(181 days)
Xomed MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.
Xomed MeroGel™ Nasal Dressing and Sinus Stent is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of the extracellular matrix. Due to its absorption properties, MeroGel™ may be used to help control minimal bleeding. In contact with body fluids, it changes into viscous and transparent gel, conforming to mucosal surfaces and eventually dissolves or may be irrigated from the cavity.
The provided text is a 510(k) summary for the Xomed MeroGel™ Nasal Dressing and Sinus Stent. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report that quantitatively proves device performance against those criteria.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method for a test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
- Results from a standalone (algorithm only) performance study.
- Type of ground truth used for performance validation.
- Sample size for the training set.
- How the ground truth for the training set was established.
Summary of available information related to acceptance criteria and study:
The device's "acceptance criteria" in this context are primarily defined by its intended use and demonstrating substantial equivalence to predicate devices, rather than specific performance metrics (like accuracy, sensitivity, specificity) against a clinical endpoint.
Intended Use:
- MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.
Study (Demonstration of Substantial Equivalence):
The device's acceptance is based on a comparative analysis to existing predicate devices, the Merocel® Sinus-Pak™ and Merocel® Standard Nasal Dressing. The study is a reasoned argument for substantial equivalence, not a clinical trial with specific performance metrics.
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Acceptance Criteria & Reported Device Performance: This information is not explicitly stated in a table with performance metrics in the provided document. The "acceptance" is the FDA's marketing clearance based on substantial equivalence. The "performance" is described qualitatively:
- Predicate Device Performance (Implied): Controls bleeding, aids in prevention of adhesions, absorbant for postop fluids.
- MeroGel™ Performance: Similar intended use and indications; changes into a viscous and transparent gel, conforming to mucosal surfaces; eventually dissolves or may be irrigated; helps control minimal bleeding; highly absorbent.
- Difference and Justification: The key difference is that MeroGel™ dissolves/forms a gelatinous mass and can be removed by irrigation, unlike the predicate devices which require manual removal. This difference is presented as not raising new safety or effectiveness concerns, supported by the material (HYAFF®) being biocompatible.
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Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no "test set" in the sense of a dataset for a performance study. The comparison is conceptual, based on intended use and material properties.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a clinical performance sense, is not established or discussed for a test set.
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Adjudication method for the test set: Not applicable.
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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 not an AI/imaging device requiring MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: Not applicable. The "truth" in this submission is the established safety and effectiveness of the predicate devices and the biocompatibility of the new material, which infer similar performance.
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The sample size for the training set: Not applicable. There is no "training set" for an algorithm.
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How the ground truth for the training set was established: Not applicable.
§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.