(146 days)
The Sleepnet MoJo™-NV Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
(Applies to the standard version):
For homecare applications, the Sleepnet MoJo™-NV Full Face Mask, Nonvented may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the disposable version):
The Sleepnet MoJo™-NV Full Face Mask, Nonvented Disposable is a single patient, single use interface.
The Sleepnet MoJo™ NV Full Face Mask, nonvented is an externally placed mask covering the nose and mouth of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and mouth when either or both are open. It is held in place with an adjustable headgear. It may be cleaned with mild detergent, such as Ivory® dishwasher liquid, in water. The cleaning process requires limited disassembly.
The mask consists of a molded flexible polyvinylchloride shell with a soft, resilient polyurethane encased silicone gel skin-contacting seal that conforms to the patient's facial features. The polyvinylchloride shell contains a malleable metal insert that allows the user to adjust the entire perimeter of the facial seal in any configuration.
The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source via a standard 22 mm polycarbonate elbow/swivel assembly. The elbow/swivel assembly attaches to the front of the mask with a polycarbonate split "o" clip.
The air delivery system consists of a 22mm polycarbonate swivel connector for 22mm tubing, The vent ports may be visually checked for obstruction prior to use.
An optional polypropylene adapter sold separately as an accessory may be used to connect to a pressure measurement or oxygen delivering device.
The Sleepnet MoJo™-NV Full Face Mask, Nonvented assembly will be packaged along with the applicable instructions for use sheet in a standard poly bag.
The Sleepnet MoJo™ headgear is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shelf.
The provided text is a 510(k) Summary for a medical device (Sleepnet MoJo™-NV Full Face Mask, nonvented). It states that the device is substantially equivalent to predicate devices based on technological characteristics and performance. However, it does not contain specific acceptance criteria, performance data, or details about a study that would demonstrate the device meets such criteria.
The document primarily focuses on:
- Device Description: What the mask is made of and how it works.
- Intended Use: For noninvasive ventilation in adult patients.
- Substantial Equivalence Claim: Stating that the device is similar to previously marketed devices.
- FDA Approval Letter: Confirming the substantial equivalence determination.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).