(379 days)
The BHF 104 is a disposable single-use filter for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross-contamination between patient and equipment. The BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy.
The BHF 104 filter is a single-use, barrier type filter, fabricated from a plastic resin, and delivered to the customer in a sealed, non-sterile package. The translucent housing has aligned connector ports (15mm ID x 22mm OD, 22mm ID x 15mm OD), a perpendicular filter media, and a gas sampler luer port, protruding at 45 degrees from the base of the filter housing. The entire filter is 90mm (3.54 inches) in length, with a maximum cross section diameter of 55mm (2.16 inches), and a mass of 24g (.85 ounces). The surface area is 26.4cm2.
The BHF 104 has 15mm ID x 22mm OD and 22mm ID x 15mm OD male and female connectors, which allows compatibility with various compressors, ventilators, masks, and aerosol tubes.
The provided text describes the 510(k) summary for a Bacterial/Viral HME Filter (BHF 104). It details the device's specifications, indications for use, and a comparison to a legally marketed predicate device (DATEX-OHMEDA HMEF 500) to claim substantial equivalence. The document includes a "Performance Testing" section that lists the types of tests conducted, but it does not provide the acceptance criteria or the detailed results of those tests, nor does it describe specific studies that "prove" the device meets acceptance criteria. It only states that performance was based on these tests which are in the 510(k) application.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document lists "Specifications" for the new device and performance values for both the new device and the predicate. It does not explicitly state acceptance criteria for each test in the conventional sense (e.g., "must be > X"). However, the specifications and the "Substantial Equivalence" table implicitly serve as performance targets.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate/Specifications) | Reported Device Performance (BHF 104) |
|---|---|---|
| Bacterial Filtration Eff. (BFE) | ≥ 99.999% (Predicate BFE) | 99.9999% |
| Viral Filtration Eff. (VFE) | ≥ 99.98% (Predicate VFE) | 99.999% |
| Dead Space (ml) | Comparable to predicate (30ml) | 53ml |
| HME Output (mg/L H2O at 500ml VT) | Comparable to predicate (30mg H2O/L) | 37.5mg/L H2O at 500ml VT |
| Tidal Volume Range (ml) | Comparable to predicate (120-500ml) | 150-1500ml |
| Flow Rate Resistance | Not explicitly defined as acceptance criteria but listed as a specification | 30lt/min 5mm/H20, 60lt/min 13mm/H20, 90lt/min 28mm/H20 |
| Weight | Comparable to predicate (15g) | 24g |
2. Sample Size for Test Set and Data Provenance
This information is not provided in the document. The document only lists the types of performance tests conducted (Bacterial Filtration Efficiency, Viral Filtration Efficiency, Dead Space, Resistance to Flow, Heat and Moisture Exchange, Conical Connectors).
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The performance tests are laboratory-based, not involving human readers or expert evaluation in the traditional sense of image analysis or diagnostic assessment.
4. Adjudication Method for Test Set
This information is not provided in the document. This is not applicable to the listed performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted (or at least not mentioned as part of the 510(k) summary). The device is a filter, and the performance tests are physical/biological measurements, not human-in-the-loop diagnostic studies.
6. Standalone Performance (Algorithm Only)
"Standalone performance" in the context of an algorithm or AI system is not applicable here. The listed performance tests are for the physical device itself.
7. Type of Ground Truth Used
The "ground truth" for the performance tests would be established through laboratory measurements and adherence to specific testing standards for BFE, VFE, dead space, resistance to flow, and HME output. For example, BFE and VFE would involve challenging the filter with a known concentration of bacteria/viruses and measuring the penetration. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical filter, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical filter, not an AI/ML algorithm.
§ 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).