(203 days)
Not Found
No
The description mentions a "microprocessor-controlled device" and "delivers boluses of oxygen," but there is no mention of AI, ML, or any learning or adaptive capabilities based on data. The device appears to operate based on pre-programmed logic and settings.
Yes
The "Intended Use / Indications for Use" states that it is "a portable therapeutic oxygen system for patients that require supplemental oxygen."
No
The device is described as a therapeutic oxygen delivery system, not a device used to diagnose a medical condition.
No
The device description explicitly states it is a "microprocessor-controlled device, which is a combination of a low-pressure regulator and a therapeutic oxygen device," indicating it includes hardware components beyond just software.
Based on the provided information, the Chad Therapeutics Sage is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver supplemental oxygen to patients requiring it, either at rest or during activity. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a combination of a low-pressure regulator and a therapeutic oxygen device. It delivers oxygen boluses. This aligns with a therapeutic function, not a diagnostic one.
- Lack of IVD Characteristics: The description 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 Chad Therapeutics Sage falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Chad Therapeutics Sage is intended for prescription use only, to be used as part of a portable therapeutic oxygen system for patients that require supplemental oxygen while at rest or during activity.
Product codes
NFB
Device Description
The Chad Therapeutics Sage is a microprocessor-controlled device, which is a combination of a low-pressure regulator and a therapeutic oxygen device, designed for use with ambulatory oxygen systems. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting and whether the user is at rest or active.
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
Performance, mechanical, electrical, electromagnetic compatibility, magnetic fields immunity, magnetic fields emissions, quasi-static electric fields and environmental testing was conducted to demonstrate that the Sage would perform as intended.
Key Metrics
Not Found
Predicate Device(s)
K000890, K003455, K010389, K961126
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Chad Therapeutics. The logo consists of the word "CHAD" in large, bold, sans-serif font, with the word "THERAPEUTICS" in a smaller font size underneath. Below that, the text "The Ambulatory O2 Specialists!" is displayed in an italicized font. The logo is black and white.
K03364
510(k)
510(k) SUMMARY
Chad Therapeutics, Inc.
Chad Therapeutics Sage
October 17, 2003
Submitter Information:
Chad Therapeutics, Inc. 21622 Plummer Street Chatsworth, CA 91311
Submitter's Name: | Kevin McCulloh |
---|---|
Phone: | (818) 882-0883 |
Device Name:
Chad Therapeutics Sage Proprietary names:
Therapeutic Device Common Name:
Non-continuous ventilator Classification Name:
Predicate Device Equivalence:
Substantial equivalence is claimed to the Chad Therapeutics 400 Series conservers cleared for commercial distribution per K000890, K003455, K010389 and the DeVilbiss PulseDose conserving device cleared for commercial distribution per K961126.
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Device Description:
The Chad Therapeutics Sage is a microprocessor-controlled device, which is a combination of a low-pressure regulator and a therapeutic oxygen device, designed for use with ambulatory oxygen systems. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting and whether the user is at rest or active.
Intended Use:
The Chad Therapeutics Sage is intended for prescription use only, to be used as part of a portable therapeutic oxygen system for patients that require supplemental oxygen while at rest or during activity.
Comparison of Technological Characteristics:
The device has many similar technological characteristics as the predicate devices, except that the Sage has both a rest and activity setting and incorporates a motion sensor to detect user activity to switch the device automatically from an at rest to an active flow setting.
Summary of Testing:
Performance, mechanical, electrical, electromagnetic compatibility, magnetic fields immunity, magnetic fields emissions, quasi-static electric fields and environmental testing was conducted to demonstrate that the Sage would perform as intended.
Conclusions:
Based on the above, we concluded that the Chad Therapeutics Sage is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three wavy lines that represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2004
Mr. Kevin McCulloh Vice President, Engineering Chad Therapeutics, Incorporated 21622 Plummer Street Chatsworth, CA 91311
Re: K033364
Trade Name: Chad Therapeutics Sage Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: April 23, 2004 Received: April 26, 2004
Dear Mr. McCulloh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your seemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to May 2005 103) in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic For (110) and as device, subject to the general controls provisions of the Act. The I ou may, mereloro, manel of the Act include requirements for annual registration, listing of general controls provisions of taxions of the prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elabilional controls. Existing major regulations affecting your device can inay be subject to back and Regulations, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least oc advised that I Dr o letermination that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I catel all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 -- Mr. Kevin McCulloh
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by evenss (Sections 531-542 of the Act); 21 CFR 1000-1050. product lastiation believe po begin marketing your device as described in your Section 510(k) This letter will and in you to be one finding of substantial equivalence of your device to a legally premarket notification " 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), please If you desire of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionmation of Jour Corpumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sva Runner
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Chad Therapeutics Sage
Indications For Use:
The Chad Therapeutics Sage is intended for prescription use only, to be used as part of a portable therapeutic oxygen system for patients that require supplemental oxygen while at rest or during activity.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amsulom
(Division Sign sinesiology, General Hospital, Infection Control, Dental 510(k) Number:
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