CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511

K020475 · Chad Therapeutics, Inc. · NFB · Jul 5, 2002 · Anesthesiology

Device Facts

• Record ID: K020475
• Device Name: CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
• Applicant: Chad Therapeutics, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: Jul 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 is a pneumatic-controlled oxygen conserver combined with a low-pressure regulator. It is designed for use with portable oxygen delivery systems. The device functions by delivering boluses of oxygen to the patient, equivalent to 1 to 6 liters per minute depending on the flow rate setting. It is intended for use by patients requiring supplemental oxygen in home or ambulatory environments. The device is operated by the patient or caregiver to manage oxygen delivery, helping to maintain oxygen therapy while improving portability.

Clinical Evidence

No clinical data. Performance, mechanical, and environmental bench testing was conducted to demonstrate substantial equivalence and intended performance.

Technological Characteristics

Pneumatic-controlled device; combination of low-pressure regulator and oxygen conserver. Delivers oxygen boluses equivalent to 1-6 LPM. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for patients requiring supplemental oxygen in home or ambulatory settings.

Regulatory Classification

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.

Predicate Devices

• Victor Medical Products O2n Demand II (K992659)
• Western Medica OPC Oxygen Conserving Device (K010747)
• Precision Medical PM 1800 Conserving Device (K001412)

Submission Summary (Full Text)

{0}------------------------------------------------

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

5 2002 નામ

TEL: [phone] FAX: [phone] 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: | [phone] |

#### Device Name:

| Proprietary names: | Chad Therapeutics<br>OXYPNEUMATIC 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:

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.

#### 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 [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.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:

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.

## (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter-Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|


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