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510(k) Data Aggregation

    K Number
    K250411
    Device Name
    DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
    Manufacturer
    Dannik, LLC
    Date Cleared
    2025-03-12

    (27 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K103510
    Why did this record match?
    Device Name :

    DANNIK**®** Laparoscopic Single-Use Poly Specimen Retrieval System

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

    The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.

    Device Description

    The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment of the bag with the use of the biasing arms.

    AI/ML Overview

    The provided FDA 510(k) clearance letter for the DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (K250411) does not contain information related to software, artificial intelligence (AI), diagnostic performance, or studies involving human readers or ground truth for diagnostic accuracy.

    The document describes a medical device, a specimen retrieval system, and its non-clinical testing to demonstrate substantial equivalence to a predicate device. The information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment is not applicable to a submission for a physical surgical device like this.

    Therefore, I cannot populate the requested table or answer the specific questions related to AI-driven diagnostic studies based on the provided text.

    Here's a summary of what is available regarding acceptance criteria and studies, framed according to the nature of this physical device:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this device, "acceptance criteria" and "device performance" are primarily related to its physical characteristics, functionality, and safety as compared to a predicate device, rather than diagnostic accuracy.

    Characteristic/CriterionAcceptance MethodologyReported Device Performance (as demonstrated by testing)
    Intended UseComparison to predicateMatches predicate: "receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery."
    Material BiocompatibilityConformance to ISO 10993 series standards (1, 5, 7, 10, 11, 23)Conforms to specified ISO 10993 standards.
    Sterilization EfficacyConformance to ISO 11135:2014 for Ethylene Oxide (EtO) sterilization to an SAL of 10^-6Sterilized using EtO to an SAL of 10^-6.
    Aging StabilityAging StudySuccessfully passed aging study (details of specific criteria not provided in this document).
    General Device OperationPerformance Studies (e.g., deployment, function)Met design specifications (details of specific metrics not provided).
    Bag OpeningPerformance StudiesSuccessfully demonstrates bag opening (details of specific metrics not provided).
    Bag VolumePerformance StudiesAvailable volumes from 120 to 1500 mL, matching predicate.
    Bag Integrity & Seam StrengthPerformance StudiesSuccessfully demonstrates integrity and seam strength (details of specific metrics not provided).
    Introducer DiameterDesign Specification5, 10, and 12mm, matching predicate.
    Prescription UseRegulatory ClassificationPrescription Use (Part 21 CFR 801 Subpart D), matching predicate.
    Intended EnvironmentDesign SpecificationProfessional Healthcare Facility (Surgical Room or Operating theatre), matching predicate.

    Given that this is a 510(k) for a physical medical device (a specimen retrieval system) and not an AI/software-as-medical-device, the following points are not applicable as they pertain to AI/diagnostic studies:

    1. Sample sizes for test set and data provenance: Not applicable. No test set of diagnostic data was used.
    2. Number of experts used to establish ground truth & qualifications: Not applicable. No ground truth for diagnostic accuracy was established.
    3. Adjudication method: Not applicable.
    4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. No human readers were evaluated for improvement with AI assistance.
    5. Standalone (algorithm only) performance: Not applicable. There is no algorithm.
    6. Type of ground truth used: Not applicable.
    7. Sample size for the training set: Not applicable. There is no training set for an AI/algorithm.
    8. How the ground truth for the training set was established: Not applicable.

    The "studies" conducted for this device were non-clinical performance and biocompatibility tests to demonstrate the device's physical and material safety and functionality, and its substantial equivalence to a legally marketed predicate device.

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