LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000

K072688 · International Biophysics Corp. · CAW · Jan 11, 2008 · Anesthesiology

Device Facts

• Record ID: K072688
• Device Name: LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
• Applicant: International Biophysics Corp.
• Product Code: CAW · Anesthesiology
• Decision Date: Jan 11, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.

Device Story

Portable oxygen concentrator; utilizes molecular sieve pressure swing adsorption to concentrate room air into ~90% oxygen. Delivers oxygen on demand flow basis at 1.0 to 3.0 liters per minute (in 1.0 L/min increments). Powered by AC, DC, or rechargeable batteries. Used by patients in home, institution, or travel settings. Device is prescription-only; not life-sustaining or life-supporting. Provides supplemental oxygen to improve patient respiratory status.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Molecular sieve pressure swing adsorption technology; demand flow delivery system. Power sources: AC, DC, and rechargeable batteries. Portable form factor. No specific software algorithm or connectivity details provided.

Indications for Use

Indicated for patients diagnosed as requiring supplemental oxygen. Not for life support or life sustaining use. Suitable for continuous use in home, institution, or travel environments.

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 Corporation, LifeStyle Oxygen Concentrator (K020324)

Submission Summary (Full Text)

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Section 5. 510 (K) Summary

## Non Confidential Summary of Safety and Effectiveness

Submitter Information:

International Biophysics Corporation (IBC) 2101 East St. Elmo Rd, Suite 275 Austin, TX 78744

Contact:

David Shockley President 512-326-3244 off. 512-326-3299 fax

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Date Prepared: September 19, 2007

Proprietary Name: LifeChoice Oxygen Concentrator

Model: OXY1000

Classification Name: Portable oxygen generator (concentrator)

Product Code: CAW

Device Classification: Class II

Panel: Anesthesiology

Regulation Number: 21 CFR 868.5440

Predicate Device: AirSep Corporation, LifeStyle Oxygen Concentrator, 510(K): K020324

Device Description:

The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life sustaining or to be life supporting. The LifeChoice provides approximately 90% oxygen to the patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 3.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which may be used continuously in a home, institution or travel environment.

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The LifeChoice uses molecular sieve pressure swing adsorption technology. This technology is well established and proven to concentrate room air into high concentration oxygen. The LifeChoice is equivalent in performance, function and principles of operation to the predicate device listed in this submission.

### Indications for Use:

The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable,

Technological Characteristics and Predicate Device Comparison:

The IBC LifeChoice Oxygen Concentrator utilizes well established technologies. Molecular sieve pressure swing adsorption technology has been used for many years to produce high concentration oxygen. Demand flow delivery systems have been in use on portable oxygen devices for many years also. The capability to power the device with AC, DC and/or rechargeable batteries has also been in use for many years.

The technologies used in the IBC LifeChoice Oxygen Concentrator do not create anv new questions of safety and effectiveness. These technologies are also being used in the identified predicate device. Benchtop performance testing and comparison of performance characteristics and technologies have demonstrated that the IBC LifeChoice is substantially equivalent to the identified predicate device, the AirSep LifeStyle Oxygen Concentrator. There are no significant differences between the IBC LifeChoice and the identified predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2008

Mr. David Shockley President International Biophysics Corporation 2101 East St. Elmo Road, Suite 275 Austin, Texas 78744

Re: K072688

Trade/Device Name: International Biophysics Corporation LifeChoice Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: January 3, 2008 Received: January 3, 2008

Dear Mr. Shockley:

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. Shockley

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 vour 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 yours,

Sutte Y. Michaud M.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

#### K072688:

Device Name: International Biophysics Corporation LifeChoice Oxygen Concentrator

Indications For Use:

The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.

Prescription use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K 072688

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