DEPARTMENT OF HEALTH & HUMAN SERVICES Public Hecalth Service

Food and Drug Administration

10903 New Hampshire Avenue

Document Control Room -W066-G609

Silver Spring, MID 20993-0002

Mr. Joseph E. Olsavsky NOV -4 2011

Sr. Manager, Regulatory Affairs

Respironics Incorporated

1740 Golden Mile Highway

Monroeville, Pennsylvania 15146

Re: Kll11885

Trade/Device Name: Respironics SimplyGo Oxygen Concentrator

Regulation Number: 21 CFR 868.5440

Regulation Name: Portable Oxygen Generator

Regulatory Class: 11

Product Code: CAW

Dated: October 6, 2011

Received: October 7,2011

Dear Mr. Olsavsky:

We have reviewed your Section 5 10(k) premarket notification of intent to market the device

referenced above and have determined the device is substantially equivalent (for the

in~dic-i3iidiifo r u~FstatcciA n£he 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 prernarket

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. Please note: CDRH does

not evaluate information related to contract liability warranties: We remind you, however,

that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III

(PMA), it may be subject to additional controls. Existing major regulations affecting your

device can be found in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In

addition, FDA may publish further announcements concerning your device in the Federal

Register.
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 CER Part 807); labeling (21 CFR Part 80 1); medical device reporting

(reporting of medical device-related adverse events) (21 CFll 803); 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 53 1-542 of

the Act); 21 CFR 1000- 1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 1), please go to htp/wwfapvAotD/etr~fcsCR/DIIfie

/ucmlI 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of

Compliance. Also, please note the regulation entitled, "Misbranding by reference to

premarket notification" (21CFR Part 807.97). For questions regarding the reportirig of

adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda gov/Medica1Devices/Safety/ReportaProblem/default htm for the CDRH' s

Office of Surveillance and B iometrics/Di vision of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.I'da.gov/MedicalDevices/ResourcesforYou/1ndustry/default~htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A.

Director

Division of Anesthesiology, General Hospital,

Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure
Respironics SimplyGo Oxygen Concentrator Premarket Notification - Special 5 10(k)

Section 6.0 Indications for Use

Indications for Use

5 1 0(k) Number (if known): iA'i 5B5

Device Name: Respironics SimplyGo Oxygen Concentrator

The Respironics SimnplyGo Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel /mobile environments.

Prescription Use ___X AN/R Over-The-Counter Use ____

(Part 21 CFR 801 Subpart D) AN/R(21 CER 807 Subpart C)

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

51 0(k) Number: /- 1, '?/ I - a aeIo 00019