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510(k) Data Aggregation

    K Number
    K220760
    Device Name
    Pre-Formed Penile Silicone Block
    Manufacturer
    International Medical Devices, Inc.
    Date Cleared
    2022-05-13

    (59 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K181387
    Why did this record match?
    Reference Devices :

    K181387

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

    The Pre-Formed Penile Silicone Block is intended for use in augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. When used in augmentation procedures, the device provides cosmetic augmentation of the penis and is intended for aesthetic purposes.

    Device Description

    The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in visual augmentation, reconstructive and cosmetic surgery for the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.

    AI/ML Overview

    The device in question is the Pre-Formed Penile Silicone Block.

    Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria in a quantitative format for the clinical study. Instead, it describes observed outcomes and improvements. Based on the "Clinical effectiveness" section, we can infer the measures of performance.

    Performance Metric (Implied Acceptance Criteria)Reported Device Performance (Achieved)
    Penile Circumference IncreaseIncreased from 8.5 ± 1.2 cm to 13.4 ± 1.9 cm (56.7% increase, P
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