(85 days)
The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.
The K Series CPAP systems are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems has 2 commercially available models, Curasa CPAP and Floton CPAP (K120285). This special 510(k) adds the Curasa CPAP SD model to the currently commercially available selection of models. The K series CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier, which works with all the K Series CPAP Systems, provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. Each K Series CPAP system also includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. The Curasa CPAP SD has similar electronic design and software as the Curasa CPAP, except for the addition of a SD card interface and associated software driver. The Curasa CPAP SD can store/read CPAP patient compliance data onto a SD card where it can be viewed by an external PC.
Here's a breakdown of the acceptance criteria and study information for the Curasa CPAP SD device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present specific quantitative acceptance criteria with corresponding performance metrics for the new SD card functionality. Instead, it relies on demonstrating that the new model (Curasa CPAP SD) is substantially equivalent to the predicate device (Curasa CPAP) and passes various design verification tests. The acceptance is implied by these tests passing.
| Acceptance Criteria (Measured against Predicate) | Reported Device Performance (Curasa CPAP SD) |
|---|---|
| Functional Equivalence | |
| Same intended use | Same |
| Same operating principle | Same |
| Same technology | Same |
| Same manufacturing process | Same |
| Software (with SD card driver addition) | Same (with SD card driver addition) |
| Hardware Components (with SD card board addition) | Same (with SD card board addition) |
| Humidifier | Same |
| User Interface | Same |
| Labeling (with SD card handling addition) | Same (with SD card handling addition) |
| Packaging | Same |
| Physical Equivalence | |
| Device Size (cm) | Similar (17 x 11.8 x 9.7 vs. 17 x 11.7 x 9.3) |
| Weight (kg) | Same (1.4 kg) |
| Performance Standards Compliance | |
| EN 60601-1-1:1995 + A1:1993 + A2:1995 | Compliant |
| EN 60601-1-2:2001 | Compliant |
| EN ISO 8185:2007 | Compliant |
| EN ISO 17510:2007 | Compliant |
| IEC-60601-1 | Same |
| IEC-60601-2 | Same |
| ISO 17510-1 | Same |
| Pressure Range (cm H2O) | Same (4-20) |
| Pressure Stability (cm H2O) | Same (4-20 cm H2O +/- 2.0 cm H2O) |
| Maximum Flow (LPM) | Same (35 LPM) |
| Design Verification Tests | |
| Pressure Testing | Pass |
| System and User Interface Testing | Pass |
| IFU Verification Testing | Pass |
| ESD / EMC / EMI | Pass |
| Safety Testing (IPX1 / ESD) | Pass |
| Software Verification Testing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data for the new device. The testing focuses on compliance with standards and design verification for the modifications. There's no mention of a patient-based test set or its provenance (country of origin, retrospective/prospective). The tests referenced are primarily engineering and performance verification tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The study is not a clinical study involving experts establishing ground truth for patient outcomes or diagnoses. The "ground truth" for the engineering tests would be the established specifications and standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is not a study requiring expert consensus on subjective interpretations.
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 with an added SD card for data storage, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device's primary function is to deliver CPAP therapy, and the SD card functionality is for data storage, not a standalone algorithm performing diagnostic or predictive tasks.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the engineering and performance tests, the ground truth would be defined by the established technical specifications, recognized industry standards (e.g., EN ISO 17510), and the performance of the predicate device. For example, "Pressure Stability" is compared against "4-20 cm H2O +/- 2.0 cm H20 ISO17510 compliant," indicating the ISO standard sets the ground truth.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device that requires a training set. The changes are hardware and software modifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).