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510(k) Data Aggregation

    K Number
    K251770

    Validate with FDA (Live)

    Device Name
    SleepRes PAP System
    Manufacturer
    Sleepres, Inc.
    Date Cleared
    2025-12-15

    (188 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    All
    Reference & Predicate Devices
    K241268,K200480
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K241268

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

    The SleepRes PAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lbs. (30 kg.). The SleepRes PAP system is intended for home, hospital / institutional and sleep center settings.

    Device Description

    The SleepRes PAP system consists of a firmware-controlled console, power cable and power adapter, air filter, water tank, and heated breathing tube. The PAP console is composed of a control system, motor system, and heating system. The control system includes the main board, buttons, screen, and sensor. The motor system includes the motor, fan blade, motor outer shell, and silence box. The heating system includes a heating plate and temperature sensor. The PAP console of the subject device does not include foam.

    The SleepRes PAP system also includes the following components of PAP therapy systems:

    • Water tank
    • Air filter
    • Breathing Tube

    The SleepRes PAP system offers several modes:

    • CPAP
      • Provides continuous positive airway pressure at the prescribed pressure
    • APAP
      • Functions to titrate the pressure up (and down as well) to balance reducing or eliminating sleep events while using the lowest effective pressure. Pressure limits are pre-set by the prescribing clinician.
    • Kairos Positive Airway Pressure (KPAP)
      • This algorithm reduces airway pressure during both inspiration and during most of expiration, only returning pressure to the prescribed treatment level towards the end of expiration.

    Connectivity to a Cloud platform via Wi-Fi connection.

    AI/ML Overview

    The provided FDA 510(k) clearance letter and summary for the SleepRes PAP System (K251770) offer some details about acceptance criteria and the study that proves the device meets these criteria. However, it's important to note that a 510(k) summary is a high-level overview and does not typically contain all the granular details of a full study report.

    Here's an attempt to extract and present the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The 510(k) summary broadly asserts that the device met performance and safety requirements. Specific, quantifiable acceptance criteria with corresponding performance outcomes are not explicitly listed in a detailed format within the provided document, beyond the comparison table with the predicate.

    Acceptance Criteria (Inferred from Predicate Comparison & Testing)Reported Device Performance (SleepRes PAP System)
    Pressure Range4 to 20 cmH2O
    Pressure Accuracy (Static)+/- 0.5 cmH2O
    Pressure Accuracy (Dynamic)+/- 1.0 -1.5 cmH2O from 10-20 BPM
    Flow Range10-60 lpm
    Flow Accuracy+/- 2 lpm or 10% of reading
    Operating Temperature Range5℃ to 32℃ (41˚F to 95˚F)
    Storage Temperature Range-20℃ to 55℃ (-13˚F to 158˚F)
    Atmospheric Pressure Range700 to 1060 hPa (0-3000m / 0-9880ft)
    Noise / Sound<35 dB(A) (Note: Higher than predicate's 27 dB(A), addressed by labeling mitigation)
    Therapy Algorithm Effectiveness (Comparative Sleep Studies)Substantially equivalent to predicate in disordered breathing events (AHI3a), sleep quality, and sleep architecture.
    BiocompatibilityMet ISO 10993 and ISO 18562 series requirements, including post-accelerated aging tests.
    Electrical Safety and EMCComplied with IEC 60601-1 and related collateral standards.
    Software Verification and ValidationConducted as per FDA guidances.
    Human Factors ValidationConducted as per FDA guidances.

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

    • Sample Size for Test Set: 50 OSA patients.
    • Data Provenance: The document states "Each patient underwent a full night polysomnogram." It does not specify the country of origin of the data. The study involved patients "all of whom were on standard APAP in the home," implying they were existing patients.
    • Retrospective or Prospective: Implied to be prospective for the clinical validation part, as it describes a protocol where patients "underwent a full night polysomnogram" with different treatment conditions (CPAP, APAP, and APAP + KPAP) specifically for the study.

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

    The document does not specify the number or qualifications of experts used to establish the ground truth for the test set (polysomnogram scoring). It only mentions "PSG sleep studies."

    4. Adjudication Method for the Test Set

    The document does not specify the adjudication method for the test set (PSG scoring).

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

    • Was an MRMC study done? No, an MRMC study was not explicitly described. The clinical study focused on patient outcomes comparing devices/algorithms, not on human readers' performance with or without AI assistance.
    • Effect size of human readers improvement: Not applicable, as this was not an MRMC study assessing human reader performance. The study compared the device's therapy algorithms directly through patient outcomes.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    While the clinical study evaluated the device's algorithms (APAP and KPAP) directly through patient polysomnography, it's not described as a "standalone algorithm-only" performance evaluation in the context of interpretation often seen in AI/ML applications. Rather, it evaluated the therapy delivered by the device to patients. The outcomes (AHI3a, sleep quality, sleep architecture) are direct measures of the device's therapeutic effect.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: Polysomnography (PSG) results, specifically metrics like AHI3a (Apnea-Hypopnea Index with 3% desaturation or arousal criterion), sleep quality, and measures of sleep architecture. These are clinical outcomes obtained from detailed sleep studies.

    8. The Sample Size for the Training Set

    The document does not specify the sample size for the training set. It only describes the clinical validation study's test set.

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

    Since no training set details are provided, the method for establishing its ground truth is not mentioned.

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