The Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.

Device Description

The Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 is a pneumaticcontrolled device, which is a combination of a low-pressure regulator and an oxygen conserver, 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.

AI/ML Overview

This document refers to a 510(k) premarket notification for a medical device called the "Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511," an oxygen conserver. The information provided is for regulatory clearance based on substantial equivalence, not a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from the provided text. This document is focused on regulatory clearance and substantial equivalence to predicate devices, not a clinical performance study with specific acceptance criteria as one might expect for a diagnostic or AI-driven device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" in the way one might for diagnostic accuracy (e.g., sensitivity, specificity, AUC thresholds). Instead, it relies on "substantial equivalence" to predicate devices and general performance, mechanical, and environmental testing.

Acceptance Criteria (Implied)	Reported Device Performance
Performs as intended (delivers boluses of oxygen equivalent to 1-6 LPM)	"Performance, mechanical and environmental testing was conducted to demonstrate that the OXYPNEUMATIC CYPRESS Model 511 would perform as intended." (No specific metrics or thresholds provided.)
Safe and effective for intended use (as an oxygen conserver)	"Based on the above, we concluded that the Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use."
Substantially equivalent to predicate devices	"The OXYPNEUMATIC CYPRESS Model 511 has the same technological characteristics as the predicate devices." (Predicate devices listed: Victor Medical Products O2n Demand II (K992659), Western Medica OPC Oxygen Conserving Device (K010747), Precision Medical PM 1800 Conserving Device (K001412)).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "Performance, mechanical and environmental testing" but does not detail the methodology, sample sizes, or data provenance for these tests. This is not a clinical study in the sense of a test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is not a study establishing a diagnostic ground truth or involving expert review of a test set for clinical performance. The evaluation is based on engineering and performance testing for regulatory clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as this is not a study requiring adjudication of expert opinions for a test set.

5. 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

This information is not applicable. This device is an oxygen conserver, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted or is relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This is a physical medical device (oxygen conserver), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "testing" mentioned, the "ground truth" would be related to the device's technical specifications and intended function (e.g., ability to accurately deliver oxygen boluses at specified rates, durability under environmental conditions, safety criteria). However, the document does not specify the exact types of ground truth used for "Performance, mechanical and environmental testing." It likely refers to established engineering standards and specifications for oxygen delivery devices.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. This is not an AI/ML device that requires a training set.

Summary

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C: HAD THERAPEUTICS, INC. 21622 PLUMMER STREET CHATSWORTH, CA 91311

5 2002 નામ

TEL: (818) 882-0883 FAX: (818) 882-1809 www.chadtherapeutics.com

K020473

Image /page/0/Picture/4 description: The image shows the logo for Chad Therapeutics. The logo is in black and white and features the word "CHAD" in large, block letters. Below the word "CHAD" is the word "THERAPEUTICS" in smaller letters. To the right of the word "CHAD" is a registered trademark symbol.

510(K)

510(k) SUMMARY

Chad Therapeutics, Inc.

Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511

February 11, 2002

Submitter Information:

Chad Therapeutics, Inc. 21622 Plummer Street Chatsworth, CA 91311

Submitter's Name:	Kevin McCulloh
Phone:	(818) 882-0883

Device Name:

Proprietary names:	Chad TherapeuticsOXYPNEUMATIC CYPRESS Model 511
Common Name:	Oxygen conserver

Common Name: Oxygen conserver

Classification Name: Non-continuous ventilator

Predicate Device Equivalence:

Substantial equivalence is claimed to the Victor Medical Products O2n Demand II cleared for commercial distribution per K992659, the Western Medica OPC Oxygen Conserving Device cleared for commercial distribution per K010747 and the Precision Medical PM 1800 Conserving Device cleared for commercial distribution per K001412.

CHAD, OXYMATIC, OXYMIZER, OXYMIZER Pendant, OXYLITE, TOTAL 0;, and OXYCOIL, are registered trademarks of Chad Therapeutics, Inc

ISO 9001 CERTIFIED COMPANY

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Device Description:

Intended Use:

The Chad Therapeutics. Inc. OXYPNEUMATIC CYPRESS Model 511 is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.

Comparison of Technological Characteristics:

The OXYPNEUMATIC CYPRESS Model 511 has the same technological characteristics as the predicate devices.

Summary of Testing:

Performance, mechanical and environmental testing was conducted to demonstrate that the OXYPNEUMATIC CYPRESS Model 511 would perform as intended.

Conclusions:

Based on the above, we concluded that the Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 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" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

்பட 5 2002

Mr. Kevin McCulloh Vice President, Engineering Chad Therapeutics, Incorporated 21622 Plummer Street Chatsworth, California 91311

Re: K020475

Trade/Device Name: Chad Therapeutics OXYPNEUMATIC CYPRESS, Model 511 Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: II Product Code: NFB Dated: May 10, 2002 Received: May 14, 2002

Dear Mr. McCulloh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. McCulloh

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Timothy A. Ulatowski 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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510 (k) Number (If Known): ¥020 ¥75

Device Name: Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511.

Indications for Use:

(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(Optional Format 1-2-96)
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Signature

(Division Sign-Off)	Susan Runn
Division of Dental, Infection Control,and General Hospital Devices
510(k) Number	K000975

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).