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510(k) Data Aggregation

    K Number
    K233222
    Device Name
    Aygün Sterilization Container Systems
    Manufacturer
    Aygun Surgical Instruments Co., Inc.
    Date Cleared
    2023-12-12

    (75 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Aygün Sterilization Container Systems is indicated for use by hospitals and health care facilities to:

    · Organize and protect stainless steel, aluminum, plastic, and silicone surgical instruments during the reprocessing process.

    · Facilitate the sterilization of the enclosed instruments via pre-vacuum steam sterilization cycles,

    • Maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container remains uncompromised,

    · The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is designed for use with stainless steel, aluminum, titanium, plastic, and silicone surgical instruments.

    For effective sterilization and drying of any size Aygün Sterilization Container System, the recommended maximum combined weight of the single container, lid, baskettray, and basket/tray contents is defined below. The qualified lumen size, representing the minimum diameter and maximum length, which has been qualified for use, is also shown below.

    Type: Pre-vacuum Steam Sterilization.

    Cycle: Temperature: 132°C, Exposure Time: 4 minutes, Drying Time: 30 minutes. Stackable: No. Instrument Type: stainless steel, aluminum, titanium, plastic, and silicone surgical instruments. Lumen Size: ≥ Full Size:1mm x 500mm, ≤ Three Quarter Size: 1mm x 200mm Maximum Weight: > Three Quarter Size: 25 lbs., ≤ Half Size 15 lbs.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for sterilization container systems. This document does not describe a software-driven medical device, an AI algorithm, or a study that evaluates its performance against acceptance criteria.

    The information requested in the prompt (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is typically associated with the validation of AI/ML-based medical devices or diagnostic tools.

    Since the provided document pertains to a physical sterilization container system and a traditional 510(k) clearance (not an AI/ML device), it does not contain the information necessary to fulfill the request. Therefore, I cannot generate the table or the detailed description of a study as requested.

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