CHAD THERAPEUTICS SAGE

K033364 · Chad Therapeutics, Inc. · NFB · May 11, 2004 · Anesthesiology

Device Facts

• Record ID: K033364
• Device Name: CHAD THERAPEUTICS SAGE
• Applicant: Chad Therapeutics, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: May 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Microprocessor-controlled oxygen conserving device; integrates low-pressure regulator with therapeutic oxygen delivery system. Inputs: oxygen source; motion sensor data. Operation: detects user activity via motion sensor; automatically switches between 'rest' and 'active' flow settings; delivers oxygen boluses equivalent to 1-6 liters per minute. Output: controlled oxygen bolus delivery. Used in ambulatory settings by patients requiring supplemental oxygen. Healthcare providers use output to manage patient oxygenation; device benefits patients by optimizing oxygen delivery based on activity level.

Clinical Evidence

Bench testing only. Performance, mechanical, electrical, electromagnetic compatibility, magnetic fields immunity/emissions, quasi-static electric fields, and environmental testing conducted to verify device functionality.

Technological Characteristics

Microprocessor-controlled oxygen conserving device; low-pressure regulator; motion sensor for activity detection; flow settings 1-6 LPM; electrical/electromagnetic compatibility compliant.

Indications for Use

Indicated for patients requiring supplemental oxygen during rest or activity. Prescription use only.

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

• Chad Therapeutics 400 Series conservers (K000890, K003455, K010389)
• DeVilbiss PulseDose conserving device (K961126)

Submission Summary (Full Text)

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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: | [phone] |

## 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:

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.

#### Intended Use:

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.

#### 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 [phone]. 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 [phone] or [phone] 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:

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.

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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