(98 days)
The Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The Passive Waste Gas Scavenger is designed for use with non-recirculating waste gas disposal systems and is intended for prescription use only.
The Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The Passive Waste Gas Scavenger is designed for use with non-recirculating waste gas disposal systems and is intended for prescription use only. This scavenging approach relies on the pressure of the waste gas to transfer the gas from the scavenger to the exhaust system.
The scavenger body incorporates one 30mm/27mm/19mm horizontal hose terminal to connect the scavenger to the anesthesia machine. The vertically oriented 30mm/19mm hose terminal is intended to connect the scavenger to the exhaust system.
The G. Dundas Passive Scavenger incorporates the same safety systems as predicate devices, providing relief of excess positive pressure and excess negative pressure to the patient through the use of pressure relief valves, in compliance with ASTM 1343-02 -Anesthetic Equipment -- Scavenging Systems for Anesthetic Gases. Although there is no standard for passive waste gas scavenging systems, the G. Dundas Passive Scavenger is designed to fail safe under active waste disposal conditions.
The G. Dundas Passive Scavenger and the predicate devices were tested and found to have similar performance. Testing procedures and data can be found in Section 7 of this application.
The provided text describes a medical device, the "Passive Waste Gas Scavenger," and its 510(k) submission to the FDA. It does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/ML device evaluations (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth dataset).
Instead, the document focuses on the device's design specifications and functional performance in relation to safety standards for medical gas scavenging systems. The "acceptance criteria" here are defined by the device's operational parameters and compliance with an existing ASTM standard, rather than statistical performance against a diagnostic endpoint.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission. I will extract the relevant information and indicate where categories are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Design/Functional Specification) | Reported Device Performance (Operational Parameter) |
|---|---|
| Inlet pressure during normal operation (75 L/min flow) | Shall not exceed 3.0 cm H$_{2}$O |
| Positive pressure relief valve activation | Limits inlet pressure to $\leq$ 9 cm H$_{2}$O |
| Negative pressure relief valve activation | Prevents inlet pressure from going below -2.5 mm H$_{2}$O |
| Compliance with ASTM 1343-02 | Device incorporates safety systems providing relief of excess positive and negative pressure to the patient, similar to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. The "testing" referred to appears to be engineering and functional validation, not a clinical study on a patient sample. The device's performance is described in terms of its operational parameters under specific flow and pressure conditions.
- Data Provenance: Not applicable. The testing is likely internal engineering validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for this type of device is based on established engineering principles and medical device safety standards (e.g., ASTM 1343-02), rather than expert clinical consensus on diagnostic outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Not applicable. There's no indication of a ground truth adjudication process in the clinical sense. Performance is assessed against predefined physical parameters.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a mechanical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Engineering specifications and established medical device safety standards (specifically ASTM 1343-02 for "Anesthetic Equipment -- Scavenging Systems for Anesthetic Gases"). The performance is measured against these defined physical and safety thresholds.
8. The sample size for the training set
- Not applicable. This is a mechanical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the "Study" mentioned:
The document states, "The G. Dundas Passive Scavenger and the predicate devices were tested and found to have similar performance. Testing procedures and data can be found in Section 7 of this application." This indicates that the "study" was a performance validation by comparing its functional operation to its predicate devices and against the safety requirements outlined in ASTM 1343-02. The described "performance" relates to maintaining specific pressure thresholds within the scavenging system under normal and fault conditions (e.g., positive and negative pressure relief valve activation). The provided data points (3.0 cm H₂O max inlet pressure, $\leq$ 9 cm H₂O positive relief, $\geq$ -2.5 mm H₂O negative relief) are the direct results of this functional testing.
§ 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).