RUSCH EASY TUBE

K043205 · Teleflex Medical · BTR · Jan 7, 2005 · Anesthesiology

Device Facts

• Record ID: K043205
• Device Name: RUSCH EASY TUBE
• Applicant: Teleflex Medical
• Product Code: BTR · Anesthesiology
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Rüsch Easy Tube is a sterile single patient use, combination esophageal/tracheal tube intended to be used for emergency intubation, difficult intubation or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea.

Device Story

Rüsch Easy Tube is a twin-lumen, sterile, single-use airway device; designed to occlude oro- and nasopharynx; features inflatable distal esophageal cuff and proximal oropharyngeal cuff; cuffs inflated via luer-activated valves with color-coded pilot balloons. Device provides ventilation regardless of whether placement is esophageal or tracheal. Used by clinicians in emergency, difficult intubation, or general anesthesia settings. Radiopaque stripe and centimeter markings assist in placement verification. Benefits include reliable ventilation in varied clinical scenarios.

Clinical Evidence

Bench testing only. Materials evaluated per ISO 10993 Part 1 biological qualification safety tests. Comparative testing performed against industry-recognized methods.

Technological Characteristics

Twin-lumen tube; PVC construction; high volume, low pressure inflatable cuffs; luer-activated inflation valves; radiopaque stripe; centimeter markings; color-coded pilot balloons. Sizes: 28 Fr and 41 Fr. Sterile, single-patient use.

Indications for Use

Indicated for emergency, difficult, or general anesthesia intubation in patients requiring airway management. Small (28 Fr) for patients 90-130 cm height; Large (41 Fr) for patients >130 cm height.

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

• Kendall Combitube (K844746)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and white. The word "Teleflex" is in a bold, sans-serif font, and the word "MEDICAL" is in a smaller, sans-serif font below the word "Teleflex."

JAN - 7 2005

K043205

Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA 847-572-8002 Phone: Fax: [phone] www.teleflex.com

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Rüsch Easy Tube

# A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: [phone] Fax: [phone]

## B. Contact Person

Lori Hays Senior Manager, Regulatory Affairs

## C. Date Prepared

November 18, 2004

## D. Device Name

Trade Name: Rüsch Easy Tube

Common Name: Tracheal Tube

Classification Name: Tube, Tracheal (w/wo Connector)

Product Code: BTR

Regulation Number: 868.5730

Class: Il

## E. Device Description

The Rüsch Easy Tube consists of a 28 Fr (Small) or 41 Fr (Large), clear, twin lumen tube with a radiopaque stripe and graduated centimeter markings. The 28 Fr size is for use with patients 90 - 130 cm in height. The 41 Fr size is for use with patients over 130 cm in height.

A Division of Teleflex Incorporated

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The device is designed to occlude the oro- and nasopharynx. The tube has a PVC high volume, low pressure, inflatable distal esophageal cuff and a larger proximal oropharyngeal cuff. Both cuffs are provided with self-sealing luer connector valves. A color-coded pilot balloon is provided for each of the color coding facilitates identification of the cuff/pilot balloon relationship. The clear pilot balloon corresponds with the clear distal cuff. The blue pilot balloon corresponds with the green proximal cuff. The shaft for the proximal cuff is also color-coded with a matching blue sleeve.

### F. Intended Use

The Rüsch Easy Tube is a sterile single patient use, combination esophageal/tracheal tube intended to be used for emergency intubation, difficult intubation or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea.

### G. Substantial Equivalence

The Rüsch Easy Tube is substantially equivalent to the Kendall Combitube (K844746) in intended use, design and components, materials, and performance characteristics. See Table 1.

| Comparison Point | Easy Tube | Kendall Combitube -<br>K844746 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To be used for emergency,<br>difficult or general anesthesia<br>intubation. The device will<br>provide sufficient ventilation<br>whether the airway is placed<br>into the esophagus or into the<br>trachea. | To be used for emergency,<br>difficult or general anesthesia<br>intubation. The device will<br>provide sufficient ventilation<br>whether the airway is placed<br>into the esophagus or into the<br>trachea. |
| I.D. Size | Small - 28Fr<br>Large - 41Fr | Small Adult - 37Fr,<br>Regular - 41Fr |
| Cuff Style | High Volume, Low Pressure | High Volume, Low Pressure |
| Pilot Balloons -<br>Color Coded | Yes | Yes |
| Tube Available<br>Separately | Yes | Yes |
| Graduations | Yes | No |
| Radiopaque Marker | Yes | No |
| Inflation Valve Type | Luer Activated | Luer Activated |
| Sterile | Yes | No |

#### Table 1

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# H. Summary of Testing

All materials used in the fabrication of the Rüsch Easy Tube were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Comparative testing was performed. The materials used were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Ms. Lori Hays Senior Manager, Regulatory Affairs Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, Illinois 60015

Re: K043205

Trade/Device Name: Rüsch Easy Tube Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: November 18, 2004 Received: November 19, 2004

Dear Ms. Hays:

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.

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Page 2 - Ms. Hays

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. or the rest of mply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (1) CF CF CF 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) rine reter 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), rf you contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Suitte Michael OMD. for DR. CHIU LIN

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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Image /page/5/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and consists of the word "Teleflex" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. The logo is simple and modern, and it is likely used to represent the company's brand identity.

Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: [phone] Fax: www.teleflex.com

# Indications for Use

510(k) Number (if known):

Rüsch Easy Tube Device Name:

Indications For Use:

The Rüsch Easy Tube is a sterile, single use, combination esophageal/ tracheal tube intende to be used for emergency intubation, difficult intubation or general anesthesia intubation. Th to be adou for entilation whether the airway is placed into the esophagus or in the trachea

Jan K. Lemille Smichaelo MD

FOR

sthesiology, General Hospital, ion Control, Dental

510(k) Number:_Koy3205

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use _ X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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A Division of Teleflex Incorporated

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