A nebulizer cap deliver an aerosol of oxygen, air, and either water or saline. It consists of a dry device attached to a bottle of sterile solution. In use, the device attaches to a 50 psi source of oxygen. which is regulated by a flow meter. An air entrainment dial regulates airflow to adjust for desired oxygen concentration. The outlet port attaches to 22 mm corrugated tubing, which acts as a conduit for the aerosol to the patient.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cardinal Health Airlife Nebulizer Cap:

Based on the provided document, the "acceptance criteria" and "study" are not presented in a typical format of a clinical trial or algorithm performance study. Instead, the document details a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device.

The "acceptance criteria" for a 510(k) submission are fundamentally based on demonstrating substantial equivalence, meaning the new device is as safe and effective as a predicate device. The "study" described is a non-clinical testing summary designed to prove this substantial equivalence.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (Summary of Testing)
Intended Use Equivalence: Same as predicate device.	"The intended use is the same"
Performance Attributes Equivalence: Same as predicate device.	"The performance attributes are the same"
Technological Characteristics Equivalence: Composed of same or similar design, materials, manufacturing characteristics.	"The proposed device and the predicate device are composed of the same or similar design, materials and the manufacturing characteristics."
Biocompatibility/Safety: Materials meet biological qualification standards.	"All materials used in the fabrication of the Airlife Nebulizer Cap were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'."
Functional Characteristics: Equivalent to predicate device.	"Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed Nebulizer Cap with regard to functional characteristics."
Material Quality: Materials meet industry-recognized test methods and are acceptable for intended use.	"These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "materials" and "the proposed device" being tested, implying that samples of the device and its components were subjected to various tests. It's not a human-subject study, so there's no "test set" in the sense of patient data.
Data Provenance: The testing was carried out by the manufacturer, Cardinal Health, likely at their facilities or certified labs. No country of origin for specific "data" is mentioned, as it's not a study with diverse patient populations. This is retrospective in the sense that the testing was performed on the device components/product to satisfy regulatory requirements before marketing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as there is no "ground truth" in the context of expert consensus on medical images or diagnoses. The "ground truth" for this type of device (a nebulizer cap) is its adherence to material safety standards, functional specifications, and established engineering principles, which are verified through objective non-clinical tests rather than expert interpretation of a clinical outcome.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" is essentially the regulatory body (FDA) reviewing the test results presented by the manufacturer to determine substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This is a physical medical device (nebulizer cap), not an AI algorithm or diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is based on accepted industry standards and regulatory requirements for medical device materials (e.g., ISO 10993 Part-1 for biocompatibility) and functional performance metrics. The predicate device's established safety and effectiveness also serve as a 'ground truth' benchmark for the substantial equivalence claim.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for a physical medical device undergoing non-clinical testing for 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device. The "study" described is a series of non-clinical tests (biocompatibility, performance testing) to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" are derived from the requirements for substantial equivalence, focusing on identical intended use, performance attributes, and similar technological characteristics, backed by evidence of material safety and functional equivalency. It does not involve AI, human readers, or clinical trials with ground truth established by experts or pathology in the way a diagnostic algorithm would.

Summary

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CardinalHealth

AUG 1 0 2007

K072119
page 1 of 2

Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506

SMDA REQUIREMENTS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife Nebulizer Cap

1430 Waukegan Road MPKB

McGaw Park, IL 60085

Sponsor:

Regulatory Affairs: Contact

Sharon Nichols

(847) 578-6610

Airlife Nebulizer Cap

Nebulizer (Direct Patient Interface)

Class II per 21CFR §868.5630

Airlife Nebulizer Cap, K962161 Nebulizer with Air Entrainment and Immersion Heater Adapter, K801251

May 2007

Cardinal Health

Telephone:

Date Summary Prepared:

Common Name:

Classification Name:

Classification:

Predicate Device:

Description:

000022

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The Nebulizer cap is for use with Sterile Intended Use: Water or Saline for Inhalation, USP in 500 ml and 1000 ml, and 1500 ml bottles for inhalation therapy only. Substantial Equivalence: The Airlife Nebulizer Cap is substantially equivalent to the Airlife Nebulizer Cap in that: - the intended use is the same - the performance attributes are the same . Summary of Technological Characteristics: The proposed device and the predicate device are composed of the same or similar design, materials and the manufacturing characteristics. Summary of testing: All materials used in the fabrication of the

Non-Clinical Testing:

Airlife Nebulizer Cap were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.

Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed Nebulizer Cap with regard to functional characteristics.

000023

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.

AUG 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K072119

Trade/Device Name: Airlife Nebulizer Cap Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 31, 2007 Received: August 1, 2007

Dear Mr. Devine:

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. Devine

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 (OS) 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) 276-0120. 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/industry/support/index.html.

Sincerely yours,

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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Indication for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Unknown at this time

Airlife Nebulizer Cap

The Nebulizer cap is for use with Sterile Water or Saline for Inhalation, USP in 500 ml, 1000 ml, and 1500 ml bottles for inhalation therapy only.

Prescription Use X (Per 21 CFR 801.109)

Over-The C

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

N.Ch

. Bc Division Sign-Off) actiong BC . Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072119

000019

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).