CAIRE COMPANION 5 OXYGEN CONCENTRATOR

K121167 · Caire, Inc. · CAW · May 2, 2012 · Anesthesiology

Device Facts

• Record ID: K121167
• Device Name: CAIRE COMPANION 5 OXYGEN CONCENTRATOR
• Applicant: Caire, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: May 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The CAIRE Companion 5, Oxygen Concentrator, is Intended for the administration of supplemental oxygen up to 5 liters/minute. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Device Story

CAIRE Companion 5 is a portable oxygen concentrator designed to provide supplemental oxygen to patients. It functions by concentrating oxygen from ambient air and delivering it to the patient at flow rates up to 5 liters per minute. The device is intended for use in home or clinical settings. It does not provide life support or patient monitoring. Healthcare providers prescribe the device based on patient oxygen requirements. The device benefits patients by providing a continuous source of supplemental oxygen, improving oxygenation levels for those with respiratory insufficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable oxygen concentrator; flow rate up to 5 L/min; electrical power source; non-life support; no monitoring sensors.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy up to 5 liters/minute. 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).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

CAIRE Inc. C/O Ms. Paula Wilkerson Responsible Third Party Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAY - 2 2012

Re: K121167

Trade/Device Name: CAIRE Companion 5 Oxygen Concentrator Regulation Number: 21 CFR 868.5540 Regulation Name: Portable oxygen generator Regulatory Class: II Product Code: CAW Dated: April 16, 2012 Received: April 17, 2012

Dear Ms. Wilkerson:

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 - Ms. Wilkerson

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 /ucm115809.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/Safetv/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh for

nthony 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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# Indications for Use Form

510(k) Number (if known): ¸

Device Name: CAIRE Companion 5 Oxygen Concentrator

Indications for Use:

The CAIRE Companion 5, Oxygen Concentrator, is Intended for the administration of supplemental oxygen up to 5 liters/minute. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Indications for Use: Prescription Use (Part 21 CFR 801 Subpart D) X

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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L. Schuller

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

510(k) Number: K121167