(42 days)
The SleepWeaver élan Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy. The SleepWeaver élan Nasal CPAP Mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 Ibs (30 kg).
The SleepWeaver élan Nasal CPAP Mask serves as a mechanism for reliably connecting a patient > 66 lbs (30 kg) diagnosed with sleep apnea to a source of continuous or bi-level positive air pressure needed to maintain an open airway. The nasal mask is placed over a patient's nose and held in place by use of an adjustable elastic headgear. A cloth cushion contacts the patient's face. The mask assembly has an L-shaped tubing swivel connector which is compatible with the industry standard 22 mm air tubing. Air is supplied to the mask by a CPAP device (which can be standard CPAP or a bi-level device). The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask exhalation holes. The SleepWeaver élan can be used in the home environment (single-patient, multi-use) or the institutional environment (multi-patient, multi-use). Cleaning instructions are provided for each environment. Home use calls for washing with warm water and a mild non-abrasive soap. The institutional environment calls for cleaning a validated cleaning agent and a high-level disinfecting agent/process. The mask features a cloth cushion made of polyester fabric with a polyester/lycra/nylon interface material. The mask exhalation feature is incorporated into the cloth cushion. Attached to the cushion is an L-shaped 22-mm tubing swivel connector that can rotate 360°. The tubing connector can be detached by unscrewing the nut off the threaded connector for ease of cleaning and cushion replacement. The cloth headgear is connected to the mask through slots in the cushion wings. The headgear is removable for ease of cleaning and replacement. The SleepWeaver élan Nasal CPAP Mask also offers two optional accessories, the Feather Weight tube and the tether strap. The Feather Weight tube is an 18" plastic home-use only extension tube to improve flexibility at the mask connection point. The tether strap, when used, keeps the tubing from resting on the patient's head while he/she sleeps.
The SleepWeaver élan Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy for patients weighing over 66 lbs (30 kg). It is designed for single-patient reuse in the home and multi-patient, multi-use in hospital/institutional environments.
1. Acceptance Criteria and Reported Device Performance
The submission states that Design Verification tests were performed, and the device meets the safety and effectiveness requirements. However, specific numerical acceptance criteria and reported device performance values are generally detailed in the accompanying testing reports which are not provided in this extract. The table below outlines the performance characteristics mentioned in the "Substantial Equivalency Matrix" and implies that the performance must be comparable to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Implied) |
|---|---|---|
| Pressure drop | Positive pressure delivered to patient airway within +/-5 cm H2O of inspiratory pressure setting on CPAP machine up to 20 cm H20. Includes expiratory resistance. | Device meets this criterion. |
| Expiratory resistance | Pressure drop at patient connection port no greater than 5 cm H2O at a flow of 50 L/min. | Device meets this criterion. |
| Fixed leakage | Flow rate of the exhalation port at 5 and 20 cm H20 (comparable to predicate). | Device meets this criterion. |
| Inadvertent leak | Mask inadvertent leak should be less than 20 l/min at a pressure of 20 cmH2O. | Device meets this criterion. |
| Device Interface | Waveform testing on Bi-level machines shall include basic waveform data (comparable to predicate). | Device meets this criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission refers to "Design Verification tests" being performed, but details regarding these tests, including the size and nature of the test set, are not included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing appears to be primarily engineering performance testing rather than clinical or expert-reviewed ground truth assessment.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method, as the tests mentioned are primarily performance-based engineering assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device through design verification and material changes, not on comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
This device is a physical CPAP mask, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned. The "performance" assessment refers to engineering specifications like pressure drop and leakage.
7. Type of Ground Truth Used
The ground truth for the performance criteria appears to be based on engineering specifications, industry standards (e.g., ISO 5367, ISO 5356-1), and comparison to the predicate device's established performance ranges. For biocompatibility, the ground truth is established by adherence to ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation tests).
8. Sample Size for the Training Set
As this device is a physical product and not an AI/machine learning algorithm, the concept of a "training set" is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
Similarly, as there is no training set for this type of device, this question is not applicable.
§ 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).