K Number
K971260
Device Name
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
Manufacturer
Date Cleared
1997-09-04

(153 days)

Product Code
Regulation Number
868.5450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
Not Found
More Information

Not Found

Not Found

No
The document describes a heated humidifier for CPAP/bi-level systems and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.

No
The device is used for humidification and warming of air from CPAP and bi-level systems for comfort, not for directly treating a disease or condition. While CPAP itself is therapeutic, this device is an accessory to improve comfort during its use.

No
The device information describes it as a heated humidifier for CPAP and bi-level systems, intended for humidification and warming of air. There is no indication that it diagnoses any condition or disease.

No

The device description and intended use clearly indicate a hardware device (Heated Humidifier) used with CPAP/bi-level systems, not a software-only application.

Based on the provided information, the HumidAire™ Heated Humidifier is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for humidifying and warming air from CPAP and bi-level systems for breathing. This is a therapeutic function related to respiratory support, not a diagnostic test performed on biological samples.
  • Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic testing.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

Therefore, the HumidAire™ Heated Humidifier is a medical device used for respiratory therapy, not an in vitro diagnostic device.

N/A

Intended Use / 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.

Product codes

73 BTT

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 868.5450 Respiratory gas humidifier.

(a)
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.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP - 4 199

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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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.

1

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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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51Q(k) Number (if known): K971260

Device Name:_SULLIVAN® HumidAire™ Heated Humidifier

The HumidAire™ Heated Humidifier is indicated for the Indications For Use: 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.

IPLEASE DO NOT WRITE BELOW THIS UNE-CONTINUE.ON ANOTHER PAGE IF NEEDED!

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use U (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Mr. Ruz

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

K9712600 510(k) Number _