CHAD TOTAL O2 DELIVERY SYSTEM

K971889 · Chad Therapeutics, Inc. · CAW · Nov 17, 1997 · Anesthesiology

Device Facts

• Record ID: K971889
• Device Name: CHAD TOTAL O2 DELIVERY SYSTEM
• Applicant: Chad Therapeutics, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Nov 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TOTAL O,TM Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.

Device Story

The Chad TOTAL O2 Delivery System is a medical device designed to provide supplemental oxygen to patients with respiratory diseases. It functions as an oxygen delivery system, regulating the flow of medical-grade oxygen to the patient. The device is intended for use in clinical or home settings under the direction of a healthcare provider. By delivering controlled oxygen therapy, the system assists in managing respiratory conditions, potentially improving patient oxygenation levels and overall respiratory function. The device is operated by the patient or a caregiver following prescription guidelines.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Oxygen delivery system; Class II device; Product Code: CAW.

Indications for Use

Indicated for patients requiring supplemental medical oxygen for the treatment of respiratory diseases.

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 1997

Ms. Louie Goryoka Chad Therapeutics, Inc. 21622 Plummer Street Chatsworth, California 91311

Re: K971889 Chad TOTAL O2™ Delivery System Requlatory Class: II (two) Product Code: 73 CAW Dated: Auqust 19, 1997 Received: August 20, 1997

Dear Ms. Goryoka:

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 Requlation (QS) for Medical Devices: General requlation (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 - Ms. Louie Goryoka

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 requlation 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. Callehan

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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INDICATIONS FOR USE:

510(k) Number (if known):

Device Name: Chad TOTAL O2 ™ Delivery System

Indication for Use:

The TOTAL O,TM Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

1971686 510(k) Number

**CONFIDENTIAL**

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