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    K Number
    DEN200063
    Device Name
    Kerasave
    Manufacturer
    AL.CHI.MI.A. S.r.l
    Date Cleared
    2022-05-02

    (578 days)

    Product Code
    QCW
    Regulation Number
    886.4320
    Type
    Post-NSE
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Kerasave

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Kerasave is indicated for storage of human corneas at 2-8°C for up to 14 days. It is intended for prescription (Rx) use by physicians or highly skilled personnel, such as Eye Bank operators.

    Device Description

    Kerasave is made of a buffered corneal storage medium, which provides basic nutrients for cell maintenance during storage of donor corneas at 2-8°C for up to 14 days, at physiological pH. The device also includes antimicrobial agents. The antibiotics are dissolved in the solution and an antifungal agent is formulated as a tablet for stability reason and constitutes integral part of the device; it shall be dissolved in the medium prior to use.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

    Acceptance Criteria and Device Performance for Kerasave

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document defines "Special Controls" which serve as the acceptance criteria for the Kerasave device. These are primarily evaluated through non-clinical performance testing.

    Acceptance CriterionReported Device Performance
    Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use.Corneal Endothelial Cell Layer Preservation: Kerasave was non-inferior to Optisol-GS (FDA-cleared comparator) for Endothelial Cell Density (ECD) and Hexagonality (HEX) at Day 14. An exploratory analysis also showed non-inferiority for Coefficient of Variation (%CV) after removing an outlier. (Tables 4, 5, 7)
    (i) Following performance characteristics of the cornea following storage must be demonstrated:
    (A) Endothelial cell densityNon-inferior to Optisol-GS at Day 14 (Table 4).
    (B) Endothelial cell morphology (pleomorphism: Hexagonality (HEX) and polymegathism: %CV)HEX: Non-inferior to Optisol-GS at Day 14 (Table 5). %CV: Failed to statistically clear non-inferiority initially, but exploratory analysis (excluding outlier) showed non-inferiority at Day 14 (Table 6, 7).
    (C) Corneal transparencyNo statistical difference in clarity scores between Kerasave and Optisol-GS at Day 14. However, Kerasave showed increased opacity (score 1 to 2) in 7/27 corneas, compared to 2/27 for Optisol-GS. Increased edema and folds/striae were observed in these corneas. (Table 9, and related text)
    (D) Central corneal thicknessCCT changes were similar between Kerasave and Optisol-GS arms, with no statistical difference (Table 8).
    (ii) Antimicrobial activity of the device must be demonstrated at the initial and maximum labeled storage time.Demonstrated effective inhibition of bacterial growth (streptomycin and gentamicin) and fungal growth (Amphotericin B). Amphotericin B reduced Candida sp. population by 5-log and Fusarium sp. population by ~1-log. (Antimicrobial Evaluation section)
    (iii) Characterization of all preservatives, including antifungals, must include:
    (A) Characterization of impurities, heavy metal analysis, concentration, and dissolutionAmphotericin B in Kerasave was identified as equivalent to the reference substance. Impurity profile met USP/EP limits. Heavy metals met acceptance (
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