OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS

K080082 · Oxlife, LLC · CAW · Apr 16, 2008 · Anesthesiology

Device Facts

• Record ID: K080082
• Device Name: OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS
• Applicant: Oxlife, LLC
• Product Code: CAW · Anesthesiology
• Decision Date: Apr 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen.

Device Story

Portable oxygen concentrator; uses molecular sieve adsorption technology to extract oxygen from ambient air. Compressor draws air through filters; nitrogen adsorbed by sieve beds; oxygen collected in accumulator reservoir. Delivers oxygen via nasal cannula. Features continuous flow and conserver (demand) flow modes; senses inhalation cycle to release precise oxygen doses, reducing waste. Operates on AC, DC, or rechargeable batteries for home, institutional, or mobile use. Used by patients under prescription; managed by clinicians or patients. Provides ~90% oxygen concentration. Benefits include mobility and efficient oxygen delivery.

Clinical Evidence

Bench testing only. Performance testing confirmed oxygen concentration output and 12V DC power inverter functionality meet specifications equivalent to the predicate device.

Technological Characteristics

Molecular sieve/pressure swing adsorption technology. Delivers ~90% oxygen. Continuous and conserver flow modes. Power: 110-220 VAC, 12-14 VDC, or rechargeable batteries. Non-sterile. Portable form factor.

Indications for Use

Indicated for patients requiring supplemental oxygen, including those with chronic obstructive pulmonary disease (COPD). Not for life-sustaining or life-supporting use.

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

• SeQual Eclipse Model 1000 (K013931)

Submission Summary (Full Text)

{0}------------------------------------------------

APR 1 6 2008

OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "The Independence" 01/21/08 updated on 4/8/2008 Page 12

#### 10.0 510(k) Summary

K080082

| 10.1 Submitters Name: | OxLife LLC |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------|
| 10.2 Submitters Address: | 141 Twin Springs Rd Hendersonville NC<br>28792 |
| 10.3 Submitters Phone & Fax: | 828-684-7353 ph. 828-684-8990 fx. |
| 10.4 Contact Person: | Margaret K. Poteat<br>General Manager/Management<br>Representative |
| 10.5 Date Summary Prepared: | January 7, 2008 |
| 10.6 Trade/Proprietary Name: | OxLife Independence™ Oxygen<br>Concentrators |
| 10.7 Common/Usual Name: | Oxygen Concentrator |
| 10.8 Classification Name: | Portable Oxygen Concentrator |
| 10.9 Comparison to Currently Marketed Devices:<br>The OxLife Independence Oxygen | |

Concentrator is substantially equivalent to the SeQual Eclipse Model 1000 K013931

10.10 Device Description:

The Oxlife Independence Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are nonsterile.

The Oxlife Independence Oxygen Concentrator provides approximately 90% oxygen to the patient on continuous to 3 and on a conserver flow basis at an "equivalent" rate of 1.0 liters per minute to 6.0 liters to minute. The Oxlife Independence Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110-220 VAC, 12-14 VDC or rechargeable batteries.

The Oxlife Independence Oxygen Concentrator uses molecular sieve adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from molecular sieve, allowing it to adsorb again during next

{1}------------------------------------------------

OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "The Independence" 01/21/08 updated on 4/8/2008 Page 13

cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a valve, and timers are used to make the system function.

Oxygen is delivered to the patient on a continuous flow basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Oxlife Independence Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient.

The design of the Oxlife Independence Oxygen Concentrator has focused on maximizing efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use.

The basic technology of the Oxife Independence Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.

10.11 Indications for Use:

Indications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen.

## 10.12 Technological Characteristics:

The Oxlife Independence Oxygen Concentrator utilizes well established technologies. Molecular sieve/pressure swing adsorption technology has been used for many years to produce oxygen. Demand flow delivery systems have been in use on portable oxygen sources for many years. The capability of AC,DC or rechargeable battery power has also been in use.

Technologies utilized by the Oxlife Independence Oxygen Concentrator brings forth no new questions of safety and effectiveness. These technologies are also currently being used in the identified predicate device.

{2}------------------------------------------------

OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "The Independence" 01/21/08 updated on 4/8/2008 Page 14 Bench top performance testing has demonstrated that the Oxlife Independence Oxygen Concentrator is equivalent to the SeQual Eclipse Model 1000 K013931

### 10.13 Performance Data:

The results of the oxygen concentration testing confirm that the oxygen output of the modified devices meets specifications and is substantially equivalent to the predicate device. Also, the inverter provides adequate power to run the devices from a 12 Volt DC power source.

#### 10.14 Conclusion:

Based on the design, performance specifications and testing and intended use, the Oxlife Independence Oxygen Concentrator are substantially equivalent to the currently marketed devices.

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret K. Poteat General Manager/ Management Representative OxLife LLC 141 Twin Springs Road Hendersonville, North Carolina 28792

APR 1 6 2008

Re: K080082

Trade/Device Name: Oxlife Independence Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 21, 2007 Received: January 17, 2008

Dear Ms. Poteat:

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.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wings, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Page 2 - Ms. Poteat

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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 your 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,

Yutta G.M. Melchior Onda

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

{5}------------------------------------------------

# Attachment 2 8.0 Statement of Indications for Use

Indications for Use

510 (k) Number: K080082

Device Name: Oxlife Independence Oxygen Concentrator

Indications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen.

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

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

Min Thul

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

KU40042 510(k) Number: