📋 FDA Reference
Ambu Paedi Anaesthesia System
Narco Air-Shields
Summary: The Ambu Paedi Anaesthesia System is a non-rebreathing valve system used in pediatric anesthesia. It is designed for use by anesthesiologists and other trained clinicians to manage ventilation in young patients during surgical procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K792499 ↗
Decision Date ?
December 19, 1979
Product Code ?
CAI
Device Class ?
Class 1
Evidence ?
0 studies
The Ambu Paedi Anaesthesia System was cleared through the FDA 510k pathway on December 19, 1979. It is manufactured by Narco Air-Shields and classified as a Class 1 medical device.
What It Is
The Ambu Paedi Anaesthesia System is a specialized non-rebreathing valve system used in pediatric anesthesia. It helps deliver anesthetic gases to young patients while allowing for accurate monitoring of exhaled gases. The system includes a breathing balloon in the inspiratory limb, which is crucial for its function, particularly in maintaining low fresh gas flow settings to minimize gas-shunting.
FDA-Cleared Indications
- Use in pediatric patients during administration of anesthesia.
- Delivery of anesthetic gases through a non-rebreathing valve system.
- Support of ventilation and monitoring of exhaled gases during pediatric anesthesia.
Clinical Applications
- Pediatric anesthesia for surgical procedures.
- Ventilation management in an operating room during anesthesia.
- Anesthetic gas delivery for young or small patients.
- Use with compatible anesthesia equipment when controlled fresh-gas flow and monitoring are required.
Practical Considerations
- The system is intended for pediatric use; appropriate patient size, breathing circuit configuration and fresh-gas flow must be selected by trained clinicians.
- The breathing balloon is positioned in the inspiratory limb and is important to system performance, particularly at low fresh-gas-flow settings.
- Compatibility with an anesthesia machine, connectors and monitoring equipment should be confirmed before use.
- This is an anesthesia breathing system, not an airway access device; an appropriate airway and continuous monitoring are required.
- MRI compatibility is not established from the available FDA record. The system should not be taken into the MRI environment unless the specific configuration has been evaluated and labeled as MRI safe or MR conditional.
Related Literature
The linked study investigated the performance of the Ambu Paedi Anaesthesia System in measuring expired minute volume during anesthesia. It found that at low fresh gas flow settings, the system effectively minimized gas-shunting, making it reliable for analyzing exhaled gases. However, at higher flow rates, significant gas-shunting occurred, which could lead to measurement inaccuracies. The study was limited by its small sample size and focus on a single volunteer.
Frequently Asked Questions
What is the Ambu Paedi Anaesthesia System used for?
It is used for delivering and monitoring anesthetic gases in pediatric patients during surgical procedures.
What specialties typically use this device?
Anesthesiologists and pediatric specialists in surgical and intensive care settings.
What are the FDA-cleared indications?
The device is indicated for use in pediatric anesthesia to manage and monitor ventilation and anesthetic gas delivery.
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.