(86 days)
The ISO-Gard® Mask is intended to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAG) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAG is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
This document describes the Teleflex Medical, Inc. ISO-Gard Mask (K142138), a gas-scavenging apparatus intended to remove waste anesthetic gases and provide supplemental oxygen to patients recovering from general anesthesia.
Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Test Objective | Acceptance Criteria | Reported Device Performance and Conclusion |
|---|---|---|---|
| Oxygen Delivery with Vacuum Tubing | To evaluate the oxygen delivery performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml. | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all vacuum settings and oxygen flow rates. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Oxygen Delivery with Vacuum Tubing Removed | To evaluate the oxygen delivery performance with vacuum tubing removed at variable oxygen flow rates. | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all oxygen flow rates. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Strength of Connection | To validate the Oxygen Flow Concentrator to Mask bond strength. | The Oxygen Flow Concentrator will not detach at 30 lpm flow rate and the initial gauge pressure reading will remain the same as the final pressure reading for each tested mask. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Biocompatibility Testing: Cytotoxicity | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration ( |
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).