AMBU TUBECHECK

K981891 · Ambu, Inc. · BTR · Jul 17, 1998 · Anesthesiology

Device Facts

• Record ID: K981891
• Device Name: AMBU TUBECHECK
• Applicant: Ambu, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2

Indications for Use

To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.

Device Story

Ambu Esophageal Intubation Detector (Bulb and Syringe versions) serves as an adjunct tool for verifying correct endotracheal tube placement in the trachea. Device operates by assessing airway resistance; the bulb or syringe is attached to the proximal end of the endotracheal tube. If the tube is in the trachea, the device reinflates easily due to patent airway; if in the esophagus, the device fails to reinflate or reinflates slowly due to high resistance of esophageal tissues. Used by clinicians in emergency or clinical settings during intubation procedures. Output is physical feedback (reinflation speed/ability) observed by the clinician. Provides immediate confirmation to support clinical decision-making, reducing risk of unrecognized esophageal intubation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual, non-powered device. Consists of a bulb or syringe mechanism for aspiration/airway resistance assessment. No electronic components, software, or external energy sources. Materials and construction are consistent with standard medical-grade respiratory accessories.

Indications for Use

Indicated for use as an adjunct to assist in the verification of endotracheal tube placement in the trachea for patients requiring intubation.

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

JUL 1 7 1998

Mr. Sanjay Parikh Ambu Inc. 611 N. Hammonds Ferry Road Linthicum, MD 21090

K981891 Re: Ambu Esophageal Intubation Detector (Bulb version and Syringe version) Requlatory Class: II (two) Product Code: 73 BTR Dated: May 20, 1998 Received: May 29, 1998

Dear Mr. Parikh:

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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 requlations.

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Page 2 - Mr. Sanjay Parikh

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 diaqnostic 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,

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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Esophageal Intubation Detector

Intended Use

## BULB VERSION

## ESOPHAGEAL INTUBATION DETECTOR (BULB) INDICATION FOR USE

To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.

Mark Reiner

(Division Sign-On)
on of Cardiovascular, Respiratory,
eurological Devices
5.K: Number K981891

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Esophageal Intubation Detector

Intended Use

## SYRINGE VERSION

## ESOPHAGEAL INTUBATION DETECTOR (SYRINGE) INDICATION FOR USE

To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.

e kame

(Division Sign-Off) Division of Cardiovascula and Neurological Device 510(k) Number