COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA

K061736 · Teleflex Medical · BTT · Aug 18, 2006 · Anesthesiology

Device Facts

• Record ID: K061736
• Device Name: COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
• Applicant: Teleflex Medical
• Product Code: BTT · Anesthesiology
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The COMFORT FLO™ Humidification System is intended to provide a continuous flow of heated and humidified gases to spontaneously breathing patients.

Device Story

Gas delivery system providing heated, humidified respiratory gases to spontaneously breathing patients; used in clinical settings. System components include heated circuit, Concha® Column, and nasal cannula patient interface; operates in conjunction with ConchaTherm Heated Humidifier product line. Device delivers gas at 1-40 LPM, 37°C, and near 100% relative humidity. Modifications from predicates include addition of oxygen accessory kit, temperature probe wire clip, and modified Concha® Column (check valves removed for pressure normalization). Healthcare providers use system to support respiratory therapy; benefits include maintenance of airway moisture and temperature during gas delivery.

Clinical Evidence

Bench testing only. Evaluated under simulated and extended use hospital conditions. Testing demonstrated components operate at or near 100% relative humidity and 37°C at flow rates of 1 to 40 LPM for up to 14 days without loss of functional integrity.

Technological Characteristics

Respiratory gas humidifier system consisting of heated circuit, Concha® Column (gamma-sterilized), and nasal cannula. Operates with heated wire assembly. Designed for 1-40 LPM flow. Non-sterile components except for Concha® Column.

Indications for Use

Indicated for spontaneously breathing adult, pediatric, infant, and neonatal patients requiring continuous flow of heated and humidified respiratory gases.

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

• Hudson RCI Breathing Circuits (K031383)
• Hudson RCI Breathing Circuits (K010402)
• Hudson RCI ConchaTherm IV Heated Molecular Humidifier (K923946)
• Fisher & Paykel MR850 Respiratory Humidifier (K033710)

Submission Summary (Full Text)

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847-572-8001

AUG 1 8 2006 Teleflex Medical Group Headquarters 2345 Waukegan Road, Suite 120 Bannockburn, IL 60015 USA Phone: [phone]

Fax:

www.teleflex.com

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS COMFORT FLO™ Humidification System

#### A. Name. Address. Phone and Fax Number of Applicant

Teleflex Medical 2345 Waukegan Road Suite 120 Bannockburn, IL 60015

## B. Contact Person

Lori Hays Senior Manager, Regulatory Affairs

#### C. Date Prepared

August 9, 2006

#### D. Device Name

Trade Name: COMFORT FLO™ Humidification System

Common Name: Humidification System

Classification Name: Respiratory Gas Humidifier

Product Code: BTT

Regulation Number: 21 CFR 868.5450

Class: Il

#### E. Device Description

The COMFORT FLO™ Humidification System is a gas delivery system.This system is designed to deliver heated and humidified respiratory gases to spontaneously breathing adult, pediatric, infant, and/or neonatal patients. This delivery system will be used in conjunction with the ConchaTherm Heated Humidifier product line.

The COMFORT FLO™ Humidification System consists of a heated circuit, a Concha® Column, and a nasal cannula patient interface. All components of the COMFORT

A Division of Telex incorporated

beere | KMedic | Pilling | SURGICAL SERVICES | RUSCH | WECK | C Yevolutions

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FLO™ Humidification System are non-sterile with the exception of the gamma-sterilized Concha® Column.

# F. Intended Use

The COMFORT FLO™ Humidification System is intended to provide a continuous flow of heated and humidified gases to spontaneously breathing patients.

## G. Substantial Equivalence

The COMFORT FLO™ Humidification System is substantially equivalent to the components of the currently marketed Hudson RCI Breathing Circuits (K031383 and K010402), Hudson RCI ConchaTherm IV Heated Molecular Humidifier (K923946) and Fisher & Paykel MR850 Respiratory Humidifier (K033710). These systems have the following similarities:

- 1. Can be used with a heated wire assembly.
- 2. Intended to deliver heated humidified gas to patients.

The major differences between the COMFORT FLO™ Humidification System and the currently marketed Hudson RCI Breathing Circuits (K031383 and K010402), Hudson RCI ConchaTherm IV Heated Molecular Humidifier (K923946) and Fisher & Paykel MR850 Respiratory Humidifier (K033710) are as follows:

- 1. The COMFORT FLO™ Humidification System will be sold with the oxygen accessory kit. These components are not sold with the currently marketed system.
- 2. The COMFORT FLO™ Humidification System will contain a temperature probe wire clip not found on the currently marketed system.
- 3. The COMFORT FLO™ Humidification System will contain a Concha® Column which has the check valves removed to help normalize the pressure in the water bottle with the pressure in the circuit.

# H. Summary of Testing

The COMFORT FLO™ Humidification System was evaluated and tested under simulated and extended use hospital conditions to demonstrate that all components can operate at or near 100% Relative Humidity, 37°C, and a rate of 1 to 40 LPM for up to 14 days without loss of functional integrity.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three overlapping profiles suggesting a sense of community or interconnectedness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2006

Teleflex Medical C/O Mr. Neil E. Devine Responsible Third Party Official Tntertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K061736

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Trade/Device Name: COMFORT FLO™ Humidification System Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: August 3, 2006 Received: August 4, 2006

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 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 (QS) 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), please contact the Office of Compliance 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 Division 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.

Clrs
Chin-Lien, Ph.D.

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

510(k) Number (if known):

Device Name: COMFORT FLO™ Humidification System

Indications For Use:

To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Aur Suliom

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K061136