AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P

K983631 · Instrumentation Industries, Inc. · CBP · Jul 1, 1999 · Anesthesiology

Device Facts

• Record ID: K983631
• Device Name: AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
• Applicant: Instrumentation Industries, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2

Indications for Use

The disposable KC 9-P one-way valve with removable cap allows a single breath measurement of auto-PEEP when used with certain ventilator circuits.

Device Story

The KC 9-P is a disposable one-way valve with a removable cap designed for use within ventilator circuits. It enables clinicians to perform a single-breath measurement of auto-PEEP (positive end-expiratory pressure). By manipulating the valve and cap during the respiratory cycle, the device allows for the isolation of a single breath to measure trapped air pressure. This measurement assists clinicians in adjusting ventilator settings to optimize patient ventilation and reduce the risk of complications associated with auto-PEEP, such as hemodynamic instability or barotrauma.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable one-way valve with removable cap. Designed for integration into standard ventilator circuits. Mechanical operation; no electronic components, software, or external power source required.

Indications for Use

Indicated for patients requiring auto-PEEP measurement during mechanical ventilation. Used with compatible ventilator circuits to facilitate single-breath auto-PEEP assessment.

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

JUL - 1 1999

Ms. Tricia Wood Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102

Re: K983631 Auto-PEEP Measurement Device Regulatory Class: II (two) Product Code: 73 СВР May 6, 1999 Dated: Received: May 7, 1999

Dear Ms. Wood:

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 Existing major regulations affecting your device additional controls. 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 assumptions. Failure to comply with the GMP regulation may result in requlatory 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. Tricia Wood

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. Callahan

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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Indications for Use

## Center for Devices and Radiological Health

Page 1 of 1

510(k) Number (if known): K983631

Device Name: KC 9-P Auto-PEEP Measurement Device

Indications for Use:

The disposable KC 9-P one-way valve with removable cap allows a single breath

measurement of auto-PEEP when used with certain ventilator circuits.

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Concurence of CDRH, Office of Device Evaulation (ODE)

Ur. Ruy

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

510(k) Number

Prescription USC

(Optional Format 3-10-98)

(Posted July 1, 1998)

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