LMA FAMILY OF AIRWAYS

K130304 · The Laryngeal Mask Co., Ltd. · CAE · May 30, 2014 · Anesthesiology

Device Facts

• Record ID: K130304
• Device Name: LMA FAMILY OF AIRWAYS
• Applicant: The Laryngeal Mask Co., Ltd.
• Product Code: CAE · Anesthesiology
• Decision Date: May 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5110
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The LMA Unique™, LMA Classic™, LMA Classic Excel™, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are devices inserted into a patient's pharynx through the mouth to provide a patent airway. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field. The LMA Fastrach™ ETT (reusable) and LMA Fastrach™ ETT Single Use are indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Device Story

Family of supraglottic airway devices and wire-reinforced tracheal tubes; used to establish/maintain airway during anesthesia, CPR, or difficult airway management. Devices inserted into pharynx via mouth; cuff inflated to seal glottic opening. LMA Fastrach includes rigid handle for insertion; LMA ProSeal/Supreme include drainage lumen. Operated by clinicians in OR or emergency settings. Modification adds MR Conditional status (up to 3.0 Tesla); requires fixation with tape/cloth in MRI suite. Benefits include clear airway in unconscious patients and rescue ventilation when intubation fails.

Clinical Evidence

Bench testing only. Testing performed per ASTM F2052-06e1 to evaluate magnetically induced displacement force in 3.0 Tesla MR environments. Evaluation of inflation check valve performance under MR conditions showed no adverse effects. Fixation protocols established for devices exhibiting deflection >45 degrees.

Technological Characteristics

Supraglottic airways and wire-reinforced tracheal tubes. Materials unchanged from predicate. Features include 15mm OD connectors, inflatable cuffs, pilot balloons, and check valves. MR Conditional up to 3.0 Tesla. Testing per ASTM F2052-06e1.

Indications for Use

Indicated for airway management, tracheal intubation, and maintenance of patent airway in patients requiring anesthesia or emergency ventilation, including difficult airway scenarios. Suitable for use in MR environments up to 3.0 Tesla.

Regulatory Classification

Identification

An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

Predicate Devices

• LMA Fastrach™ ETT (K991580)
• LMA Fastrach™ ETT Single Use (K051993)
• LMA Classic™ (K904834)
• LMA ProSeal™ (K001425)

Submission Summary (Full Text)

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K130304

510(k) Summary Page 1 of 9 30-May-14

MAY 3 0 2014

Teleflex Medical, Inc. 2917 Weck Drive Tel - 919-433-8076 P.O. Box 12600 Fax - 919-433-4996 Research Triangle Park, NC 27709

Official Contact:

Liz Paul Director, Regulatory Affairs/Quality Engineering Anesthesia/Respiratory

Trade Name:

LMA Unique™M LMA ClassicTM LMA Classic™ Excel LMA Flexible™ LMA Flexible™ Single Use LMA ProSeal™ LMA Fastrach™ Single Use LMA Supreme™

Airway, oropharyngeal, anesthesiology

CAE - airway, oropharyngeal, anesthesiology

Common/Usual Name:

Classification Name:

Predicate Devices:

Trade Name:

LMA Fastrach™ ETT Single Use

Common/Usual Name: Tracheal tube

Classification Name: BTR - tracheal tube 21 CFR 868.5730 Class 2

- LMA Fastrach™ ETT (reusable) K991580 Predicate Devices: LMA Fastrach™ ETT Single Use -- K051993
21 CFR 868.5110

LMA Classic™ - K904834

LMA Fastrach™ ETT

LMA Supreme™ - K001425 All others are Class 1 exempt

Class I

# Modification and Changes to Predicate:

To seek MR Conditional environment of use. There have been no other modifications to any of the LMA product series.

### Device Description:

The LMA™ family of airways includes 2 types of airways:

- Generically referred to as supraglottic airways and .

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# 510(k) Summary Page 2 of 9 30-May-14

- Tracheal Tubes specific for use with the LMA Fastrach™ device 0
## Device Description:

The LMATM family of airways includes 2 types of airways:

- Generically referred to as supraglottic airways and .
- Tracheal Tubes specific for use with the LMA Fastrach™ device .

The supraglottic airways are airways that incorporate a large cuff that sits above the glottic opening and the opposite end has a standard 15 mm OD connector that connector to a gas source.

Figure 1 is a typical example of the LMA Classic™. The LMA Unique™, Classic™ Excel are also similar in design, the differences are listed.

Image /page/1/Picture/8 description: The image shows a medical device labeled as Figure 1. The device includes a 15 mm connector at the top, connected to an airway tube. A cuff inflation line runs along the tube, leading to an inflation pilot balloon and a check valve, which are connected to the cuff at the bottom.

The LMA Flexible™ is the same as the Classic™ except that the shaft is wire reinforced allowing for great flexibility.

Figure 2 is a picture of the LMA ProSeal™ which has a second lumen for drainage.

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Image /page/2/Figure/0 description: This image is a diagram of the LMA ProSeal, labeled as Figure 2. The diagram shows the different parts of the device, including the 15 mm connector, drain tube, airway tube, cuff inflation line, inflation pilot balloon, check valve, cuff, and drain tube orifice. The image also includes the text "510(k) Summary Page 3 of 9 30-May-14".

Figure 3 is the LMA Fastrach™ single use which has a rigid handle to assist with insertion.

Image /page/2/Figure/2 description: This image shows a medical device called the LMA Fastrach, which is labeled as single use in Figure 3. The device includes a 15 mm connector, an inflation line for the ET tube, and an ET tube with wire reinforcement. The image also identifies the check valve for the ET tube, the handle, the cuff inflation line, the airway tube, and the cuff epiglottic elevating bar (FEB).

Table 1 below lists the styles and their general design.

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## -510(k) Summary Page 4 of 9 30-May-14

These have been and continued to be considered Class 1 exempt medical devices, however to be marketed for use in MRI suites, even as Class 1 devices requires testing and a review by CDRH for the change in indications for use as MR conditional.

The LMA Fastrach™ ETT and LMA Fastrach™ ETT Single Use is straight, cuffed, wire reinforced tracheal tube that is designed to be used with the LMA Fastrach™ supraglottic airway.

| Product | Brief Description |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Classification CAE – oropharyngeal airway | |
| LMA Classic™ | Standard cuff - reusable |
| LMA Unique™ | Same as Classic™ except single use |
| LMA Classic Excel™ | Similar to Classic™ but can be reused more times |
| LMA Flexible™ | Similar to Classic™ except with flexible wire<br>reinforced shaft<br>Reusable and Single Use models |
| LMA ProSeal™ | Similar to Classic™ but with built-in drain lumen |
| LMA Fastrach™ | To help facilitate intubation, has a rigid shaft to help<br>with insertion / placement |
| LMA Supreme™ | Similar to LMA ProSeal™ with built-in drain lumen<br>and is single use |
| Classification - BTR - tracheal tube | |
| LMA Fastrach™ ETT | Endotracheal tube which is wire reinforced to be used<br>only with the LMA Fastrach™ |

### Table 1 - Overall Device Description

## Indications for Use:

#### Classification - CAE

The LMA Fastrach™ is indicated for use as a guide for intubation of the trachea The LMA Fastrach™ is indicated for achieving and maintaining control of the airway during routine and emergency situations, including anticipated or unexpected difficult airways. The LMA

Fastrach™ is indicated as a method of establishing an airway in the profoundly unconscious patient with absent glossopharyngeal and laryngeal reflexes.

LMA Classic™, Classic™ Excel, Unique™ and Flexible™ are indicated for use in achieving and maintaining control of the airway during routine anesthetic procedures on fasted patients and emergency procedures using either spontaneous or Positive Pressure Ventilation (PPV). .

- An alternative to a face mask. .
- An airway device in routine anesthesia procedures. .
- Securing the immediate airway in anticipated or unexpected difficult airway situations. .
- Use in elective surgical procedures where tracheal intubation is not necessary. .

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# 510(k) Summary Page 5 of 9 30-May-14

- Establishing an immediate, clear airway during cardiopulmonary resuscitation (CPR) in . the profoundly unconscious patient requiring artificial ventilation when tracheal intubation is not possible.
The LMA Supreme™ is indicated for use in achieving and maintaining control of the airway during routine anesthetic procedures on fasted patients using either spontaneous or Positive Pressure Ventilation (PPV), LMA Supreme™ is also intended for use as a rescue device in emergency situations.

- . An alternative to a face mask.
- . An airway device in routine anesthesia procedures.
- . A rescue airway device in anticipated or unexpected difficult airway situations.
- . A rescue airway device in CPR procedures. The LMA Supreme™ may be used to establish an immediate clear airway during resuscitation in the profoundly unconscious patient with absent glossopharyngeal and laryngeal reflexes who may need artificial ventilation.
- . It may also be used to secure an immediate airway when tracheal intubation is precluded by lack of available expertise or equipment, or when attempts at tracheal intubation have failed.

The LMA ProSeal™ is indicated for use in achieving and maintaining control of the airway during routine anesthetic procedures on fasted patients using either spontaneous or Positive Pressure Ventilation (PPV). LMA ProSeal™ is also intended for use as a rescue device in emergency situations.

- The LMA ProSeal™ is indicated for use as: .
- An alternative to a face mask. .
- . An airway device in routine anesthesia procedures.
- A rescue airway device in anticipated or unexpected difficult airway situations. .
- A rescue airway device in CPR procedures. .
- . The LMA ProSeal™ may be used to establish an immediate clear airway during resuscitation in the profoundly unconscious patient with absent glossopharyngeal and laryngeal reflexes who may need artificial ventilation.

### Classification - BTR

The LMA Fastrach™ ETT is indicated for tracheal intubation through the LMA Fastrach™ or for conventional intubation of the trachea using direct or indirect laryngoscopy.

#### Environment of Use:

Adding Magnetic Resonance (MR) environments up to 3.0 Tesla strength.

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# 510(k) Summary Page 6 of 9 30-May-14

### Predicate Device Comparison:

| Characteristic | LMA™ Airway devices | Predicate LMA™ Airway devices<br>(Class 1 exempt)<br>LMA Classic™ - K904834<br>LMA ProSeal™ - K001425 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Classification | CAE - airway, oropharyngeal,<br>anesthesiology<br>CFR 868.5110, Class 1 | CAE - airway, oropharyngeal,<br>anesthesiology<br>CFR 868.5110, Class 1 |
| Intended Use | Devices inserted into a patient's pharynx<br>through the mouth to provide a patent<br>airway (see above detailed description)<br>Adding can be used in a Magnetic<br>Resonance (MR) environment, not to<br>exceed a 3.0 Tesla static magnetic field. | The LMA family of airway have the<br>substantially equivalent indications for use:<br>Devices inserted into a patient's pharynx<br>through the mouth to provide a patent<br>airway. |
| Environment<br>of Use | MR environments<br>Not to exceed 3.0 Tesla | Not tested |
| Performance<br>Testing | ASTM F2052-06e1<br>Standard Test Method of Magnetically<br>Induced Displacement Force of Medical<br>devices in the Magnetic Resonance<br>Environment<br>Effects of MR conditions on the check<br>valve | |

# Table 2 - Comparison to Predicates - CAE Classification

# Substantial Equivalence Comparison to Predicates:

## Discussion of Classification - CAE

The LMA Unique™, LMA Classic™, LMA Classic™ Excel LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are substantially equivalent to the predicate device because:

## Indications -

- Substantially equivalent to predicate LMA Unique™, LMA Classic™, LMA Classic™ . Excel LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™
- . Intended to provide a patent airway in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Discussion: There are no differences between the devices only the addition of the MR conditional indication.

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## Technology -

- Substantially equivalent to predicate LMA Unique™, LMA Classic™, LMA Classic™ . Excel, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™M
Discussion: There are no differences in technology between the devices. Both devices are Class 1 exempt

## Materials -

- There have been no changes in materials .
Discussion: There are no differences in materials between the devices and they are Class I exempt devices.

#### Environment of Use -

- Addition of the MR Conditional environment .
Discussion: The addition of the Magnetic Resonance (MR) environments up to 3.0 Tesla strength has been tested per ASTM F2502-06e1.

| Characteristic | LMA Fastrach™ ETT<br>And<br>LMA Fastrach™ ETT Single Use | Predicate LMA Fastrach™ ET Tube<br>K991580<br>K051993 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Classification | BTR - tracheal tube<br>CFR 868.5730<br>Class 2 | BTR - tracheal tube<br>CFR 868.5730<br>Class 2 |
| Indications for<br>Use | The LMA Fastrach™ ETT is indicated<br>for tracheal intubation through the<br>LMA Fastrach™ or for conventional<br>intubation of the trachea using direct or<br>indirect laryngoscopy.<br>Adding can be used in a Magnetic<br>Resonance (MR) environment, not to<br>exceed a 3.0 Tesla static magnetic field. | The LMA Fastrach™ ETT and LMA<br>Fastrach™ Single Use is indicated for<br>airway management by oral intubation of<br>the trachea. Reinforced ETT may be used<br>to reduce the potential for kinking<br>whenever an unusual positioning of the<br>head or neck is required following<br>intubation. |
| Environment<br>of Use | MR environments<br>Not to exceed 3.0 Tesla | Not tested |
| Performance<br>Testing | ASTM F2052-06e1<br>Standard Test Method of Magnetically<br>Induced Displacement Force of Medical<br>devices in the Magnetic Resonance<br>Environment<br>Effects of MR conditions on the check<br>valve | |

## Table 3 - Comparison to Predicates - BTR Classification

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# 510(k) Summary Page 8 of 9 30-May-14

### Substantial Equivalence Comparison to Predicates:

#### Discussion of Classification - BTR

The LMA Fastrach™ ETT and LMA Fastrach™ ETT Single Use are substantially equivalent to the predicate device because:

#### Indications -

- Substantially equivalent to predicate LMA Fastrach™ ETT and LMA Fastrach™ ETT . Single Use
- . Intended to provide a patent airway in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
- Discussion: There are no differences between the devices only the addition of the MR conditional indication. Predicate LMA Fastrach™ ETT (reusable) - K991580 and LMA Fastrach™ ETT Single Use - K051993.

### Technology -

- Substantially equivalent to predicate LMA Fastrach™ ETT (reusable) K991580 and . LMA Fastrach™ ETT Single Use - K051993.
Discussion: There are no differences in technology between the devices.

#### Materials -

- There have been no changes in materials .
Discussion: There are no differences in materials between the predicate LMA Fastrach™ ETT (reusable) - K991580 and LMA Fastrach™ ETT Single Use - K051993.

# Environment of Use -

- Addition of the MR Conditional environment .
Discussion: The addition of the Magnetic Resonance (MR) environments up to 3.0 Tesla strength has been tested per ASTM F2502-06e1.

#### Non-clinical Comparative Performance and Specifications:

#### MRI Testing

Bench testing per ASTM F2502-06e1 demonstrated that the devices meet the pass / fail criteria and thus there are no new risks associated with MR Conditional use. We have performed testing in accordance to ASTM F2052-06e1.

We have performed testing in accordance to ASTM F2052-06e1 on 4 models of the LMA™ devices.

- LMA ProSeal™ .
- LMA Fastrach™ ETT ●
- LMA Supreme™ .
- LMA Flexible™ .

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- As noted above the LMA Classic™, LMA Unique™, LMA Classic Excel™, and LMA . Fastrach™ Single Use are almost substantially equivalent to the LMA Supreme™ as they are of complete plastic, non-magnetic materials, except for the Check Valve, which is substantially equivalent for each style as was part of the MRI evaluation of the LMA SupremeTM.
Since the LMA Supreme™ meets the ASTM F2502-06e1 requirements, one can justify that the LMA Classic™, LMA Unique™, LMA Classic Excel™, and LMA Fastrach™ Single Use would also meet the requirements.

For those devices which exhibited a deflection greater than 45 degrees during their intended use, they will be held in place or "fixed in place" with adhesive tape, cloth material, and/or a plastic holding device. Based upon this normal condition of use, it was deemed that the device will not dislodge or move is properly fixed in place. Our instructions include that fixation in a MRI environment is mandated.

#### Effects of MR conditions on check valve

We evaluated the performance of the inflation check valve used in each device during MRI exposure and post exposure to determine if there was an influence. There was no affects.

## Substantial Equivalence Conclusion:

The addition of MR Conditional environment of use to the LMA airway devices does not raise any new safety or performance questions which have not been addressed via testing to ASTM F2502-06e1.

The bench testing per ASTM F2502-06e1 and the requirement of fixing the device in place which is the normal practice support that the devices are substantially equivalent to the predicates.

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Image /page/9/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 30, 2014

Teleflex Medical, Inc. c/o Paul Dryden Regulatory Consultant 2917 Weck Drive P.O. Box 12600 Research Triangle Park, NC 27709

## Re: K130304

Trade/Device Name: LMA Unique, LMA Classic, LMA Classic Excel, LMA Flexible, LMA Flexible Single Use, LMA ProSeal, LMA Fastrach Single Use, LMA Fastrach ETT, LMA Fastrach ETT Single Use, LMA Supreme Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR, CAE Dated: May 23, 2014 Received: May 27, 2014

## Dear Mr. Dryden:

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). and Ocometer fore, market the device, subject to the general controls provisions of the Act. The r ou mays norsisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be may be subject to additional vehicles - 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. Dryden

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 (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Teiashri

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

Page 1 of 1

510(k) Number:

K130304_(To be assigned)

Device Name:

LMA Unique™ LMA Classic™ LMA Classic Excel™ LMA Flexible™ LMA Flexible™ Single Use LMA ProSeal™ LMA Fastrach™ Single Use LMA Supreme™

## Indications for Use:

The LMA Unique™, LMA Classic™, LMA Classic Excel™, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are devices inserted into a patient's pharynx through the mouth to provide a patent airway. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Prescription Use XX (Part 21 CFR 801 Subpart D)

or

Over-the-counter use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/11/Picture/13 description: The image shows the text "Todd D Courtney -S 2014.0 5:29:20:59:02 -04'00'". The text appears to be a timestamp or a record of some kind. The text is black and the background is white.

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# Indications for Use Statement

Page 1 of 1

510(k) Number:

K130304_(To be assigned)

Device Name:

LMA Fastrach™ ETT LMA Fastrach™ Single Use

Indications for Use:

The LMA Fastrach™ ETT (reusable) and LMA Fastrach™ ETT Single Use are indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.

These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/12/Picture/14 description: The image shows a timestamp and some text. The text reads "Todd D. Courtney-S". The timestamp is "2014 05:29 20:59:24 -04'00".

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