SULLIVAN HUMIDAIRE HEATED HUMIDIFIER

K971260 · Resmed Corp · BTT · Sep 4, 1997 · Anesthesiology

Device Facts

• Record ID: K971260
• Device Name: SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
• Applicant: Resmed Corp
• Product Code: BTT · Anesthesiology
• Decision Date: Sep 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HumidAire™ Heated Humidifier is indicated for the humidification and warming of the air from nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems, but not autoset systems. The HumidAire is for prescription use only.

Device Story

SULLIVAN HumidAire Heated Humidifier is an accessory device for CPAP and bi-level respiratory systems. It functions by warming and humidifying air delivered to the patient to improve comfort and reduce airway dryness. The device is intended for use in clinical or home settings under prescription. It integrates with existing CPAP/bi-level airflow circuits. The healthcare provider or patient connects the humidifier to the airflow path; the device operates to condition the air before it reaches the patient interface. By maintaining appropriate moisture and temperature levels, the device helps mitigate side effects associated with dry, unconditioned pressurized air, potentially improving patient compliance with respiratory therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Heated humidifier accessory for CPAP/bi-level systems. Designed for warming and humidifying pressurized air. Standalone accessory unit. No software or complex algorithms described.

Indications for Use

Indicated for patients requiring humidification and warming of air delivered via nasal CPAP or bi-level respiratory systems. Contraindicated for use with autoset systems. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

SEP - 4 1997

Mr. David D'Cruz
ResMed Ltd.
CAN 003 765 142
82 Waterloo Road
North Ryde NSW 2113
AUSTRALIA

Re: K971260
SULLIVAN® HumidAire™ Heated Humidifier
Regulatory Class: II (two)
Product Code: 73 BTT
Dated: July 16, 1997
Received: July 18, 1997

Dear Mr. D'Cruz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have 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. David D'Cruz

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K971260

Device Name: SULLIVAN® HumidAire™ Heated Humidifier

Indications For Use:
The HumidAire™ Heated Humidifier is indicated for the humidification and warming of the air from nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems, but not autoset systems. The HumidAire is for prescription use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (For 21 CFR 801.109)
OR
Over-The-Counter Use ☐
(Optional Format 1-2-96)

Mr. Pugl
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971260