(75 days)
Not Found
Not Found
No
The summary describes a heated humidifier system for CPAP/Bilevel devices and does not mention any AI or ML capabilities.
No
The device is a heated humidifier system that adds humidity to the circuitry of positive airway pressure devices (like CPAP and Bilevel devices), which are therapeutic devices themselves. The humidifier itself does not provide therapy but supports the function of other therapeutic devices.
No
The device is a humidifier system used in conjunction with positive airway pressure devices to add humidity to the circuitry, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly mentions "Model 9200D Heated Humidifier," indicating a physical hardware component. The intended use also describes a "Heated Humidifier System" consisting of a humidifier and a heater, further confirming it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The DeVilbiss Heated Humidifier System is used to add humidity to the air delivered by positive airway pressure devices (CPAP, Bilevel, noninvasive ventilation). Its function is to improve patient comfort and potentially therapeutic effectiveness by preventing dryness in the airways.
- Lack of Diagnostic Testing: The description does not mention any capability for analyzing biological samples or providing diagnostic information about a patient's health status.
The device is a therapeutic accessory used in conjunction with respiratory support devices, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The DeVilbiss Heated Humidifier System, consisting of the 9100D DeVilbiss CPAP Humidifier and the 9200 DeVilbiss Humidifier Heater, is to be used in conjunction with most positive airway pressure devices that require humidity to be added to the circuitry.
The DeVilbiss Heated Humidifier System is not intended to be used with auto-adjusting CPAP devices unless the labeling for the CPAP machine states that the CPAP machine will function in autoset mode when used with the 9200 heated humidifier system. The heated humidifier system may adversely affect the operation of certain CPAP machines that have automated pressure setting.
The DeVilbiss Heated Humidifier System is for use in the home environment and is to be used only on the order of a physician. The humidifier can be used with CPAP and Bilevel devices, which have a maximum operating pressure of 20 cm H20. The humidifier can also be used with noninvasive ventilation devices that have a maximum operating pressure of 40 cmH20.
Product codes
73 BTT
Device Description
Not Found
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
home environment / physician order
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)
Not Found
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2002
Sunrise Medical HHG, Inc. c/o Mr. Ned Devine Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548
Re: K020900
Model 9200D Heated Humidifier Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II (two) Product Code: 73 BTT Dated: May 20, 2002 Received: May 21, 2002
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.
1
Page 2 - Mr. Ned 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K020900
Device Name DeVilbiss Model 9200D Heated Humidifier
Indications For Use:
The DeVilbiss Heated Humidifier System, consisting of the 9100D DeVilbiss CPAP Humidifier and the 9200 DeVilbiss Humidifier Heater, is to be used in conjunction with most positive airway pressure devices that require humidity to be added to the circuitry.
The DeVilbiss Heated Humidifier System is not intended to be used with auto-adjusting CPAP devices unless the labeling for the CPAP machine states that the CPAP machine will function in autoset mode when used with the 9200 heated humidifier system. The heated humidifier system may adversely affect the operation of certain CPAP machines that have automated pressure setting.
The DeVilbiss Heated Humidifier System is for use in the home environment and is to be used only on the order of a physician. The humidifier can be used with CPAP and Bilevel devices, which have a maximum operating pressure of 20 cm H20. The humidifier can also be used with noninvasive ventilation devices that have a maximum operating pressure of 40 cmH20.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020100