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510(k) Data Aggregation

    K Number
    K992384
    Device Name
    CPAP/PRO CPAP INTERFACE
    Manufacturer
    STEVENSON INDUSTRIES, INC.
    Date Cleared
    1999-12-01

    (138 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CPAP/PRO CPAP INTERFACE

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

    The CPAP/PRO® CPAP Interface is intended to treat adult obstructive sleep apnea(OSA).

    Device Description

    The CPAP/PRO® CPAP Interface consists of a boil & bite type dental appliance or a bracket, which may be professionally fitted to a custom dental appliance. With either mouth appliance, a small bracket extends beyond the lips to attach to a pair of corrugated nasal tubes. The paired nasal tubes are made from corrugated polyethylene and are pressure tested. The paired tubes combine to form a "Y", The lower arm of which attaches to a CPAP machine using a fitting connected to standard respirator tubing. The upper arms of the "Y" shaped nasel tubes terminate in soft silicone nasal inserts. The inserts provide a soft, comfortable seal against the nostrils.

    The CPAP/PRO® consists of the following major components:

    1. Boil & bite molded dental appliance with integral tubing clamp.
    2. CPAP/PRO® tubing clamp for use with professionally fitted dental appliance.
    3. Polycarbonate dual lumen respiratory tubing connector.
    4. Corrugated 15mm (nominal diameter) polyethylene tubing with 1/8m " vent holes.
    5. Silicone elastomer nasal inserts.
    6. Dual lumen (polycarbonate) tubing/appliance bracket .
    AI/ML Overview

    The provided document, K992384, is a 510(k) Premarket Notification for the CPAP/PRO® CPAP Interface. It details the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

    Here's an analysis of the acceptance criteria and the study as per your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implicit)Reported Device Performance (Summary from Section 7)
    Functional equivalence in terms of airflow to predicate devices.Comparative testing demonstrated that, in terms of airflow, the CPAP/PRO® is the functional equivalent of "SoftNair™ by Vital Signs, Inc." and "Adam CPAP Circuit by Nellcor Puritan-Bennett."
    Functional equivalence in terms of dead-space to predicate devices.Comparative testing demonstrated that, in terms of dead-space, the CPAP/PRO® is the functional equivalent of "SoftNair™ by Vital Signs, Inc." and "Adam CPAP Circuit by Nellcor Puritan-Bennett."
    Materials are safe and suitable for intended use.Implied by the declaration in Section 10: "Based on the materials...the CPAP/PRO unit is equivalent to the referenced legally marketed comparison devices." (No specific criteria outlined, but general safety/suitability is a core regulatory requirement)
    Design is safe and effective for intended use.Implied by the declaration in Section 10: "Based on the...design...the CPAP/PRO unit is equivalent to the referenced legally marketed comparison devices." (No specific criteria outlined)
    Intended use (treatment of adult obstructive sleep apnea (OSA)) is met.Indication for Use: "The CPAP/PRO® CPAP Interface is intended to treat adult obstructive sleep apnea(OSA)." The FDA's substantial equivalence finding supports this.

    Important Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria. The acceptance criteria are therefore inferred from regulatory requirements for a 510(k) submission, which hinge on similarity to already approved devices.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify a sample size for any "test set" in the context of clinical trials or performance evaluations with human subjects. The comparative testing mentioned in Section 7 (airflow and dead-space) likely refers to bench testing or engineering testing comparing the physical properties of the CPAP/PRO® with the predicate devices.

    • Sample Size for Test Set: Not specified, and likely not applicable in the sense of human subject clinical data.
    • Data Provenance: Not specified, but given the nature of the comparative testing, it would be laboratory-based rather than from a specific country or clinical setting. It is not labelled as retrospective or prospective.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not provided in the document. The "ground truth" for the comparative testing (airflow and dead-space) would be based on established engineering or physiological standards and measurement techniques, not typically "expert consensus" in the clinical sense.

    4. Adjudication Method for the Test Set

    This information is not provided and is not applicable given the type of testing described (bench/engineering comparison). Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or image interpretation studies to resolve discrepancies among expert readers.

    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

    A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done, nor is it applicable to this device. This device is a physical CPAP interface, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no mention of human readers improving with or without "AI assistance" and no "effect size" information.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

    A standalone performance study was not done in the context of an algorithm. The device is a physical medical device, not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for the comparative testing (airflow and dead-space) would be based on objective physical measurements using scientific instruments and established protocols, comparing the CPAP/PRO® against the known performance characteristics of the predicate devices. It is not based on expert consensus, pathology, or outcomes data.

    8. The Sample Size for the Training Set

    This information is not applicable to this device. "Training set" typically refers to data used to train machine learning models, which are not involved here.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable to this device as there is no training set for a machine learning model.

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