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510(k) Data Aggregation

    K Number
    K203569
    Device Name
    Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2021-06-11

    (186 days)

    Product Code
    NCB
    Regulation Number
    886.5700
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K011740,K983607,K000127,K170591,K011115,K150986
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    Product Code :

    NCB

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

    Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

    Device Description

    The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices for the gravityassisted treatment of lagophthalmos by the addition of weight to the upper eyelid. The device is made of either 99.99% purity gold or platinum. Platinum devices can be implanted in patients who are allergic to gold. The Gold and Platinum Tapered Weight Eyelid Implants come in two thicknesses (thin and normal profiles) and in seven different weights ranging from 0.6 g to 1.8 g (in 0.2 g increments). The Gold and Platinum Tapered Weight Eyelid Implants are each provided as a sterilized product.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for Gold and Platinum Tapered Weight Eyelid Implants. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study for novel device acceptance criteria. Therefore, much of the requested information regarding clinical study design, ground truth, expert opinions, and sample sizes for diagnostic performance is not directly applicable or available in this document.

    However, based on the provided text, I can extract and infer information relevant to the non-clinical acceptance criteria and the studies performed to meet them.

    1. Table of Acceptance Criteria and Reported Device Performance

    Given that this is a 510(k) submission focused on substantial equivalence to an existing device, the "acceptance criteria" are primarily established by demonstrating that the new device shares fundamental technological characteristics and performance (or equivalent performance) with the predicate device, especially considering any differences. The key performance metrics evaluated are MRI safety, biocompatibility, and sterility/shelf-life.

    CategoryAcceptance Criteria (typically from established standards or predicate performance)Reported Device Performance (FCI Gold/Platinum Eyelid Implants)
    MRI SafetyDevice is "MR Conditional" under specified conditions (e.g., static field ≤ 3T, spatial gradient ≤ 4000 Gauss/cm, SAR ≤ 4 W/kg for 15 min).MR Conditional: meets these conditions.
    MRI-Related ForceNegligible deflection/torque in a 3T MR system. (e.g., 2° deflection or "0" on a 0-4 torque scale). Adherence to ASTM F2052-06.Gold: 2° deflection, Torque "0".
    Platinum: 2° deflection, Torque "0".
    MRI-Related HeatingMaximum temperature rise ≤ acceptable limits (e.g., usually
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