← Product Code [BTT](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT) · K090915 # STERILE WATER FOR INHALATION FLEX BAG, USP (K090915) _Cardinal Health, Inc. · BTT · Nov 18, 2009 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K090915 ## Device Facts - **Applicant:** Cardinal Health, Inc. - **Product Code:** [BTT](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT.md) - **Decision Date:** Nov 18, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5450 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** 3rd-Party Reviewed ## Indications for Use The Sterile Water for Inhalation Flex Bag USP bag 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 Story Device consists of flexible plastic bag pre-filled with sterile water; includes single port at base. Tubular feed sets connect bag to unfilled humidifier chambers. Water flows via gravity to fill humidifier chambers. Used in institutional and non-institutional care settings. Provides sterile water supply for respiratory humidification systems. ## Clinical Evidence No clinical data. Verification and validation testing demonstrated the device meets performance requirements. ## Technological Characteristics Flexible plastic bag with single port; gravity-fed delivery system. Sterile water for inhalation USP. Disposable container. ## Regulatory 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. ## Predicate Devices - Respiratory Therapy Solutions - Flexible ([K780381](/device/K780381.md)) - Prefilled Respiratory Therapy Humidifier containing Sterile Water for Inhalation USP ([K853146](/device/K853146.md)) - U Mid Prefilled Humidifier Becton Dickinson Vacutainer Systems Pre-Analytic ([K760584](/device/K760584.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K090915 ## 510 (K) SUMMARY NOV 1 g 2009 | . Manufacturer | Cardinal Health
1500 Waukegan Road
McGaw Park Illinois 60085 | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Kimberly Southwell
760-778-7280 (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 for
Inhalation | | 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 Humidifier
containing Sterile Water for Inhalation USP | | | K760584 U Mid Prefilled Humidifier Becton
Dickinson Vacutainer Systems Pre-Analytic | | 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 | 1 5 {1}------------------------------------------------ ## 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 {2}------------------------------------------------ ## 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. {3}------------------------------------------------ ## 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known) K090915 Device Name Sterile Water for Inhalation Flex Bag USP Indications for Use 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 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 1 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K090915](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K090915) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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