EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)

K980725 · Instrumentation Industries, Inc. · CBP · Aug 24, 1998 · Anesthesiology

Device Facts

• Record ID: K980725
• Device Name: EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
• Applicant: Instrumentation Industries, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prevent escape of inspiratory gases and re-breathing of expired gases while providing a means of egress for expired gases. The reusable exhalation valves are designed for use with ventilators. The exhalation valve prevents the reasured gases from escaping through the passage that will be made available to expired gases via the inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.

Device Story

Reusable exhalation valves for use with ventilators; function via inflatable balloon mechanism; balloon prevents inspiratory gas escape and patient re-breathing of expired gases; provides egress path for expired gases; used in clinical settings by healthcare professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable exhalation valve; utilizes inflatable balloon mechanism for gas flow control; designed for integration with ventilator circuits.

Indications for Use

Indicated for use with ventilators to manage gas flow, preventing inspiratory gas escape and patient re-breathing of expired gases.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 24 1998

Ms. Lori Zuravleff Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102

Re: K980725 Exhalation Valve Models BE 30-115-B, NS 30-115-U, NS 30-115-5, and PS 54-A Regulatory Class: II (two) Product Code: 73 CBP Dated: June 16, 1998 Received: June 22, 1998

Dear Ms. Zuravleff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Lori Zuravleff

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT

Exhalation Valves Device:

Prevent escape of inspiratory gases and re-breathing of expired gases while providing a Summary: means of egress for expired gases

The reusable exhalation valves are designed for use with ventilators. The exhalation valve prevents the reasured gases from escaping through the passage that will be made available to expired gases via the inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.

Mare Krappe

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K980725

Lori Burauleft
Signature

Lori Zuravleff Typed Name

Prescription Use:
(Per 21 CFR 801.109)

February 20, 1998
Date

K980725

Premarket notification (510(k)) number