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510(k) Data Aggregation

    K Number
    K012982
    Date Cleared
    2001-10-02

    (27 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K003781, K010316

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

    The CoolTouch VariZoom Variable Spot Size Reusable Fiber Optic Handpiece is indicated as an accessory for use with the CoolTouch "Varia" Nd:YAG Laser System, which has been cleared for the following indications: Hair removal (destruction of hair follicles) in all skin types and for soft tissue hemostasis of vascular lesions. For pigmented lesions appropriate for 1 or more treatments that would potentially benefit from aggressive to reduce lesion size, for patients that have not responded to other laser treatments.

    Device Description

    The fiber optic handpiece used with the CoolTouch Varia laser system has had a fixed spot size. The user selects a 4mm, 6mm, or 8mm spot size, depending on the application. The VariZoom handpiece combines the various spot size handpieces into one, allowing the user to dial the desired spot size instead of changing handpieces. The VariZoom handpiece has the same coolant capability and incorporates a sensor to alert the user that the coolant is depleted.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device, the CoolTouch "VariZoom" Variable Spot Size Reusable Fiber Optic Handpiece. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than extensive de novo clinical studies with acceptance criteria.

    Therefore, the information regarding acceptance criteria, study details, and performance metrics as typically found in a clinical trial report with specific quantitative outcomes is not present in this document. The submission focuses on comparing the new device's specifications and intended use to a previously cleared predicate device.

    Here's an analysis based on the information provided, highlighting the absence of typical clinical study data:

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

    The document does not provide a table of acceptance criteria or reported device performance in the manner of a clinical study with quantitative outcomes. The "performance" is implicitly demonstrated through the comparison of specifications to the predicate device.

    SpecificationCoolTouch "Varia" Fixed Spot Size Fiber Optic Handpiece (Predicate)CoolTouch "VariZoom" Variable Spot Size Fiber Optic Handpiece (New Device Performance)Acceptance Criteria (Implicit)
    Wavelength1064 nmSame (1064 nm)Maintain predicate's wavelength
    Dimensions20cm x 5cm x 10cm (LxDxH)Same (20cm x 5cm x 10cm)Maintain predicate's dimensions
    Weight2 lbs.Same (2 lbs.)Maintain predicate's weight
    CoolingDynamic cooling using a solenoid valve and self-contained coolantSameMaintain predicate's cooling method
    CompatibilityCoolTouch Varia Nd:YAG Laser SystemSameMaintain compatibility with predicate laser system
    Laser Spot Size4, 6, 8mm (fixed)Variable, 3mm to 10mm (variable)Provide variable spot size within a reasonable and safe range, and encompass predicate's sizes
    IndicationsNumerous (same as predicate laser system)Same (as predicate laser system)Maintain predicate's indications for use

    2. Sample size used for the test set and the data provenance

    No test set data from actual device usage is presented. The submission relies on comparison to a predicate device's established performance and specifications. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a test set is not applicable.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. There was no test set requiring expert ground truthing as this was primarily a technical and functional equivalence submission.

    4. Adjudication method for the test set

    Not applicable. No test set requiring adjudication was performed.

    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 device is a fiber optic handpiece for a laser system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are not relevant.

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

    Not applicable. This is a hardware device, not an algorithm.

    7. The type of ground truth used

    The "ground truth" equivalent in this submission is the established safety and effectiveness profile of the predicate device, the CoolTouch "Varia" Nd:YAG Laser System and its fixed spot size handpieces, as cleared by previous 510(k) submissions. The new device is deemed substantially equivalent based on its similar design, materials, and intended use as an accessory, with the primary difference being a variable spot size mechanism.

    8. The sample size for the training set

    Not applicable. This is not a machine learning device or algorithm that requires a training set.

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

    Not applicable. No training set was used.

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