(270 days)
AirFit F30i Mask System
The AirFit F30i mask has two product variants:
· AirFit F30i mask is intended for single-patent reuse in the home environment.
• AirFit F30i SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.
AirFit F30i NM Mask System
The AirFit F30i Non Magnetic mask has two product variants:
· The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment.
· The AirFit F30i Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multipatient reprocessing and must be reprocessed if reused between patients.
Arcadia Mask System
The Arcadia has two product variants:
· Arcadia mask is intended for single-patient reuse in the home environment.
· Arcadia SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
These masks are intended for patients weighing more than 66 lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.
The AirFit F30i, AirFit F30i NM and Arcadia mask systems are full-face conduit masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or non-life supporting ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.
The AirFit F30i, AirFit F30i NM and Arcadia mask systems each have two product variants:
- . AirFit F30i Mask/ AirFit F30i NM Mask/ Arcadia Mask: This is the home use variant that is intended for single patient re-use.
- . AirFit F30i SLM/ AirFit F30i NM SLM/ Arcadia SLM (sleep lab mask): This is intended for multipatient re-use and must be reprocessed if reused between patients using the disinfection guide
The AirFit F30i, AirFit F30i NM and Arcadia mask systems are made up of the following four main component assemblies: Cushion, conduit frame, elbow and headgear. The cushion and conduit frame are available in various sizes to allow for adequate mask fit over the intended patient population.
The AirFit F30i, AirFit F30i NM and Arcadia mask systems are prescription devices supplied non-sterile.
The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in the format requested. The document is a 510(k) summary and FDA clearance letter, which outlines the device's substantial equivalence to a predicate device based on various performance and safety tests. However, it does not provide the specific "acceptance criteria" (e.g., minimum sensitivity, specificity, or accuracy thresholds) or the detailed methodology and results of a single study with the requested metrics.
Instead, the document lists several non-clinical data submitted, which include performance and safety tests in accordance with ISO standards and other bench tests. The conclusion states that "Non-clinical verification and validation assessment/testing demonstrated that AirFit F30i NM and Arcadia mask systems met all intended performance requirements." and "Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit F30i mask system (K183512)."
Therefore, I can extract the types of tests performed and the comparison to the predicate device, but I cannot fill in the table or answer all sub-questions as the specific numerical acceptance criteria and a single "study" proving it with the requested detail are not present.
Here's what can be extracted based on the provided text, with an explanation for missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative (e.g., "met all intended performance requirements") and tied to ISO standards or established performance of the predicate device. Specific numerical thresholds for acceptance are not explicitly listed in the 510(k) summary, except for some comparative parameters.
| Acceptance Criteria (General) | Reported Device Performance (as compared to predicate) |
|---|---|
| CO2 rebreathing ( |
§ 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).