(335 days)
The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours.
The Heat and Moisture Exchanger and Filter (HMEF) consists of a plastic body which incorporates an electrostatic/ mechanical filter pad. 22 mm female / 15 mm male connectors in accordance with ISO 5356 (Anaesthetic and respiratory equipment-Conical connectors- Part 1: Cones and sockets) and a luer lock connector which is only used for gas monitoring.
The VR Medical Heat and Moisture Exchanger and Filter (HMEF) is a disposable, single-use device intended to provide humidification during ventilator gas delivery and reduce cross-contamination between patients and equipment. The manufacturer provided a 510(k) premarket notification to demonstrate substantial equivalence to predicate devices. The study conducted was a non-clinical in-vitro test program comparing the performance of the VR Medical HMEF to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the VR Medical HMEF are implied by its substantial equivalence to predicate devices, meaning its performance should be similar or within acceptable ranges of the predicate devices. The document provides performance data for two models of the VR Medical HMEF (VR003 and VR005).
| Item | Acceptance Criteria (Implied by Predicate Devices) | VR003 Reported Performance | VR005 Reported Performance |
|---|---|---|---|
| Filtration efficiency (Bacterial - BFE) | Similar to predicate devices | 99.999% | 99.9999% |
| Filtration efficiency (Viral - VFE) | Similar to predicate devices | 99.99% | 99.999% |
| Pressure Drop (at 30 L/min) | Similar to predicate devices | 0.7 cm H₂O | 1.5 cm H₂O |
| Internal Volume | Similar to predicate devices | 60mL | 85mL |
| Recommended tidal volume | Similar to predicate devices | 250 to 1500 mL | 250 to 1500 mL |
| Moisture loss (ISO 9360, VT=500mL) | Similar to predicate devices | 10.5 mg/L | 7.8 mg/L |
2. Sample Size Used for the Test Set and Data Pprovenance
- Sample Size: The document does not explicitly state the numerical sample size for each in-vitro test conducted on the VR Medical HMEF. However, it indicates that "design verification tests" were conducted.
- Data Provenance: The tests were conducted in-vitro, and at least some filtration efficiency testing was performed by "Nelson Lab." The country of origin for the HMEF manufacturer is China. The data would be considered prospective as it was generated specifically for the premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the study involved non-clinical in-vitro testing against established standards and metrics, not human expert assessment of a test set.
4. Adjudication Method for the Test Set
This is not applicable, as there was no test set requiring human adjudication. The performance was measured against objective, quantifiable physical and biological parameters.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The VR Medical HMEF is a physical medical device, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm-only) performance study was done. This concept is typically applicable to AI/ML software devices. The VR Medical HMEF is a physical medical device. The performance data presented are for the device itself.
7. Type of Ground Truth Used
The "ground truth" for this device, in the context of its performance testing, was established by recognized international standards and laboratory measurements. Examples include:
- Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE) testing by laboratories like Nelson Lab.
- Pressure Drop measurements.
- Internal Volume measurements.
- Moisture Loss according to ISO 9360.
- Conical Connectors performance according to ISO 5356.
- Biocompatibility according to ISO 10993-1.
8. Sample Size for the Training Set
This is not applicable. The VR Medical HMEF is a physical device, and its development and evaluation do not involve a "training set" in the context of AI/ML algorithms. Its design is based on engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there was no training set. The "ground truth" for the device's design and expected performance relies on established scientific and engineering principles, material specifications, and relevant international standards for medical devices of this type.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).