(284 days)
To remove unwanted anesthetic gases from the patient breathing circuit
This device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.
Here's a breakdown of the acceptance criteria and study information for the Vapor-Clear device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Anesthetic adsorption rate | Vapor-Clear scavenges >99.95% of isoflurane at a high flow rate. |
| Scavenging residual vapor from modern anesthesia gas machines to 99% was observed. No degradation of anesthetic gas removal capacity was observed when using aged product (71 months). | |
| Environmental testing | No change in device performance was observed following mechanical and environmental stresses (shock, vibration, high/low temperature, humidity) for anesthetic removal, leakage, and increased back pressure. |
| Internal volume | The internal volume of the device is 92 ml. |
| Internal compliance | The internal compliance is 14 ml/kPa. |
| Burst pressure | The Vapor-Clear burst at a pressure of 70 pounds per square inch. |
| Back-pressure | Added back pressure of 0.5 cm H₂O at 30 L/min was observed. |
| Leak rate | No leak (0.0 ml/min) was detectable. |
Study Details
The provided document describes non-clinical bench testing to demonstrate the substantial equivalence of the Vapor-Clear device to its predicate.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in terms of patient data. The testing involved multiple units of the Vapor-Clear device and utilized two modern anesthesia gas machines (Draeger Apollo and Ohmeda Aestiva) for the residual vapor scavenging test. "A single Vapor-Clear canister" was used for the removal capacity test. "Product containing activated charcoal that has been aged for 71 months" was tested for product life testing.
- Data Provenance: The data is from non-clinical bench testing. The country of origin is not specified but is implied to be related to the manufacturer (Axon Medical Inc., Park City, Utah, USA) and the FDA submission process. This is retrospective in the sense that the studies were completed before the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth for this non-clinical testing was established through direct measurement using analytical instruments (e.g., anesthetic gas analyzer capable of detection 99% removal) was determined by comparing measured input and output concentrations.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a physical medical device and does not involve AI or machine learning models that require a training set.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As above, no training set was used.
§ 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).