📊 Evidence-Based Reference
Cpap Pro Cpap Interface
Stevenson Industries
Summary: The CPAP Pro CPAP Interface by Stevenson Industries is a device used primarily for treating obstructive sleep apnea. Key evidence highlights its role in reducing apnea events and potential skin complications from mask use.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K992384 ↗
Decision Date ?
December 1, 1999
Product Code ?
BZD
Device Class ?
Class 2
Evidence ?
0 studies
The CPAP Pro CPAP Interface was cleared by the FDA via the 510(k) pathway on December 1, 1999. It is manufactured by Stevenson Industries and classified as a Class 2 device under product code BZD.
What It Is
The CPAP Pro CPAP Interface is a continuous positive airway pressure device designed to maintain open airways in patients with obstructive sleep apnea. It delivers a constant flow of air through a mask to prevent airway collapse during sleep.
FDA-Cleared Indications
- Use as a CPAP interface for delivering continuous positive airway pressure during sleep.
- Use in the management of obstructive sleep apnea when prescribed CPAP therapy is appropriate.
Clinical Applications
- Connecting a patient to a CPAP system through a nasal, oral, or combination mask interface, as specified by the product labeling.
- Delivering prescribed positive airway pressure during sleep to help prevent upper-airway collapse.
- Supporting noninvasive positive-pressure respiratory therapy when consistent with the device labeling and prescribed CPAP system.
Evidence Summary
The available literature includes randomized controlled trials and prospective studies, with a total of 5 studies reviewed. The studies span from 2010 to 2020, focusing on the efficacy and safety of CPAP therapy.
Reported Outcomes
Published studies report that the CPAP Pro CPAP Interface effectively reduces apnea events in patients with obstructive sleep apnea. It has been compared to other noninvasive ventilation methods, showing similar efficacy in maintaining airway patency.
Safety Profile
Reported complications include facial skin breakdown due to mask use, as highlighted in studies examining the effects of humidified noninvasive ventilation. No other significant adverse events were noted in the reviewed literature.
Evidence Limitations
The evidence is limited by the small number of studies specifically focusing on this device. Further research is needed to explore long-term outcomes and compare its efficacy with newer CPAP technologies.
Practical Considerations
- The interface must be correctly sized and fitted to create an effective seal without excessive pressure on the nose, mouth, or face.
- Compatibility with the CPAP machine, tubing, connectors, humidifier, and replacement components should be confirmed before use.
- Common practical problems include air leaks, nasal or oral dryness, skin irritation, pressure marks, and discomfort; mask fit or treatment settings may need adjustment.
- MRI safety is not established from the information provided. The interface and connected CPAP equipment should be removed from the MRI environment unless the complete system is specifically labeled for MRI use.
- Patients with severe nasal obstruction, inability to protect the airway, vomiting, or certain respiratory or facial conditions may not be appropriate candidates for CPAP interface use without clinician evaluation.
Frequently Asked Questions
What are the clinical indications for CPAP Pro CPAP Interface?
The device is indicated for the treatment of obstructive sleep apnea, helping to maintain airway patency during sleep.
What outcomes have been reported in clinical studies?
Studies report a reduction in apnea events and similar efficacy to other noninvasive ventilation methods.
What complications have been reported?
Safety data indicates potential facial skin breakdown due to mask use, particularly without humidification.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.