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510(k) Data Aggregation
(239 days)
Oran Park Mask
The Oran Park mask is intended for use in the home or hospital/institutional environment on patients weighing more than 661b (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy.
Only the Sleep Lab Mask (SLM) variant is intended and validated for multi-patient reuse and must be reprocessed if reused between patients.
The Oran Park Mask is an accessory to deliver air flow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilator support (non-life support). It delivers the treatment pressure from the source device to the patient's upper airway by providing an air seal between the PAP device and under the patient's nose and mouth.
There are 2 variants to the Oran Park Mask:
- . Oran Park Mask (Home Use) Intended for single patient re-use (SPMU) for home use. It is configured with a diffused venting port located on the elbow, known as the QuietAir elbow.
- . Oran Park SLM (Sleep Lab Mask)
Intended for multi-patient re-use (MPMU) and must be reprocessed if reused between patients. It is configured with a non-diffused venting port located on the elbow, known as the Multihole elbow.
The Oran Park mask comprises of 4 sub-assemblies: headgear, frame, cushion and elbow. The venting ports and anti-asphyxia valve are incorporated into the elbow assembly. There are four magnets incorporated in the Oran Park mask – two magnets in the frame assembly and 2 magnets in the lower headgear clips – with a magnetic field strength up to 400 mT. The mask help facilitate attaching and detaching the headgear to the mask frame when regularly fitting the mask for use. The cushion and headgear are available in various sizes to fit a wide patient population. Soft wraps, which are attached to the Oran Park mask frame, are available as an optional accessory for patient's comfort.
The Oran Park mask is a prescription device and is supplied non-sterile.
The Oran Park Mask is a medical device accessory used to deliver airflow and positive air pressure from PAP devices for the treatment of Obstructive Sleep Apnea or ventilator support. The device underwent non-clinical testing to demonstrate its performance and safety, aiming to prove substantial equivalence to the predicate device, AirFit F20 (K153563).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison table between the predicate device (AirFit F20, K153563) and the subject device (Oran Park Mask System) for various design parameters and features. The "Comments" column often indicates the acceptance criteria for the subject device by stating "Equivalent," "Identical," or referencing compliance with specific ISO standards.
| Acceptance Criteria / Design Parameter | Predicate Device Performance (AirFit F20) | Reported Device Performance (Oran Park Mask) | Evaluation / Comment |
|---|---|---|---|
| Indications for Use | Non-invasive CPAP or bi-level PAP therapy for patients > 66lb (30kg). Single-patient reuse home, multi-patient reuse hospital/institutional. | Non-invasive CPAP or bi-level PAP therapy for patients > 66lb (30kg). Home use: single-patient reuse. SLM variant: multi-patient reuse. | Equivalent |
| FDA Product Code | BZD | BZD | Identical |
| Reprocessing | Single patient re-use or multi-patient re-use | Single patient re-use (Oran Park Mask) or multi-patient re-use (Oran Park SLM) | Identical |
| Physical Dead Space (mL) | Small: 199mL, Medium: 219mL, Large: 240mL | Small: 101.1mL, Medium: 107.6mL, Large: 107.0mL | Record-only parameter (implies this value is reported, not directly compared for equivalence acceptance, but still meets a performance standard if it's within expected range for masks) |
| Leakage Flow (L/min) @ Specified Pressure (cmH2O) | 3cmH2O: 19, 4cmH2O: 22, 13cmH2O: 42, 22cmH2O: 57, 31cmH2O: 70, 40cmH2O: 82 | (No N/A for 3cmH2O), 4cmH2O: 20, 13cmH2O: 38, 22cmH2O: 51, 31cmH2O: 62, 40cmH2O: 72 | Equivalent (values are generally similar, within reasonable physiological range, and deemed acceptable) |
| Use Life | AirFit F20 (single patient, multi-use): Visual inspection. AirFit F20 (multi patient, multi-use): 30 validated reprocessing cycles. | Oran Park mask: Visual inspection. Oran Park SLM: 30 validated reprocessing cycles. | Identical |
| Operating and Storage Temperature | Operating: 5°C to 40°C, Storage: -20°C to +60°C | Operating: 5°C to 40°C, Storage: -20°C to +60°C | Identical |
| Sound Power Level & Pressure | Tested and declared in accordance with ISO4871 and ISO3744 | Tested and declared in accordance with ISO4871 and ISO3744 | Equivalent |
| Cushion Assembly Design | Seals above nose and around mouth | Seals under nose and around mouth | Equivalent (due to prior clearance of 'under the nose' design) |
| Elbow Assembly Design | Ball joint, 360-degree rotation | Short tube and swivel cuff | Equivalent (in terms of decoupling and freedom of movement) |
| Vent Design | Multi-hole Vent array in elbow assembly | Two design variants: Multi-hole Vent, QuietAir Vent | Equivalent (both verified to satisfy ISO 17510:2015 mask pressure flow and CO2 rebreathing performance) |
| AAV Design | Two Anti-Asphyxia Valves (AAV) | Single Anti-Asphyxia Valve (AAV) | Equivalent (function is same, verification testing conducted) |
| Patient Connection Port | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | Identical |
| Flow Generator Setting on ResMed Flow Generators | Full Face Mask | Pillows | Different (but intended to achieve equivalent therapy at patient's airways via appropriate pressure compensation) |
| Pressure Range | 3-40cmH2O | 4-40cmH2O | Subset of predicate device (acceptable) |
| Mask Exhaust Flow (Nominal, ISO 17510:2015 Annex B) | (Values provided at various pressures) | (Values provided at various pressures) | Equivalent (implies the reported values are within an acceptable range compared to the predicate/standard) |
| Resistance to Flow (Pressure drop across mask, ISO 17510:2015 Annex C) | 50L/min: 0.2cmH2O, 100L/min: 0.9cmH2O | 50L/min: 0.3cmH2O, 100L/min: 1.6cmH2O | The pressure drop values have been reported in accordance with ISO17510:2015. (Implies compliance with standard limits, thus acceptable). |
| CO2 Re-breathing Performance ( |
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