POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION

K062091 · Porous Media Corp. · BTT · Aug 8, 2006 · Anesthesiology

Device Facts

• Record ID: K062091
• Device Name: POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
• Applicant: Porous Media Corp.
• Product Code: BTT · Anesthesiology
• Decision Date: Aug 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient. The HUMIDIFLOW™ is intended to be installed on oxygen concentrators to add moisture to the breathing gases for administration to a patient.

Device Story

HUMIDIFLOW™ is a respiratory gas humidifier designed for installation on oxygen concentrators. It attaches to the inlet side of the air compressor and the outlet oxygen stream. The device functions as a mass exchanger, transferring humidity from atmospheric air to the dry oxygen stream via diffusion. This process adds moisture to the breathing gases administered to the patient. It is intended for use in clinical or home settings where oxygen concentrators are utilized. The device provides a humidified gas output to improve patient comfort during oxygen therapy.

Clinical Evidence

Bench testing only. Performance testing evaluated humidity output and the impact of device installation on various oxygen concentrators. Biocompatibility testing was performed to confirm safety. No clinical data was required or presented.

Technological Characteristics

Materials: Nylon shell/end caps, Buna-N O-ring, USP Class VI flexible vinyl tubing, Nylon fittings, and proprietary membrane. Operates via passive diffusion of moisture vapor from atmospheric air to oxygen stream. Standalone mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy who need moisture added to breathing 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

• Allegiance bubble humidifier (K991484)
• Salter Labs' bubbler (REF 7600)

Reference Devices

• Puritan Bennett 840 ventilator (K053388)
• Respironics Millenium concentrator (K043006)

Submission Summary (Full Text)

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## 510(k) Summary

### APPLICANT

Porous Media Corporation 1350 Hammond Road St. Paul, MN 55110 Telephone: [phone] Fax: [phone] Contact: Keith Roberts Title: Technical Business Development

# DATE

6/20/06

NAME HUMIDIFLOW™ Humidifier

### CLASSIFICATION

Respiratory gas humidifier, 21 CFR 868.5450, Class II

# PRODUCT CODE

BTT

## DEVICE DESCRIPTION

The HUMIDIFLOW™ is a new device that humidifies oxygen. The device attaches to the inlet side of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas.

#### PREDICATE DEVICE

The Porous Media HUMIDIFLOW™ is substantially equivalent to the Allegiance bubble humidifier (subject of premarket notification K991484) and Salter Labs' bubbler (part number REF 7600) which has been on the market prior to 1976.

#### PERFORMANCE TESTING

Performance characteristics that could be affected by the installation of the HUMIDIFLOW™ were identified for the various oxygen concentrators for which HUMIDIFLOW™ would be installed. The device was also measured for humidity output. All testing indicates that the device is substantially equivalent to the predicate device.

#### INTENDED USE

Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient. The HUMIDIFLOW™ is intended to be installed on oxygen concentrators to add moisture to the breathing gases for administration to a patient.

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| | HUMIDIFLOW™ | Predicate Device (Salter Labs<br>REF 7600) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Intended Use | For gas humidification | For gas humidification |
| Method of operation | Transfer of moisture vapor<br>from atmospheric air to dry<br>oxygen stream via diffusion | Transfer of moisture vapor and<br>droplets to dry gas stream via<br>bubble-through operation |
| Materials of<br>construction | ProprietaryShell/End Caps:<br>Nylon<br>O-ring: Buna-N<br>Tubing: USP Class VI,<br>flexible vinyl<br>Fittings: Nylon<br>Membrane: [redacted] | N/A |
| Method of installation | Installs on the inlet side of<br>the air compressor and<br>oxygen outlet | Installs on the outlet oxygen<br>stream |

# SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

## CONCLUSIONS DRAWN FROM NON-CLINICAL TESTING

The conclusions that can be drawn from the non-clinical testing are that the HUMIDIFLOW™ humidifier performs substantially equivalent as the predicate bubbler humidifier. The HUMIDIFLOW™ is biocompatible and manufactured with the identical membrane and adhesive components that are already used in other products we supply for gas flow path applications for the Puritan Bennett 840 ventilator subject of premarket notification K053388. The Polyester shell and endcaps used in the construction of the HUMIDIFLOW™ is identical to the Polvester shell used for a filter capsule provided to Respironics for the Millenium concentrator which was the subject of premarket notification K043006. Porous Media has also performed additional biocompatibility testing to show the HUMIDIFLOW™ is biocompatible.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in all capital letters. The text is arranged in a circular fashion around the eagle.

NOV 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Porous Media Corporation C/O Mr. Neil E. Devine Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

Re: K062091

Trade/Device Name: Humidflow TM Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: July 21, 2006 Received: July 24, 2006

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of August 8, 2006.

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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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 premiance results and the 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), nlease 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,

Sutte y. Michael Oms.

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): N / A

Device Name: Humidflow TM

Indications For Use: Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient.

K062091

Prescription Use (Part 21 CFR 801 Sybpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Guy Sullivan

Division Sig , General Hospital, sthesiolog Division of A Infection Control, Der

510(k) Number:***_***_

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