PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY

K020700 · Pegasus Research Corp. · BTT · Apr 26, 2004 · Anesthesiology

Device Facts

• Record ID: K020700
• Device Name: PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
• Applicant: Pegasus Research Corp.
• Product Code: BTT · Anesthesiology
• Decision Date: Apr 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PMH Humidifier is intended to add moisture and To warm the breathing gases for administration to a patient. The humidifier is intended for use with flows of 5 liters per Minute or more through the humidifier.

Device Story

The PMH 5000 Heated Humidifier is a respiratory therapy device designed to warm and humidify breathing gases before delivery to a patient. It operates by passing gas through a heating and humidification chamber. The device is intended for clinical use in settings where patients require respiratory support at flow rates of 5 liters per minute or higher. By conditioning the gas, the device helps maintain airway moisture and temperature, potentially improving patient comfort and preventing complications associated with dry, cold medical gases. It is operated by healthcare professionals in a clinical environment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Respiratory gas humidifier; heating element for warming gases; humidification chamber; designed for flow rates of 5 L/min or greater; Class II device (Product Code BTT).

Indications for Use

Indicated for patients requiring warmed, humidified breathing gases at flow rates of 5 liters per minute or greater.

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.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 6 2004

Mr. Kenneth G. Miller President Pegasus Research Corporation 1714 South Lyon Street Santa Ana, California 92705

Re: K020700

Trade/Device Name: Pmh 5000 Heated Humidifier for Respiratory Therapy Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: February 16, 2004 Received: February 20, 2004

Dear Mr. Miller:

We have reviewed your Section 510(k) promarket 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 cither 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. Miller

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/dsma/dsmamain.html

Sincerely yours,

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): K020700

PMH 5000 HEATED HUMIDIFIER Device Name:

Indications For Use: The PMH Humidifier is intended to add moisture and To warm the breathing gases for administration to a patient. The humidifier is intended for use with flows of 5 liters per Minute or more through the humidifier.

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)

Cdh

510(k) Number:

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

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