CHAD THERAPEUTICS BONSAI MODEL 800

K070740 · Chad Therapeutics, Inc. · NFB · May 7, 2007 · Anesthesiology

Device Facts

• Record ID: K070740
• Device Name: CHAD THERAPEUTICS BONSAI MODEL 800
• Applicant: Chad Therapeutics, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Chad Therapeutics, Inc. Bonsai is intended for prescription use only to be used as The Offau Thorapouriles) delivery system for patients that require supplemental oxygen in their home and for ambulatory use.

Device Story

Pneumatic-controlled oxygen conserver; combines regulator and oxygen delivery system. Input: supplemental oxygen source. Operation: detects patient inhalation via sensor diaphragm; delivers oxygen boluses equivalent to 1-7 liters per minute. Output: controlled oxygen boluses. Used in home or ambulatory settings by patients. Healthcare providers use output to manage oxygen therapy; benefits patient by providing portable, demand-based oxygen delivery. Modified from predicate to reduce size/weight and adjust flow regulator.

Clinical Evidence

Bench testing only. Device passed ASTM G 175-03 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications. Design verification and validation tests confirmed performance requirements were met.

Technological Characteristics

Pneumatic-controlled oxygen conserver. Components: patient inhalation detection sensor diaphragm, oxygen delivery portion, flow regulator. Dimensions/weight reduced compared to predicate. Complies with ASTM G 175-03 for oxygen regulator safety. Non-electronic/mechanical operation.

Indications for Use

Indicated for patients requiring supplemental oxygen in home or ambulatory settings. 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 Unmodified OXYPNEUMATIC CYPRESS 511 (K020475)

Submission Summary (Full Text)

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# K070740

MAY - 7 2007

#### SPECIAL 510(k)

### 510(k) SUMMARY

#### Chad Therapeutics, Inc.

## Chad Therapeutics Bonsai Model 800 (Modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511)

| Date Prepared: | March 14, 2007 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information: | Chad Therapeutics, Inc.<br>21622 Plummer Street<br>Chatsworth, CA 91311 |
| Official Contact:<br>Phone:<br>FAX:<br>E-mail: | Kevin McCulloh<br>Executive Vice President<br>Vice President of Engineering<br>[phone] extension 335<br>[phone]<br>[e-mail] |
| Proprietary Names: | Chad Therapeutics Bonsai Model 800 |
| Common Name: | Oxygen conserver |
| Classification Name: | Non-continuous ventilator |
| Classification Reference: | Class II, 21 CFR 868.5905 |
| Product Code: | NFB |

#### Predicate Device Equivalence:

Substantial equivalence is claimed to the Chad Therapeutics Unmodified OXYPNEUMATIC CYPRESS 511, cleared for commercial distribution per K020475.

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#### Device Description:

The Chad Therapeutics Bonsai a pneumatic-controlled device, which is a combination of r the Onad Therapoulator and an oxygen conserver, designed for use with ambulatory a low probute regulativers boluses of oxygen that is equivalent to 1 to 7 liters per minute, depending on the flow rate setting.

#### Intended Use:

The Chad Therapeutics, Inc. Bonsai is intended for prescription use only to be used as The Offau Thorapouriles) delivery system for patients that require supplemental oxygen in their home and for ambulatory use.

# Comparison of Technological Characteristics:

The Chad Therapeutics Bonsai Model 800 has the same technological characteristics as The onau Therapour.co The hardware has been modified to reduce the size and weight the preditate ab noob. The hardware has been modified to include an additional flow of regulator portion. The have been modified to be similar to the Chad Therapeutics Setting and the believe here he labeling has been modified. Major portions of the patient inhalation detection sensor diaphragm and oxygen delivery portion of the device are identical to the primary predicate device.

#### Summary of Testing:

All risk assessment, design verification and validation activities were conducted in All hisk assessment, dosign product requirements to demonstrate that the Chad Therapeutics Bonsai would perform as intended.

- The regulator in the device passed the ASTM G 175-03 Standard Test Method for > The regulation in the acositivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications safety test.
- ✓ The Bonsai passed all of the test criteria established in the Bonsai design verification and validation tests.

#### Substantial Equivalence:

Based on the above, we concluded that the Chad Therapeutics modified Dasod on the are, no, no, no, it =, the Bonsai Model 800) are substantially OX iT NEOMATIC OTH REDS MOSEMAT (CYPRESS 511 devices and are safe and effective for their intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY - 7 2007

Re: K070740

Trade/Device Name: Chad Therapeutics Bonsai Model 800 (Modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: April 21, 2007 Received: April 24, 2007

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.

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Page 2 -Mr. McCulloh

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. 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), please contact the Office 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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):

Device Name: Chad Therapeutics Bonsai Model 800 (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511).

#### Indications For Use:

The Chad Therapeutics Bonsai (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) is intended for use in the same manner as the unmodified device, i.e., 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

Challho

Sign-Off)
ision of Anesthesiology, General Hospital,
Section Control, Dental Devices

510(k) Number: K070740

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