may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-opcrative incisions and donor sites), and second degree burns.

BIONECT® Hydrogel Foam is a white foam that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

The provided document is a 510(k) summary for the BIONECT® Hydrogel Foam and related products. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a novel AI diagnostic device might.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test sets, expert qualifications, MRMC studies, ground truth types) are not applicable or not explicitly stated in this type of submission.

However, I can extract information related to performance assessment and "acceptance criteria" as implied by the FDA's review process for substantial equivalence.

Here's a breakdown of the relevant information:

Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implied by the FDA's standard for substantial equivalence for this type of medical device (wound dressing), which primarily focuses on safety and efficacy being equivalent to a legally marketed predicate device. Specific quantitative thresholds (e.g., sensitivity, specificity) common in diagnostic device studies are not present.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated for the BIONECT® Hydrogel Foam directly. The document refers to "22 clinical trials (17 controlled) conducted in Europe" with the predicate devices (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads). The number of patients in these trials is not specified.
   • Data provenance: Europe (for the clinical trials on predicate devices). The data for biocompatibility testing is not specified in terms of origin, but it is implied to be laboratory testing. The submission itself is dated February 1, 1999, making it retrospective relative to the submission date.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device (wound dressing) and submission (510(k) for substantial equivalence), ground truth is not typically established by expert consensus on specific cases in the same way as for an AI diagnostic algorithm. The safety and efficacy data from clinical trials on predicate devices serve as the basis for comparison.

3. Adjudication method for the test set: Not applicable. There is no mention of adjudication for a test set in the context of this 510(k) submission.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a wound dressing submission focused on substantial equivalence.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone algorithm performance study was not done. This device is a physical wound dressing, not an algorithm.

6. The type of ground truth used:

   • For biocompatibility: Laboratory test results (cytotoxicity, dermal irritation, dermal sensitization).
   • For safety/efficacy (by inference from predicate): Clinical outcomes from human patients with various wound types (ulcers, burns, surgical wounds) treated with the predicate devices. This would involve standard clinical assessments, which would serve as the "ground truth" for the predicate's performance.

7. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm, so there is no training set in the machine learning sense. Clinical experience with predicate devices serves as the basis for demonstrating similarity.

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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BIONECT® Hydrogel Foam is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns.

BIONECT® Hydrogel Foam is a white foam that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

The provided text is a 510(k) Premarket Notification for BIONECT® Hydrogel Foam and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (BIONECT® Hydrogel) by comparing technological characteristics, intended use, and providing a summary of prior biocompatibility testing and clinical experience.

Here's a breakdown of what is and is not in the document, based on your request:

What IS in the document:

• BIONECT® Hydrogel Foam Device Description: It's a white foam prepared from sodium hyaluronate and purified water, designed to provide a soothing, moist environment for wound healing.
• Intended Use: Dressing and management of partial to full thickness dermal ulcers, various wounds (cuts, abrasions, donor sites, post-operative incisions), skin irritations, and first and second-degree burns.
• Predicate Device: BIONECT® Hydrogel.
• Biocompatibility Testing: In vitro and in vivo testing (cytotoxicity, dermal irritation, dermal sensitization) was performed on the bulk solution in accordance with FDA recommendations (ISO-10993). These tests supported safe use. This is a type of performance data, but not framed as meeting specific numerical acceptance criteria.
• Clinical Experience (for predicate device/similar products): "Clinical experience with BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads in 22 clinical trials (17 controlled) conducted in Europe in patients with various types of ulcers, burns, and surgical wounds indicates that BIONECT® Hydrogel Foam is safe for its intended use." This is a statement of safety based on past clinical use, but lacks specific statistical performance metrics for the proposed device.
• FDA Clearance: The FDA found the device substantially equivalent to a legally marketed predicate device, with specific limitations on labeling (e.g., not for third-degree burns, no claims of accelerating wound healing).

What IS NOT (or not sufficiently) in the document to fulfill your request:

1. A table of acceptance criteria and the reported device performance: No specific, quantifiable acceptance criteria (e.g., "must demonstrate a 90% wound closure rate by X weeks") are listed, nor are numerical performance results against such criteria. The document relies on substantial equivalence and a general statement of safety from prior clinical experience.
2. Sample size used for the test set and the data provenance: The document mentions "22 clinical trials (17 controlled) conducted in Europe" for related products (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads). This is a general reference to support safety for the intended use of the new foam, not a specific "test set" for the foam itself with detailed provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there isn't a described "test set" with ground truth established by experts in the context of device performance metrics.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable, as this device is not an imaging or diagnostic AI device. The document describes a medical dressing.
6. If a standalone performance study was done: The biocompatibility tests are standalone performance tests for material safety, but not for its clinical efficacy in wound healing against specific benchmarks. The clinical experience refers to related products.
7. The type of ground truth used: Not applicable in the context of quantitative performance ground truth, but implicitly, "safety for its intended use" from clinical trials would have relied on physician assessments of patient outcomes.
8. The sample size for the training set: Not applicable, as this is a medical device (hydrogel foam), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided submission (K973722) for BIONECT® Hydrogel Foam focuses on demonstrating substantial equivalence to a predicate device and relies on prior biocompatibility testing and general clinical experience with similar hydrogel products to assert its safety and intended use, rather than presenting a study with specific, quantifiable acceptance criteria and performance data for the device itself.

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