TOTAL O2

K013472 · Chad Therapeutics, Inc. · CAW · Nov 28, 2001 · Anesthesiology

Device Facts

• Record ID: K013472
• Device Name: TOTAL O2
• Applicant: Chad Therapeutics, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Nov 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 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 the case with oxygen concentrators currently in use. The device is not sold sterile or intended to be sterilized.

Device Story

Portable oxygen generator; utilizes pressure adsorption technology; supplies low-pressure oxygen to nasal cannula; includes integral pressure intensifier for filling oxygen cylinders. Used in home or healthcare facilities; operated by patients or caregivers. Modified version supports two cylinder types: original with built-in pressure reducer and new 'post valve' version with unique fill port and index pin to prevent attachment of incompatible conserving devices. Device provides supplemental oxygen for ambulatory use; reduces need for bulk liquid oxygen storage/transport. Healthcare providers prescribe device for respiratory disease management; patient benefits from increased mobility via refilled portable cylinders.

Clinical Evidence

Bench testing only. Performance, mechanical, electrical, and electromagnetic compatibility testing conducted to demonstrate intended performance.

Technological Characteristics

Portable oxygen generator; pressure adsorption technology; integral pressure intensifier. Supports two cylinder types: original with built-in pressure reducer and post valve version with unique fill port and CGA V-1 index pin (position 13) to prevent incompatible attachments. Non-sterile.

Indications for Use

Indicated for supplemental medical oxygen for treatment of respiratory diseases in patients requiring supplemental oxygen. Not for life support or use with flammable anesthetics.

Regulatory Classification

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).

Predicate Devices

• Chad Total O2 Delivery System (K971889)

Submission Summary (Full Text)

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K013472

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: | [phone] |

#### 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.

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#### 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:

- 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 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.

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#### 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:

- 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 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.

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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

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#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-The-Counter-Use (Optional Format 1-2-96) |
|-------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------|
| <div><img alt="Prescription Use Tick" src="prescription_use_tick.png"/></div> | | |

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K015472 |
|---------------|---------|
|---------------|---------|