(173 days)
The CURVE™ Positive Airway Pressure System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).
The CURVE™ Positive Airway System is comprised of five components: a Nasal Pillow, Headgear, Valve, Hose, and Flow Generator.
The CURVE™ System Airbox is a flow generator that provides airflow and pressure to the mask and delivers therapeutic pressure to the patient's airway during disordered breathing. The valve allows positive airway pressure to be generated during expiration but at the same time it (1) reduces the airflow required to provide positive airway pressure during inspiration and expiration, and (2) utilizes the patient's own breathing effort during both normal inspiration and expiration. During disordered breathing events, such as apnea or hypopnea, the valve opens to allow positive airway pressure to be provided to the patient directly from the flow generator. In addition, the valve is designed to channel excess airflow directly into the room, thereby minimizing spikes in pressure and preventing carbon dioxide rebreathing from the hose.
The CURVE™ System patient interface consists of a nasal pillow mask, headgear and a hose. The nasal pillow mask includes the valve and the mask is held in contact with the patient's nares via the headgear. The nasal pillow mask is available in three sizes (small. medium and large). The hose connects the flow generator to the valve in the mask to deliver air from the flow generator to the mask.
The CURVE™ System is designed to have pressurized air from the flow generator always available to provide airway support. During treatment, the flow generator is never "off" or paused. Pressurized air is always being delivered through the hose to the valve, and flows into the mask whenever there is a drop in pressure or flow rate.
The CURVE™ System flow generator can only be used with the CURVE™ System patient interface and vice versa. The size and configuration of the Curve System hose and flow generator connectors are designed to prevent connection to a standard Continuous Positive Airway Pressure (CPAP) hose, mask or flow generator.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The provided document outlines various criteria, primarily focusing on safety, biocompatibility, and performance, with a specific clinical non-inferiority endpoint.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | External Communicating Components (Permanent Duration): Cytotoxicity, Sensitization, Intracutaneous reactivity, Extractables and leachables testing with risk assessment. Dry Gas Contacting Components: Total VOCs 10 L/minute at various generator settings. Max Expiratory Pressure: Pressure drop into mask ≤ 2 cm H2O greater than generator pressure. Inhalation Pressure: Pressure drop into mask ≥ -1.0 cm H2O at 25 L/minute. Intra-Mask Static Pressure: Therapeutic pressure provided. Air Bolus Testing: No impact on specifications for generator/mask pressures, airflow, exhaust pressure, inspiratory resistance. Packaging Testing: No impact on specifications after simulated shipping challenges. Use Life Testing: Meets performance specs for up to 90 days after 712,800 breathing cycles and 100 cleaning cycles. Max Limited Pressure: Normal conditions: max pressure output ≤ 20 cm H2O; Simulated fault: max pressure output ≤ 30 cm H2O. Waveform Testing: Equivalent pressure/flow responses between clinical and final device configurations across simulated breathing conditions (normal, hypopnea, apnea). | All specified bench tests passed. Specific quantitative results provided for acoustics (≤30dB), CO2 rebreathing (normal: ≤20%, fault: ≤60%), system flow rate (>10 L/min), max expiratory pressure (≤2 cm H2O drop), inhalation pressure (≥ -1.0 cm H2O drop), max limited pressure (normal: ≤20 cm H2O, fault: ≤30 cm H2O). Use life testing validated 90-day use. Waveform testing demonstrated equivalence for 4 simulated patients at various settings and conditions. |
| Clinical Efficacy (Non-Inferiority) | Co-Primary Efficacy Assessments: AHI and ODI. Non-Inferiority Margin: Difference |
§ 868.5273 Positive airway pressure delivery system.
(a)
Identification. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes.
(ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device.
(iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use.
(iv) Carbon dioxide rebreathing testing must be performed.
(v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed.
(vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.
(vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed.
(viii) Maximum output temperature testing of delivered gas, if humidified, must be performed.
(3) Performance data must validate reprocessing instructions for any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Therapy pressure range;
(ii) Use life and replacement schedule for all components;
(iii) Cleaning instructions; and
(iv) Instructions for assembly and connection of device components.