BARD ENDOTRACHEAL TUBE, CUFFED

K030792 · C.R. Bard, Inc. · BTR · Nov 14, 2003 · Anesthesiology

Device Facts

• Record ID: K030792
• Device Name: BARD ENDOTRACHEAL TUBE, CUFFED
• Applicant: C.R. Bard, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard Endotracheal Tube, Cuffed is indicated for airway management by oral/nasal intubation of the trachea for anesthesia

Device Story

Bard Endotracheal Tube, Cuffed is a single-lumen tube designed for airway management and gas transport. Device features a cuff, pilot inflation line, pilot balloon assembly, and two-way valve. Used by clinicians for oral or nasal intubation of the trachea during anesthesia. Tube connects to a ventilator to facilitate gas exchange. Available in sizes 6.0mm to 10.0mm. Device provides a secure airway for patients undergoing anesthesia.

Clinical Evidence

Bench testing only. The device was tested for compliance with ASTM F 1242-96, "Standard Specification for Cuffed and Uncuffed Tracheal Tubes." Both the subject and predicate devices met the standard requirements, with noted exceptions regarding radius of curvature and device markings.

Technological Characteristics

Constructed of polyvinyl chloride (PVC). Features a single lumen, cuff, pilot inflation line, pilot balloon, and two-way valve. Sizes: 6.0-10.0mm. Complies with ASTM F 1242-96. Mechanical device; no energy source or software.

Indications for Use

Indicated for airway management via oral or nasal tracheal intubation for anesthesia in patients requiring mechanical ventilation.

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.

Predicate Devices

• Mallinckrodt Hi-Lo®/Intermediate Hi-Lo Tracheal Tube, Cuffed

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

- A. Submitter's Information:

| Submitter's Name: | C. R. Bard, Inc., Medical Division |
|-------------------------|---------------------------------------------------|
| Address: | 8195 Industrial Blvd.<br>Covington, Georgia 30014 |
| Contact Person: | Frances E. Harrison, RAC |
| Contact Person's Phone: | [phone] |
| Contact Person's Fax: | [phone] |
| Date of Preparation: | August 28, 2003 |

- B. Device Name:

| Trade Name: | Bard® Endotracheal Tube, Cuffed |
|----------------------|---------------------------------|
| Common / Usual Name: | ET Tube |
| Classification Name: | Tracheal Tube |

- C. Predicate Device Name:
Mallinckrodt Hi-Lo®/Intermediate Hi-Lo Tracheal Tube, Cuffed

Trade Name: Same as above.

- D. Device Description: The Bard® Endotracheal Tube, Cuffed is a single lumen tube with a cuff. The lumen is used for ainway management/gas transport and is connected to a ventilator via a connector. The two-way valve on the cuff inflation tube is assembled to a pilot inflation line/pilot balloon assembly that is bonded to the tube to lead into the inflation lumen. The Bard Endotracheal Tube is offered in the following sizes: 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, and 10.0mm.
- The Bard Endotracheal Tube, Cuffed is indicated for airway E. Intended Use: management by oral/nasal intubation of the trachea for anesthesia.

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- F. Technological Characteristics Summary: The Bard® Endotracheal Tube, Cuffed is constructed of polyvinyl chloride. It has the same intended use and design and is manufactured from the same biocompatible materials and offered in the same sizes as the predicate device.
- G. Performance Data Summary: The Bard® Endotracheal Tube, Cuffed is constructed of biocompatible materials and has been tested using ASTM F 1242-96, "Standard Specification for Cuffed and Uncuffed Tracheal Tubes". Both the Bard device and the predicate device meet the ASTM standard with the exceptions of radius of curvature and device markings.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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NOV 1 4 2003

Food and Drug Administration

Public Health Service

9200 Corporate Boulevard Rockville MD 20850

Ms. Frances E. Harrison, RAC Director, Regulatory Affairs C.R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30014

Re K030792

Trade/Device Name: Bard Endotracheal Tube, Cuffed Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: August 15, 2003 Received: August 20, 2003

Dear Ms. Harrison:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration

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Page 2 - Ms. Harrison

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K030792 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Bard® Endotracheal Tube

Indications for Use:

The Bard Endotracheal Tube, Cuffed is indicated for airway management by oral/nasal intubation of the trachea for anesthesia

(PLEASE DO NOT WRITE BELOW THIS LINE - CC NTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

1 Prescription Use (Per 21 CFR 801.109)

OR , Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1/2/96)

Huthausen

510(k) Number: K030792