LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K182264
    Device Name
    ICONN Revolution Knotless Suture Anchor
    Manufacturer
    ICONN Orthopedics, LLC
    Date Cleared
    2018-10-19

    (59 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K093897
    Why did this record match?
    Device Name :

    ICONN Revolution Knotless Suture Anchor

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

    The ICONN Revolution Knotless Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

    Shoulder: Rotator cuff repair, Bankart repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

    Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

    Device Description

    The ICONN Revolution Knotless Suture Anchor (P/N 350000) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in one size (Diameter x Length): 5mm x 23mm. The implants with attached disposable inserter are supplied sterile and the instrument is supplied Non-Sterile and is to be sterilized in the ICONN instrument tray prior to surgery. The disposable inserter is made out of 17-4 stainless steel and the reusable driver is made out of 17-4 stainless steel (shaft) and silicone (handle). All anchors are intended to be used with the supplied #2 sutures and/or 1.5mm ICONN TetherTape, both made from Ultra High Molecular Weight Polyethylene (UHMWPE). The sutures/tape are supplied sterile, are packaged individually, and are single strands measuring 36/38 inches in length.

    AI/ML Overview

    The provided text is a 510(k) summary for the ICONN Revolution Knotless Suture Anchor, a medical device. It describes the device, its intended use, and comparative studies against a predicate device to establish substantial equivalence for FDA clearance. The summary does not provide information about an AI/algorithm-based device as requested in the original prompt. Therefore, I cannot extract the specific details you've asked for regarding acceptance criteria and an AI study.

    However, I can provide the available information related to the device's performance testing and acceptance criteria as described in the document, which are related to its mechanical and biocompatibility properties, not AI performance.

    Here's a breakdown of the information that is available in the provided text:

    1. A table of acceptance criteria and the reported device performance

    The document mentions performance testing but does not present a formal table of "acceptance criteria" with specific numerical targets alongside "reported device performance." Instead, it states the following regarding the outcomes of the performance tests:

    Test TypeAcceptance Criteria (Implicit)Reported Device Performance
    Pullout CharacteristicsCompliance with FDA's Draft Guidance Document for Testing Bone Anchor Devices (April 20, 1996)"performed similarly or better than the predicate or within acceptable ranges for the intended use."
    - Anchor displacement after cyclic loading(Implicitly, within limits acceptable for safe and effective use and comparable to predicate)(Met implicit criteria)
    - Ultimate anchor pull-out(Implicitly, within limits acceptable for safe and effective use and comparable to predicate)(Met implicit criteria)
    Insertion TestingCompliance with ASTM F543-2013 (specifically sections A1 and A2)"demonstrate the device can be safely implanted."
    - Torsional properties(Implicitly, within limits acceptable for safe implantation)(Met implicit criteria)
    - Driving torque(Implicitly, within limits acceptable for safe implantation)(Met implicit criteria)
    Biocompatibility TestingCompliance with ISO 10993/(R)2013"all testing met acceptance criteria."
    - Cytotoxicity(Met ISO 10993/(R)2013 acceptance criteria)(Met acceptance criteria)
    - Irritation(Met ISO 10993/(R)2013 acceptance criteria)(Met acceptance criteria)
    - Sensitization(Met ISO 10993/(R)2013 acceptance criteria)(Met acceptance criteria)
    LAL testing (Endotoxin)In accordance with ANSI/AAMI ST72:2006, result
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1