The Sterile Water for Inhalation Flex Bag USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers It is intended to be used In institutional and non institutional care settings

Device Description

The Sterile Water for Inhalation Flex Bag USP is a flexible plastic bag with a single port at the base and is pre-filled with sterile water Tubular feed sets connect the sterile water bags to unfilled humidifier chambers The humidifier chamber is then filled with sterile water from the sterile water bags via gravity

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Sterile Water for Inhalation Flex Bag USP":

Acceptance Criteria and Study for Sterile Water for Inhalation Flex Bag USP

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a "Sterile Water for Inhalation Flex Bag USP." The primary objective is to prove that the new device meets its intended performance requirements and is comparable to existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	Supply of sterile water to unfilled respiratory humidifier chambers.	Fully meets intended use.
Classification	BTT Classification.	Meets BTT Classification.
Manufacturing & Packaging	Manufactured and packaged utilizing same basic processes as predicates for sterile water for inhalation USP in a disposable plastic container.	Meets manufacturing and packaging process criteria.
End Use	Sterile water end use is in conjunction with humidification systems.	Meets end use criteria.
Overall Performance	Meets intended performance requirements at all levels.	"Verification and Validation Testing demonstrates that the Cardinal Health Sterile Water for Inhalation Flex Bag meets its intended performance requirements at all levels."
Substantial Equivalence	Demonstrably comparable to predicate devices in terms of intended use, classification, manufacturing, packaging, and end use.	Demonstrated substantial equivalence to predicate devices (K780381, K853146, K760584).

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

The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The summary only broadly mentions "Verification and Validation Testing."

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

This information is not provided in the document. The type of device (sterile water in a bag) typically relies on chemical, microbiological, and physical testing, rather than expert interpretation of complex images or data to establish 'ground truth' in the way a medical AI device would.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this device. Adjudication methods like '2+1' or '3+1' are typically used for studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution. This is not relevant for the testing of a sterile water bag.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human readers interpreting medical images or data, which is not applicable to a sterile water bag.

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

No, a standalone algorithm performance study was not done. This device is a medical product (sterile water bag), not a software algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for this device would be established through a combination of:

Chemical Analysis: Verifying the water meets USP (United States Pharmacopeia) standards for sterile water for inhalation.
Microbiological Testing: Confirming sterility.
Physical Testing: Assessing bag integrity, port functionality, and compatibility with humidification systems.
Performance Testing: Ensuring effective delivery of sterile water from the bag to humidifier chambers via gravity feed as intended.

The document refers to "Verification and Validation Testing," which implies these types of objective, measurable criteria were used to establish the "ground truth" of the device's performance characteristics.

8. The Sample Size for the Training Set

This information is not provided and is not applicable for this type of device. The concept of a "training set" is relevant for machine learning or AI models, not for a physical medical device like a sterile water bag.

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

This information is not provided and is not applicable for this type of device. As explained above, there is no "training set" in the context of this product. The 'ground truth' for the device itself is established through direct, objective testing and adherence to established standards (like USP).

Summary

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K090915

510 (K) SUMMARY

NOV 1 g 2009

. Manufacturer	Cardinal Health1500 Waukegan RoadMcGaw Park Illinois 60085
Contact	Kimberly Southwell760-778-7280 (phone/fax)
Summary Date	March 18 2009
Device Trade Name	Sterile Water for Inhalation Flex Bag USP
Device Common/Classification Name	Humidifier Respiratory Gas / Sterile Water forInhalation
Regulation Number	868 5450
Product Code	BTT
Device Class	Class II
Classification Panel	Anesthesiology
Predicate Device	The predicate device(s) are
	K780381 Respiratory Therapy Solutions - Flexible
	K853146 Prefilled Respiratory Therapy Humidifiercontaining Sterile Water for Inhalation USP
	K760584 U Mid Prefilled Humidifier BectonDickinson Vacutainer Systems Pre-Analytic
Device Description	The Sterile Water for Inhalation Flex Bag USP is aflexible plastic bag with a single port at the baseand is pre-filled with sterile water
	Tubular feed sets connect the sterile water bags tounfilled humidifier chambers
	The humidifier chamber is then filled with sterilewater from the sterile water bags via gravity

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Intended Use

The Stenle Water for Inhalation Flex Bag USP bag is intended to provide a supply of stenle water to unfilled respiratory humidifier chambers It is intended to be used in institutional and non institutional care settings

Substantial equivalence

The Sterile Water for Inhalation Flex Bag USP bag is comparable to the predicate devices in so far as it is a supply of stenle water for inhalation and is used in conjunction with a humidification system

The Cardinal Health Sterile Water for Inhalation Flex Bag has the following similanties to those which previously received 510(k) concurrence

the same basic intended use (supply of stenle water for inhalation)

BTT Classification

manufactured and packaged utilizing same basic processes (stenle water for inhalation USP in a disposable plastic container)

sterile water end use is in conjunction with humidification systems

The Cardinal Health Stenle Water for Inhalation Flex Bag described in this submission is in our opinion is substantially equivalent to the predicate device(s) disclosed

Summary of Testing Verification and Validatıon

Venfication and Validation Testing demonstrates that the Cardinal Health Sterile Water for Inhalation Flex Bag meets its intended performance requirements at all levels and that this device is substantially equivalent to medical devices currently legally marketed in the United States

Response to 30 Party Findings

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062-2096

NOV 1 8 2009

Re: K090915

Trade/Device Name: Sterile Water for Inhalation Flex Bag USP Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: November 6, 2009 Received: November 9, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting 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) K090915

Device Name Sterile Water for Inhalation Flex Bag USP

Indications for Use

Prescription Use XX Over The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE OF NEEDED

L. Smith
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

) Number: K090915

Response to 30 Party Findings

Pag 19 f 27

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).