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K Number
K150111
Device Name
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
Manufacturer
APEX MEDICAL CORP.
Date Cleared
2015-09-15

(238 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
K141522
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.

Device Description

The modified iCH CPAP with PVA 9S-007XXX Series is a modification of predicate iCH CPAP with PVA 9S-007XXX (K141522). It changed the material of impeller as well as PCB layout compare to the predicate device. A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the iCH CPAP with PVA 9S-007XXX Series. This is a modified version of a previously cleared predicate device (K141522). The document focuses on demonstrating substantial equivalence to the predicate device, rather than proving the device meets acceptance criteria in the sense of a clinical performance study with specific metrics like sensitivity or specificity.

Instead, the "acceptance criteria" here are defined by compliance with recognized standards and successful performance of a suite of engineering and functional tests designed to show that the modified device performs as safely and effectively as the predicate. The study described is a design verification and comparison study against a predicate device.

Here's a breakdown based on your request, interpreting "acceptance criteria" as the performance benchmarks and regulatory compliance targets set by the referenced standards and the comparison with the predicate device.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it establishes acceptance by demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.

The "acceptance criteria" implicitly include:

  • Compliance with various safety, EMC, and performance standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 17510-1, ISO 8185).
  • Demonstration that changes (impeller material, PCB layout) do not negatively impact the device's safety or effectiveness compared to the predicate.
  • Successful completion of design verification tests, including (but not limited to):
    • Safety and EMC tests
    • Firmware Validation
    • Noise Test
    • Performance Tests (Pressure Long-term Stability, Dynamic Pressure Stability, Static Pressure Stability, Maximum Temperature, Maximum Flow, Limitation of Maximum Pressure, Overflow Test, Expected Useful Life Validation)
    • Humidification Performance
    • PVA Function Comparison Test (Endurance Operation, Dynamic Testing, APAP Auto titration & AHI Test, PVA Waveform comparison, PVA feature handling disordered breathing, PVA Waveform upper and lower pressure control, PVA Pressure Average and Tolerance Error, Performance Characteristics of PVA Comparison)
    • Biocompatibility Assessment
    • Particle Test
    • VOC Test

The reported device performance is that the "modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards" and the "above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522)."

No specific numerical performance metrics (e.g., accuracy percentages, error rates) are provided in this summary, as the focus is on equivalence and compliance, not novel clinical performance claims.

Study Details

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

    • Acceptance Criteria (Implicitly from Standards & Predicate Comparison):
      • Safety and EMC compliance (ANSI/AAMI ES60601-1, IEC 60601-1-2)
      • Firmware validation according to FDA guidance.
      • Noise levels within acceptable limits (ISO 11201, ISO 7779).
      • Performance (pressure stability, flow, temperature, maximum pressure limitation) meets ISO 17510-1.
      • Humidification performance meets ISO 8185.
      • PVA function comparable to predicate (Endurance, Dynamic, APAP Auto titration & AHI, Waveform, disordered breathing handling, pressure control, average/tolerance error, performance characteristics).
      • Biocompatibility (ISO 10993 series).
      • Particle and VOC emissions meet US EPA standards.
      • Overall substantial equivalence to predicate device (K141522) in terms of intended use, operating principle, technology, and manufacturing process.
    • Reported Device Performance:
      • "The modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards..."
      • "...the above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522)."
      • Specific comparative details were provided (e.g., intended user, air outlet, user, operating environment, pressure range, increment, ramp time, pressure/altitude compensate, APAP mode, PVA, alarm system) showing equivalence.

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

    • The document does not specify sample sizes in terms of patient data or clinical cases. This is primarily an engineering and performance verification study, likely using a limited number of device units for testing against established standards and the predicate.
    • The data provenance is not explicitly mentioned as a clinical study with patients; rather, it refers to laboratory testing and design verification.

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

    • Not applicable in the context of this engineering and predicate comparison study. "Ground truth" here is defined by compliance with recognized standards and the performance of the predicate device. The experts involved would be engineers and technical specialists conducting the tests, not clinical adjudicators establishing a diagnostic ground truth from patient data.

  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

    • Not applicable. This is not a clinical study involving human interpretation of results requiring adjudication. Performance is assessed against quantitative engineering specifications and comparative data to the predicate.

  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 CPAP machine, not an AI-powered diagnostic tool. No MRMC studies were conducted.

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

    • This is a standalone medical device (CPAP machine) but not an "algorithm only" device in the context of AI/ML. Its performance is measured directly through engineering tests.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • The "ground truth" for this submission is implicitly established by:
      • Recognized International and National Standards: e.g., ISO 17510-1 for sleep apnea breathing therapy equipment, ISO 8185 for humidifiers, ISO 10993 series for biocompatibility, etc.
      • The Performance of the Predicate Device: The modified device's performance is compared directly to its legally marketed predecessor (K141522) to demonstrate substantial equivalence.

  8. The sample size for the training set

    • Not applicable. This is not a machine learning or AI device that requires a "training set."

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

    • Not applicable, as there is no training set for this type of device submission.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).