(23 days)
The HMEF 750 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 750 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 750 incorporates a hygroscopically treated HME media and electrostatic filter media into a housing made of translucent plastic.
Dimensions and Materials
- Diameter: 62 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 99.998 % ●
- Filtration efficiency bacterial 99.9999 % ●
The HMEF 750 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 text describes a medical device, the Datex-Ohmeda HMEF 750, and its substantial equivalence to a predicate device (Datex-Ohmeda HMEF500, K021265). It outlines the device's characteristics, intended use, and a summary of nonclinical testing. However, the document does not contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or details regarding sample sizes, ground truth establishment, expert involvement, or MRMC studies for AI/algorithm performance. The text focuses on the regulatory submission for premarket notification (510(k)) and demonstrates the device's compliance with safety standards and substantial equivalence, rather than detailing a specific study design to prove performance against pre-defined acceptance criteria as one would find in a clinical trial or algorithm validation study.
Therefore, I cannot provide the requested information from the given text. The text highlights:
- Device characteristics: Dimensions, materials, and filtration efficiency.
- Intended Use: Humidification during ventilation, filtration to reduce cross-contamination.
- Comparison to predicate device: Differences in length, weight, dead space, moisture output, moisture loss, breathing resistance, and maximum tidal volume, as well as improved filtration efficiencies (BFE and VFE).
- Compliance with standards: ISO 9360:2000, ISO 5356-1:1996, ISO 594-1:1986, ISO 594-2:1998, EN 980:1996, EN 1041:1998, EN 13014, ASTM F 1054-8721.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing specific performance studies with acceptance criteria in the manner requested for AI/algorithm validation.
§ 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).