(127 days)
The ISO-GARD® ClearAir™ Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-GARD® ClearAir™ Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-GARD® ClearAir™ mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases ("WAGS") exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit ("PACU"). Vacuum/suction for scavenging of WAGS 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.
The ISO-GARD® ClearAir™ mask is offered in several configurations, the differences being some of the components.
The provided document describes a 510(k) premarket notification for the ISO-GARD® ClearAir™ mask. This device is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAGS) and provides supplemental oxygen. The submission is a comparison to legally marketed predicate devices, not a study presenting novel acceptance criteria.
The document explicitly states: "There is no pass / fail criteria for the ISO-GARD® ClearAir™ mask. The testing performed is for disclosure only." This indicates that the study was not designed to meet specific, pre-defined acceptance criteria with pass/fail thresholds. Instead, the testing aimed to characterize the device's performance and demonstrate substantial equivalence to predicate devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, as such criteria were not defined as "pass/fail" for this submission type. However, I can summarize the performance data disclosed and the nature of the study.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
As mentioned, no explicit "pass/fail" acceptance criteria were set for this device in the context of this 510(k) submission for the performance testing. The reported performance data is primarily for disclosure and comparison.
| Performance Characteristic | Reported Device Performance (ISO-GARD® ClearAir™ Mask) | Comparison/Context |
|---|---|---|
| Delivered Oxygen % (4 lpm O2 flow, 30-50 mm Hg Vacuum) | 21-23% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (6 lpm O2 flow, 30-50 mm Hg Vacuum) | 31-32% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (8 lpm O2 flow, 30-50 mm Hg Vacuum) | 38% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (10 lpm O2 flow, 30-50 mm Hg Vacuum) | 43-44% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| No₂O detection in chamber | No measurable N₂O detected | Supports effective scavenging at the patient. |
| Delivered Oxygen % (with no N₂O, compared to standard mask with no N₂O) | Higher than a standard oxygen mask at all flow rates and vacuum settings. | Performance superior to a standard oxygen mask in these conditions. |
| End-tidal CO₂ tracing and waveform | More consistent than the predicate Bi-Flo nasal sampling cannula. | Indicates improved or equivalent ETCO2 monitoring capabilities. |
| Biocompatibility | Meets the requirements of ISO 10993 (cytotoxicity, sensitization, irritation). | Demonstrates material safety. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many devices were tested or how many test conditions were numerically replicated. It describes performance testing in a "simulation bench set-up."
- Data Provenance: The studies are described as "Non-clinical Performance Testing" and "simulation bench set-up." This indicates a prospective, controlled laboratory setting. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA by Teleflex Medical, Inc., located in Research Triangle Park, NC, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this submission. The "ground truth" for this device's performance (e.g., oxygen percentage, scavenging effectiveness) would be established through a validated physical measurement system in the benchtop simulation, not through expert consensus or clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. As the testing involved objective physical measurements on a benchtop, there was no need for expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This is a medical device, not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device. "Standalone (algorithm only)" is a concept for AI or software devices, not relevant here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims in this submission is based on objective physical measurements from a validated simulation bench set-up. For example, oxygen percentage was measured, and the absence of N₂O was detected. Biocompatibility was assessed against ISO 10993 standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this traditional medical device submission. Training sets are typically associated with machine learning or AI algorithm development.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 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).