RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE

K990619 · Rusch Intl. · BTR · Aug 3, 1999 · Anesthesiology

Device Facts

• Record ID: K990619
• Device Name: RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE
• Applicant: Rusch Intl.
• Product Code: BTR · Anesthesiology
• Decision Date: Aug 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rüsch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.

Device Story

Reinforced endotracheal tube designed for airway management; used for oral or nasal intubation. Features clear PVC tube with stainless steel reinforcing spiral to prevent kinking during unusual head/neck positioning. Available in cuffed or uncuffed configurations; Murphy or Magill tip styles. Includes centimeter markings for depth determination and connector. Cuffed versions include inflation line and lumen. Used by clinicians in clinical settings to maintain patient airway.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: PVC tube, stainless steel reinforcing spiral. Design: Cuffed or uncuffed, Murphy or Magill tip, centimeter markings, connector. Connectivity: None. Sterilization: Sterile. Software: None.

Indications for Use

Indicated for airway management via oral or nasal intubation in patients requiring intubation, particularly when unusual head or neck positioning is necessary to prevent tube kinking.

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

• Willy Rüsch Reinforced Tracheal Tube
• Sheridan Reinforced Cuffed Tracheal Tube
• SIMS/Portex Reinforced Cuffed Silicone Tracheal Tube
• NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for RUSCH International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). At the top right of the logo is the number K990619. The word RUSCH is in a large, bold font. The words International Group Regulatory Affairs are in a smaller font below the word RUSCH.

Tall Pines Park Jaffrey, NH 03452 [phone] FAX [phone] or 6108

510(k) Summary

## 1. Submitter Name, Address, and Date of Submission.

Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452

Telephone: [phone] Facsimile: [phone]

Contact: Same as above

- Classification Name: Tube, Tracheal (with/without connector) 2.
Common Name: Tracheal Tube, or Endotracheal Tube

Proprietary Name: Rüsch Reinforced Endotracheal Tube Cuffed and Uncuffed of Murphy/Magill, sterile

- 3. ldentification of the legally marketed device to which the submitter claims equivalence.
The Rusch Reinforced Endotracheal Tube is substantially equivalent to the Willy Rüsch Reinforced Tracheal Tube, Cuffed, Sheridan Reinforced Cuffed Tracheal Tube, SIMS/Portex Reinforced Cuffed Silicone Tracheal Tube and NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed.

- 4. Description of the Device.
The Rusch Reinforced Endotracheal Tube consists of a specially designed, clear PVC tube with stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of intubation length, and is terminated with a connector. An optional Murphy eye provides an alternative opening. This eye is the

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difference between the Murphy (with eye) and the Magill (without eye) tracheal tube. The device is for nasal/oral use.

The Rusch Reinforced Endotracheal tube, cuffed is fitted with a cuff, which is inflated through an inflation line and a lumen in the wall of the tube.

## Intended Use of the Device 5.

Rüsch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.

Summary of Technological Characteristics 6.

The device is equivalent in design and intended use with Willy Rüsch Reinforced Tracheal Tube and alternative predicates. The products are spiral PVC tubes, cuffed and uncuffed, with or without (uncuffed) luer activated valve.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 1999

Ms. Karenann J. Brozowski Group Requlatory Affairs Director Rusch International Tall Pines Park Jaffrey, NH 03452

K990619 Re: Rusch Reinforced Endotracheal (or Tracheal) Tube Trade Name: Cuffed or Uncuffed, Murphy/Magill, Sterile Requlatory Class: II Product Code: BTR Dated: April 30, 1999 May 5, 1999 Received:

Dear Ms. Brozowski:

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 A substantially equivalent determination assumes compliance with 895. 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 - Ms. Karenann J. Brozowski

This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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. Cillelon

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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510(k) Number (il known): ___

Ocvice Name:Rusch Reinforced Endotracheal (or Tracheal) Tube

Cuffed or Uncuffed, Murphy/Magill Indications I-or Use:

Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking wherever an unusual positioning of the head or neck is required following intubation.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!

Concurrence of CDRH, Office of Device Evaluation (ODE) ruscepüren Use ೧೧ Over The-Counter Use____________ 12cc 21 CFR 801 1091

(Optional Format 1-2-96)