MERCURY MEDICAL PEEP VALVE

K081266 · Mercury Enterprizes Dba Mercury Medical · BYE · Mar 5, 2009 · Anesthesiology

Device Facts

• Record ID: K081266
• Device Name: MERCURY MEDICAL PEEP VALVE
• Applicant: Mercury Enterprizes Dba Mercury Medical
• Product Code: BYE · Anesthesiology
• Decision Date: Mar 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positiveend expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.

Device Story

PEEP Valve is a mechanical attachment for manual resuscitators and portable ventilators; provides positive end expiratory pressure to patient airways. Device is adjustable from 0-20 cm H2O. Used in clinical or emergency settings by healthcare professionals to assist ventilation. Benefits include maintenance of airway pressure to improve oxygenation. Single patient use design.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical PEEP valve; adjustable pressure range 0-20 cm H2O; designed for attachment to manual resuscitators and portable ventilators; single patient use.

Indications for Use

Indicated for patients requiring positive end expiratory pressure (PEEP) during ventilation via manual resuscitators or portable ventilators. Adjustable range 0-20 cm H2O.

Regulatory Classification

Identification

A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

Submission Summary (Full Text)

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Public Health Service

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. Brian L. Morrison Manager, Quality Assurance and Regulatory Affairs Mercury Enterprizes DBA Mercury Medical Corporate Headquarters 11300 49th Street North Clearwater, Florida 33762.

MAR - 5 2009

K081266 Re:

> Trade/Device Name: PEEP Valve Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: February 20, 2009 Received: March 3, 2009

Dear Mr. Morrison:

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. Morrison

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,

Sutte y. Michael md.

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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od and Drug Administration

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

## Indications for Use

510(k) Number (if known): # K081266

Device Name: PEEP Valve

Indications for Use:

The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positiveend expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sworn

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

510(k) Number: K082664