OXYTEC, MODEL 900

K043615 · Oxytec Medical Corporation · CAW · Feb 9, 2005 · Anesthesiology

Device Facts

• Record ID: K043615
• Device Name: OXYTEC, MODEL 900
• Applicant: Oxytec Medical Corporation
• Product Code: CAW · Anesthesiology
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.

Device Story

OxyTec 900 is a portable oxygen concentrator using pressure swing adsorption (PSA) with a molecular sieve to generate oxygen. It delivers 89% ± 3% pure oxygen via variable flow settings and an integrated conserver trigger method. The device is designed for continuous use in home, institutional, and mobile environments. It is powered by AC (100-250 VAC), DC (12-14 VDC), or battery. The device includes various user alarms to monitor performance. Healthcare providers prescribe the device for patients needing supplemental oxygen; patients operate the device to receive oxygen therapy, which supports respiratory function and improves patient mobility.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance specifications compared to the predicate device.

Technological Characteristics

Portable oxygen concentrator; pressure swing adsorption (PSA) technology with molecular sieve; oxygen purity 89% ± 3%; variable flow settings with integrated conserver; power inputs 100-250 VAC, 12-14 VDC, or battery; includes user alarm system.

Indications for Use

Indicated for patients requiring supplemental oxygen. Suitable for home, hospital, sub-acute institutional, and mobile environments. No contraindications.

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

• AirSep - LifeStyle - K020324

Submission Summary (Full Text)

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OxyTec 900

#### Summary of Safety and Effectiveness 3.1

K 043615

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 December 28, 2004

| 5150 E. La Palma Ave.<br>Suite 203<br>Anaheim Hills, CA 92807 | Tel: | [phone] |
|---------------------------------------------------------------|------------------------------------------|----------------|
| | Fax: | [phone] |
| Official Contact: | Charles Atlas, President | |
| Proprietary or Trade Name: | OxyTec 900 | |
| Common/Usual Name: | Portable oxygen generator (concentrator) | |
| Classification Name: | Portable oxygen generator | |
| Device: | OxyTec 900 | |
| Predicate Devices: | AirSep - LifeStyle - K020324 | |

## Device Description:

OxyTec Medical Corp.

The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molecular sieve. It has various flow rate settings, utilizes a conserver trigger method, and delivers 89% ± 3% pure oxygen. It is capable of continuous use in the home, institutional settings and mobile environments. It may be powered by 100-250 VAC, 12-14 VDC or batteries.

## Indications:

| Indications for Use -- | The OxyTec 900 is intended for prescription use by patients<br>requiring high concentrations of oxygen on a supplemental<br>basis. It is small, portable and is capable of continuous use in<br>the home, institutional, and travel / mobile environments. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population -- | Patients requiring supplemental oxygen. |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions, Mobile environments |

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...

# Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 December 28, 2004

## Comparison to Predicate Devices:

| | OxyTec 900 | Predicate |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Attributes | | |
| Indications for use | The OxyTec 900 is intended for prescription<br>use by patients requiring high concentrations of<br>oxygen on a supplemental basis. It is small,<br>portable and may be used in the home,<br>institutional, and travel / mobile environments. | AirSep Lifestyle – K020324<br>Same |
| Environments of use | Home, Hospital, Sub-acute Institutions,<br>Mobile environments | Same |
| Patient Population | Patients requiring supplemental oxygen | Same |
| Contraindications | None | Same |
| Technology | | |
| Oxygen separation | PSA - pressure swing adsorption | Yes |
| Portable, battery<br>operated | Yes | Yes |
| Oxygen purity | 89% $\pm$ 3% | AirSep - 90% $\pm$ 3% |
| Alarms | Various user alarms | Yes |
| Variable flow settings<br>with pulsed doses | Yes | Yes |
| Conserver integrated<br>in the system | Yes | Yes |

# Differences Between Other Legally Marketed Predicate Devices

There are no significant differences between the proposed device, OxyTec 900 and the identified predicates.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.

Public Health Service

FEB - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OxyTec Medical Corporation C/O Mr. Paul E. Dryden President ProMedic, Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501

Re: K043615

Trade/Device Name: OxyTec 900 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 29, 2004 Received: January 4, 2005

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device w C nave roviewed your betermined the device is substantially equivalent (for the indications ferenced about and sure) to legally marketed predicate devices marketed in interstate 10 and caronior 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). and Oosmetier fore, market the device, subject to the general controls provisions of the Act. The I ou may, ateres, mains 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 If your de rice is classinod (voral controls. Existing major regulations affecting your device can may or subject to back acceral 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. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actived that I Drivisian 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 1 ou must compt 7 mixt an 2 1 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 1000: The reast notification. The FDA finding of substantial equivalence of your device to a s ro(ts) promatice nedicate 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 11 you atent 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 other gottorers, 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 yours,

Shin-Lian, 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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| 3.3 Indications for Use | Page 1 of 1 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K043615 (To be assigned) |
| Device Name: | OxyTec 900 |
| Indications for Use: | The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. |
| | It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments. |
| Prescription Use XX (Per CFR 801.109) | or Over-the-counter use |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ouu Sution

(Division Sign-Off) (Division Sign-Chi)
Division of Anesthesiology, General Hospital, ്. സംഖ്യാപരാഹരാമത്തിന്റെ സ്വീകര 643615

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്‍10(k) Number ______________________________________________________________________________________________________________________________________________________________