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510(k) Data Aggregation

    K Number
    K112774
    Device Name
    BD RECYKLEEN SHARPS COLLECTORS
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2012-03-28

    (187 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K943134
    Predicate For
    K132476
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sharps collectors are intended to be used for the disposal of contaminated medical sharps in health care facilities.

    Device Description

    The BD Recykleen™ Sharps Collector is a single use device designed for the safe disposal of regulated medical waste such as contaminated sharps waste. All materials, including sides, bottom, and top are manufactured with polypropylene or polyolefin plastics. The basis of this new Traditional 510(k) submission is for a material change of the sharps collector. The material change, which will incorporate the use of a new resin grade of recycled plastic recovered from the hospital and healthcare facility medical sharps waste-stream. The use of post-hospital recycled resins in the manufacture of the BD Recykleen Sharps Collectors has been demonstrated to be safe and effective. BD has developed the BD ecoFinity™ Life Cycle Solution, which is a program for recycling clinically used hospital-generated medical sharps waste. The basics of this new recycling program are that plastics, recovered from recycling post-hopital sharps waste, are utilized to manufacture new sharps collectors rather than being treated and disposed in landfills or incinerated. After sanitization, the treated sharps waste is separated into metal, light plastics, and other materials. The light plastics are recovered, extruded and pellitized into a final resin pellet form. The recycled resin pellets are then injection molded into components that make up the finished BD Recykleen™ Sharps Collectors.

    AI/ML Overview

    The provided text describes the BD Recykleen™ Sharps Collector, a single-use device designed for the safe disposal of regulated medical waste. The primary change in this 510(k) submission is the incorporation of a new resin grade of recycled plastic from the hospital and healthcare facility medical sharps waste-stream. The manufacturer, BD Medical Surgical Systems, asserts that the new device is substantially equivalent to the legally marketed BD Guardian™ Sharps Collector (K943134).

    Here's a breakdown of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaTest Standard/MethodPass/Fail CriteriaReported Device Performance
    Puncture ResistanceASTM F2132-01 (2008), "Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps".No single needle puncture force less than 2.8 lbf. Average puncture force of 3.4 lbf.Met: Individual NPR regression analyses of wall thickness versus needle puncture force were completed for each of the following: 100% recycled resin grades (PH, PI, and PC); virgin and recycled resin blends. Each resin material is characterized to have a unique minimum wall thickness to meet ASTM F 2132-01 (page 6).
    Impact ResistanceDrop test (39" from base onto hard surface floor) with a filled collector (assorted sharps/syringes or equivalent weight with resin beads).No gross fractures (external wall of container open enough to allow escape of solid contents) or loss of contents. Stress fractures permitted.Met: The results of product performance testing demonstrated equivalent performance to the predicate device performance (page 6).
    Leak ResistanceOSHA Specification (29 CFR 1910.1030) - container filled with water to labeled fill line and left to stand for 1 hour.No leaks observed with product standing in upright position.Met: The results of product performance testing demonstrated equivalent performance to the predicate device performance (page 6).
    Transit Damage ResistanceShipping case with appropriate number of products dropped from 24" onto a hard surface floor in 10 different orientations.Product free from any visible damage that may affect customer usage, safety, or satisfaction with a 90% pass rate.Met: The results of product performance testing demonstrated equivalent performance to the predicate device performance (page 6).
    BiocompatibilityISO 10993 (Cell Toxicity, Murine Local Lymph Node Assay, Primary Dermal Irritation)PassedPassed: For both Principle Device (recycled resins) and Predicate Device (virgin PP) (Table 6, page 7).
    Bioburden (Resin Pellets)ISO 11737-1-Met: (PI,PC,PH):
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