(180 days)
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Not Found
No
The provided text does not mention AI, ML, or any related concepts like image processing, deep neural networks, or performance metrics typically associated with AI/ML-powered devices. The description is limited to the intended use of a supplemental oxygen delivery system.
Yes
The device is indicated for "treatment of Respiratory Diseases," which signifies a therapeutic purpose.
No
Explanation: The device is indicated for "Supplemental Medical Oxygen for treatment of Respiratory Diseases," which describes a therapeutic rather than a diagnostic function.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only. The intended use suggests a hardware component for oxygen delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Supplemental Medical Oxygen for treatment of Respiratory Diseases." This describes a device that is used directly on or with a patient to provide a therapeutic intervention (oxygen delivery).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The description of this device's intended use does not involve the analysis of any biological specimens.
Therefore, the TOTAL O,TM Delivery System, as described, is a medical device used for patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TOTAL O₂™ Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.
Product codes
73 CAW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/10 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HC. AN" is visible on the left side of the logo, and "USA" is visible on the right side.
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.
1
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
2
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
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