LMA FASTRACH ETT SINGLE USE

K051993 · The Laryngeal Mask Co., Ltd. · BTR · Dec 13, 2005 · Anesthesiology

Device Facts

• Record ID: K051993
• Device Name: LMA FASTRACH ETT SINGLE USE
• Applicant: The Laryngeal Mask Co., Ltd.
• Product Code: BTR · Anesthesiology
• Decision Date: Dec 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LMA Fastrach™ ETT SU is intended to be inserted through the patient's mouth into the trachea to maintain an open airway and is attached to the modif into the traction after insertion into the patient. It is intended andootherio machine the user will be able to inflate the device cuff and ventilate the patient.

Device Story

LMA Fastrach™ ETT SU is a straight, cuffed, wire-reinforced, single-use tracheal tube with a Murphy Eye. Metal wire spiral reinforcement provides kink-resistance during procedures requiring high tube flexibility, such as prone positioning or head/neck surgery. Device is inserted orally by clinicians to maintain an open airway during anesthesia; cuff is inflated to seal against the trachea, preventing gas leakage and aspiration of stomach contents. Compatible with LMA Fastrach™ and LMA CTrach airways. Benefits include maintained ventilation in positions where non-reinforced tubes might kink or occlude.

Clinical Evidence

Clinical evaluation data provided in Section 6 of the submission. No specific performance metrics (e.g., sensitivity, specificity) are detailed in the summary document.

Technological Characteristics

Wire-reinforced tracheal tube; cuffed; Murphy Eye; sizes 6.0-8.0 mm. Materials identical to predicate reinforced ETTs. Sterile, single-use. Kink-resistant spring design.

Indications for Use

Indicated for airway management by oral intubation of the trachea. Used to reduce potential for kinking when positioning of head or neck is required following 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.

Predicate Devices

• LMA Fastrach™ ETT (K991580)
• Sheridan Spiral-Flex ETT (K860105)
• Rusch Reinforced ETT (K990619)
• Portex reinforced ETT (K032112)

Submission Summary (Full Text)

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DEC 1 3 2005

2051993

The Laryngeal Mask Company Limited

LMA Fastrach™ ETT SU

# 510(K) SUMMARY

Submitter:

The Laryngeal Mask Company Limited PO Box 221, Mahe, Seychelles

### US Agent for Submission And Contact Person:

Mr. Foster Boop LMA North America, Inc. 4660 La Jolla Village Drive Suite 900 San Diego, CA 92122 Phone: [phone]

Date Prepared:

04 July 2005

Trade Name:

LMA Fastrach™ETT SU

Reinforced Tracheal Tube (Cuffed)

Common Name:

Device Type and Class:

Reinforced Tracheal Tube. Class II BTR, 21 CFR 868.5730

### Predicate Device:

- Predicate 1: LMA Fastrach™ ETT already marketed in the USA under . K991580
- Predicate 2: Sheridan Spiral-Flex ETT already marketed in the USA under . K860105
- Predicate 3: Rusch Reinforced ETT already marketed in USA under . K990619
- Predicate 4: Portex reinforced ETT already marketed in the USA under ● K032112

### Device Description:

The LMA Fastrach™ ETT SU is a straight, cuffed, wire-reinforced, single use tracheal tube with a Murphy Eye. The metal wire spiral reinforcement is to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery.

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LMA Fastrach™ ETT SU

The Laryngeal Mask Company Limited

## 510(K) SUMMARY

The plastic material and the spring allow the tube to be easily bent in all direction. The plastic material and the ophing crevent kinking or occlusion of the tube.

The cuff is intended to provide a seal against the trachea, ensuring that The Cull 1s Intended to provied through the tube and not allowed to Inspiratory and expiratory gasses are atthus preventing loss of ventiation / escape to the patients "upper" direct" and aspirated stomach contents from entering the lungs.

This reinforced tracheal tube is available in size 6, 6.5, 7.0, 7.5 and 8.0 mm only, This reinforced trached tube is available in size of other fract and as the comment.
And it is designed to be compatible with the LMA Fastrach™, LMA Fastrach™ And it is coolig. LMA CTrach Airways.

### Intended Use:

The LMA Fastrach™ ETT SU is intended to be used for oral intubation for arway management during anaesthesia. The product maybe used where the patient's management uunny anaesthoolar 11c froo atient is in the prone position so that a non-reinforced tracheal tube might become kinked.

# Technological Characteristics of the Proposed Versus Prodicate Devices:

The proposed device is substantially equivalent to predicate 1 – LMA Fastrach™ ETT, in all aspects except the followings:

- Material. The proposed device is identical in material to the tubing . Material: The propossa Sheridan Spiral-Flex ETT, Predicate 3: Rusch Reinforced ETT and Predicate 4: Portex reinforced ETT.
- Sterile. The proposed device is a sterile single use device which is . Sterfic. The Predicate 4- Portex reinforced ETT and Predicate 2-Sheridan Spiral-Flex ETT.
- Cuff. The proposed device is identical in material and design to that of 1 Predicate 2- Sheridan Spiral-Flex ETT.

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The Laryngeal Mask Company Limited

LMA Fastrach™ ETT SU

:

## 510(K) SUMMARY

# Performance / Clinical Data:

Clinical evaluation data is shown in Section 6.

### Conclusion:

Comparison of the proposed device to the predicate devices supports the Companson of the proposed device is substantially equivalent in safety and conclusion that the proposed - to existing legally marketed devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

DEC 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Laryngeal Mask Company Limited C/O Mr. Foster Boop Director, Technical Affairs LMA North America, Incorporated 9360 Towne Centre Drive San Diego, California 92121

Re: K051993

Trade/Device Name: LMA Fastrach™ ETT Single Use Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: December 2, 2005 Received: December 5, 2005

Dear Mr. Boop:

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 - Mr. Boop

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 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), please 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/industry/support/index.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

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## Indications for Use

510(k) Number (if known): K051993

LMA Fastrach™ ETT Single Use

The LMA Fastrach™ ETT SU is intended to be inserted through the patient's mouth into the trachea to maintain an open airway and is attached to the modif into the traction after insertion into the patient. It is intended andootherio machine the user will be able to inflate the device cuff and ventilate the patient.

### Indications for Use:

Device Name:

The LMA Fastrach™ ETT SU is indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for intubation of the traonomist of the head or neck is required following intubation.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Cune Egleom

K051993

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