FRESH AIR

K981047 · Colorado Medtech, Inc. · CAW · Sep 16, 1999 · Anesthesiology

Device Facts

• Record ID: K981047
• Device Name: FRESH AIR
• Applicant: Colorado Medtech, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Sep 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen in conformance with official USP designation "Oxygen 93 Percent", and supplemental delivery for oxygen therapy. Note: The intended use of this system is as a secondary oxygen source. The primary oxygen source for the facility is normally provided by liquid oxygen and distributed in a gaseous state via (typically) 'H' or 'K' supply cylinders in a conventional configuration. (reference: NFPA 99C,1996, fig. 4-3.1.1.6)

Device Story

FreshAir System utilizes molecular sieve technology to concentrate oxygen from ambient air; produces supplemental oxygen meeting USP "Oxygen 93 Percent" standards. Designed as secondary oxygen source for clinical facilities; supplements primary liquid oxygen supply systems (e.g., 'H' or 'K' cylinders). Operated by clinical staff within healthcare settings. Provides continuous oxygen flow to support therapy; ensures backup availability during primary system depletion or maintenance. Benefits patients by maintaining uninterrupted oxygen delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Molecular sieve technology for oxygen concentration; produces USP "Oxygen 93 Percent". Designed for integration with facility-based gaseous oxygen distribution systems. Complies with NFPA 99C standards for secondary oxygen sources.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy. Used as a secondary oxygen source in clinical facilities.

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).

Reference Devices

• NFPA 99C, 1996

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP | 6 1999

Mr. John Kortgardner Colorado MEDtech, Inc. 6175 Longbow Drive Boulder, CO 80301

K981047 Re: Fresh Air Project Regulatory Class: II (two) Product Code: 73 CAW Dated: Auqust 13, 1999 Received: August 23, 1999

Dear Mr. Kortgardner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. John Kortgardner

This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION E

## Product Information

Revised: 7/19/99

K981047 510 (k) number:_______________________________________________________________________________________________________________________________________________________________

Device Name: FreshAir System

Indications for Use:

Prescription Use

(Per 21 CFR 801.109)

Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen in conformance with official USP designation "Oxygen 93 Percent", and supplemental delivery for oxygen therapy.

Note:

The intended use of this system is as a secondary oxygen source. The primary oxygen source for the facility is normally provided by liquid oxygen and distributed in a gaseous state via (typically) 'H' or 'K' supply cylinders in a conventional configuration. (reference: NFPA 99C,1996, fig. 4-3.1.1.6)

Please do not write below this line - Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Over-the-Counter-Use__________________________________________________________________________________________________________________________________________________________

| (Division Sign-Off) |
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| Division of Cardiovascular, Respiratory, |
| and Neurological Devices |

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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