EXHALATION VALVE

K984481 · Intersurgical, Inc. · CBP · Jan 29, 1999 · Anesthesiology

Device Facts

• Record ID: K984481
• Device Name: EXHALATION VALVE
• Applicant: Intersurgical, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2

Intended Use

A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port. ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. All ports should remain capped when not is use. Recommended Change: every 24 hours or more frequently if visible deterioration is observed. Single patient use. Non-conductive. Non-sterile. Do not autoclave. CAUTIONS: Federal law restricts this device to sale by or on the order of a physician.

Device Story

Exhalation valve (PN 1922) functions as one-way flow control component in respiratory circuits; prevents inspiratory gas escape and rebreathing; facilitates expired gas egress via 22mm port; compatible with 22mm male T-pieces and PEEP valves. Used in clinical settings; operated by healthcare professionals. Device is non-conductive, non-sterile, single-patient use; requires replacement every 24 hours or upon visible deterioration.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

One-way valve; non-conductive material; non-sterile; 22mm ISO connections; single-patient use; manual assembly via push-and-twist.

Indications for Use

Indicated for use as a one-way valve in respiratory circuits to prevent inspiratory gas escape and rebreathing of expired gases, while providing egress for expired gases. Intended for single-patient use in clinical settings under physician order.

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

JAN 29 1999

Mr. Thomas R. Gunerman Intersurgical Incorporated 417 Electronics Parkway Liverpool, NY 13088-6098

Re: K984481 Exhalation Valve - PN 1922 Regulatory Class: II (two) Product Code: 73 CBP Dated: January 21, 1999 Received: January 26, 1999

Dear Mr. Gunerman:

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 leqally 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 reqistration, 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 Requlations, 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 Requlation (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 requlation 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 - Mr. Thomas R. Gunerman

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 requlation (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 yours,
Thomas J. Callehan

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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## Appendix G. Indication For Use

510(k) Number (if known):

Device Name: 1922 - Exhalation Valve

Indications For Use: A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port. ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. All ports should remain capped when not is use. Recommended Change: every 24 hours or more frequently if visible deterioration is observed. Single patient use. Non-conductive. Non-sterile. Do not autoclave. CAUTIONS: Federal law restricts this device to sale by or on the order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K984481

Prescription Use (Per 21 CFR 801.109)

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를 두 곳 이 때 때 때 등 내 다 만 내 유의 바 가 와 바 아 아 에

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)