KOO AMERICAS VALVE PEEP, MODEL KM-809

K050918 · Koo Americas, Inc. · BYE · Jun 6, 2005 · Anesthesiology

Device Facts

• Record ID: K050918
• Device Name: KOO AMERICAS VALVE PEEP, MODEL KM-809
• Applicant: Koo Americas, Inc.
• Product Code: BYE · Anesthesiology
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Koo Americas valve PEEP is intended as a single-patient use device to provide positive-end expiratory pressure or Continuous Positive Airway Pressure when used with masks and manual resuscitators. The device is adjustable from 0cm to 20cm H2O pressure.

Device Story

Adjustable PEEP valve for use in respiratory circuits; provides positive end expiratory pressure or CPAP. Spring-actuated mechanism; clear construction for visual confirmation of functionality; includes graduated markings for pressure settings. Features 30mm male connector with 22mm adapter. Used in clinical settings with masks and manual resuscitators. Operated by healthcare professionals to manage patient airway pressure. Benefits patient by maintaining airway patency and improving oxygenation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Spring-actuated adjustable valve; clear plastic construction; graduated markings for pressure settings; 30mm male connector with 22mm adapter; pressure range 0-20 cm H2O; single-patient use.

Indications for Use

Indicated for patients requiring positive end expiratory pressure (PEEP) or Continuous Positive Airway Pressure (CPAP) via masks and manual resuscitators. Adjustable pressure range 0-20 cm H2O. Single-patient use.

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.

Predicate Devices

• Mercury Medical PEEP Valve

Submission Summary (Full Text)

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K050918

JUN 6 - 2005

## Substantial Equivalence 510(k) Summary

## Koo Valve PEEP

To Whom It May Concern:

Date: 5/26/05

Submitter/ Contact Name and Address William Slevin Koo Americas, Inc 1050 Suite C Nine North Drive Alpharetta, GA 30004

Tel: [phone]

Trade Name: Koo Americas Valve PEEP

Breathing attachment - positive end expiratory pressure Classification Name:

Common/ Usual Name: PEEP Valve

Predicate Legally Marketed Device: Mercury Medical PEEP Valve

Intended Use

The Koo Americas valve PEEP is intended as a single-patient use device to provide positive-end expiratory pressure or Continuous Positive Airway Pressure when used with masks and manual resuscitators. The device is adjustable from 0cm to 20cm H2O pressure.

Description of the Device:

The Koo Americas Valve PEEP is an adjustable valve, which is placed in a circuit and provides for positive end expiratory pressure for the patient. It is spring actuated and is a single patient use device. It is clear in construction allowing confirmation of functionality. Graduated markings allow for confirmation of settings. A convenience connector is provided to allow for conversion to 22mm. The connector is a male 30mm that connects to the female Peep Valve to provide 22mm.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

JUN 6 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William Slevin Quality Contractor Koo Americas, Incorporated 1050-C Nine North Drive Alpharetta, Georgia 30004

Re: K050918

Trade/Device Name: Valve Peep Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: April 4, 2005 Received: April 12, 2005

Dear Mr. Slevin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to roweand 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 Interstate conmisees prior to tray are, as, as a reclassified in accordance with the provisions of Amendinents, or to act 1000 and Cosmetic Act (Act) that do not require approval of a premarket the roderal I out, Drag, and Comments , therefore, market the device, subject to the general approvin upprivation (the Act. The general controls provisions of the Act include controls providents or a 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 II your device is classified (see as a vitional controls. Existing major regulations affecting (1 Wrig, it may of casinos in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fourther announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Slevin

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 mean that 1 27 mm and statutes and regulations administered by other Federal agencies. or the Act of all , I outh all the Act's requirements, including, but not limited to: registration 1 od intist contify was a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 es read on );
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet rerrir 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) I mis letter will anon you to one finding of substantial equivalence of your device to a promained fredicate 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), rr you dente speedfice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj overn band 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,

Sylute J. Michaudmd

Chiu Lin, Ph.D. 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

510(k) Number (if known): K 050918

Device Name: Valve Peep

Indications For Use: The Koo PEEP valve is intended as a single-patient use device to multations Por Society Pressure or Continuous Positive Airway Pressure provide pooltive one expirators. The device is adjustable from 0cm to 20cm H2O pressure.

1 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amy Sheldon

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

510(k) Number. K050918

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