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.

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.

AI/ML Overview

The provided 510(k) submission for the Chad Therapeutics Sage does not provide detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically expected for AI/ML-based medical devices.

Instead, this submission is for a physical medical device (a non-continuous ventilator/oxygen conserver) and its acceptance criteria and "studies" are focused on demonstrating substantial equivalence to predicate devices through various types of engineering and performance testing.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not applicable or not provided in this type of submission:

Acceptance Criteria and Device Performance (Based on the document):

The document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) as would be the case for an AI/ML algorithm. Instead, the "acceptance criteria" are implied by demonstrating that the device performs as intended and is substantially equivalent to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Delivers oxygen boluses equivalent to 1-6 LPM (at rest/activity).	The device is a "microprocessor-controlled 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." This is the core functionality description, implying it meets this range successfully.
Safety and Effectiveness: Performed as intended and is safe and effective.	"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." "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."
Technological Equivalence: Incorporates a motion sensor for automatic mode switching.	"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." (This is a differentiating feature, implying it functions as designed.)

Since this is a submission for a physical device, not an AI/ML algorithm, most of the specific questions regarding test sets, ground truth, experts, and AI-specific studies are not applicable (N/A) for this document.

Detailed Breakdown of Requested Information:

A table of acceptance criteria and the reported device performance:
- See table above. The acceptance criteria are inferred from the device description and the claim of substantial equivalence, as specific performance metrics like sensitivity/specificity are not relevant for this type of device.
Sample size used for the test set and the data provenance:
- N/A. This device does not use a "test set" in the context of AI/ML data. The "testing" involved engineering and performance verification of the physical product, likely involving a limited number of physical prototypes or production units, not a dataset of patient information. The document does not specify the number of units tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the AI/ML sense (e.g., expert-labeled images) is not applicable here. The "ground truth" for a physical device is its adherence to engineering specifications and performance standards, verified through objective measurements and physical tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not relevant.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a physical oxygen delivery device, not a diagnostic or AI-assisted interpretation tool. MRMC studies are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. There is no standalone algorithm being evaluated in this submission. The device is a physical product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance would be derived from objective engineering measurements, calibration standards, and validated test methods (e.g., precise oxygen flow meters, pressure gauges, electrical safety testers). These are not typically described as "ground truth" in regulatory summaries for physical devices.
The sample size for the training set:
- N/A. This is not an AI/ML device; there is no "training set." The microprocessor controls are programmed based on engineering design and performance requirements.
How the ground truth for the training set was established:
- N/A. Not applicable.

In summary: The provided 510(k) is for a hardware medical device (an oxygen conserver). The acceptance criteria are implicitly met by demonstrating that the device functions as described, meets safety standards, and is substantially equivalent to existing predicate devices. The "studies" involve various engineering, electrical, mechanical, and environmental tests, rather than clinical studies or AI/ML performance evaluations with specific datasets and ground truth.

Summary

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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:

Intended Use:

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

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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

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Indications for Use

510(k) Number (if known):

K033364

Device Name:

Chad Therapeutics Sage

Indications For Use:

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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Regulation Number and Section

§ 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).