AQUINOX

K050314 · Smiths Medical Asd, Inc. · BTT · Feb 18, 2005 · Anesthesiology

Device Facts

• Record ID: K050314
• Device Name: AQUINOX
• Applicant: Smiths Medical Asd, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Feb 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

AquinOx is designed for use to add moisture to and to warm breathing gases for administration to a patient.

Device Story

AquinOx is a single-patient-use respiratory gas humidifier; attaches to compressed air or oxygen sources. Device integrates with P20000 heater (Pegasus Research) and standard water bottles. Water is drawn into a chamber onto a heating surface to warm and humidify gas before delivery to patient. Designed for high-flow delivery via nasal cannula. Safety mechanism prevents heating without water and proper gas flow. Used in clinical settings to provide moisture and warmth to breathing gases, potentially improving patient comfort and airway management.

Clinical Evidence

No clinical studies were performed. Safety and effectiveness were demonstrated through non-clinical bench testing, including thermal safety, environmental, and functional performance evaluations.

Technological Characteristics

Respiratory gas humidifier; single-patient-use. Attaches to external heater (P20000). Heating/humidification via water chamber and heating surface. Compatible with standard water bottles. High-flow gas delivery via nasal cannula. Inherently safe thermal design prevents heating without water/flow.

Indications for Use

Indicated for patients requiring warmed and humidified breathing gases, including high-flow gas delivery via nasal cannula.

Regulatory Classification

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

• Thera-Mist P35000 Humidifier (K894000)
• Vapotherm 2000i (K000401)

Submission Summary (Full Text)

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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: [phone] 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

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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 [phone]. 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 [phone] or [phone] 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

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