(28 days)
The HMEF Mini 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 Mini 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 Mini incorporates a hygroscopically treated HME media and electrostatic filter media into a housing made of translucent plastic.
Dimensions and Materials
- Diameter: 45 mm .
- . Length: 64 mm
- . Housing: PP Polypropylene
- . HME-element: PU Polyurethane impregnated with calcium chloride CaCl2
- Filter: PP and acrylic fibers .
Filtration efficiency: - Filtration efficiency viral 99.98 % ●
- . Filtration efficiency bacterial 99.999 %
The HMEF Mini is for use in small 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 mm OD 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 document describes a 510(k) premarket notification for the Datex-Ohmeda HMEF Mini, a disposable heat and moisture exchanger and bacteria/viral filter. The document focuses on demonstrating substantial equivalence to a predicate device, the Datex-Ohmeda HMEF500 (K021265), rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
Therefore, the information required to answer the questions in the prompt, such as sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, and ground truth establishment for an AI/algorithm device, is not present in this document. The provided text details the physical characteristics, intended use, and non-clinical testing of a physical medical device.
However, I can extract the acceptance criteria (performance specifications) and reported device performance from the document where applicable for this physical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate [HMEF500] Performance) | Reported Device Performance (HMEF Mini) |
|---|---|
| Bacterial Filtration Efficiency (BFE): 99.999999% (CAMR lab, UK) | Bacterial Filtration Efficiency (BFE): 99.999% (Nelson lab) |
| Viral Filtration Efficiency (VFE): 99.9% (stated accuracy prior to update) | Viral Filtration Efficiency (VFE): 99.98% (same as predicate, accuracy increased) |
| Intended Use: Same as predicate | Intended Use: Same as predicate |
| Fundamental Scientific Technology: Same as predicate | Fundamental Scientific Technology: Same as predicate |
| Operating Principle: Same as predicate | Operating Principle: Same as predicate |
| Manufacturing Processes: Same as predicate | Manufacturing Processes: Same as predicate |
| Materials: Identical to predicate | Materials: Identical to predicate |
| Efficient protection against transfer of bacteria/viruses: Yes | Efficient protection against transfer of bacteria/viruses: Yes |
| Compliance with ISO 9360:1992 | Compliance with ISO 9360:1992 |
| Compliance with ISO 5356-1:1996 | Compliance with ISO 5356-1:1996 |
| Compliance with ISO 594-1:1986 | Compliance with ISO 594-1:1986 |
| Compliance with ISO 594-2:1998 | Compliance with ISO 594-2:1998 |
| Compliance with EN 980:1996 | Compliance with EN 980:1996 |
| Compliance with EN 1041:1998 | Compliance with EN 1041:1998 |
| Compliance with EN 13014 | Compliance with EN 13014 |
| Compliance with ASTM F 1054-8721 | Compliance with ASTM F 1054-8721 |
Note on Differences: The document explicitly states differences in length, weight, dead space, moisture output, moisture loss, breathing resistance, and minimum tidal volume between the HMEF Mini and the HMEF500, primarily due to the HMEF Mini's smaller size. However, specific numerical acceptance criteria (e.g., "dead space must be
§ 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).