(91 days)
The American Bantex Humidifier is intended for use with oxygen concentrators or gas sources in a patients home, physicians office or hospital / institutional environment. The humidifier increases the moisture content of the airstream gases for administration directly to the patient.
Single patient use only
Non-sterile
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
The American Bantex Humidifier is device that provides humidity in a non-heated pathway. The American Bantex Humidifier works with most all Oxygen Concentrators or to an oxygen source used in homes, doctors' office, hospital or institutional environments. The inlet uses an easy-to-grab winged styled nut that universally adapts to most all gas connections. The outlet is a push-on standard medical tubing connector with a tapered end. The American Bantex Humidifier is equipped with either a 3 or 6-PS1 safety valve that will alarm if there is a kink or blockage in the delivery system.
The provided text describes a 510(k) submission for the "American Bantex Humidifier" as a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics against a defined ground truth.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not applicable in the context of this 510(k) submission document. The submission focuses on comparing the new device's technological characteristics and intended use to a predicate device to prove it is "as safe and effective."
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not applicable. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) that would typically be associated with an algorithm or diagnostic device. Instead, it demonstrates substantial equivalence by comparing the new device's characteristics and operation to a predicate device. The "performance" mentioned is that the device "consistently performed within its design parameters," implying it met its functional specifications, not a clinical outcome metric.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a medical device (humidifier) that is compared to a predicate device based on its design, materials, and intended use. There is no "test set" of data or patient samples in the context of an algorithm or diagnostic test. The evaluation is centered on engineering and functional comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As there is no "test set" of data requiring ground truth establishment, no experts were used for this purpose in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method was used as there was no test set of data.
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. A multi-reader multi-case (MRMC) study is typically performed for diagnostic imaging devices or algorithms that assist human interpretation. The American Bantex Humidifier is a respiratory gas humidifier, which is a physical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a physical medical device (humidifier), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. Ground truth is not a concept applied in this 510(k) submission, as it relates to evaluating the accuracy of a diagnostic or predictive system against a definitive standard. This submission is about demonstrating equivalence of a physical device.
8. The sample size for the training set
- Not applicable. As this is not an artificial intelligence or machine learning device, there is no "training set" of data.
9. How the ground truth for the training set was established
- Not applicable. There is no training set mentioned in the document.
Summary of the Study (as described in the document):
The "study" described in the provided document is a 510(k) premarket notification process for the American Bantex Humidifier. Instead of a clinical trial with acceptance criteria, the manufacturer performed a comparison to a legally marketed predicate device (K991484 - Airlife Bubble Humidifier, Allegiance Healthcare Corporation).
The core of the "study" was to demonstrate substantial equivalence through:
- Comparison of Intended Use: Both devices are intended to moisten breathing gases delivered directly to the patient for breathing.
- Comparison of Technological Characteristics: A table (Table Ib) is provided comparing components, materials (clear polypropylene for humidifier bottle, ABS for lid, brass/ABS for check valve and lid, PVC/PVC for filter tube/bulb), method of operation, accessory use, and single-patient use.
- Material Biocompatibility: The document states that the materials used are identical to the predicate and have been previously tested and accepted for biocompatibility, being widely accepted industry standards. Both devices are latex-free.
- Safety Features: Both devices include a safety valve (3 or 6-PSI for the submitted device) to alarm for kinks or blockages.
- Functional Testing: The conclusion states, "The successful testing demonstrated the device consistently performed within its design parameters," implying internal functional and engineering tests were conducted to ensure it operates as intended. However, details of these functional tests (e.g., flow rate consistency, humidification effectiveness, pressure relief accuracy) are not provided in this summary.
The "study" successfully concluded that the American Bantex Humidifier is "as safe and effective, and performs as well as, or better than, the predicated device." This conclusion led to the FDA's "substantial equivalence determination" and permitted the device to be marketed.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).