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510(k) Data Aggregation

    K Number
    K181845
    Device Name
    Pivot System Sterilization case
    Manufacturer
    RP Medical, Inc.
    Date Cleared
    2019-11-25

    (502 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K173615
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RP Medical Pivot System Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Pivot System surgical instruments within a healthcare facility when used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap for use in healthcare facilities in order to maintain sterility of the enclosed devices. The Pivot System Sterilization Tray System has been validated for use in the following sterilization cycles:

    Enclosure Pivot System Sterilization Tray Cycle Pre-Vacuum 132°C (270°F) Temperature Sterilization Time 4 minutes Pressure 2-15 PSIA Minimum Dry Time 30 minutes in chamber

    The maximum validated product loads for the trays in containers are as follows: 2-Level Rack, Level 2, Pivot System Sterilization Tray 39.1960.01, RP OST Tool Handle, 3 each 39.1960.02, RP OST Tool Rod, 3 each 39.1960.51.01, RP OST Tool 1D RH 16mm, 1 each 39.1960.51.02 RP OST Tool 1D RH 22mm, 1 each 39.1960.20.01 RP OST Angle 162mm, 1 each 39.1960.20.02 RP OST Angle 19mm, 1 each 39.1960.20.03 RP OST Angle 21.5mm , 1 each 39.1960.40.01 RP TM Spike Blade, 1 each 39.1960.60.01 OST Reverse Blade 11mm, 1 each 39.1960.60.02 OST Reverse Blade 16mm, 1 each 39.1960.30.01 RP OST Tool Curve 16mm, 1 each 39.1960.30.02 RP OST Tool Curve 19mm, 1 each 39.1960.30.03 RP OST Tool Curve 21.5mm, 1 each 39.1960.10.01 RP OST Straight 20mm, 1 each 39.1960.10.02 RP OST Straight 40mm, 1 each 39.1960.10.03 RP OST Straight 43mm, 1 each 39.1960.10.04 RP OST Straight 47.5mm, 1 each 39.1960.52.01, RP OST Tool 1D LH 16mm, 1 each 39.1960.52.02 RP OST Tool 1D LH 22mm, 1 each

    2-Level Rack - Level 1, Pivot System Sterilization Tray 39.1960.01, RP OST Tool Handle, 1 each 39.1960.02, RP OST Tool Rod, 1 each 39.1960.05, Retractor, 1 each 39.1960.07, RP OST System, 1 each 39.1960.70.01 RP Curved Hip Long, 1 each 39.1960.70.02 RP Curved Hip Short, 1 each 39.1960.70.03 RP Curved Hip, 1 each

    Device Description

    The RP Medical Pivot System Sterilization Tray System platform is designed to be compatible with the RP Medical Pivot Implant Extraction Osteotome surgical instruments. The Pivot System Sterilization Tray is constructed from thermoplastic plastics, aluminum and stainless steel. Each tray has evenly distributed steam holes.

    Individuals instruments were designed to slide into 2 level storage racks. The racks have handles on the side to facilitate carrying. The Pivot System Sterilization Tray has a sliding latch mechanism to facilitate containment.

    Each storage rack is set to a specific configuration and have stainless steel and silicone brackets and silkscreened artwork to assist the end user in correct placement of the instruments. The rack is designed to fit in a standard autoclave. The Pivot System Sterilization Tray System is reusable and provided in a non-sterile condition.

    AI/ML Overview

    This document is a 510(k) Pre-market Notification for the RP Medical Pivot System Sterilization Tray System. The information provided primarily focuses on demonstrating substantial equivalence to a predicate device and includes non-clinical testing results.

    Here's a breakdown of the requested information based on the provided text:

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

    Name of the Test MethodPurposeAcceptance CriteriaReported Device Performance
    Agar Overlay Method per ISO 10993-5 (Cytotoxicity)To evaluate an extract of the test article for cytotoxicity to mammalian cells in cultureTest articles scoring 0, 1 or 2 will be considered 'non-cytotoxic'.The test article scored 0 at 24, 48 and 72 +/- 4 hours and is considered non-cytotoxic.
    AAMI ST77:2013, Containment Devices for Reusable Medical Device Sterilization (Handle Weight Capacity Test)Handle Weight Capacity Test for the Sterilization CaseNo visible deformation, cracking or other evidence of damage on the Handles after testing.There was no visible deformation, cracking or other evidence of damage on the Handles after testing.
    Reliability testing for the Sterilization CaseNo significant wear after 100 sterilization cycles.Significant wear is defined as extreme discoloration, peeling and/or cracking of any component of the sterilization tray.A side by side comparison of a new vs the Sterilization Case sterilized 102 times showed a "slight yellowing of the case color and the white print within the Sterilization Case." The "discoloration was minimum and none of the printing was erased or faded so that it could not be read." There was "no peeling and/or cracking of any of the components of the sterilization case."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    The document does not explicitly state the sample sizes for the individual non-clinical tests (e.g., number of sterilization cases tested for cytotoxicity or reliability). The data provenance is not specified, but the applicant is RP Medical, Inc. from Maple Ridge, BC, Canada, suggesting the testing likely occurred in North America or at a lab collaborating with the applicant. The testing is for a new device seeking clearance, making it prospective in nature for regulatory purposes.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This is a non-clinical device submission for a sterilization tray and does not involve human expert interpretation or ground truth establishment in the way that an AI/imaging device would. The "ground truth" for these tests are objective measurements and observations against pre-defined engineering and biological safety standards (e.g., cytotoxicity score, absence of visible damage, structural integrity).

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable, as this is a non-clinical device test where results are based on objective measurement against defined criteria, not human adjudication of subjective data.

    5. 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

    Not applicable. This is a non-clinical device that is not an AI-powered diagnostic or interpretive tool, so no MRMC study was conducted.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This is a physical medical device (sterilization tray), not an algorithm or AI.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    The "ground truth" for the non-clinical tests is based on objective laboratory measurements and observations against established industry standards and internal specifications regarding:

    • Biocompatibility: Absence of cytotoxicity as per ISO 10993-5.
    • Mechanical Integrity: Absence of visible deformation or damage under specified weight (AAMI ST77:2013).
    • Durability and Wear: Absence of "significant wear" (extreme discoloration, peeling, cracking) after a specified number of sterilization cycles.

    8. The sample size for the training set

    Not applicable. This is a non-clinical device; there is no "training set" in the context of machine learning or AI.

    9. How the ground truth for the training set was established

    Not applicable, as there is no training set for this type of device.

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