(126 days)
The Oxygen Diverter Valve is an accessory to a CPAP or Bilevel Flow Generator intended to prevent the backflow of oxygen or water when the unit is not operating.
The Oxygen Diverter Valve is an in-line one-way valve that is intended to prevent oxygen or water in the patient circuit from back flowing into a CPAP or Bilevel Flow Generator when the unit is not operating. The Oxygen Diverter Valve incorporates a silicone membrane that seals against the outer housing to vent any backflow to the atmosphere when the pressure drops of the CPAP or Bilevel Flow Generator drops below 2.0cm H20.
The principle of operation is the same as used in the Full Face Mask Anti-asphyxia valve (510(k) number K982530), the difference being in application - in the Full Face Mask, the valve is used to vent CO2 to atmosphere to prevent patient rebreathing.
The ResMed Oxygen Diverter Valve is an accessory designed to prevent the backflow of oxygen or water into a CPAP or Bilevel Flow Generator when the unit is not operating. The device operates by incorporating a silicone membrane that seals against an outer housing, venting any backflow to the atmosphere when the pressure drops below 2.0cm H2O.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a series of performance tests without explicitly stating predefined acceptance criteria with numerical targets. Instead, the "Effectiveness of intended use to prevent oxygen backflow" and "Effectiveness of its intended use to divert water" are considered key criteria, implying successful prevention of backflow. The other tests ensure the device's functional integrity and compatibility with the therapy system.
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance |
|---|---|
| Effectiveness of intended use to prevent oxygen backflow | Demonstrated effectiveness |
| Activation and Deactivation Pressure | Tested |
| Deactivation Pressure during Therapy | Tested |
| Pneumatic performance (Impedance added during therapy) | Tested |
| Leak rate and pressure range | Tested |
| Effectiveness of its intended use to divert water | Demonstrated effectiveness |
| Effectiveness of oxygen diversion after wetting | Tested |
| Lifetime testing | Tested |
| Environmental testing | Tested |
| System Compatibility | Tested |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the precise sample size used for each test. It uses the general phrase "Performance testing has been conducted to ensure the safety and effectiveness." There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for the performance tests. Given this is a 510(k) for a medical device accessory, these tests are typically performed in a laboratory setting by the manufacturer, rather than on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to the Remsed Oxygen Diverter Valve. The "ground truth" for this device is based on objective physical measurements and engineering specifications, not expert interpretation of medical images or patient data. The performance tests would be evaluated against established engineering standards and functional requirements.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments. For a device like the Oxygen Diverter Valve, the evaluation of performance tests would be based on objective measurements and comparison against predefined technical specifications, typically reviewed and verified by engineering and quality assurance teams, not by an adjudication panel in the medical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the impact of an AI algorithm on human reader performance, particularly in diagnostic imaging or clinical decision-making. The Oxygen Diverter Valve is a passive mechanical accessory, and its function does not involve human interpretation or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of "standalone performance" in the context of an algorithm does not apply here. The device itself is a standalone mechanical accessory. The performance tests conducted evaluated the device's mechanical and pneumatic functionality independently, without human intervention during the measurement phase (though humans operate the testing equipment).
7. The Type of Ground Truth Used:
The "ground truth" for the Oxygen Diverter Valve is based on objective engineering measurements and functional specifications. For example:
- Effectiveness of preventing backflow: Measured by observing if oxygen or water successfully breaches the valve under specific conditions.
- Activation and Deactivation Pressure: Measured using pressure gauges to confirm the valve opens and closes at specified pressure thresholds.
- Leak rate: Measured using flow meters to quantify any gas leakage.
- Impedance: Measured to quantify the resistance the device adds to the airflow during therapy.
These are not based on expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic medical devices.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable to this device. Training sets are used in machine learning or AI development to teach an algorithm patterns. The Oxygen Diverter Valve is a mechanical device, and its design and functionality are based on engineering principles, not on learned data.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this mechanical device, the ground truth establishment for a training set is not applicable.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).