(126 days)
The Respironics SimplyGo 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.
Not Found
I am sorry, but the provided documentation, which is an FDA 510(k) clearance letter for the "Respironics SimplyGo Oxygen Concentrator," does not contain the detailed information necessary to answer your request.
Specifically, this document focuses on the regulatory approval of the oxygen concentrator, stating that it is substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and reporting requirements.
The document does not include information about:
- Acceptance criteria and reported device performance in a table format.
- Details of any specific study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Whether MRMC or standalone studies were performed, or their results.
- Training set details.
Therefore, I cannot fulfill your request based on the provided input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 4 2011
Mr. Joseph E. Olsavsky Sr. Manager, Regulatory Affairs Respironics Incorporated 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
Re: K111885
Trade/Device Name: Respironics SimplyGo Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 6, 2011 Received: October 7, 2011
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. 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 II (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm ! 15809.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 reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division 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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Nh for
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
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Section 6.0 Indications for Use
Indications for Use
510(k) Number (if known): _K | | | | 885
Device Name: Respironics SimplyGo Oxygen Concentrator
The Respironics SimplyGo 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 (Part 21 CFR 801 Subpart D)
ાંદા જ ૪ ડ
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schulthin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
-Tab 6 Page 1 of 1
080019
§ 868.5440 Portable oxygen generator.
(a)
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).(b)
Classification. Class II (performance standards).