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)

Device Description

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.

AI/ML Overview

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.

Summary

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AMERICAN BANTEX CORPORATION

1815 Rollins Road Burlingame, California (650) 697 - 3545 (650) 697 - 3596 Tracy S. Best, Regulatory Affairs Consultant Preparation Date: July 10, 2004

Summary of Safety and Effectiveness for the:

Trade Name:	American Bantex Humidifier
Common Name:	Bubble Humidifier, Dry
Classification Name:	Respiratory gas humidifier, 21 CFR 868.5450, 73BTT, Direct PatientInterface - Class II

Legally Marketed Predicate Devices for Substantial Equivalence:

*K991484 - Airlife Bubble Humidifier, Allegiance Healthcare Corporation

Rationale for SE: The Airlife Bubble Humidifier is a Class II device that is intended to moisten the breathing gases that are delivered directly to the patient for breathing. This predicate device, along with the submitted device operate similarly by having the patient breathing gases pass through distilled water or sterile water in a refiliable plastic jar. Both devices are reusable for not more than 30 days. These are made from acrylic and polypropylene plastics and are intended for single patient use. The material types used in this and in the predicate devices are identical. The materials have previously been tested and accepted for biocompatibility and are widely accepted as industry material standards. Both the submitted device, and the predicate are latex free.

Description of Submitted Device:

Intended Uses of the American Bantex Humidifier:

The American Bantex Humidifier is intended for use with Oxygen Concentrators in a patients home, physicians office or hospital / institutional environment. The humidifier increases the moisture content of the airstream gases for administration to the patient.

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Technological Characteristics and Substantial Equivalence:

Component:	American Bantex Humidifier	Airlife Bubble Humidifier
Humidifier Bottle:	Clear polypropylene	Clear polypropylene
Lid:	ABS	ABS
Check valve and lid:	Brass / ABS	Brass / ABS
Filter tube / bulb:	PVC / PVC	PVC / ABS
510(k) Approval	This submission	K991484

Table I b: Comparison of American Bantex Humidifier to the predicate Airlife Bubble Humidifie

The characteristics, method of operation, accessory use and single patient use are equivalent to that of the predicate device. Both have a double helix threaded jar that is impact resistant and seals easily.

Conclusion:

The successful testing demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicated device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

American Bantex Corporation C/O Mr. Tracy S. Best Regulatory Affairs Consultant 994 North Main Street Bountiful, Utah 84010

Re: K041963

Trade/Device Name: American Bantex Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: October 4, 2004 Received: October 7, 2004

Dear Mr. Best:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Best

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: AMERICAN BANTEX HUMIDIFIER

Indications for Use:

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)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ques

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number. K041963

011

Page 1 of __

Regulation Number and Section

§ 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).