(265 days)
AirFit F20 Mask System:
The AirFit F20 mask has two product variants:
- AirFit F20 mask is intended for single-patent reuse in the home environment.
- AirFit F20 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 F20 NM Mask System:
The AirFit F20 Non Magnetic mask has two product variants:
- The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment.
- The AirFit F20 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 multi-patient reprocessing and must be reprocessed if reused between patients.
The AirFit F20 and AirFit F20 NM Mask Systems are both full-face masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices. CPAP & Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or 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 F20 mask system has two product variants:
- AirFit F20 Mask: This is the home use variant that is intended for single patient re-use.
- AirFit F20 SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.
AirFit F20 (K170924) had a "For Her" variant which was cleared with aesthetic colour pops, the AirFit F20 Mask and AirFit F20 SLM also have the same "For Her" variant.
The AirFit F20 NM mask system has two product variants:
- AirFit F20 NM Mask: This is the home use variant that is intended for single patient re-use.
- AirFit F20 NM SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.
The AirFit F20 and AirFit F20 NM Mask Systems share a common design architecture as the predicate AirFit F20 (K170924), except that the AirFit F20 NM Mask System has non-magnetic clips.
The AirFit F20 and AirFit F20 NM mask systems are made up of the following four main component assemblies: cushion, elbow, frame, and headgear. The cushion and headgear are available in various sizes to allow for adequate mask fit over the intended patient population.
The AirFit F20 and AirFit F20 NM mask systems are prescription devices supplied non-sterile.
The provided FDA 510(k) clearance letter and associated summary pertain to the AirFit F20 Mask Systems, which are non-continuous ventilators (CPAP/Bi-Level masks). This type of device does not typically involve complex diagnostic algorithms or AI components that would necessitate the study structure outlined in your request (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance for AI).
Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (AirFit F20, K170924) through non-clinical performance and safety testing, adherence to recognized standards, and biocompatibility evaluations.
Therefore, many of the specific questions you've asked cannot be directly answered from this document as they are not relevant to the type of device and clearance process involved.
Here's an attempt to extract the relevant information and address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a format typically used for diagnostic algorithm validation. Instead, it compares specific design parameters and performance characteristics of the new devices (AirFit F20 Mask System and AirFit F20 NM Mask System) against the predicate device (AirFit F20, K170924). The "Comments" column often indicates that the performance is "Equivalent" or "Identical," implying that the new devices meet or perform similarly to the established safety and performance profile of the predicate, which serves as the de facto acceptance benchmark.
Here's a summary derived from the comparison table (Pages 9-12 of the provided document):
| Design parameter or feature | Predicate device: AirFit F20, K170924 (Performance/Criteria based on predicate) | Modified device: AirFit F20 Mask System (Reported Performance) | Modified device: AirFit F20 NM Mask System (Reported Performance) | Acceptance Criteria (Implied) |
|---|---|---|---|---|
| Indications for Use | Specified for CPAP/bi-level, >66lb (30kg), single-patient home, multi-patient hospital use. | Equivalent to predicate, with variants for home/sleep lab use. | Equivalent to predicate, with variants for home/sleep lab use. | Equivalent to predicate |
| Intended Use | Interface for CPAP/bi-level devices. | Identical | Identical | Identical to predicate |
| FDA Product Code | BZD | BZD | BZD | Identical to predicate |
| Patient population | Weighing more than 66 lb (30 kg) | Patients weighing more than 66lb (30kg) | Patients weighing more than 66lb (30kg) | Identical to predicate |
| Environment of Use | Home or health institution | Home or health institution | Home or health institution | Identical to predicate |
| Reprocessing claims | Single patient re-use or multi-patient re-use. | Identical | Identical | Identical to predicate |
| Sterility state as provided | Non-sterile | Non-sterile | Non-sterile | Identical to predicate |
| Validated reprocessing methods | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | Identical to predicate |
| Vent type | Multi-hole vent | Multi-hole vent and diffuser vent | Multi-hole vent and diffuser vent | Equivalent to predicate's safety/efficacy profile |
| PAP tubing connection point | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | Identical to predicate |
| Construction material | Polymeric, Textile, magnets | Polymeric, Textile, magnets | Polymeric, Textile | Equivalent to predicate's safety/efficacy profile (NM variant removes magnets) |
| Operating pressure range (cmH2O) | 3 - 40 | 3 – 40 | 3 – 40 | Identical to predicate |
| Sizes | Cushion (3), Headgear (3), Frame (1) | Identical | Identical | Identical to predicate |
| Mask exhaust flow (Nominal) ISO 17510:2015 Annex B | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 20.1, 55.5, 82.4 | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 19, 54, 82 | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 19, 54, 82 | Equivalent to predicate (minor differences within acceptable range for substantial equivalence) |
| CO2 rebreathing performance (normal condition) ISO 17510:2015 Annex F | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: 14.8%, 7.5%, 6.8% SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Equivalent ( Relative CO2 increase Non-SLM: 32.3%, 39.5% SLM: 40.5%, 52.7% |
§ 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).