(9 days)
Not Found
No
The summary describes a standard humidifier for breathing gases and does not mention any AI or ML components or functionalities.
Yes
The device is described as warming and humidifying breathing gases for administration to a patient, which directly serves a therapeutic purpose by improving the quality of the gas delivered to the respiratory system. The predicate devices also explicitly mention "Humidifier."
No.
The device's intended use is to add moisture and warm breathing gases for patient administration, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a hardware device that attaches to air/oxygen sources, warms and humidifies gases, and connects to a heater and water bottles. It is not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "add moisture to and to warm breathing gases for administration to a patient." This describes a device used in vivo (on or within a living organism) to modify gases for respiration.
- Device Description: The description reinforces this by stating it attaches to air/oxygen sources and warms/humidifies the gases before administration to a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to diagnose diseases, monitor conditions, or screen for health issues by examining samples outside the body.
Therefore, the AquinOx Humidifier is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AquinOx is designed for use to add moisture to and to warm breathing gases for administration to a patient.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
The AquinOx Humidifier is a single patient use device. The device attaches to a compressed air or oxygen source. The input air or oxygen is warmed and humidified before leaving the device. AquinOx attaches to the P20000 heater manufactured by Pegasus Research Corporation and is compatible with multiple commercially available water bottles.
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
Not Found
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)
No clinical studies were necessary to demonstrate the safety, effectiveness, and performance of the device.
Non-clinical studies were performed covering thermal safety, environmental, and functional performance.
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
Smiths Medical ASD, Inc.
AquinOx
050314
510(k) Summary
FEB 1 8 2005
December 2, 2004
Submitter:
Smiths Medical ASD, Inc. One Madison Street Wampsville, NY 13163
Contact: David Geary, Regulatory Affairs Manager Phone: 315-363-2330 x267 315-363-9462 Fax:
Device Name:
Product Code Name: Trade name: Common Name: Classification Name: DRIP AquinOx Humidifier Respiratory Gas Humidifier - 868.5450
Predicate Devices:
Thera-Mist P35000 Humidifier K894000 Pegasus Research Corporation 1714 South Lyon St. Santa Ana, CA 92705
Vapotherm 2000i K000401 Vapotherm Inc. 107 Ridgely Ave. Suite 9 Annapolis, MD 21401
Device Description:
The AquinOx Humidifier is a single patient use device. The device attaches to a compressed air or oxygen source. The input air or oxygen is warmed and humidified before leaving the device. AquinOx attaches to the P20000 heater manufactured by Pegasus Research Corporation and is compatible with multiple commercially available water bottles.
Intended Use:
AquinOx is designed for use to add moisture to and to warm breathing gases for administration to a patient.
Technological Characteristics Compared to Predicate:
AquinOx uses the same technology as the Thera-Mist P35000 for heating and humidifying the breathing gases for introduction to the patient. The water is drawn into the chamber and onto the heating surface. Like the P35000, AquinOx will not heat the delivery gases without water and proper gas flow and is therefore inherently unable to generate an unsafe delivery temperature. As is the case with the Vapotherm predicate, AquinOx delivers high flows of warmed and humidified gases via nasal cannula.
1
Summary of Studies:
No clinical studies were necessary to demonstrate the safety, effectiveness, and performance of the device.
Non-clinical studies were performed covering thermal safety, environmental, and functional performance.
Conclusion Drawn from Studies
For the indication for use, the AquinOx humidifier performs substantially equivalent to the predicate devices. In the opinion of Smiths Medical ASD, Inc., it is substantially equivalent to the predicate devices and does not adversely affect safety and effectiveness compared to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smiths Medical ASD, Incorporated C/O Mr. Ned Devine Senior Staff Engineer ENTELA. Incorporated 3033 Madison Avenue. SE Grand Rapids, Michigan 49548
Re: K050314
Trade/Device Name: AquinOx Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: February 7, 2005 Received: February 9, 2005
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.
3
Page 2 - Mr. Devine
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be auvisor that 1 DTT o losaines on that your device complies with other requirements mean that I DA nas made a detess and regulations administered by other Federal agencies. 01 the Act of ally I oderal bates and securements, including, but not limited to: registration 1 our must comply with an all also hose (21 CFR Part 801); good manufacturing practice and and listing (21 CFR Part 807), lavelity systems (QS) regulation (21 CFR Part 820); and if requirements as sectorin in the quality is 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) This letter will anow you to begal finding of substantial equivalence of your device to a premitser notified.com. - The PDF 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), If you desire specific at no 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 may obtain 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,
Jenette M, chintons.
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
4
Indications For Use
KOSO314 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: AquinOx
Indications For Use
forms For Use
AquinOx is designed for use to add moisture to and to warm breathing gases for administration to a patient.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cuyblom
Prision Sign-Off
vision of Anesthesiology, General Hospital,
rection Control, Dental Devices
5:0(k) Number: K050314
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