(180 days)
The TOTAL O,TM Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.
Not Found
This document is an FDA 510(k) clearance letter for the Chad TOTAL O2™ Delivery System. It primarily addresses the regulatory approval of the device and does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance.
The letter only includes:
- Device Name: Chad TOTAL O2™ Delivery System
- Indication for Use: "Supplemental Medical Oxygen for treatment of Respiratory Diseases."
- Regulatory Class: II
- Product Code: 73 CAW
- 510(k) Number: K971889
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification/validation report, or the actual study report submitted to the FDA for review. These documents typically contain the detailed information about performance criteria, study design, sample sizes, and ground truth establishment.
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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 (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 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 (800) 638-2041 or (301) 443-6597 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 _________________________________________________________________________________________________________________________________________________________
Zt
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
1971686 510(k) Number
CONFIDENTIAL
Chad TOTAL O2 Delivery System-amend page 7.doc Page 7
§ 868.5440 Portable oxygen generator.
(a)
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).(b)
Classification. Class II (performance standards).