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 Description

The LMA™ 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. The LMA Flexible™ is the same as the Classic™ except that the shaft is wire reinforced allowing for great flexibility. The LMA ProSeal™ which has a second lumen for drainage. The LMA Fastrach™ single use which has a rigid handle to assist with insertion. 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.

AI/ML Overview

The provided 510(k) summary focuses on demonstrating the MR Conditional environment of use for various LMA airway devices and tracheal tubes. It does not contain information about studies related to diagnostic performance, accuracy, or human reader improvement with AI assistance. The "acceptance criteria" and "device performance" in this context refer to engineering and safety specifications related to MRI compatibility, not clinical diagnostic metrics.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by ASTM F2052-06e1)	Reported Device Performance (as stated in the document)
No new risks associated with MR Conditional use.	Bench testing per ASTM F2502-06e1 demonstrated that the devices meet the pass/fail criteria.
Magnetic field-induced displacement force should not pose a hazard.	Devices meet the requirements, with additional instructions for fixation (taping, cloth, or plastic holding device) for those exceeding 45 degrees deflection.
Performance of the inflation check valve during and after MRI exposure should not be affected.	"There was no affects [sic]" on the check valve performance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions testing on "4 models of the LMA™ devices" (LMA ProSeal™, LMA Fastrach™ ETT, LMA Supreme™, LMA Flexible™). It also states that other models (LMA Classic™, LMA Unique™, LMA Classic Excel™, and LMA Fastrach™ Single Use) were deemed substantially equivalent based on the LMA Supreme™'s results due to similar complete plastic, non-magnetic materials (except for the check valve). The exact number of individual units tested within these models is not specified.
Data Provenance: Not applicable in the traditional sense of clinical data. This refers to bench testing conducted according to a specific ASTM standard (F2052-06e1) to assess MRI compatibility. The country of origin of this specific testing data is not specified, but the submission is to the FDA (USA). The testing is non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this type of test is defined by the technical specifications and pass/fail criteria of the ASTM F2052-06e1 standard for magnetically induced displacement force and material compatibility in an MRI environment. It does not involve human experts establishing a "ground truth" for clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable. The assessment is based on objective measurements against the ASTM F2052-06e1 standard, not on human interpretation or adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This 510(k) submission is for the MRI compatibility of medical devices, not for a diagnostic AI system. Therefore, an MRMC comparative effectiveness study is not relevant and was not conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is the physical properties and behavior of the devices as measured against the pass/fail criteria defined by the ASTM F2052-06e1 standard. This standard is an engineering specification for assessing magnetic field-induced displacement force and other MRI compatibility factors for medical devices.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm being trained in this context. The study involves bench testing of physical devices.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no AI algorithm or training set involved.

Summary

{0}------------------------------------------------

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 .

{1}------------------------------------------------

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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

-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 wirereinforced shaftReusable 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 helpwith insertion / placement
LMA Supreme™	Similar to LMA ProSeal™ with built-in drain lumenand is single use
Classification - BTR - tracheal tube
LMA Fastrach™ ETT	Endotracheal tube which is wire reinforced to be usedonly 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. .

{4}------------------------------------------------

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.

{5}------------------------------------------------

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

Predicate Device Comparison:

Characteristic	LMA™ Airway devices	Predicate LMA™ Airway devices(Class 1 exempt)LMA Classic™ - K904834LMA ProSeal™ - K001425
ProductClassification	CAE - airway, oropharyngeal,anesthesiologyCFR 868.5110, Class 1	CAE - airway, oropharyngeal,anesthesiologyCFR 868.5110, Class 1
Intended Use	Devices inserted into a patient's pharynxthrough the mouth to provide a patentairway (see above detailed description)Adding can be used in a MagneticResonance (MR) environment, not toexceed a 3.0 Tesla static magnetic field.	The LMA family of airway have thesubstantially equivalent indications for use:Devices inserted into a patient's pharynxthrough the mouth to provide a patentairway.
Environmentof Use	MR environmentsNot to exceed 3.0 Tesla	Not tested
PerformanceTesting	ASTM F2052-06e1Standard Test Method of MagneticallyInduced Displacement Force of Medicaldevices in the Magnetic ResonanceEnvironmentEffects of MR conditions on the checkvalve

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.

{6}------------------------------------------------

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™ ETTAndLMA Fastrach™ ETT Single Use	Predicate LMA Fastrach™ ET TubeK991580 K051993
ProductClassification	BTR - tracheal tubeCFR 868.5730Class 2	BTR - tracheal tubeCFR 868.5730Class 2
Indications forUse	The LMA Fastrach™ ETT is indicatedfor tracheal intubation through theLMA Fastrach™ or for conventionalintubation of the trachea using direct orindirect laryngoscopy.Adding can be used in a MagneticResonance (MR) environment, not toexceed a 3.0 Tesla static magnetic field.	The LMA Fastrach™ ETT and LMAFastrach™ Single Use is indicated forairway management by oral intubation ofthe trachea. Reinforced ETT may be usedto reduce the potential for kinkingwhenever an unusual positioning of thehead or neck is required followingintubation.
Environmentof Use	MR environmentsNot to exceed 3.0 Tesla	Not tested
PerformanceTesting	ASTM F2052-06e1Standard Test Method of MagneticallyInduced Displacement Force of Medicaldevices in the Magnetic ResonanceEnvironmentEffects of MR conditions on the checkvalve

Table 3 - Comparison to Predicates - BTR Classification

{7}------------------------------------------------

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™ .

{8}------------------------------------------------

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.

{9}------------------------------------------------

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.

{10}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{11}------------------------------------------------

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:

Prescription Use XX (Part 21 CFR 801 Subpart D)

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.

{12}------------------------------------------------

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:

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".

PDF PAGE 41 of 263

Regulation Number and Section

§ 868.5110 Oropharyngeal airway.

(a)
Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.