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510(k) Data Aggregation

    K Number
    K222801
    Device Name
    Safety Lancet
    Manufacturer
    Sarstedt AG & CO KG
    Date Cleared
    2023-01-25

    (131 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Safety-Lancets with safety feature are used for single use capillary blood sampling.

    Device Description

    The Safety Lancet consists of the following components: colorless plastic body, needle holder with needle or blade shaped lancing device, protective cap, carrier device, two springs, and the release button. The release button, the needle holder, and the protective cap are colored according to the variant available. The lancets are offered with different needle or blade shaped lancing devices, different sharpening and penetration depths, and accordingly in different colors. The lancets contain a safety feature. After puncture the needle retracts automatically into the housing to prevent sharps injuries.

    AI/ML Overview

    The provided text describes the 510(k) submission for a Safety Lancet, and while it covers non-clinical testing, it does not include information about a study that assesses AI performance. The document focuses on the substantial equivalence of the new Safety Lancet to a predicate device, primarily through bench tests verifying physical and functional aspects.

    Therefore, I cannot extract the detailed information requested regarding AI acceptance criteria and study performance from this document. The questions about AI performance, test set characteristics, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable to this Safety Lancet submission.

    The document describes non-clinical testing for a medical device (a lancet), not a software or AI-driven diagnostic tool.

    However, I can provide the acceptance criteria and reported device performance from the provided text as it relates to the physical device:

    1. A table of acceptance criteria and the reported device performance (for the physical device):

    Acceptance Criteria (Design Specification Tests)Reported Device Performance (Conclusion)
    Aesthetics and correct assembly"The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful performance in all design specifications, including aesthetics and correct assembly.)
    Inspection for self-activation"The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful performance in preventing self-activation.)
    Activation according to instructions for use"The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful performance in activating as instructed.)
    Needle retraction after activation"The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." Also, under "Safety protection features": "Yes, after puncture the needle retracts automatically into the housing to prevent sharps injuries." (Successful retraction confirmed.)
    Sterilization validation"The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." Specifically, "Sterilize by radiation SAL = $10^{-6}$" is stated for both new and predicate devices.
    Packaging validation"The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful packaging validation.)
    Shelf-life validation"The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." Specifically, "5 years" shelf life is stated for both new and predicate devices.
    Biocompatibility testing"The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful biocompatibility testing.)

    Since the provided document is a 510(k) clearance for a physical medical device (Safety Lancet) and not an AI/software product, the following points are not applicable and cannot be answered from the provided text:

    1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    3. Adjudication method for the test set
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
    7. The sample size for the training set
    8. How the ground truth for the training set was established
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