(41 days)
The intended use of the Chad Total O2 Delivery System is to supply low-pressure supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use. The oxygen supplied by the Total O2 Delivery System is supplemental and is not life supporting and not intended to be used with or for any life support applications or in the presence of flammable anesthetics.
The modified Chad Total O2™ Delivery System is intended for use in the same manner as the unmodified device: The Total O2™ Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.
The Chad Total O2 Delivery System addresses several needs of patients and homecare providers. The Total O2 Delivery System has been designed to reduce the need for built storage and transport of liquid oxygen as well as the storage and transport of high-pressure oxygen gas cylinders for ambulatory use. The Total O2 Delivery System is comprised of conventional procedures and/or an integral pressure intensifier which supplies low pressure oxygen to a nasal cannula and/or an integral proposition of the oxygen gas cylinder for ambulatory use. The Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily, and safely connect to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O2 oxygen cylinders can only be filled by the Total O2 Delivery System. The Total O2 oxygen cylinders will be offered in two versions: 1. The original Total O2 cylinders with built in pressure reducer. 2. The Total O2 Post Valve cylinders with the same unique fill port as the original The Total O2, no built in pressure reducer but with a unique post valve outlet. The Total O2 post valve incorporates an internal mechanism to prevent filling the cylinders through the unique post valve port. Furthermore the Total O2 post valve would incorporate an index pin in the CGA V-1 number 13 position to prevent CGA-870 accordators, conserving devices, etc. from attaching to the unique post valve.
The provided document K013472 describes a Special 510(k) for the Modified Chad Total O₂™ Delivery System. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modification does not affect the device's indications for use or its fundamental scientific technology. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a full de novo study with extensive performance metrics against a predefined set of acceptance criteria.
Based on the provided text, the document states:
"Performance, mechanical, electrical, electromagnetic compatibility and r onomance, moshal testing was conducted to demonstrate that the Chad Total O₂ Delivery System would perform as intended."
However, there are no specific acceptance criteria or detailed results of these tests provided in the document. The rationale for substantial equivalence primarily relies on the device having the "same technological characteristics" and the "hardware portion of the device is identical to the predicate device" with only modifications to the cylinder adapters and a unique post valve outlet for new cylinder types.
Since specific acceptance criteria and detailed study results are not present, much of the requested information cannot be extracted from this document.
Here's what can be inferred or explicitly stated from the provided text:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document. For a Special 510(k), acceptance is typically based on demonstrating that the modifications do not alter the safety or effectiveness compared to the predicate device, often through bench testing validating specific changes.
- Reported Device Performance: The document only generically states that "Performance, mechanical, electrical, electromagnetic compatibility and r onomance, moshal (sic) testing was conducted to demonstrate that the Chad Total O₂ Delivery System would perform as intended." No specific performance metrics (e.g., flow rates, oxygen concentration, battery life, fill times, pressure retention) or their values are provided.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The testing mentioned appears to be bench testing on the device prototypes, not a clinical trial with human subjects.
- Data Provenance: Not specified, but implied to be internal testing conducted by Chad Therapeutics, Inc. (the manufacturer).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a modified oxygen delivery system, and the testing described is technical/engineering performance testing, not a diagnostic or AI-driven system that requires expert ground truth for interpretation.
4. Adjudication method for the test set:
- Not applicable. As above, this type of testing (mechanical, electrical, performance) does not typically involve adjudication by experts in the way clinical diagnostic studies do.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No. An MRMC study is not mentioned as this is not a diagnostic imaging device or an AI-assisted interpretation system requiring human reader comparison.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical oxygen delivery device, not an algorithm.
7. The type of ground truth used:
- Not explicitly stated/applicable for this context. For mechanical and electrical performance, the "ground truth" would be engineering specifications and established standards for oxygen delivery systems. The document states testing was done to ensure the device "would perform as intended," implying comparison against these internal specifications and safety standards for the device type.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
In summary, the provided document is a regulatory submission for a device modification, focusing on demonstrating equivalence to an existing predicate device rather than detailing a comprehensive new product validation study with specific acceptance criteria and performance data. The "Summary of Testing" section is very brief and high-level, indicating only that various types of engineering tests were conducted without providing any specific results or acceptance thresholds.
{0}------------------------------------------------
NOV 2 8 2001
SPECIAL 510(k)
510(k) SUMMARY
Chad Therapeutics, Inc.
Modified Chad Total O₂™ Delivery System®
September 18, 2001
Submitter Information:
Chad Therapeutics, Inc. 21622 Plummer Street Chatsworth, CA 91311
| Submitter's Name: | Kevin McCulloh |
|---|---|
| Phone: | (818) 882-0883 |
Device Name:
| Proprietary name: | Total O₂™ |
|---|---|
| Common Name: | Chad Total O₂™ Delivery System |
| Classification Name: | Portable Oxygen Generator |
Predicate Device Equivalence:
Substantial equivalence is claimed to the Chad Therapeutics Unmodified Chad Total O2 Delivery System, cleared for commercial distribution per K971889.
{1}------------------------------------------------
Device Description:
The Chad Total O2 Delivery System addresses several needs of patients and The Chad Total O2 Delivery Oystom alunces So so thas been designed to reduce homecare providers. The Total Of Soll of liquid oxygen as well as the storage the need for built storage and transpent only The Total O2 Delivery System is and transport of migh-procesure adsorption technology which supplies low comprised of conventional procedes and/or an integral pressure intensifier which pressure oxygen to a hasal outhalia and or an integral proposition of the paygen gas cylinder for ambulatory use.
The Total O2 Delivery System has a unique cylinder fill mechanism, which allows The Total O2 Delivery Cyclom hat a the patient's Total O2 oxygen cylinder. It to be easily, and Salery Conness that Total O2 oxygen cylinders can The unique Cylinder illi moonaniem oneawse the Total O2 Delivery System. The Total O2 oxygen cylinders will be offered in two versions:
-
- The original Total O2 cylinders with built in pressure reducer.
-
- The Total O2 Post Valve cylinders with the same unique fill port as the original The Total O2, no built in pressure reducer but with a unique post valve outlet. The I otal O2, no built in procerral mechanism to prevent filling the cylinders valve incorporatos an internal monection port. Furthermore the Total O2 post through the unique pool vario be dispense the oxygen in the cylinder through the unique post valve port.
Intended Use:
The intended use of the Chad Total O2 Delivery System is to supply low-The intended use of the onain to patients in the home, health care facility or pressure supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use.
The oxygen supplied by the Total O2 Delivery System is supplemental and is not r the oxygen supplied by the supporting and not intended to be used with or for any life support applications or in the presence of flammable anesthetics. Geriatric, pediatric or other patients unable to communicate discomfort may require pediatio or other patients atth the case with oxygen concentrators currently in use. The device is not sold sterile or intended to be sterilized.
{2}------------------------------------------------
Indications for use:
The modified Chad Total O2 Delivery System is intended for use in the same manner as the unmodified device:
The Total O2 Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.
Comparison of Technological Characteristics:
The modified Chad Total O2 Delivery System has the same technological characteristics as the predicate device.
characterior as the procession is identical to the predicate device. The Soltware portion of the device is identical except for the following; the The hardware portlounders have been modified to allow for the use of two versions:
-
- The original Total O2 cylinders with built in pressure reducer.
-
- The Total O2 post valve cylinders with the same unique fill port as the original The Total O2, no built in pressure reducer but with a unique post valve outlet incorporating a mechanism to prevent filling the cylinders through the unique incorporating a moonament to p. Chad Total O2 post valve cylinders could only be filled through the unique fill port and dispense through the unique post bo miou through the unique post valve would incorporate an index pin in varro port. The CGA V-1 number 13 position to prevent CGA-870 accordators, conserving devices, etc. from attaching to the unique post valve.
Summary of Testing:
Performance, mechanical, electrical, electromagnetic compatibility and r onomance, moshal testing was conducted to demonstrate that the Chad Total O₂ Delivery System would perform as intended.
Conclusions:
Based on the above, we concluded that the Chad Therapeutics modified Chad Total O2 Delivery System is substantially equivalent to the unmodified Chad Total O2 Delivery System and is safe and effective for its intended use.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Mr. Kevin McCulloh Vice President, Engineering Chad Therapeutics, Inc. 21622 Plummer Street Chatsworth, CA 91311
Re: K013472
Chad Total O2TM Delivery System Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II (two) Product Code: 73 CAW Dated: September 18, 2001 Received: October 18, 2001
Dear Mr. McCulloh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Soctor 3 rQst) pressed is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commence prior to May 20, 1978, are exactions of the Federal Food, Drug, devices that have been recuasined in accera servire approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou inay, incretore, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class II (PMA), it If your device is classified (see above) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controls. Existing may on 898. In addition, FDA may be found in the Code of Feach. Ing anning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuales of a backers.
that FDA has made a determination that your device complies with other requirements of the Act
{4}------------------------------------------------
Page 2 - Mr. Kevin McCulloh
or any Federal statutes and regulations administered by other Federal agencies. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
N. Dale Telle
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page 1 of 1
510 (k) Number (If Known): Kol 3472
Device Name: Modified Chad Total O₂™ Delivery System
Indications for Use:
The modified Chad Total O2™ Delivery System is intended for use in the same manner as the unmodified device:
The Total O2™ 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 (Optional Format 1-2-96) |
|---|---|---|
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K015472 |
|---|---|
| --------------- | --------- |
§ 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).