The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.

Device Description

The nebulizer is a single patient use device which is filled with a fluid, typically respiratory medication, and connected to an air source via flexible tubing. The nebulizer works by having the fluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized.

AI/ML Overview

The provided text describes a 510(k) submission for the Allegiance Healthcare Corporation's Airlife® Misty Max 10™ Nebulizer. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.

Therefore, many of the requested details, such as acceptance criteria in terms of performance metrics (sensitivity, specificity, AUC), sample sizes for test and training sets, data provenance for AI model development, expert qualifications, and adjudication methods for ground truth, are not applicable to this type of regulatory submission. The document explicitly states that the substantial equivalence is based on the same intended use and similar performance attributes to the predicate device.

However, I can extract the information that is present and explain why other requested information is not available in this document.

Acceptance Criteria and Device Performance (as interpreted for a 510(k) submission for a non-AI medical device):

Criterion	Reported Device Performance Statement
Biocompatibility	"All materials used in the fabrication of the Airlife® Misty Max 10™ Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'."
Particle Size Distribution	"Comparative testing was performed using the proposed, predicate and Pari-LC with regards to particle size distribution testing." (Implied: performance comparable to predicate and industry standard)
General Safety/Effectiveness	"These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." (Broad statement indicating compliance with relevant standards and suitability for its purpose.)
Intended Use	"The intended use is the same" as the predicate device, which is "a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient." (Criterion met by matching predicate device's intended use.)
Performance Attributes	"The performance attributes are similar" to the predicate device. (Criterion met by demonstrating comparable functionality to the predicate nebulizer.)

Detailed Information (as per your request, with explanations for missing data):

A table of acceptance criteria and the reported device performance:
- See table above. The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence by showing the new device is as safe and effective as a legally marketed predicate device, meeting relevant material safety and performance benchmarks. The performance is reported in terms of meeting those standards and being comparable to the predicate.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This document does not detail specific sample sizes for clinical "test sets" in the context of an AI/diagnostic algorithm testing. The testing described is primarily focused on material safety (biological compatibility) and comparative physical performance (particle size distribution) of the nebulizer hardware, not a diagnostic algorithm. Therefore, concepts like data provenance (country, retrospective/prospective) are not relevant here.
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 / Not provided. "Ground truth" in the context of expert consensus or pathology for a diagnostic algorithm is not relevant to this submission for a simple medical device (nebulizer). The "truth" here is established by standardized material and device performance tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are typically used for establishing consensus ground truth in studies involving subjective assessment (e.g., image interpretation). This is not relevant to the described testing for a nebulizer.
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:
- No. An MRMC study is not mentioned. This is a submission for a pneumatic nebulizer, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm; it is a physical medical device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Not provided in these terms. The "ground truth" for this device would be established through objective, standardized test methods for material safety (ISO 10993 Part-1) and physical performance (particle size distribution), as well as comparison to the established performance of the predicate device. There is no subjective "ground truth" established by experts or pathology in this context.
The sample size for the training set:
- Not applicable / Not provided. There is no "training set" as this is not an AI/machine learning model.
How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for a legacy class II medical device (nebulizer) seeking clearance based on substantial equivalence to a predicate device. It demonstrates performance through standard engineering and biocompatibility testing rather than clinical study designs focused on diagnostic accuracy or AI performance metrics. Therefore, most of the specific questions geared towards AI/diagnostic device evaluation are not applicable or answered within this type of regulatory submission.

Summary

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MAY = 1 2003

Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a graphic of a plus sign made up of small circles. The word is in all capital letters and is in bold.

a Cardinal Health company

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500

SMDA REQUIREMENTS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESSS

Submitter:

Allegiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, IL 60085

Regulatory Affairs Contact:	Sharon Nichols
Telephone:	(847) 785-3311
Date Summary Prepared:	April, 2003
Common Name:	Airlife ® Misty Max 10™ Nebulizer
Classification:	Class II per 21CFR § 868.5630
Predicate Device:	Airlife Misty Nebulizer
Description:	The nebulizer is a single patient use device which is filled with a fluid, typically respiratory medication, and connected to an air source via flexible tubing. The nebulizer works by having the fluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized.

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Image /page/1/Picture/0 description: The image shows the logo for Allegiance, a Cardinal Health company. The logo features a stylized cross made of small dots to the left of the word "Allegiance" in a bold, italicized font. Below the company name is the text "a Cardinal Health company" in a smaller, non-italicized font.

SMDA REQUIREMENTS (continued)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Intended Use:	The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.
Substantial Equivalence:	Airlife ® Misty Max 10 TM Nebulizer is substantially equivalent to the Airlife® Misty-Neb Nebulizer in that: - the intended use is the same - the performance attributes are similar
Summary of testing:	All materials used in the fabrication of the Airlife® Misty Max 10 TM Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". Comparative testing was performed using the proposed, predicate and Pari-LC with regards to particle size distribution testing. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.

Intended Use:

Substantial Equivalence:

Airlife ® Misty Max 10 TM Nebulizer is substantially equivalent to the Airlife® Misty-Neb Nebulizer in that: - the intended use is the same - the performance attributes are similar

Summary of testing:

All materials used in the fabrication of the Airlife® Misty Max 10 TM Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". Comparative testing was performed using the proposed, predicate and Pari-LC with regards to particle size distribution testing. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 1 2003

Ms. Sharon Nichols Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085

Re: K023602

Trade/Device Name: Airlife® Misty Max 10™ Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 31, 2003 Received: April 1, 2003

Dear Ms. Nichols:

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 - Ms. Nichols

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 (301) 594-4646. 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 vours.

Susa Runner

Susan Runner, DDS, MA Interim 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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Image /page/4/Picture/0 description: The image shows the logo for Allegiance Health. The logo features a stylized cross made of small dots to the left of the word "Allegiance" in a bold, italicized font. The logo is simple and professional, conveying a sense of trust and reliability.

a Cardinal Health company

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461

Page 1 of 1

510(k) Number (if known):

Device Name:

Indications For Use:

K023602

Airlife®Misty Max 10™ Nebulizer

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

SAHutchinson

n of Anesthesiology, General Hospital,

510(k) Number: K023602

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).