HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009

K012037 · Airsep Corp. · CAW · Jan 17, 2002 · Anesthesiology

Device Facts

• Record ID: K012037
• Device Name: HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
• Applicant: Airsep Corp.
• Product Code: CAW · Anesthesiology
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HealthLife Oxygen Concentrator delivers supplemental oxygen in a nominal 9 liters-per-minute flow of 38% oxygen for inhalation with mask delivery to the patient.

Device Story

HealthLife Oxygen Concentrator provides supplemental oxygen to patients. Device takes ambient air as input; utilizes concentration technology to produce output of 38% oxygen at nominal 9 liters-per-minute flow. Intended for use in clinical or home settings; operated by patients or caregivers under prescription. Output delivered via mask for inhalation. Benefits include increased oxygen availability for patients with respiratory needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable oxygen generator; delivers 38% oxygen concentration at 9 LPM flow rate. Class II device (Product Code: 73 CAW).

Indications for Use

Indicated for patients requiring supplemental oxygen therapy via mask delivery.

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Ms. Charlotte H. Hamilton Airsep Corp. 290 Creekside Drive Buffalo, NY 14228-2070

Re: K012037

HealthLife Oxygen Cencentrator Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: Class II (two) Product Code: 73 CAW Dated: November 16, 2001 Received: November 19, 2001

Dear Ms. Hamilton:

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. Charlotte H. Hamilton

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 or any I vith 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 Of It in the quality systems (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 premated notication "The 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 8041. Additionally, for questions on the promotion and advertising of Compliance at (301) 59% the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ouvision 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,

l. Oeder Teh

ram D. Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) NUMBER (IF KNOWN): | KO12037 |
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| DEVICE NAME: | HealthLife Oxygen Concentrator. |

INDICATIONS FOR USE:

Revised, 1-15-02

The HealthLife Oxygen Concentrator delivers supplemental oxygen in a nominal 9 liters-per-minute flow of 38% oxygen for inhalation with mask delivery to the patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-Counter-Use (Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012037