(9 days)
AquinOx is designed for use to add moisture to and to warm breathing gases for administration to a patient.
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.
The provided text describes the AquinOx Humidifier and its 510(k) submission. However, it explicitly states that no clinical studies were necessary to demonstrate the device's safety, effectiveness, and performance. Therefore, a comprehensive set of acceptance criteria and a study proving device performance against those criteria, as typically seen in clinical trials or performance studies involving efficacy endpoints, are not present in this document.
Instead, the submission relies on non-clinical studies (thermal safety, environmental, and functional performance) and a claim of substantial equivalence to predicate devices. This means the acceptance criteria are implicitly met by demonstrating that the AquinOx performs similarly to already-approved devices, rather than establishing de novo performance benchmarks.
Below is an attempt to address your request based on the information provided, acknowledging the limitations for a full response:
1. Table of Acceptance Criteria and Reported Device Performance
As no specific quantitative acceptance criteria or detailed performance results from a clinical study are provided, this table is based on the general statements made in the submission.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Thermal Safety | Device operates without generating unsafe delivery temperatures. | Device will not heat delivery gases without water and proper gas flow; inherently unable to generate unsafe delivery temperature (similar to predicate). Non-clinical studies performed. |
| Environmental Safety | Device performs safely in expected environmental conditions. | Non-clinical studies performed. |
| Functional Performance | Device successfully adds moisture and warms breathing gases for administration to a patient. | Non-clinical studies performed. Performs substantially equivalent to predicate devices (Thera-Mist P35000 and Vapotherm 2000i). |
| Substantial Equivalence | Device performs as safely and effectively as predicate devices for its intended use. | Found to be substantially equivalent to predicate devices K894000 and K000401. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable, as no clinical test set involving human subjects was used for performance evaluation in the context of efficacy or diagnostic accuracy. The "test set" would refer to the units tested in non-clinical lab studies. The document does not specify the number of units tested.
- Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering and lab testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as there was no clinical test set requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be defined by engineering specifications and standards.
4. Adjudication Method for the Test Set
- Not applicable as there was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device does not involve human interpretation of outputs that would benefit from such a study (e.g., medical imaging AI).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This concept is not directly applicable. The AquinOx is a medical device, not an AI algorithm. Its performance is inherent to its physical operation, not a software algorithm that can be evaluated in "standalone" mode. The non-clinical studies implicitly evaluate its "standalone" physical performance.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical studies would be defined by engineering specifications, established physical principles, and relevant industry/regulatory standards for humidifier performance (e.g., temperature and humidity output accuracy, safety limits). There is no "expert consensus," "pathology," or "outcomes data" ground truth referenced, as no clinical study was performed.
8. The Sample Size for the Training Set
- Not applicable. The AquinOx Humidifier is not an AI/ML device that requires a training set. Its design and validation rely on engineering principles, materials science, and testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
Summary of Study (Based on Provided Text):
The submission for the AquinOx Humidifier did not include, nor did FDA require, clinical studies. The "studies" performed were non-clinical, focusing on thermal safety, environmental performance, and functional performance. The device's acceptance was based on demonstrating substantial equivalence to two legally marketed predicate devices by confirming that it uses similar technology and performs similarly in terms of safety and intended function. The ground truth for these non-clinical tests would have been engineering specifications and safety standards rather than clinical outcomes or expert consensus.
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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.
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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.
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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.
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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
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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
Page 1 of 1 Page 2-1
§ 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).