Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid® allows aspiration of contaminated mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.

The BLUselect® Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect® Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

Device Description

The Smiths Medical Portex® BLUselect and BLUselect Suctionaid Tracheostomy Tubes are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. BLUselect Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect Tracheostomy Tubes. The subject device package consists of a tracheostomy tube, a tube holder, cleaning brush, an inner cannula, obturator, disconnection wedge, and a vacuum control valve (with Suctionaid® tubes only) and a maximum recommended period of use is 29 days; intended to be used critical care settings, acute care settings, long term care facilities, and for home use.

The tube is manufactured with a flange, inflation line, suction line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for safe use when in-contact with patient tissue/bodily fluids/secretions.

AI/ML Overview

This document, K173384, is a 510(k) Summary for medical tracheostomy tubes and inner cannulas. It asserts substantial equivalence to predicate devices, focusing on design, materials, and performance testing rather than clinical study data with human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent if it meets the criteria of the predicate device and relevant international standards. The criteria are based on physical and functional characteristics, and the reported performance indicates compliance with these.

Acceptance Criteria (from predicate/standards)	Reported Device Performance
Product Code: BTO	BTO
Product Classification: Class II	Class II
Device Classification Name & 21 CFR: Tracheostomy tube and tube cuff § 868.5800	Tracheostomy tube and tube cuff § 868.5800
Invasive or Non-Invasive: Surgically Invasive	Surgically Invasive
Patient Population: Adults with average height, weight, and anthropometrics	Adults with average height, weight, and anthropometrics
Intended Use: For patients requiring an artificial airway due to trauma or medical condition	For patients requiring an artificial airway due to trauma or medical condition
Maximum Use: Recommended 29 Days	Recommended 29 Days
Indications for Use (Tracheostomy Tube): Airway maintenance of tracheostomized patients	Airway maintenance of tracheostomized patients
Indications for Use (Suctionaid): Aspiration of contaminated mucous and subglottic secretions	Aspiration of contaminated mucous and subglottic secretions
Indications for Use (Inner Cannula): Used with tracheostomy tube for airway maintenance	Used with tracheostomy tube for airway maintenance
Functionality: Airway maintenance; optionally with cuff, Suctionaid®, fenestrations in 6.0mm to 10.0mm range	Airway maintenance; optionally with cuff, Suctionaid®, fenestrations in 6.0mm to 10.0mm range
Sterilization: Ethylene Oxide (EO) Sterile SAL 10-6	Ethylene Oxide (EO) Sterile SAL 10-6
Biocompatibility: Compatibility materials ISO 10993-1: 2009	Compatibility materials ISO 10993-1: 2009
MRI Conditional: Yes	Yes
Shelf Life: 5-year shelf life	5-year shelf life intended
Single Use/Single Patient Use: Yes	Yes
Environment of Use: Critical care, Acute care, Long term care facilities	Critical care, Acute care, Long term care facilities
Home Care Use: Yes	Yes
Tracheostomy Tube Materials (Flexible PVCs): Main Tube Body, Inflation Line, Pilot Balloon, Suction Line, Cuff Bonding Cement (DEHP PVC)	Main Tube Body, Inflation Line, Pilot Balloon, Suction Line, Cuff Bonding Cement (DEHT PVC). All other materials equivalent.
Flange Marking/Color Coding: Clear Embossed Mark	Laser Marked Product Information with Vinyl Ink Printed Color Coding Band
Suctionaid feature: Available	Available
Varied Components: Included	Included
Inner Cannula: Included	Included
Cleaning Instructions: Included	Included
IFU: Included	Included
Bench Testing (ISO 5366:2016): Meets essential requirements for pediatric tracheostomy tubes	Conducted, device meets requirements
Bench Testing (ISO 5356-1): Compatible with 15mm connector for breathing system	Conducted, device is compatible
Bench Testing (ISO 18190): Safe and effective as an airway device	Conducted, device is safe and effective
MRI Assessment (ASTM F2052-15 & ASTM F2503): Safe for MRI environment	Conducted, device is safe for MRI
Cleaning Instruction Validation (FDA Guidance, AAMI TIR 30, AAMI TIR12, AAMI TIR34): Inner cannula effectively cleaned for re-use	Conducted, inner cannula can be effectively cleaned
Sterilization/Microbiology Validation (ISO 11135, AAMI TIR28, ISO 11747): Acceptable product sterility	Conducted, acceptable product sterility
Biocompatibility Assessment (ISO 10993-1): Materials biocompatible, equivalent to predicate	Conducted, materials are biocompatible and equivalent
Design Validation / Human Factors (ISO 62366): Acceptable performance for intended use	Conducted, performance is acceptable

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

The document does not explicitly state sample sizes for specific tests. The tests were bench tests conducted on the physical device components. Data provenance would be from internal laboratory testing at Smiths Medical. The tests are non-clinical, so country of origin of patient data or retrospective/prospective is not applicable.

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 performance was established through compliance with recognized international standards (ISO, ASTM) and FDA guidance for medical device testing, rather than expert consensus on a test set of cases.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human assessment or adjudication of cases.

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

Not applicable. This submission is for a physical medical device (tracheostomy tube), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted.

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

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is objective compliance with established performance standards (ISO 5366, ISO 5356-1, ISO 18190, ASTM F2052-15, ASTM F2503), FDA guidance (e.g., for cleaning validation), and biocompatibility standards (ISO 10993-1). There is no clinical ground truth (e.g., pathology, outcomes data) as this is a premarket notification based on substantial equivalence to predicate devices and non-clinical testing.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model. Therefore, there is no training set involved.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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April 10, 2018

Smiths Medical ADS, Inc. Donna Semlak Principal Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442

Re: K173384

Trade/Device Name: Smiths Medical Portex® BLUselect® Tracheostomy Tube Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: BTO Dated: March 2, 2018 Received: March 5, 2018

Dear Donna Semlak:

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. Iisting 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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tina
Kiang-S

Tina Kiang, Ph.D. Acting 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)

K173384

Device Name Smiths Medical Portex® BLUselect® Tracheostomy Tube

Indications for Use (Describe)

Smiths Medical Portex® BLUselect® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.

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."

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Indications for Use

510(k) Number (if known)

K173384

Device Name Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube

Indications for Use (Describe)

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

☑ 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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Indications for Use

510(k) Number (if known)

K173384

Device Name Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula

Indications for Use (Describe)

The BLUselect® Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect® Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart

ion 300 (Part 2: 3.11.00: Support B)

| | 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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smiths medical

bringing technology to life

510(k) SUMMARY

BLUselect® Devices

Date of Summary Preparation:

Submitter:

Establishment Registration Number:

Company Contact (Primary):

Trade Name(s):

Device Names(s):

Device Classification:

Regulation Number and Product Code(s):

April 9, 2018 (revised)

Smiths Medical 6000 Nathan Lane Minneapolis, MN 55442 USA

3012307300 (Minneapolis)

Donna M. Semlak Principal Regulatory Affairs Specialist Email: donna.semlak@smiths-medical.com Office: 763-383-3076

Tracheostomy Tube

· Smiths Medical Portex® BLUselect® Tracheostomy Tube
· Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube
· Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula

Class II

21 CFR § 868.5800 Tracheostomy, Tube вто

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Purpose

The purpose of this premarket notification Traditional 510(k) is to obtain FDA clearance for adult patient population requiring an artificial airway for breathing. This submission is submitted to establish substantial equivalence and obtain 510(k) clearance for the following:

Smiths Medical Portex® BLUselect® Tracheostomy Tube .
Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube ●
Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula ●

Predicate Device(s) for Smiths Medical Portex® BLUselect® Devices

Information for the predicate device is provided in the table below for the subject devices. BLUselect®, BLUselect® Suctionaid®, and BLUselect® Inner Cannula.

PredicateDevice Name	FDA 510(k)Number andClearance Date	Classification	Primary Code
Portex Blue Line UltraSuctionaidTracheostomy Tube	K030570Sept 17, 2003Original Applicant:Portex Limited	Class II	BTO21 CFR 868.5800

Reference Devices for Smiths Medical Portex® BLUselect® Devices

ReferenceDevice Name	FDA 510(k)Number andClearance Date	Classification	Primary Code
Portex UniPercPercutaneous DilationTracheostomy Kit	K083031August 18, 2009Original Applicant:Smiths Medical	Class II	BTO21 CFR 868.5800
Bivona TracheostomyTubesMRI Labeling	K083641Feb 23, 2009Original Applicant:Smiths Medical	Class II	JOH21 CFR 868.500
Blue Line UltraTracheostomy TubeIncludes innercannula	K030381Aug 23, 2003Original Applicant:Portex Limited	Class II	BTO21 CFR 868.5800

General Device Description

Smiths Medical Portex® BLUselect®, BLUselect® Suctionaid®, and BLUselect® Inner Cannula:

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for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. BLUselect Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect Tracheostomy Tubes. The subject device package consists of a tracheostomy tube, a tube holder, cleaning brush, an inner cannula, obturator, disconnection wedge, and a vacuum control valve (with Suctionaid® tubes only) and a maximum recommended period of use is 29 days; intended to be used critical care settings, acute care settings, long term care facilities, and for home use.

Smiths Medical Product Name	Indications For Use
Smiths Medical Portex® BLUselect®Tracheostomy Tube	Smiths Medical Portex® BLUselect® TracheostomyTube is indicated for airway maintenance oftracheostomised patients.
Smiths Medical Portex® BLUselect®Suctionaid® Tracheostomy Tube	Smiths Medical Portex® BLUselect® Suctionaid®Tracheostomy Tube is indicated for airwaymaintenance of tracheostomised patients. Suctionaid®allows aspiration of contaminated mucous andsubglottic secretions that collect and build up betweenthe tracheostomy tube cuff and the glottis.
Smiths Medical Portex® BLUselect®Tracheostomy Inner Cannula	The BLUselect® Inner Cannula is intended to be usedwith the Smiths Medical Portex® BLUselect®Tracheostomy Tube indicated for airway maintenanceof tracheostomy patients.

Indications for Use:

Summary of Technological Characteristics:

The Smiths Medical Portex® BLUselect subject devices shares the similar technological characteristics as their 510(k) cleared predicates, Blue Line Ultra devices. These characteristics include the same intended use of 29 days for the adult patient population, same overall design, same base materials, and same range of sizes, Also, both the subject device and the predicate devices meet the ISO 5366 and ISO 5356 standards and requirements for tracheostomy tubes; including ISO 18190 for airway equipment; which concludes substantially equivalent performance characteristics.

The BLUselect subject device and the Blue Line Ultra Tracheostomy Tube predicate device are manufactured with the same type of material, Polyvinyl Chloride (PVC). The BLUselect Inner Cannula and Blue Line Ultra Inner Cannula predicate device material is a medical grade polyethylene.

The subject devices and the predicate devices are designed to aid the adult population with an artificial airway due to trauma, a medical condition or airway maintenance. Both have 15mm connectors for attachment to airway circuits. which are compatible with standard healthcare systems for use of humidification and/or ventilation equipment. Both, the subject and predicate devices provide a neck strap (tube holder) for use to secure the tracheostomy tube placement to the patient.

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The surqical procedure is the same for BLUselect; anterior surgical approach of the patient's trachea anatomy. An invasive incision is made at the tracheal anatomy, in which a surgical stoma is created for the tracheostomy tube insertion. Both the subject and predicate devices are manufactured with a radio-opaque material, which assists the physician for device placement with x-ray.

The BLUselect trach tubes, subject device(s) and predicate devices are by prescription only, for single use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user.

The BLUselect inner cannula and predicate inner cannula are intended to be used with the tracheostomy tube and are by prescription only, for single-patient use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user. The inner cannula cleaning instructions allows for re-use with the same patient.

Principle of Operation

The Smiths Medical Portex® BLUselect and BLUselect Suctionaid Tracheostomy Tubes and BLUselect Inner Cannula are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction.

A tracheotomy is a surgical procedure in which a direct airway is established by creating an opening in the anterior neck and placing a tracheostomy tube through the anterior neck into the trachea to secure the airway.

Summary of Performance Testing:

The Smiths Portex® Medical BLUselect and BLUselect Suctionaid Tracheostomy Tubes and BLUselect Inner Cannula incorporates the same indications for use, similar technological characteristics, including MRI conditional labeling and the similar tube sizes as the legally marketed primary predicate device the Blue Line Ultra Tracheostomy Tubes, K030381, 510(k) clearance issued August 27, 2003: Blue Line Ultra Suctionaid Tracheostomy Tube with reusable inner cannula, K030570; 510(k) clearance issued Sept 17, 2003. MRI Conditional labeling primary predicate device is the Bivona Tracheostomy Tubes, K083641; 510(k) clearance issued Feb 23, 2009.

Non-clinical testing of the components comprising each configuration of the subject devices Smiths Medical Portex® BLUselect, BLUselect Suctionaid Tracheostomy Tubes and BLUselect Inner Cannula were assessed and tested appropriately to design controls; i.e. design verification, design validations. The test results conclude the subject products are substantially equivalent to the predicate devices described herein (above). Testing listed below:

Smiths Medical Portex® BLUselect Tracheostomy Tubes / Inner Cannula:

. Bench Testing was conducted per ISO 5366:2016 to ensure the BLUselect devices meets the essential requirements for paediatric tracheostomy tubes.

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Bench Testing was conducted per ISO 5356-11to ensure the BLUselect devices is . compatible with breathing system connection via 15mm connector; which are used for standard anesthetic and respiratory equipment.
. Bench Testing was conducted per ISO 18190 to ensure the BLUselect devices is safe and effective when used as an airway device and/or equipment.
Magnetic Resonance Environment use was assessed per SSTM F2052-15 and MRI Conditional marking per ASTM F2503 to ensure BLUselect devices are safe for Magnetic Resonance Imaging (MRI).
. Cleaning Instruction Validation for the BLUselect Inner Cannula was conducted per the FDA Guidance, AAMI TIR 30, AAMI TIR12 and AAMI TIR34. The inner cannula is a single-patient use and can be effectively cleaned for re-use with the IFU instructions.
Tube External Maintenance instructions for the BLUselect device to remove secretions or debris from the external surfaces of the accessible portion of the device, will the device is in-situ. Instructions comply too the common practice in a healthcare or home care setting: similar to cleaning instructions of the predicate devices.
. Design Validation / Human Factors per ISO 62366 was conducted to ensure the subject device(s) performance is acceptable for its intended use.
. Sterilization/Microbiology Validation was conducted to ensure the subject device product sterility to the end user for ISO 11135. AAMI TIR28 and ISO 11747 is acceptable.
I Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the subject devices materials are biocompatible and equivalent with the same base materials of the predicate devices. The following end-points were evaluated: cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subchronic toxicity, and implantation.

	BLUselectComponent(s)	Contact Type	Duration of Use
Tracheostomy Tube Components	15mmconnector	ExternallyCommunicating –Tissue	≤29 days, prolonged
	Tube withmoldedflange	Tube: ExternallyCommunicating –TissueFlange: Surface Device– CompromisedSurface	≤29 days, prolonged
	Soft-seal cuff	Surface Device –Mucosal Membrane	≤29 days, prolonged
	Inflation line	Surface Device –Mucosal Membrane	≤29 days, prolonged

. Patient Contacting Components
1 ISO 5356 - Smiths complies with revision 2004 and 2015 Smith Medical K173384/003 510k Summary

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BLUselectComponent(s)	Contact Type	Duration of Use
Pilot line	Surface Device - Intact Skin	≤29 days, prolonged
Inflation lineValve assembly	Surface Device - Intact Skin	≤29 days, prolonged
Suction line	Surface Device - Mucosal Membrane	≤29 days, prolonged
Suction connector	Surface Device - Intact Skin	≤29 days, prolonged
Valve guard	Surface Device - Intact Skin	≤29 days, prolonged
Inner Cannula	Externally Communicating - Tissue	≤29 days, prolonged

Substantial Equivalence

Smiths Medical considers the subject devices performance to be substantially equivalent to the predicate device(s), because these devices are intended for same patient population that require an artificial airway due to trauma, a medical condition and/or airway maintenance.

Subject Devices:

Smiths Medical Portex® BLUselect® Tracheostomy Tube
Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube ●
Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula ●

There are no significant differences in the intended use, mechanical and functional performance and functional scientific technology. Overall and including the difference in the material change for the tracheostomy tube, Smiths Medical demonstrations there are no new issues of safety and effectiveness are raised due to the similarities/differences between the subject and predicate/commercialized devices, as each are used to treat the same clinical condition and represent a similar/basic design concept.

Table 3 below provides a substantial equivalence summary of the subject device and predicate devices, including device pictures.

Table 3: Substantial Equivalence Summaries:

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BLUselect / Suctionaid / Inner Cannula

ProductComponent	Subject DeviceBLUselect Tracheostomy Tubew/wo Suctionaid andInner Cannula	Predicate DeviceK030570Blue Line Ultra/Suctionaid	Compare
Product Code	BTO	BTO	Same
ProductClassification	Class II	Class II	Same
Device ClassificationName and 21 CFR	Tracheostomy tube and tube cuff§ 868.5800	Tracheostomy tube and tube cuff§ 868.5800	Same
Invasive or Non-Invasive	Surgically Invasive	Surgically Invasive	Same
Patient Population	Adults with average height, weight,and anthropometrics.	Adults with average height, weight,and anthropometrics.	Same
Intended Use	For use with patients that require anartificial airway due to trauma ormedical condition.	For use with patients that require anartificial airway due to trauma ormedical condition.	Same
Maximum Use	Recommended 29 Days	Recommended 29 Days	Same
Indications for UseTracheostomy Tube	Smiths Medical Portex®BLUselect® and SuctionaidTracheostomy Tube is indicated forairway maintenance oftracheostomised patients.	Portex® Blue Line Ultra® andSuctionaid Tracheostomy Tube isindicated for airway maintenance oftracheostomised patients.	Same
Indications for UseSuctionaid	Smiths Medical Portex®BLUselect® Suctionaid®Tracheostomy Tube is indicated forairway maintenance oftracheostomised patients.Suctionaid® allows aspiration ofcontaminated mucous and subglotticsecretions that collect and build upbetween the tracheostomy tube cuffand the glottis.	Portex® Blue Line Ultra®Suctionaid® Tracheostomy Tube isindicated for airway maintenance oftracheostomised patients.Suctionaid® allows aspiration ofcontaminated mucous and subglotticsecretions that collect and build upbetween the tracheostomy tube cuffand the glottis.	Same
Indications for UseInner Cannula	The BLUselect® Inner Cannulais intended to be used with theSmiths Medical Portex®BLUselect® Tracheostomy Tubeindicated for airway maintenanceof tracheostomy patients.	Portex® Blue Line UltraTracheostomy Inner Cannula isintended to be used with the SmithsMedical Portex® Blue Line UltraTracheostomy Tube indicated forairway maintenance of tracheostomypatients.(not included in IFU)	Same
Functionality	Smiths Medical Portex®BLUselect® Tracheostomy Tube isintended for airway maintenance andis optionally available with a range ofsecondary features including cuff,Suctionaid®, and fenestrations in asize range from 6.0mm to 10.0mmfor adult patients	Portex® Blue Line Ultra®Tracheostomy Tube is intended forairway maintenance and is optionallyavailable with a range of secondaryfeatures including cuff, Suctionaid®,and fenestrations in a size rangefrom 6.0mm to 10.0mm for adultpatients	Same
Sterilization	Ethylene Oxide (EO) Sterile SAL 10-6 to End User	Ethylene Oxide (EO) Sterile SAL 10-6 to End User	Same
ProductComponent	Subject DeviceBLUselect Tracheostomy Tubew/wo Suctionaid andInner Cannula	Predicate DeviceK030570Blue Line Ultra/Suctionaid	Compare
Biocompatibility	Compatibility materialsISO 10993-1: 2009	Compatibility materialsISO 10993-1: 2009	Same
MRI Conditional	Yes	Yes	Same
Shelf Life	5-year shelf life intended	5-year shelf life	Same
Single UseSingle Patient Use	Yes	Yes	Same
Environment of Use	Critical care settings, Acute caresettings, Long term care facilities	Critical care settings, Acute caresettings, Long term care facilities	Same
Home Care Use	Yes	Yes	Same
Tracheostomy TubeMaterials (FlexiblePVCs)	Main Tube Body: DEHT PVCInflation Line: DEHT PVCPilot Balloon: DEHT PVCSuction Line: DEHT PVCCuff Bonding Cement: DEHT PVCAll other materials of Constructionare equivalent	Main Tube Body: DEHP PVCInflation Line: DEHP PVCPilot Balloon: DEHP PVCSuction Line: DEHP PVCCuff Bonding Cement: DEHP PVCAll other materials of Constructionare equivalent	Different
Flange MarkingColor Coding	Laser Marked Product Informationwith Vinyl Ink Printed Color CodingBandImage: tracheostomy tube with the text '7.0' on it	Clear Embossed MarkImage: tracheostomy tube	Different
Suctionaid feature	Available	Available	Same
Varied Components	Included	Included	Same
Inner Cannula	Included	Included	Same
Cleaning Instructions	Included	Included	Same
IFU	Included	Included	Same

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Conclusion

Smiths Medical's evaluation concludes that the subject devices are substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.