PMH 1000 HEATED HUMIDIFIER

K013856 · Pegasus Research Corp. · BTT · Feb 21, 2003 · Anesthesiology

Device Facts

• Record ID: K013856
• Device Name: PMH 1000 HEATED HUMIDIFIER
• Applicant: Pegasus Research Corp.
• Product Code: BTT · Anesthesiology
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PMH 1000 Heated Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.

Device Story

PMH 1000 Heated Humidifier adds moisture and heat to breathing gases administered to patients. Device operates by warming and humidifying gas flow before delivery to patient. Used in clinical settings to support respiratory therapy. Healthcare providers monitor output to ensure appropriate gas conditioning for patient comfort and airway protection. Benefits include prevention of mucosal drying and maintenance of airway humidity during mechanical ventilation or gas delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Respiratory gas humidifier; Class II; Product Code BTT; Regulation 868.5450. Device functions to heat and humidify medical gases.

Indications for Use

Indicated for patients requiring warmed and humidified breathing gases. Prescription use only.

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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FEB 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K013856

Trade/Device Name: PMH 1000 Heated Humidifier Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: January 30, 2003 Received: January 30, 2003

Dear Mr. Miller:

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. 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,

Susan Purrer

Susan Runner, DDS, MA Interim 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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510K NUMBER:

DEVICE NAME: PMH 1000 HEATED HUMIDIFIER

INDICATIONS FOR USE:

The PMH 1000 Heated Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗ OR Over-The Counter Use __
(Per CFR 801.109)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K013856