(130 days)
The HMEF500 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 HMEF 500 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult and pediatric patients. The device is indicated for use by qualified medical personnel only.
The HMEF 500 incorporates a hygroscopically treated HME media and electrostatic filter media into a housing made of translucent plastic.
Diameter: 45 mm
Length: 74 mm
Material:
HMEF 200
- Housing: PP Polypropylene
- HME-element: PU Polyurethane impregnated with calcium chloride CaCl2
- Filter: PP and acrylic fibers
Filtration efficiency: - Filtration efficiency viral 99.9 %
- Filtration efficiency bacterial 99.9999999 %
The HMEF 500 is for use in adult and pediatric patients in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators.
It incorporates standard fittings for-
15 mm ID x 22 mm OD fitting to connect to the endotracheal tube or face mask
15 mmOD x 22 mm ID fitting to connect to the breathing circuit y-piece
A gas sampling port - female luer port with cap to allow sampling of expired CO2-gases
The provided text is a 510(k) summary for a medical device called the Datex-Ohmeda HMEF 500, a Disposable Heat and Moisture Exchanger and Bacteria/Viral Filter. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical acceptance criteria through a study.
Therefore, much of the requested information regarding a study and its results, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, cannot be extracted from this document, as it does not describe such a study.
However, it does provide acceptance criteria in the form of performance specifications for the device and its compliance with relevant standards.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
The document compares the Datex-Ohmeda HMEF 500 to two predicate devices (Datex-Ohmeda HMEF1000 and EMS HEPA Filter and Hepa Filter/HME). The "acceptance criteria" are implied by the performance of the predicate devices and the HMEF 500's own stated specifications, particularly its filtration efficiency and resistance for different flow rates.
| Acceptance Criteria / Performance Metric (Implied) | Predicate Device (HMEF 1000) Performance | Predicate Device (EMS HEPA) Performance | Datex-Ohmeda HMEF 500 Performance |
|---|---|---|---|
| Filtration efficiency bacterial | 99.999999 % | 99.9999% | 99.9999999 % |
| Filtration efficiency viral | 99.99% | 99.9999% | 99.9 % |
| Breathing resistance @ 60 lpm | Not specified | 3.4 cm H2O | 3.3 cm H2O |
| Moisture output @ 500 ml Tidal Volume | Differed | Not specified | Differed |
| Size, weight, diameter, dead space | Differed | Differed | Smaller than HMEF1000 |
| Labeled shelf life | Differed | Not specified | Differed |
2. Sample size used for the test set and the data provenance:
- Not Applicable: The document does not describe a clinical or performance study with a test set in the traditional sense. The performance characteristics are stated as specifications rather than outcomes of a specific observational or interventional study. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This document does not describe a study involving human experts establishing ground truth. The device's performance is based on internal testing against standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: No adjudication method is mentioned as there is no human-reviewed test set described.
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:
- Not Applicable: This device is a physical medical filter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related improvement metrics are not relevant or discussed.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not Applicable: This document describes a physical medical device, not an algorithm. Performance specifications are presented as inherent characteristics of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The "ground truth" for the device's performance characteristics (like filtration efficiency and resistance) appears to be established through laboratory testing and compliance with recognized industry standards (e.g., ISO 9360, ASTM F 1054-8721). The document states, "The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made..." This implies a ground truth based on rigorously defined physical and biological testing protocols under controlled conditions, as outlined by these standards.
8. The sample size for the training set:
- Not Applicable: As this is a physical device, there is no "training set" in the context of an algorithm or AI model development.
9. How the ground truth for the training set was established:
- Not Applicable: No training set is described.
In summary: This 510(k) submission primarily relies on demonstrating that the new device (Datex-Ohmeda HMEF 500) is substantially equivalent to existing, legally marketed predicate devices by comparing their technical characteristics and showing compliance with established safety standards. It does not present a clinical study with a test set, human readers, or AI components. The "acceptance criteria" are the technical specifications and adherence to recognized performance standards for such 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).