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510(k) Data Aggregation

    K Number
    K120912
    Device Name
    INFINITI(R) VISION SYSTEM
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Date Cleared
    2012-06-15

    (81 days)

    Product Code
    HQC,HQR,KYB,MLZ
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    K112425,K093210,K091777,K082845,K063155,K021566
    Why did this record match?
    Reference Devices :

    K112425

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

    The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

    The following system modalities additionally support the described indications:

    • Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
    • AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells.
    • The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, and SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
    Device Description

    The INFINITI® Vision System is unchanged from the INFINITI® Vision System (Evergreen II - K112425) and maintains the modular design and incorporated features that include: Power Watch feature, UltraChopper tip, the AquaLase Capsule Wash Tip, the INTREPID® AutoSert™ IOL Injector Handpiece, and the system's associated software.

    AI/ML Overview

    This 510(k) premarket notification for the INFINITI® Vision System (K120912) is a submission for a device that is largely unchanged from a previously cleared device (K112425). The primary "new" aspect is the expansion of the indications for use of the INTREPID® AutoSert® IOL Injector Handpiece to include additional AcrySof® intraocular lenses (SN6AT3 through SN6AT9). As such, the "study" demonstrating performance is focused on confirming the compatibility of the device with these new lenses, rather than a full de novo study of the entire system's performance.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from EN ISO 11979-3:2006, Section 5)Reported Device Performance
    Mechanical properties and test methods for intraocular lenses (specifically related to insertion of AcrySof® intraocular lenses SN6AT3 through SN6AT9 with the INTREPID® AutoSert® IOL Injector Handpiece, Monarch® II C Cartridge, and Monarch® III D Cartridge)."Additional testing that covers the additional AcrySoft intraocular lenses SN6AT3 through SN6AT9 was completed per EN ISO 11979-3, Section 5. Each AcrySoft lens was tested with the Monarch® II C Cartridge and the Monarch® III D Cartridge." The submission states that functional requirements have been met and the device is equivalent to predicate devices.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not explicitly stated as a number of tested lenses. The text indicates "Each AcrySoft lens was tested," implying that at least one of each newly added lens type (SN6AT3 through SN6AT9) was tested.
    • Data Provenance: Not specified within the provided document (e.g., country of origin, retrospective or prospective). This information is typically found in the full test report, not usually summarized in the 510(k) itself. The testing would have been prospective to demonstrate compatibility.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    Not applicable. This type of testing involves mechanical performance standards for medical device components (i.e., whether the IOL injector can successfully inject specific lenses), not interpretation of clinical data where expert consensus for ground truth would be required. The "ground truth" here is compliance with a specified engineering standard.

    4. Adjudication Method for the Test Set

    Not applicable. See point 3. This was a mechanical engineering performance test against a standard, not a clinical trial with human observers requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No. An MRMC comparative effectiveness study was not done. The submission is for a surgical instrument and a specific component's compatibility (an IOL injector with new lenses), not for an AI-powered diagnostic or assistive tool where human reader performance would be the primary outcome. Therefore, there's no discussion of AI assistance or effect size.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

    No. This device is not an algorithm or AI system. It's a surgical system with a mechanical IOL injector.

    7. The Type of Ground Truth Used

    The ground truth used was compliance with an established international standard for ophthalmic implants (EN ISO 11979-3:2006, Section 5). This standard outlines mechanical properties and test methods.

    8. The Sample Size for the Training Set

    Not applicable. There is no mention or indication of a "training set" as this device does not involve machine learning or algorithmic development requiring such a set.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. See point 8.

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