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510(k) Data Aggregation

    K Number
    K151683
    Device Name
    SleepWeaver Advance Pediatric Nasal CPAP Mask
    Manufacturer
    Circadiance, LLC
    Date Cleared
    2016-04-05

    (288 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K092362,K120757,K130481,K102224
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K092362, K120757, K130481

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

    The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.

    Device Description

    The SleepWeaver Advance Pediatric Nasal CPAP Mask serves as a mechanism for connecting a pediatric patient between 2 and 7 years of age for whom PAP therapy has been prescribed to maintain an open airway. The nasal mask is placed over a patient's nose and held in place by use of an adjustable elastic headgear. A cloth cushion contacts the patient's face. The mask assembly has a tubing swivel connector which is compatible with the industry standard 22 mm air tubing. Air is supplied to the mask by a therapy device. The patient inhales air from the mask and exhales into the mask where continuous airflow from the therapy device purges the exhaled carbon dioxide from the mask through the mask exhalation holes. The SleepWeaver Advance Pediatric Nasal CPAP Mask can be used in the home environment (single-patient use) or the hospital/institutional environment (single-patient use). The mask features a cloth cushion made of a blue polyester fabric with a polyester / nylon / lycra / polyurethane interface material. The mask exhalation feature is incorporated into the cloth cushion. Attached to the cushion is a 22-mm tubing swivel connector that can rotate 360°. The tubing connector can be removed by unwrapping the white medical tape for cleaning and cushion replacement. The cloth headgear is connected to the mask through slots in the cushion wings. The headgear is removable for cleaning and replacement. The SleepWeaver Advance Pediatric Nasal CPAP Mask product also offers an optional accessory: the Feather Weight tube. The optional SleepWeaver FeatherWeight tube may be used with this mask, but it remains outside the scope of this submission as it has been previously cleared by its inclusion in K120757. The Feather Weight tube is an 18" plastic extension tube compliant to ISO 5356-1 and ISO 5367 that connects between the SleepWeaver Advance Pediatric Nasal CPAP Mask and standard CPAP tubing.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called the "SleepWeaver Advance Pediatric Nasal CPAP Mask." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where an AI-driven device's performance is compared against human readers or specific acceptance criteria for AI output.

    Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, stand-alone performance, training set sample size, how ground truth for training set was established) are not applicable to this type of submission. The device described is a physical medical device (a CPAP mask), not an AI/ML-driven software device.

    However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Testing Summary" and "Technological Characteristics" sections, as these effectively serve as the performance evaluation for this type of device.

    Acceptance Criteria and Reported Device Performance

    Device: SleepWeaver Advance Pediatric Nasal CPAP Mask (K151683)
    Predicate Device: ResMed Ltd., Pixi Pediatric Mask (K102224)

    Acceptance Criteria / Performance MetricPredicate Device (ResMed Pixi Pediatric Mask) PerformanceSleepWeaver Advance Pediatric Nasal CPAP Mask PerformanceEquivalence Narrative / Compliance
    Intended UseTo provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy for patients between 2 and 7 years of age. Single-patient re-use in home/hospital environment.To provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy for patients between 2 and 7 years of age. Single-patient use in home/hospital environment.Same.
    Patient PopulationPediatric patients between 2 and 7 years of age.Pediatric patients between 2 and 7 years of age.Same.
    Therapy Pressure Range3 to 20 cm H2O4 - 20 cm H2OProposed device range is within predicate range.
    Sizing1 size1 sizeBoth sized to accommodate intended population.
    Physical Dead Space101.7 mL130 mLHigher than predicate, but performance testing (CO2 rebreathing tests under ISO 17510-2) confirms no CO2 build-up due to exhalation holes.
    Resistance (Pressure Drop)0.8 cm H2O at 50 L/min; 3.1 cm H2O at 100 L/min0.4 cm H2O at 50 L/min; 1.0 cm H2O at 100 L/minLower than predicate, which is considered preferential.
    Carbon Dioxide Washout ProfileNot available (Predicate)Amount of CO2 being rebreathed
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