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510(k) Data Aggregation

    K Number
    K230759
    Device Name
    SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
    Manufacturer
    Bosungmeditech Co., Ltd.
    Date Cleared
    2023-06-13

    (85 days)

    Product Code
    QRK
    Regulation Number
    878.4850
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K214022
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bosungmeditech Co., Ltd.

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

    SafeLan® is sterile, single use device that has been designed for single patient use by lay users in a home. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples.

    SafeLan®-Pro: Use with SafeLan® for capillary blood sampling and the SafeLan®-Pro as the multiple use execution device which the SafeLan® lancet attaches.

    Device Description

    SafeLan® blood lancet is a small medical device used for capillary blood sampling. The SafeLan® is a blood lancet consisting of protective cap, needle protector, spring, lancet, and needle. The main component of blood lancet is the small, sharp objects that are used to prick the skin to obtain a small quantity of blood for testing. SafeLan® has 2 models depending on the diameter of the needle.

    • SafeLan® 26G: 0.46±0.05mm
    • SafeLan® 30G: 0.30±0.05mm

    Lancing device (SafeLan®-Pro) combines with the SafeLan® to operate the needle to prick the skin.

    SafeLan®-Pro is used with SafeLan® to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. SafeLan® is used with compatible lancing device (SafeLan®-Pro) for capillary blood sampling.

    Safel an 9-Pro consists of loading handle, operation button, depth adjustment confirmation part.

    The operating principle of SafeLan®-Pro is driven by force of the simple operating sequence is as follows.

    1. Insert the SafeLan® clockwise to the front thread of the SafeLan®-Pro.

    2. Pull the needle protector of SafeLan® to remove it.

    3. Pull and release the loading handle of SafeLan®-Pro.

    4. Press the operation button of SafeLan®-Pro.

    5. Remove the used SafeLan® from the SafeLan®-Pro by turning them counterclockwise.

    AI/ML Overview

    It appears the provided document is a 510(k) Premarket Notification from the FDA regarding a medical device, SafeLan®.

    However, the provided text does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, specifically regarding an AI/ML algorithm. The document primarily focuses on the device description, intended use, and a comparison to a predicate device for substantial equivalence, as is typical for a 510(k) submission for a physical medical device (blood lancets).

    The questions posed (e.g., sample size for test set, data provenance, number of experts, MRMC study, standalone performance, ground truth) are highly relevant to the evaluation of AI/ML-enabled medical devices. Since SafeLan® is a physical blood lancet and lancing device, an AI component is not implied or mentioned in this regulatory document.

    Therefore,Based on the provided text, I cannot answer the questions as they pertain to an AI/ML algorithm's acceptance criteria and performance study. The document is about a mechanical blood lancet, not an AI/ML device.

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