(231 days)
Not Found
No
The device description and intended use clearly describe a simple sterile water bag for humidifiers, with no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The device provides sterile water for respiratory humidifier chambers but does not directly treat a medical condition or disease.
No
Explanation: The device is a sterile water bag intended to supply water to humidifier chambers, not to diagnose any medical condition.
No
The device description clearly states it is a "flexible plastic bag with a single port at the base and is pre-filled with sterile water," indicating it is a physical product containing a substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide sterile water for respiratory humidifier chambers. This is a therapeutic or supportive use, not a diagnostic one.
- Device Description: The device is a bag of sterile water and associated tubing for filling a humidifier. This is a medical device used in patient care, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
BTT
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
institutional and non institutional care settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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