The SureSeal™ supraglottic airway with attached Cuff Pilot ™ is 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.
Establishing an immediate, clear airway during cardiopulmonary resuscitation (CPR) in the profoundly ● unconscious patient requiring artificial ventilation when tracheal intubation is not possible.

Device Description

The Cuff Pilot™ is a simple device which allows the user to monitor the cuff pressure of supraglottic airways. It has been designed to display pressure ranges via color coded zones. The Cuff Pilot™ is designed with an internal bellows, is compressed as pressure increases and expands when intra-cuff pressure is less. There is an O-ring indicator that is on the bellows and this indicates the status of pressure within the define color coded pressure zones.

The SureSeal™ supraglottic airway is very similar in design, performance, indications for use, technology of operation, and materials to our LMA airways. It will have the Cuff Pilot™ attached and is considered MR Safe.

AI/ML Overview

Let me break down the information from the provided text regarding the acceptance criteria and study for the Cuff Pilot™ and SureSeal™ with Cuff Pilot™.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to prove efficacy against a specific set of acceptance criteria in the manner one might expect for a novel AI device. Therefore, some of the requested information, particularly regarding ground truth, expert adjudication, MRMC studies, and explicit acceptance numbers for performance metrics beyond general accuracy ranges, is not present because it's not typically part of a 510(k) for this type of device. The "acceptance criteria" here are largely implied by demonstrating equivalence to the predicate device's performance characteristics.

Cuff Pilot™

1. Table of Acceptance Criteria and Reported Device Performance:

Attribute	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Cuff Pilot™)
Pressure Range	0 to 60 cm H₂O	0 to 80 cm H₂O
Detection of "good range"	Color coded and a scale	Color coded zones
Accuracy	+/- 1 cmH₂O up to 30 cmH₂O; +/- 2 cmH₂O at 40 cmH₂O; +/- 5 cmH₂O at 60 cmH₂O	+/- 5 cmH₂O up to 80 cmH₂O
Repeatability	Tested for repeatability (predicate)	Tested for repeatability
Temperature Exposure Stability	Tested for accuracy after exposure to high and low temperatures (predicate)	Subjected samples to aging and exposure to cold and hot temperatures
Shelf-life	Not provided (predicate)	3 years
Drop/Shipping Test	(Not explicitly mentioned for predicate)	Drop / Shipping test
Biocompatibility (Cytotoxicity)	Performed (predicate)	Non-reactive (ISO 10993-1 cytotoxicity testing performed)
MRI Use	Not labeled (predicate)	MR Safe based on lack of metal/magnetic materials per ASTM F2052-06

2. Sample size used for the test set and data provenance:

Sample Size: Not explicitly stated. The studies are described as "bench testing" and "subjected samples," which implies a set of physical devices were tested, but the exact number isn't quantified in this summary.
Data Provenance: The tests are non-clinical bench tests performed by the manufacturer (Teleflex Medical). There is no mention of country of origin for data as it's not human subject data. The studies are prospective in the sense that they were conducted for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Not applicable. This device is a mechanical pressure monitor, not an AI or diagnostic tool requiring expert interpretation for ground truth. The "ground truth" (actual pressure) would have been established using calibrated pressure measurement equipment during the bench testing.

4. Adjudication method for the test set:

Not applicable for a mechanical device undergoing bench testing. The "adjudication" would be direct measurement against calibrated standards.

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 is a medical device, not an AI or diagnostic imaging system. No human reader studies (MRMC) were conducted.

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

Not applicable. The Cuff Pilot™ is a standalone mechanical device. Its performance is evaluated intrinsically through the bench tests mentioned.

7. The type of ground truth used:

Calibrated pressure measurements from laboratory equipment. The accuracy of the device's reading (color-coded zones) was compared against these known, precise pressure values.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

SureSeal™ with Cuff Pilot™

This device is the SureSeal™ supraglottic airway (which includes the Cuff Pilot™ attached). The information provided focuses on the SureSeal™ component's equivalence to a predicate (LMA Classic™) and the overall device's MR safety.

1. Table of Acceptance Criteria and Reported Device Performance:

Attribute	Acceptance Criteria (Implied by Predicate - LMA Classic™)	Reported Device Performance (SureSeal™ with Cuff Pilot™)
Classification	Procode - CAE - airway, oropharyngeal; CFR – 868.5110; Class 1 - exempt	Procode - CAE – airway, oropharyngeal; CFR – 868.5110; Class 1 - exempt
Indications for Use	Achieving and maintaining control of airway during routine anesthetic procedures, emergency procedures; alternative to face mask, airway device in routine anesthesia, securing immediate airway in difficult situations, elective surgical procedures (no intubation), CPR.	Identical to predicate.
Patient Population	Patients who need an artificial airway	Identical to predicate.
Environments of Use	Hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, MRI suites (MR Conditional)	Hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, MRI suites (MR Safe when attached to airways that are MR Safe).
Technology	Inflatable cuff and tube that rest above the glottis opening	Identical to predicate.
Method of Inflating Cuff	Integrated pilot check valve with separate syringe. Manual	Used with Cuff Pilot™ and a separate syringe. Manual
Available Sizes	Sizes 1 to 6	Sizes 1 to 6
Single Patient, Disposable	Yes	Yes
MRI Use	MR Conditional	MR Safe based on lack of materials which contain metal or are magnetic per ASTM F2052-06.
Biocompatibility (Surface and External)	Surface and Externally communicating contact (indirect gas pathway); Tissue / Mucosa contact; Limited duration (<24 hours)	Identical to predicate (ISO 10993-1 testing performed for Cytotoxicity, Sensitization, Irritation, Systemic Toxicity).
Shelf-life	3 years	3 years (Real-time age testing performed)
Performance Testing	(Not explicitly detailed for predicate beyond general equivalence claim for LMA Classic™)	Age / shelf-life, Hot / Cold temperature exposure, Drop / Shipping test. The device "met its specifications" after these tests. Specific performance results like accuracy for the airway function are not provided here.

2. Sample size used for the test set and data provenance:

Sample Size: Not explicitly stated. The studies are described as "bench testing" and "subjected samples," which implies a set of physical devices were tested, but the exact number isn't quantified.
Data Provenance: Non-clinical bench tests performed by the manufacturer (Teleflex Medical). No human subject data. Prospective, for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Not applicable. The performance tests for the airway (like age testing, temperature, drop tests) are evaluated against engineering specifications, not human expert consensus. Biocompatibility tests follow standardized lab procedures.

4. Adjudication method for the test set:

Not applicable for bench testing. Results would be objectively measured against predefined specifications.

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 is a medical device, not an AI or diagnostic imaging system.

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

Not applicable. The SureSeal™ with Cuff Pilot™ is a standalone mechanical device. Its performance is evaluated intrinsically through the bench tests mentioned.

7. The type of ground truth used:

For physical performance characteristics (e.g., integrity after aging/temperature/drop), the ground truth is whether the device met its specifications as determined by engineering measurements and established test protocols.
For biocompatibility, the ground truth is established by standard laboratory cytotoxicity, sensitization, irritation, and systemic toxicity tests according to ISO 10993-1.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three faces overlapping each other.

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

May 8, 2015

Teleflex Medical c/o Mr. Paul Dryden Consultant 3015 Carrington Mill Blvd. Morrisville, NC 27560

Re: K142103

Trade/Device Name: Cuff Pilot™, SureSeal™ with Cuff Pilot™ Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: II Product Code: BSK, CAE Dated: April 27, 2015 Received: April 28, 2015

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). 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. 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 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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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); 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/Resourcesfor You/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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for 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

510(k) Number (if known)

K142103

Device Name

Cuff Pilot™

Indications for Use (Describe)

To monitor intra-cuff pressures of supraglottic airways.

Patient Population:

Patients who have an artificial airway and for which the user would like to monitor cuff pressure, pediatric to adult.

Environments of Use:

To be used under medical supervision in hospital (EMS), extended care facilities and outpatient clinics, where a patient may have an artificial airway. It may also be used in MRI suites when attached to airways that are MR conditional or MR Safe.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142103

Device Name

SureSeal™ with Cuff Pilot™

Indications for Use (Describe)

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.
Establishing an immediate, clear airway during cardiopulmonary resuscitation (CPR) in the profoundly ● unconscious patient requiring artificial ventilation when tracheal intubation is not possible.

Patient Population: Patients who need an artificial airway, pediatric to adult.

Environments of Use:

To be used under medical supervision in hospital (EMS), extended care facilities and outpatient clinics, where a patient needs an artificial airway. It may also be used in MRI suites and is considered MRI Safe.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary Page 1 of 7 8-May-15

Teleflex Medical3015 Carrington Mill BlvdMorrisville, NC 27560	Telephone: 919-361-3934Fax: 919-433-4996
Official Contact:	Justin LovelaceRegulatory Affairs Specialist
Proprietary or Trade Name:	Cuff Pilot™
Common/Usual Name:	Cuff Pilot™SureSeal™ with Cuff Pilot™
Classification Name:	Cuff, tracheal tube, inflatable (accessoryBSK – 21 CFR 868.5750, Class IIAirway, oropharyngealCAE – 21 CFR 868.5110, Class I
Predicate Devices:	Easy Cuff – K102704LMA™ Classic – K130304

Device Description:

Indications for Use - Cuff Pilot™

To monitor intra-cuff pressures of supraglottic airways.

Patient Population: Patients who have an artificial airway and for which the user would like to monitor cuff pressure, pediatric to adult.

Environments of Use: To be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may have an artificial airway. It may also be used in MRI suites when attached to airways that are MR conditional or MR Safe.

Indications for Use - SureSeal™ with Cuff Pilot™

The SureSeal™ supraglottic airway with attached Cuff Pilot™ is indicated for use in achieving and

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510(k) Summary Page 2 of 7 8-May-15

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.
. Establishing an immediate, clear airway during cardiopulmonary resuscitation (CPR) in the profoundly unconscious patient requiring artificial ventilation when tracheal intubation is not possible.

Patient Population: Patients who need an artificial airway

Environments of Use: To be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient needs an artificial airway. It may also be used in MRI suites and is considered MRI Safe.

Attribute	PredicateEasy Cuff (K102704)	Proposed DeviceCuff Pilot™
Indications for Use	To inflate cuffs and to measure andmonitor intra-cuff pressures ofendotracheal, supraglottic airways, ortracheostomy tubes.	To monitor intra-cuff pressures ofsupraglottic airways.
Environments of use	To be used under medical supervision inhospitals, pre-hospital (EMS), extendedcare facilities and outpatient clinics,where a patient may be intubated.	To be used under medical supervision inhospitals, pre-hospital (EMS), extended carefacilities and outpatient clinics, where apatient may have an artificial airway. It mayalso be used in MRI suites when attached toairways that are MR conditional or MR Safe.
Patient population	Intubated patients	Patients who have an artificial airway and forwhich the user would like to monitor cuffpressure, pediatric to adult.
Technology	Bellows that move with changes inpressureExpands with higher pressuresContracts with lower pressures	Bellows that move with changes in pressureContracts with higher pressuresExpands with lower pressures
Method of inflating cuff	Use the integrated syringeManual	Use an independent syringe(normal practice)Manual
Attaches to the Cuff InflationPilot	Yes via a luer fitting	Yes via a luer fittingMay be permanently attached to an airway'scuff inflation line
Types of airways to which itcan be used	Supraglottic airwayEndotracheal tubeTracheostomy tube	Supraglottic airway
Single patient, disposable	Yes	Yes
Pressure Range of the device	0 to 60 cm H₂O	0 to 80 cm H₂O

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510(k) Summary Page 3 of 7 8-May-15

Attribute	PredicateEasy Cuff (K102704)	Proposed DeviceCuff Pilot™
Detection of "good range"	Color coded and a scale	Color coded zones
Packaged	Non-sterile	Non-sterileSterile
Accuracy	+/- 1 cmH2O up to 30 cmH2O+/- 2 cmH2O at 40 cmH2O+/- 5 cmH2O at 60 cmH2O	+/- 5 cmH2O up to 80 cmH2O
MRI Use	Not labeled	MR Safe based upon the lack ofmaterials which contain metal or aremagnetic per ASTM F2052-06,rationale
Shelf-life	Not provided	3 years
Performance Testing	Accuracy across the pressure rangeRepeatabilityTested for accuracy after exposure to highand low temperatures	Accuracy within the pressure zonerangesRepeatabilitySubjected samples to aging andexposure to cold and hot temperatures
Drop test		Drop / Shipping test

Substantial Equivalence Discussion:

The Cuff Pilot™ is viewed as substantially equivalent to the predicate devices because:

Indications -

The Cuff Pilot™ is intended to monitor the intra-cuff pressure of Supraglottic airways. Discussion - The predicate, EasyCuff™ (K102704) is designed to inflate the cuff instead of requiring a separate syringe, which is the normal practice. This difference does not raise any new safety or effectiveness concerns, thus the proposed device is considered substantially equivalent. The proposed Cuff Pilot™ is intended to monitor changes in cuff pressure and display the pressure within a range or zone. Actual pressure will be set or checked with a separate cuff pressure gauge.

Environment of Use -

The Cuff Pilot™ has the same environment of use as the predicate plus MRI suites. Discussion - The Cuff Pilot™ has no magnetic materials and thus can be considered MR Safe. It can be used with any artificial airway that is deemed to be MR Conditional or MR Safe. The predicate is likely MR Conditional but it was not an indication in the original submission. This difference does not raise any new safety or effectiveness concerns that have not been addressed in the rationale and thus the proposed device can be considered substantially equivalent.

Patient Population -

The Cuff Pilot™ has the same patient population as the predicate.

Discussion - Since patients who have a supraglottic airway are not technically considered "intubated"; the predicate, EasyCuff™ (K102704) term in not correct. This is no different than the predicate and thus the proposed device is considered substantially equivalent.

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510(k) Summary Page 4 of 7 8-May-15

Technology -

The Cuff Pilot™ uses a bellows which moves in relationship to the intra-cuff pressure. As pressures increases the bellows collapses.

Discussion - The use of a bellows which moves in relationship to the intra-cuff pressure is identical to the predicate EasyCuff™ (K102704). The only differences is that for the proposed device the bellows compresses with increasing pressure while the predicate EasyCuff™ bellows expands with increasing pressure. Each device has color coded zones, which represent pressures, which informs the user of the relative cuff pressure within the zone. Any difference does not raise any new safety or effectiveness concerns, thus the proposed device is considered substantially equivalent.

Summary of Non-clinical Testing

The following is a summary of non-clinical bench testing.

Materials -

There are no materials of the Cuff Pilot™ in contact with the patient or in the gas pathway. Discussion - We have performed ISO 10993-1 cytotoxicity testing on the Cuff Pilot™. The results were non-reactive.

Performance -

We have performed a number of tests to demonstrate the accuracy and repeatability of the measured pressure for the Cuff Pilot™. The performance is similar to the predicate. EasyCuff™ (K102704).

The tests performed are:

Real-time age testing - 3 years
Accuracy across the pressure zone / range
Repeatability
Subjected samples to aging and exposure to cold and hot temperatures ●
Drop / Shipping test ●

Discussion - The performance specifications of the Cuff Pilot™ and the predicate are substantially equivalent.

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

SureSeal™ with Cuff Pilot™

SureSeal™ is only offered with the Cuff Pilot™ is standard Supraglottic airway similar in design and function to the LMA Classic™. It is considered a Class 1 exempt device but we are seeking to have the Cuff Pilot™ attached as well as seeking MR Safe environment of use.

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510(k) Summary

Attribute	Predicate	Proposed Device
	LMA Classic™ (K130304)	SureSeal™ with Cuff Pilot™
Classification	Procode -CAE - airway, oropharyngealCFR – 868.5110Class 1 - exempt	Procode -CAE – airway, oropharyngealCFR – 868.5110Class 1 - exempt
Indications for Use	LMA Classic™ is indicated for use inachieving and maintaining control of theairway during routine anesthetic procedureson fasted patients and emergency proceduresusing either spontaneous or Positive PressureVentilation (PPV).• An alternative to a face mask.• An airway device in routine anesthesiaprocedures.• Securing the immediate airway inanticipated or unexpected difficult airwaysituations.• Use in elective surgical procedures wheretracheal intubation is not necessary.• Establishing an immediate, clear airwayduring cardiopulmonary resuscitation (CPR)in the profoundly unconscious patientrequiring artificial ventilation when trachealintubation is not possible.	The SureSeal™ supraglottic airway isindicated for use in achieving andmaintaining control of the airway duringroutine anesthetic procedures on fastedpatients and emergency procedures usingeither spontaneous or Positive PressureVentilation (PPV).• An alternative to a face mask.• An airway device in routine anesthesiaprocedures.• Securing the immediate airway inanticipated or unexpected difficult airwaysituations.• Use in elective surgical procedures wheretracheal intubation is not necessary.• Establishing an immediate, clear airwayduring cardiopulmonary resuscitation (CPR)in the profoundly unconscious patientrequiring artificial ventilation when trachealintubation is not possible.
Patient population	Patients who need an artificial airway	Patients who need an artificial airway
Environments of use	To be used under medical supervision inhospitals, pre-hospital (EMS), extended carefacilities and outpatient clinics, where apatient needs an artificial airway. It may alsobe used in MR suites as MR Conditional.	To be used under medical supervision inhospitals, pre-hospital (EMS), extended carefacilities and outpatient clinics, where apatient needs an artificial airway. It mayalso be used in MRI suites when attached toairways that are MR Safe.
Technology	Inflatable cuff and tube that rest above theglottis opening	Inflatable cuff and tube that rest above theglottis opening
Method of inflating cuff	Use integrated pilot check valve with aseparate syringe. Manual	Used with Cuff Pilot™ anda separate syringe. Manual
Available in sizes	Sizes 1 to 6	Sizes 1 to 6
Single patient,disposable	Yes	Yes
Attribute	Predicate	Proposed Device
	LMA ClassicTM (K130304)	SureSealTM with Cuff PilotTM
MRI Use	MR Conditional	MR Safe based upon the lack of materialswhich contain metal or are magnetic perASTM F2052-06, rationale
Biocompatibility	Surface and Externally communicatingcontact(indirect gas pathway)Tissue / Mucosa contactLimited duration	Surface and Externally communicatingcontact(indirect gas pathway)Tissue / Mucosa contactLimited duration
Shelf-life	3 years	3 years
Performance Testing		AgeHot / Cold temperatureDrop / shipping

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510(k) Summary Page 6 of 7 8-May-15

Substantial Equivalence Discussion:

The SureSeal™ is viewed as substantially equivalent to the predicate device because:

Indications -

The SureSeal™ is 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).

Discussion - The predicate, LMA Classic™ (K130304) is also designed to achieve and maintain and airway. There are no differences, thus there are no new safety or effectiveness concerns raised, thus the proposed device is considered substantially equivalent.

Environment of Use -

The SureSeal™ has the same environment of use as the predicate including use in MRI suites. Discussion - The SureSeal™ and the Cuff Pilot™ have no magnetic materials and thus can be considered MR Safe. The predicate is MR Conditional because the inflation check valve does contain magnetic materials. This difference does not raise any new safety or effectiveness concerns that have not been addressed in the rationale and thus the proposed device can be considered substantially equivalent.

Patient Population -

The SureSeal™ has the same patient population as the predicate.

Discussion - There are no differences between the proposed device, thus it can be considered substantially equivalent.

Technology -

The SureSeal™M employs the same technology and principle of operation as the predicate. Discussion - The design and technology is similar between the devices and there are no differences which would raise any new safety or effectiveness concerns, thus the proposed device is considered substantially equivalent.

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510(k) Summary Page 7 of 7 8-May-15

Materials -

The materials are similar between the devices.

Discussion - We have performed ISO 10993-1 testing for the materials for the SureSeal™. Based upon ISO 10993-1 and G95-1 the SureSeal™ would be considered as:

. Surface Contact and Externally communicating (indirect gas pathway)
Tissue / Mucosa contact
Limited duration (<24 hours) .

This is identical to the predicate LMA Classic™ (K130304).

Performance -

We have performed a number of tests on the SureSeal™ including age / shelf-life, hot and cold temperatures and drop /shipping testing.

Discussion - The SureSeal™ met it specifications after these tests.

Summary of Non-clinical Testing

The following is a summary of non-clinical bench testing.

Materials -

We have performed ISO 10993-1 testing for the materials of the SureSeal™.

Cytotoxicity
Sensitization ●
Irritation ●
Systemic Toxicity

Performance -

We have performed a number of tests which included:

Real-time age testing - 3 years
Subjected samples to aging and exposure to cold and hot temperatures .
Drop / Shipping test ●

Results - The SureSeal™ met its performance specifications.

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

Regulation Number and Section

§ 868.5750 Inflatable tracheal tube cuff.

(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).