L4 OXYGEN CONCENTRATOR

K061261 · Respironics, Inc. · CAW · Jun 28, 2006 · Anesthesiology

Device Facts

• Record ID: K061261
• Device Name: L4 OXYGEN CONCENTRATOR
• Applicant: Respironics, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Jun 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The Respironics L4 Oxygen Concentrator is intended for use in the home or hospital/institutional environment.

Device Story

Portable oxygen concentrator; produces concentrated oxygen from room air; utilizes molecular sieve and pressure swing adsorption process. Delivers oxygen up to 5 LPM via nasal cannula. Optional Oxygen Percentage Indicator available. Used in home or hospital/institutional settings; operated by patients or healthcare providers. Provides supplemental oxygen to patients requiring therapy; not life-supporting or life-sustaining.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Molecular sieve; pressure swing adsorption; 5 LPM flow capacity; optional oxygen percentage indicator; nasal cannula delivery; portable form factor.

Indications for Use

Indicated for persons requiring supplemental oxygen therapy. Not for life-supporting or life-sustaining use. Suitable for home or hospital/institutional 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

• Respironics "Twister" Oxygen Concentrator (K972614)

Submission Summary (Full Text)

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. . . .

#### Respironics L4 Oxygen Concentrator

### TAB 3 510(K) SU ETY & EFFECTIVENE 【 S

| Official Contact | Zita A. Yurko<br>Manager, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|
| | 724-387-4120<br>724-387-4206 (fax)<br>Email: [e-mail] |
| Classification Reference | 21 CFR 868.5440 |
| Product Code | CAW - Generator, Oxygen, Portable |
| Common/Usual Name | Oxygen Concentrator |
| Proprietary Name | Respironics L4 Oxygen Concentrator |
| Predicate Device(s) | Respironics "Twister" Oxygen Concentrator (K972614) |
| Reason for submission | Modified design. |

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## Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate device:

- O Same intended use.
- Same operating principle. ם
- 0 Same technology.
- D Same manufacturing process.

Design verification tests were performed on the Respironics L4 Oxygen Concentrator as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.

#### Intended Use

The Respironics L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining.

The Respironics L4 Oxygen Concentrator is intended for use in the home or hospital/institutional environment.

## Device Description

The Respironics L4 Oxygen Concentrator is a smaller and lighter medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. Like its predicate the Respironics L4 Oxygen Concentrator uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 5 LPM and is offered with an optional Oxygen Percentage Indicator.

Like its predicate, the Respironics L4 Oxygen Concentrator delivers oxygen to the patient via a nasal cannula.

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Image /page/2/Picture/1 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 lines representing its body and wings. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Respironics, Incorporated Ms. Zita A. Yurko Manager, Regulatory Affairs Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

UN 2 8 2006

Re: K061261

Trade/Device Name: L4 Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 7, 2006 Received: June 9. 2006

Dear Ms. Yurko:

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 (five the indications for use stated in the enclosure) to legally marketed predicate devires 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 offecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 10.0898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Yurko

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,

Oive

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

510(k) Number (if known): K061261

Device Name: L4 Oxygen Concentrator

Indications For Use: The L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining

For use in the home or hospital/institutional environment.

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)

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