(212 days)
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient. Model with tidal volumes ranging from 20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for adults. Use up to 24 hours.
The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.
Here's an analysis of the provided text regarding the EMS Electra Filter and Filter/HME device, focusing on acceptance criteria and the study proving it meets those criteria:
The provided document is a 510(k) Premarket Notification, which is a submission to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparing the new device's characteristics and performance to those of existing, legally marketed devices, rather than comprehensive clinical trials for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" as a separate, formal list against which the device was tested as one might see in a clinical trial. Instead, it presents general technical characteristics of the proposed device and demonstrates their equivalence to predicate devices. The "acceptance criteria" are implicitly defined by the performance of the predicate devices and existing standards for such devices.
| Attribute | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (EMS Electra) |
|---|---|---|
| Dead Space (ml) | - (Should be comparable to predicate devices) | 10 to 65 ml |
| Resistance to flow (Adult) | ≤3 cm H2O @ 60 lpm | ≤3 cm H2O @ 60 lpm |
| Resistance to flow (Pediatric) | ≤1.0 cm H2O @ 20 lpm | 1.0 cm H2O @ 20 lpm |
| Resistance to flow (Neonate) | ≤0.5 cm H2O @ 5 lpm | 0.5 cm H2O @ 5 lpm |
| Bacterial Filtration Efficiency (BFE) | 99.999+% (Based on Nelson Lab. results for predicate) | 99.999+% |
| Viral Filtration Efficiency (VFE) | 99.99+% (Based on Nelson Lab. results for predicate) | 99.99+% |
| Weight (gm) | - (Should be comparable to predicate devices) | 10 to 35 gm |
| Humidification Output (Adult, 1000cc TV) | 32 mg H2O/L | 32 mg H2O/L |
| Humidification Output (Pediatric, 250cc TV) | 32 mg H2O/L | 32 mg H2O/L |
| Humidification Output (Neonate, 50cc TV) | 30 mg H2O/L | 30 mg H2O/L |
| Tidal Volume Range (Neonate) | 20-70 cc | 20-70 cc |
| Tidal Volume Range (Pediatric) | 70-250 cc | 70-250 cc |
| Tidal Volume Range (Adult) | >150 cc | >150 cc |
| Standards Compliance | ISO 5356-1, ISO 594-2, ISO 9360 | Yes (Compliance asserted) |
2. Sample Size Used for the Test Set and Data Provenance:
The document details performance data derived from laboratory testing, specifically mentioning "Nelson Lab." for Bacterial and Viral filtration efficiency. This indicates the data is likely from professional testing laboratories rather than human clinical trials.
- Sample Size: Not explicitly stated for each test. For filtration efficiency, usually multiple samples of the filter media are tested. For resistance and humidification, often a set number of devices are tested according to a standard protocol.
- Data Provenance: The document states "Nelson Lab." for BFE and VFE, implying a specialized testing facility. The country of origin is not specified, but Nelson Labs is a well-known US-based testing laboratory. The data is prospective in the sense that the new device was fabricated and then tested to determine its performance characteristics. It is not retrospective in the sense of analyzing past patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the evaluations are based on objective physical and biological performance tests, not subjective expert assessment of images or patient outcomes. The "ground truth" for these tests are the established scientific methodologies and standards by which filter performance, resistance, and humidification are measured.
4. Adjudication Method for the Test Set:
This is not applicable as the evaluation relies on direct measurement of physical properties and performance characteristics, not on subjective assessments that would require adjudication (e.g., medical image interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable. The device is a filter/heat and moisture exchanger (HME), not an imaging or diagnostic AI system. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant to this device.
6. Standalone (Algorithm Only) Performance:
This is not applicable. The device is a physical medical device (a filter), not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth used is objective laboratory measurement data and established performance standards. For example:
- For resistance, the ground truth is the measured pressure drop across the filter at specified flow rates.
- For filtration efficiency, the ground truth is the measured percentage of bacteria/viruses removed according to standardized laboratory testing protocols (e.g., using bacterial aerosols like Staphylococcus aureus).
- For humidification output, the ground truth is the gravimetric measurement of water vapor produced by the HME under specific temperature, humidity, and tidal volume conditions as per ISO 9360.
8. Sample Size for the Training Set:
This is not applicable. Since this device is a physical product and not an AI/machine learning model, there is no "training set." Its design and performance capabilities would be based on engineering principles, materials science, and testing iterations, not data training.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from engineering specifications, industry standards (like ISO for connectors and HME moisture output), and the performance characteristics observed in predicate devices.
§ 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).