DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES

K081468 · Sunrise Medical · CAW · Aug 25, 2008 · Anesthesiology

Device Facts

• Record ID: K081468
• Device Name: DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES
• Applicant: Sunrise Medical
• Product Code: CAW · Anesthesiology
• Decision Date: Aug 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DeVilbiss Portable Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. The patient typically receives the oxygen through a nasal cannula. The device delivers flow rates between .5 and 6 liters per minute of oxygen over 90% concentration. It is used at a patient's home or for their portable needs outside the home and can also be used in institutions such as nursing homes or subacute care facilities. Oxygen concentrators are not considered either life supporting or life sustaining. The device has no contraindications

Device Story

Portable oxygen concentrator; extracts nitrogen from room air to produce oxygen-enriched gas (>90% concentration). Operates in continuous flow (up to 3 LPM) or pulse dosage mode (1-6 settings; delivers 14cc bolus per setting value per inhalation). Lightweight; battery-powered for transportability. Used in homes, institutions, or mobile settings by patients. Provides supplemental oxygen to improve blood oxygen saturation. Not life-supporting or life-sustaining.

Clinical Evidence

Bench testing only. Device tested against applicable ISO, ASTM, and IEC standards and FDA guidance for respiratory devices. Met all performance criteria.

Technological Characteristics

Oxygen concentrator; nitrogen extraction via molecular sieve. Continuous flow (up to 3 LPM) and pulse dosage (1-6 settings). Battery-powered. Tested to ISO, ASTM, and IEC standards.

Indications for Use

Indicated for administration of supplemental oxygen to patients requiring low flow oxygen therapy. Not for life support; no patient monitoring capabilities.

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 Portable Oxygen Concentrator - K013931

Submission Summary (Full Text)

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#### Section 5.0 510(k) Summary

# 881468

## Administrative Information and Device Identification

| | AUG 2 5 2008 |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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>VP – Global Quality & Regulatory<br>Sunrise Medical<br>100 DeVilbiss Drive<br>Somerset, PA 15501<br>Phone: [phone]<br>Fax: [phone]<br>Email:<br>[e-mail] |
| Date Prepared: | May 15, 2008 |
| Device Name: | DeVilbiss Portable Oxygen<br>Concentrator System |
| Proprietary name of new device: | DeVilbiss Portable Oxygen<br>Concentrator System |
| Common or usual name of the device: | Portable Oxygen Concentrator |
| DeVilbiss Model Number | Model 306 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): | Sequal Eclipse Portable Oxygen<br>Concentrator - K013931 |

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#### Description of Device:

The model 306 Series oxygen concentrator system is a device that produces an oxygen enriched gas mixture by drawing in room air and extracting nitrogen, thus allowing oxygen to be delivered at a range of prescribed flows to patients with low oxygen saturation levels in the blood. The 306 Series is light weight and can operate on an external battery pack, features which allow the 306 Series to be readily transported by the patient. It has two operating modes: continuous product flow at up to 3 LPM and pulse dosage mode at settings of 1 to 6. In pulse dosage mode, the concentrator delivers a bolus of oxygen at each inhalation in an amount equal to 14cc times the setting value.

#### Comparison of Device Technological Characteristics to Predicate Device:

This device has similar technological characteristics as the predicate device. The DeVilbiss Portable Oxygen Concentrator is equivalent in functional characteristics to the existing legally marketed predicate device. The device generates no less then 91% +/-3% enriched gaseous oxygen concentration by drawing in room air and extracting nitrogen. Both devices are tested and approved to recognized safety standards. No new technologies have been introduced in the DeVilbiss Portable Oxygen Concentrator. See Section 12.0.

#### Statement of Intended Use:

The DeVilbiss Portable Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. The patient typically receives the oxygen through a nasal cannula. The device delivers flow rates between .5 and 6 liters per minute of oxygen over 90% concentration. It is used at a patient's home or for their portable needs outside the home and can also be used in institutions such as nursing homes or subacute care facilities. Oxygen concentrators are not considered either life supporting or life sustaining. The device has no contraindications

#### Non-Clinical Testing:

This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The DeVilbiss Portable Oxygen Concentrator was designed and tested according to guidance outlined in:

- 1. FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993); and
- 2. FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005),

As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for Premarket Notification Submissions – Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices" the DeVilbiss

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Portable Oxygen Concentrator was tested in accordance with the applicable voluntary standards. The DeVilbiss Portable Oxygen Concentrator met the required performance criteria and functioned as intended.

See Section 16.8, Section 17.0, Section 18.0 and Attachment B.

#### Statement of Safety and Effectiveness:

Analysis of comparison of design, function and features of the DeVilbiss Portable Oxygen Concentrator System to the Sequal Eclipse (K013931), together with the results of testing demonstrates the device to be substantially equivalent to the predicate device in terms of meeting performance criteria and functioning as intended.

#### Conclusion:

The DeVilbiss Portable Oxygen Concentrator System is substantially equivalent to the predicate device listed in this Summary and the device, as changed, does not rais to any new issues of safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### AUG 2 5 2008

Mr. Joseph E. Olsavsky Vice President Global Quality and Regulatory Sunrise Medical DeVilbiss Healthcare 100 DeVilbiss Drive Somerset, Pennsylvania 15501

Re: K081468

Trade/Device Name: DeVilbiss Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: May 22, 2008 Received: May 27, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Cle
Chin-Lien, 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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### Indications for Use

510(k) Number: (if known):

Device Name: DeVilbiss Portable Oxygen Concentrator

Indications For Use:

The Model 306 iGo Portable Oxygen Concentrator System is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

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

510(k) Number: K081468

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Section 4.0-1

510(k) Number: