CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S

K042142 · Chad Therapeutics, Inc. · NFB · Sep 20, 2004 · Anesthesiology

Device Facts

• Record ID: K042142
• Device Name: CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
• Applicant: Chad Therapeutics, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Chad Therapeutics, Inc. Lotus is intended for prescription use only to be used as a portable oxygen delivery system for patients who require supplemental oxygen, at flow rates equivalent to 1 to 6 liters per minute, in their home and for ambulatory use.

Device Story

The Chad Therapeutics Lotus (Models OM-700/OM-700S) is a microprocessor-controlled oxygen conserver designed for home and ambulatory use. It functions as a portable oxygen delivery system, utilizing a low-pressure regulator to deliver supplemental oxygen. The device detects patient inhalation via an integrated sensor to trigger oxygen pulses, matching the delivery to the patient's breathing pattern. It is intended for prescription use. The OM-700S model includes an additional failure-to-pulse alarm. The device is powered by a rechargeable battery pack. Healthcare providers prescribe the device to patients requiring supplemental oxygen; the device operates automatically to conserve oxygen supply compared to continuous flow systems, potentially extending the duration of portable oxygen tanks and improving patient mobility.

Clinical Evidence

Bench testing only. Testing included ASTM PS 127-00 promoted ignition safety testing for the regulator, and electromagnetic compatibility/immunity testing in accordance with FDA guidance and EN 60601 standards. Software verification was conducted per FDA guidance for premarket submissions.

Technological Characteristics

Microprocessor-controlled oxygen conserver; low-pressure regulator; rechargeable battery pack. Dimensions/weight reduced compared to predicate. Connectivity: None. Sterilization: Not specified. Software: Rule-based algorithm for inhalation detection and pulse delivery. Standards: ASTM PS 127-00 (ignition safety), EN 60601 (electrical/EMC).

Indications for Use

Indicated for patients requiring supplemental oxygen therapy at flow rates equivalent to 1-6 L/min for home and ambulatory use.

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 OXYMATIC 411 (K003455)

Submission Summary (Full Text)

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K042142

21622 Plummer Streft CHATSWORTH, CA 91311 TOLL FREE: 800.423.8870 PHONE: [phone] Main Fax: [phone]

SEP 2 0 2004

### SPECIAL 510(k)

### 510(k) SUMMARY

## Chad Therapeutics, Inc.

## Chad Therapeutics Lotus (Modified Chad Therapeutics OXYMATIC Model 411)

| Date Prepared: | August 6, 2004 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 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>Vice President of Engineering<br>[phone] extension 335<br>[phone]<br>[e-mail] |
| Proprietary Names: | Chad Therapeutics Lotus Model OM-700<br>Chad Therapeutics Lotus Model OM-700S |
| 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 OXYMATIC 411, cleared for commercial distribution per K003455.

www.chadtherapeutics.com

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## Device Description:

The Chad Therapeutics Lotus is microprocessor-controlled device, which is a The Chad Therapeutics Eotus is mioroprocoses, Society, Society, designed for use with combination of a low-pressure regulator and an onygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.

#### Intended Use:

The Chad Therapeutics, Inc. Lotus is intended for prescription use only to be used as The Chad Therapedies, Inc. Eotal is the fact to the require supplemental oxygen in their home and for ambulatory use.

## Comparison of Technological Characteristics:

The Chad Therapeutics Lotus Model OM-700 and Model OM-700S has the same The Chau Therapedico Ectablicate devices. The hardware has been modified technological onaracterial aof regulator portion. The software and electronics have to reduce the size and wolght on regains a rechargeable battery pack circuit and been model OM-700S the addition of a failure to pulse alarm. In addition the labeling has for Model Owl's book the addition the software and the patient inhalation detection sensor portion of the device are identical to the predicate device.

### Summary of Testing:

All risk assessment, design verification and validation activities were conducted in All HSK assessmont, doolgh vehice requirements to demonstrate that the Chad Therapeutics Lotus would perform as intended.

- The regulator in the device passed the ASTM PS 127-00 Promoted Ignition Safety > Test.
- The Electromagnetic Compatibility, Electrostatic Discharge, Immunity, Magnetic > Fields Immunity, Magnetic Fields Emissions, Quasi-Static Electric Fields, Radiated and Conducted Field Emissions, etc. were conducted in accordance with the and Sondass in the FDA Reviewer Guidance for Premarket Submissions, Anesthesiology and Respiratory Devices Branch, Division of Cardiovascular, Respiratory and Neurological Devices Document and applicable EN 60601 Medical Electrical Equipment specifications.
- The software complies with the applicable standards per the FDA Reviewers and > I he sontain o content of premarket submissions for software contained in medical devices.

### Substantial Equivalence:

Based on the above, we concluded that the Chad Therapeutics modified OXYMATIC Bused on the above, we sthe els OM-700 & OM-700S) are substantially equivalent to unmodified OXYMATIC 411 devices and are safe and effective for their intended use.

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SEP 2 0 2004

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

Re: K042142

Trade/Device Name: Chad Therapeutics Lotus Models OM-700 and OM-700S Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: September 7, 2004 Received: September 13, 2004

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 (1 Nr.), it hay obe as a be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your con, 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 I least to advised and to a determination that your device complies with other requirements modification any Federal statutes and regulations administered by other Federal agencies. or the Free of all the Act's requirements, including, but not limited to: registration 1 od indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and libring (2) Cr read in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form in are quadiation 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), 11 you dontact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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 Lotus Models OM-700 and OM-700S (modified Chad Therapeutics OXYMATIC Model 411)

### Indications For Use:

The Chad Therapeutics Lotus (modified Chad Therapeutics OXYMATIC Model 411) The Chad Therapoutios Ectab (manner as the unmodified device, i.e., for is intended for use in the same manner as a portable oxygen delivery system for prescription use only, to be assula as parter a percures of minute, 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)

Auy Sagrom

(Division Sign-Qff) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

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