HEATED HUMIDIFIER

K983783 · Pegasus Research Corp. · BTT · Oct 24, 2000 · Anesthesiology

Device Facts

• Record ID: K983783
• Device Name: HEATED HUMIDIFIER
• Applicant: Pegasus Research Corp.
• Product Code: BTT · Anesthesiology
• Decision Date: Oct 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Patient End Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.

Device Story

Patient-End Humidifier adds moisture and heat to breathing gases administered to patients. Device operates as an accessory to respiratory therapy equipment. Used in clinical settings under physician direction. Provides humidification and warming to improve patient comfort and airway management during gas delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Heated humidifier for respiratory gas conditioning. Device functions as a thermal and moisture transfer interface. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for patients requiring warmed and humidified breathing gases during respiratory therapy. 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 20

Mr. Ken Miller Pegasus Research Corporation 1714 South Lyon Street Santa Ana, CA 92705

K983783 Re: Heated Humidifier Regulatory Class: II (two) 73 BTT Product Code: Dated: September 19, 2000 September 20, 2000 Received:

Dear Mr. Miller:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosi and we have determined the device is the device releived above and a indications for use stated in the Substantially equivalens (collected predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Intelstate Commerce prior of the devices that have been reclassified Medical Device Amendales, of the Federal Food, Drug, and in accordance with the provisions of the market the device, subject to the general controls provisions of the Act. The general controls the general concrols provisions of the manual registration, provisions of the ... o od manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device is class III (Premarket Approval), it may be subject to such controls) of Clabo III (Freman major regulations affecting your device add cronar concern the Code of Federal Regulations, Title 21, Parts 800 can be round in choise determination assumes compliance co oss. If babbeansed to the entire requirements, as set with the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regaracter.
The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in abounpeasin. concerning your device in the Federal Register. Please note: this cesponse to your premarket notification submission does not affect any rebbense to your promave under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Ken Miller

This letter will allow you to begin marketing your device as described This letter will allow you co begin marketing your advace of substantial
in your 510(k) premarket notification. The Finding of substantial in your 510(K) premarket notification. I marketed predicate device equivalence of your device to a regardy
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 If you desire specific advice for your router for in vitro regulation (21 Crk Fart our and the Office of Compliance at diagnostic devices), preace contact constions on the promotion and [phone]. AdditIonally, for quoters' on 665 - of Compliance at
advertising of your device, please contact and the entitled advertising of your device, prease the regilation entitled, and to response of .
(101) 594–4639. Also, please, note the regilation entitled, and .97) .
"Misbranding by refere "Misbranding by reference on your responsibilities under the Act may Other general Information on your seall Manufacturers Assistance at its internet be obtained Irom the Drision of Email (193–6597, or at its internet correllee number (000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sincerely yours,

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James/E. Dillard III Diredtor Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510K NUMBER: K983783

DEVICE NAME: PATIENT-END HUMIDIFIER

INDICATIONS FOR USE:

The Patient End 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)

Division of Cardiovascular & Respiratory Devi
K983783

Prescription Use _X (Per CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________