DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES

K053240 · Sunrise Medical · CAW · Feb 3, 2006 · Anesthesiology

Device Facts

• Record ID: K053240
• Device Name: DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
• Applicant: Sunrise Medical
• Product Code: CAW · Anesthesiology
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model 535D Oxygen Cyling System is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. The device is intended to provide 93% (± 3%) oxygen. This device can be used in homes, nursing homes, patient care facilities, etc.

Device Story

The DeVilbiss Model 535D Oxygen Cylinder Filling System is a stationary device designed to fill portable oxygen cylinders for ambulatory patient use. It functions by concentrating oxygen from ambient air to a purity of 93% (± 3%) and pressurizing it into cylinders. The system is intended for use in homes, nursing homes, and other patient care facilities. By enabling the on-site filling of cylinders, the device provides patients with a continuous supply of supplemental oxygen for mobility outside of the home environment. The device is operated by patients or caregivers to maintain their oxygen therapy requirements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stationary oxygen cylinder filling system. Produces 93% (± 3%) oxygen concentration. Designed for home and clinical facility use. Mechanical/pneumatic system for oxygen concentration and cylinder pressurization.

Indications for Use

Indicated for patients requiring supplemental oxygen who need to fill oxygen cylinders for ambulatory use. Suitable for use in home, nursing home, and patient care facility settings.

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

• CHAD Therapeutics Total O2 Delivery System (K013472)
• CHAD Therapeutics Total O2 Delivery System (K971889)

Submission Summary (Full Text)

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Kos3240

## Section 5.0 510(k) Summary

## Administrative Information and Device Identification

| Name and address of the manufacturer and<br>sponsor of the 510(k) submission: | Sunrise Medical<br>100 Devilbiss Drive<br>Somerset, PA 15501 |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA registration number of the manufacturer<br>of the new device: | 2515872 |
| Official contact person for all correspondence: | Joseph E. Olsavsky<br>Director - Regulatory Affairs<br>Sunrise Medical<br>100 DeVilbiss Drive<br>Somerset, PA 15501<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | November 17, 2005 |
| Device Name: | Oxygen Cylinder Filling System |
| Proprietary name of new device: | DeVilbiss Oxygen Cylinder Filling<br>System |
| Common or usual name of the device: | Oxygen Cylinder Filling System |
| DeVilbiss Model Number | Model 535 Series |
| Classification of the predicate device: | Class II |
| Classification of new device: | Class II |
| Classification Panel: | Anesthesiology |
| Panel Code: | CAW |
| CFR Regulation Number: | 21 CFR 868.5440 |
| Predicate Device Name(s) and 510(k)<br>number(s): | CHAD Therapeutics Total O2<br>Delivery System (K013472)<br><br>CHAD Therapeutics Total O2<br>Delivery System (K971889) |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

3 2006

Sunrise Medical Mr. Joseph E. Olsavsky Director Regulatory Affairs Respiratory Products Division 100 DeVilbiss Drive Somerset, Pennsylvania 15501-2125

Re: K053240

Trade/Device Name: DeVilbiss Oxygen Cylinder Filling Systems Regulation Number: 868.5440 Regulation Name: Portable oxygen Generator Regulatory Class: II Product Code: CAW Dated: November 17, 2005 Received: November 18, 2005

Dear Mr. Olsavsky:

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. Olsavsky

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,

Chiu Lin, Ph.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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K053240 DeVilbiss Oxygen Filling System Additional Information Request

## Indications for Use

510(k) Number: (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: _____________ DeVilbiss Model 535D Oxygen Cylinder Filling System

Indications For Use:

The Model 535D Oxygen Cyling System is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. The device is intended to provide 93% (± 3%) oxygen. This device can be used in homes, nursing homes, patient care facilities, etc.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qum Sylom

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(Division Sign-Off)

Division of Ano thoriningy, General Hospital. Infection Control, Dental Devices

510(k) Number:

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