OXYGEN DEMAND VALVE

K082345 · Bpr Medical, Ltd. · CBP · Mar 13, 2009 · Anesthesiology

Device Facts

• Record ID: K082345
• Device Name: OXYGEN DEMAND VALVE
• Applicant: Bpr Medical, Ltd.
• Product Code: CBP · Anesthesiology
• Decision Date: Mar 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Carnét Oxygen Demand Valve is intended to be used for the delivery of 100% oxygen in response to the patient's inspiratory effort on the order of a physician. This product is designed for use with adult and paediatric patients in hospitals, ambulances or other managed clinical environments. This product is not intended to be used with infants or neonates.

Device Story

Oxygen Demand Valve delivers 100% oxygen to patients; device triggers oxygen flow based on patient inspiratory effort. Used in hospitals, ambulances, or managed clinical environments; operated by healthcare professionals. Device provides oxygen therapy to support patient respiration; intended for adult and pediatric populations. No software or electronic processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nonrebreathing valve (21 CFR 868.5870). Mechanical oxygen delivery system; triggered by patient inspiratory effort. No electronic components, software, or external power source.

Indications for Use

Indicated for delivery of 100% oxygen triggered by patient inspiratory effort. Intended for adult and pediatric patients in clinical settings (hospitals, ambulances). Contraindicated for infants and neonates.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 1 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ben Johnson Marketing and Product Development Manager BPR Medical Limited 22 Hamilton Way Mansfield, Nottinghamshire UNITED KINGDOM NG18 5BU

K082345 Re:

> Trade/Device Name: Oxygen Demand Valve Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP. Dated: February 11, 2009 Received: February 12, 2009

Dear Mr. Johnson:

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. Johnson

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 (OS) 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,

Susan Bonner

Ginette Y. Michaud, M.D. Acting 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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#### Statement of Indications for Use 5.

# 5.1 Indications for Use Statement

510(k) Number (if known):

K082345

Device Name:

Oxygen Demand Valve

Indications For Use:

The Carnét Oxygen Demand Valve is intended to be used for the delivery of 100% oxygen in response to the patient's inspiratory effort on the order of a physician.

This product is designed for use with adult and paediatric patients in hospitals, ambulances or other managed clinical environments. This product is not intended to be used with infants or neonates.

Susan Dunne

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antochoontal Devices

K082345

510(k) Number:

Revision 4 - 2nd January 2009

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