VENTLAB VERIFY II

K990098 · Ventlab Corp. · BTR · Feb 11, 1999 · Anesthesiology

Device Facts

• Record ID: K990098
• Device Name: VENTLAB VERIFY II
• Applicant: Ventlab Corp.
• Product Code: BTR · Anesthesiology
• Decision Date: Feb 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2

Indications for Use

The Ventlab Verify II is designed to assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation and does not eliminate clinical judgment. Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

Ventlab Verify II assists clinicians in verifying endotracheal tube placement within the trachea. Device serves as an adjunct to standard clinical assessment methods; does not replace clinical judgment. Used by physicians or under physician order in clinical settings. Provides visual or physical confirmation of tube position to ensure proper airway management and prevent esophageal intubation. Benefits patient by reducing risks associated with misplaced endotracheal tubes.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence determination.

Technological Characteristics

Class II device (21 CFR 876.5730, Product Code BTR). Device functions as an adjunct for tracheal intubation verification. Technical specifications and materials not detailed in the provided documentation.

Indications for Use

Indicated for use as an adjunct to assess endotracheal tube placement in the trachea. For use by or on the order of a physician.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Mr. E. J. Smith Ventlab Corporation c/o Smith Associates P.O. Box 4341 Crofton, MD 21114-4341

K990098 Re: Ventlab Verify II Regulatory Class: II (two) Product Code: BTR January 7, 1999 Dated: Received: January 12, 1999

Dear Mr. Smith:

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, Druq, 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 regulation (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 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. E. J. Smith

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. Vallahan, 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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510(k) Number (if known)

Device Name; Ventlab Verify II

Classification Panel: Class II, 876.5730, BTR

Indications for Use: The Ventlab Verify II is designed to assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation and does not eliminate clinical judgment.

Federal (USA) law restricts this device to sale by or on the order of a physician.

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or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over the Counter Use_

Christy Louman forms

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

510(k) Number K990098