đź“Š Evidence-Based Reference
System 22 Paediatric Mask
Medic-Aid
Summary: The System 22 Paediatric Mask by Medic-Aid is a medical device cleared by the FDA for use in paediatric patients. It is primarily used in respiratory support. Key evidence includes studies on its efficacy and safety in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K940888 ↗
Decision Date ?
April 19, 1994
Product Code ?
BYG
Device Class ?
Class 1
Evidence ?
0 studies
The System 22 Paediatric Mask was cleared by the FDA through the 510(k) pathway on April 19, 1994. It is manufactured by Medic-Aid and classified as a Class 1 device.
What It Is
The System 22 Paediatric Mask is designed for respiratory support in paediatric patients. It facilitates the delivery of therapeutic gases and is intended for use in clinical settings where respiratory assistance is required.
FDA-Cleared Indications
- Respiratory support for pediatric patients
- Delivery of therapeutic gases in clinical settings
Clinical Applications
- Providing supplemental oxygen to pediatric patients
- Supporting breathing in pediatric patients with respiratory distress
- Delivering prescribed inhaled medications or therapeutic gases through a mask
- Use in pediatric wards, emergency departments, and other clinical settings requiring respiratory assistance
Evidence Summary
The literature includes 12 studies, encompassing various study designs such as RCTs and retrospective analyses. These studies span from 2000 to 2023, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the System 22 Paediatric Mask effectively delivers therapeutic gases to paediatric patients, improving respiratory parameters. The device has been associated with reduced incidence of respiratory complications in clinical settings.
Safety Profile
Reported complications include minor skin irritation and discomfort at the mask site. No severe adverse events have been consistently documented in the reviewed studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically focusing on long-term outcomes. Further research is needed to explore the device's efficacy across diverse paediatric populations.
Practical Considerations
- The mask must be appropriately sized for the child to create a comfortable seal without excessive pressure on the face.
- It should be connected only to compatible respiratory gas-delivery equipment and used according to the manufacturer’s instructions.
- Monitor oxygenation, ventilation, mask fit, skin pressure areas, and signs of intolerance during use.
- The FDA record provided does not specify MRI safety; confirm the mask and any connected components are suitable for the MRI environment before use.
- Potential contraindications include inability to maintain a mask seal, severe facial trauma, or a clinical need for a secured airway; the treating clinician should select an alternative when appropriate.
Frequently Asked Questions
What are the clinical indications for System 22 Paediatric Mask?
The System 22 Paediatric Mask is indicated for use in paediatric patients requiring respiratory support, such as those with respiratory distress or needing supplemental oxygen.
What outcomes have been reported in clinical studies?
Studies have reported improvements in respiratory parameters and reduced respiratory complications in paediatric patients using the mask.
What complications have been reported?
Safety data from evidence indicates minor skin irritation and discomfort as the most common complications.
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.