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510(k) Data Aggregation
(578 days)
NEW REGULATION NUMBER: 21 CFR 886.4320
CLASSIFICATION: Class II
PRODUCT CODE: QCW
BACKGROUND
Device Type: Corneal storage medium with preservatives including antifungals Regulation Number: 21 CFR 886.4320
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.
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.
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 Criterion | Reported 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 density | Non-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 transparency | No 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 thickness | CCT 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 dissolution | Amphotericin B in Kerasave was identified as equivalent to the reference substance. Impurity profile met USP/EP limits. Heavy metals met acceptance (<10 ppm). Uniform distribution of Amphotericin B demonstrated after dissolution. (Chemical Characterization section) |
| (B) Chemical activity of all preservatives over the labeled use life of the device. | Amphotericin B concentration remained above 11% after 72 hours of light exposure, indicating stability. Osmolality and pH remained within acceptance limits for 14 days after Amphotericin B dissolution. Shelf-life studies support stability and sterility for 24 months (device) and 6 months (Amphotericin B tablets). (Chemical Characterization, Shelf-Life/Sterility sections) |
| (2) Performance data must demonstrate the sterility of the device. | Achieved through filter sterilization, dry heat, and gamma irradiation (SAL 10-6). Bacterial endotoxin levels were below recommended limits. Supported by real-time and accelerated aging studies. (Shelf-Life/Sterility section) |
| (3) The device must be demonstrated to be biocompatible and non-pyrogenic. | Biocompatibility evidenced by non-cytotoxic, non-sensitizer, non-irritant, non-toxic (acute and subacute/subchronic systemic), and non-pyrogenic results according to ISO 10993 and FDA Guidance. (Table 3) |
| (4) Performance data must support the claimed shelf life by demonstrating continued sterility, controlled bioburden, package integrity, and device functionality over the intended shelf life. | Shelf-life of 24 months (Kerasave) and 6 months (Amphotericin B tablets) established, supported by sterility & stability in real-time & accelerated aging studies. (Shelf-Life/Sterility section) |
| (5) The device and each of its components (e.g., antifungal, antibiotic, medium) must be demonstrated to be compatible with their respective commercial container closure system/packaging. | Not explicitly detailed in the provided text beyond the general statement of "supported by real-time and accelerated aging studies, as well as after short term storage at high temperatures" under Shelf-Life/Sterility. A specific study demonstrating "compatibility with container closure system/packaging" isn't individually called out with results. |
| (6) An analysis must be provided that identifies and evaluates any contribution to the development and spread of antimicrobial resistance. | FDA determined low likelihood of antimicrobial resistance emergence/spread due to concentrations of antibiotics/antifungal in Kerasave. (Antimicrobial Evaluation section) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Twenty-seven (27) paired donor corneas were used for the performance testing related to endothelial cell layer preservation, corneal clarity, and central corneal thickness.
- Data Provenance: The text does not explicitly state the country of origin. It indicates it was an ex-vivo (bench) study using donor corneas, suggesting it's not patient data and is prospective for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The study involved comparisons of corneal storage conditions and measurements performed using a Konan specular microscope, optical coherence tomography (OCT), and slit lamp examination. It is implied these measurements were performed by trained personnel, but the text does not specify the number or qualifications of experts used to establish "ground truth" as typically defined for AI/ML device evaluations (e.g., expert consensus on image interpretation). The "ground truth" here is objective measurements and observations of the corneal health parameters.
4. Adjudication Method for the Test Set
Not applicable. This was a direct measurement study comparing a new device against a predicate device on biophysical parameters, not an expert-based subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This study's focus was on the performance of the corneal storage medium itself, not on human readers interpreting medical images or data with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. Kerasave is a physical corneal storage medium, not an AI algorithm. Therefore, a standalone algorithm-only performance study was not performed.
7. Type of Ground Truth Used
The ground truth for the performance parameters (Endothelial Cell Density, Hexagonality, Coefficient of Variation, Central Corneal Thickness, Corneal Clarity) was established through direct objective measurements using established laboratory techniques such as Konan specular microscopy, optical coherence tomography, and slit lamp examination.
8. Sample Size for the Training Set
Not applicable. Kerasave is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As Kerasave is a physical medical device, there is no training set or associated ground truth establishment for an AI/ML model.
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