The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

Portex® BLUxI™ Extra Length Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.

Portex® BLUxl™ Extra Length Tracheostomy Tube is for the adult patient category that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.
200/710, 720 and 730/xxx are extra proximal length (y measurement) tracheostomy tubes and are indicated for use in patients with excessive skin surface to anterior tracheal wall distance as frequently seen in obesity.
200/715, 725 and 735/xxx are extra distal length (x measurement) tracheostomy tubes and are indicated for use in patients with normal skin surface to anterior tracheal wall distance and require the distal length of the tracheostomy tube to extend more caudally within the trachea.

The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube for patients that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.

Device Description

Portex® BLUxl™ Extra Length Tracheostomy Tubes and BLUxl™ Suctionaid® Extra Length 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.
Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tubes and Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes. The inner cannulas are single use only.

AI/ML Overview

The provided FDA 510(k) summary for the Portex® BLUxl™ Extra Length Tracheostomy Tube, BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and BLUxl™ Extra Length Tracheostomy Inner Cannula focuses on establishing substantial equivalence to a predicate device rather than demonstrating the device meets a specific set of primary acceptance criteria through a clinical study.

Therefore, many of the typical elements requested in a description of acceptance criteria and a study proving a device meets them (such as MRMC studies, specific expert qualifications for ground truth, or effect sizes for AI assistance) are not applicable to this type of submission. This document describes a non-clinical performance evaluation to show similarity and safety compared to an already cleared device.

Here's a breakdown of the information that can be extracted and how it relates to your request:

Study Overview and Acceptance Criteria (as applicable for a 510(k) of this nature)

The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating that the subject devices are substantially equivalent (SE) to the predicate devices (Smiths Medical BLUselect® Tracheostomy Tube, BLUselect® Suctionaid® Tracheostomy Tube, and BLUselect® Inner Cannula) in terms of:

Intended Use
Technological Characteristics (materials, design, performance features)
Safety and Effectiveness (demonstrated through non-clinical testing)

The study proving the device meets these "acceptance criteria" is a non-clinical performance evaluation comparing the subject device to the predicate device. The conclusion states: "The non-clinical performance data included in this submission supports that any differences in technological characteristics from the predicate device do not raise any new questions of safety and effectiveness. It is concluded that the information provided in this submission supports substantial equivalence."

1. Table of acceptance criteria and reported device performance

Since this is a substantial equivalence submission based on non-clinical testing, the "acceptance criteria" are implied by successful demonstration of performance similar to the predicate and compliance with relevant standards. The "reported device performance" refers to the successful completion of these tests.

Acceptance Criteria (Implied for SE)	Reported Device Performance (as stated in 510(k) Summary)
Mechanical Performance: Device components meet specified dimensional and mechanical requirements (e.g., kink resistance, tensile strength, cuff performance, inner cannula cycling, obturator function, marking robustness).	Passed: Testing included: Dimensional requirements (Tracheostomy tube outer diameter, Tube overall length, Tube inner diameter at patient end and 15mm connector taper gauging); mechanical requirements (Tube kink resistance, Tensile strength of flange, Cuff inflation/deflation, Cuff resting diameter, Cuff herniation, Cuff attachment, Cuff burst, puncture and leak resistance, Inner Cannula insertion/removal cycling, Obturator insertion and fallout, Robustness of product markings).
Aging Performance: Device maintains performance after artificial aging, indicative of expected shelf life.	Passed: 6-month, 2-year, 3-year, and 5-year artificially aged samples tested to design requirements. Real-time aging will be carried out for the same periods.
MRI Compatibility: Device does not pose an undue risk in an MRI environment.	Rationale Provided: Utilized legacy testing data. (Note: Specific MRI safety levels like "MR Conditional" are typically stated elsewhere but implied by the rationale.)
Cleaning Validation: Reusable components can be effectively cleaned.	Passed: Cleaning validation of BLUxl™ Extra Length Tracheostomy Inner Cannula. Cleaning validation of external surface of the BLUxl™ Extra Length Tracheostomy Tube.
Biocompatibility: Materials are safe for patient contact and do not elicit adverse biological responses.	Passed: Testing evaluated: Cytotoxicity, Sensitization, Irritation, Acute System Toxicity, Pyrogenicity, Subchronic Toxicity, Genotoxicity, and Implantation, compatible to ISO 10993-1:2009 for the specified contact classifications and duration (up to 29 days, prolonged).
Sterilization Efficacy: Device can be effectively sterilized to a minimum Sterility Assurance Level (SAL).	Passed: Validations in accordance with ISO 11135:2014, ISO 11138-1:2017, ISO 11137-1:2018, ISO 11737-2:2020, and ISO 10993-7:2008 demonstrated results indicating acceptability and distribution as sterile at SAL of 10-6.
Packaging Integrity: Packaging maintains sterility and product integrity.	Passed: Testing performed to ASTM F2096-11 and ASTM F88-15, with passing results.
Overall Substantial Equivalence: Subject device has same intended use, similar technological characteristics, and no new safety/effectiveness issues compared to predicate.	Concluded Substantially Equivalent: "The subject Portex® BLUxl™ Extra Length Tracheostomy Tubes, Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes, and Portex® BLUxl™ Extra Length Tracheostomy Inner Cannulas has the same indications for use and technological characteristics compared to the predicate devices." "The non-clinical performance data included in this submission supports that any differences in technological characteristics from the predicate device do not raise any new questions of safety and effectiveness."

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

Sample Size: Not specified in terms of clinical patient numbers since this was a non-clinical (bench and lab) performance evaluation. The "sample size" would refer to the number of devices or components tested for each mechanical, biocompatibility, sterilization, and packaging validation. These numbers are typically defined by engineering standards and internal quality procedures.
Data Provenance: The data is from non-clinical laboratory testing and validation conducted by Smiths Medical ASD, Inc. (the manufacturer). The country of origin for the data generation is not explicitly stated but would typically be where the manufacturer's R&D and testing facilities are located (Minneapolis, MN, USA, based on the address). The data is prospective in the sense that the tests were designed and executed to support this submission.

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

Not applicable in the typical sense of clinical ground truth. For a non-clinical performance evaluation, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM) and internal design specifications validated by skilled engineers, microbiologists, and other technical experts within the manufacturer's organization or through certified testing labs. These are not "experts" establishing a clinical diagnosis or interpretation but rather technical professionals verifying physical and biological properties against predefined criteria.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., subjective image assessment) to resolve discrepancies. For non-clinical performance testing, the results are typically quantitative and objective (e.g., passing/failing a force test, meeting dimensional specifications, biological assay results). Any discrepancies would be resolved through retesting, root cause analysis, or verification against the defined test methods.

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, not done. This type of study is entirely irrelevant to the submission for a tracheostomy tube. MRMC studies are specific to diagnostic devices, particularly those involving image interpretation by human readers, often comparing AI-assisted performance to unassisted performance.

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

No, not done. This describes the performance evaluation of an AI algorithm, which is not applicable to a physical medical device like a tracheostomy tube.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is based on defined engineering specifications, performance standards (e.g., ISO 11135 for sterilization, ISO 10993 for biocompatibility, ASTM for packaging), and comparison to the predicate device's established safe and effective performance. There is no clinical "ground truth" in terms of disease diagnosis or patient outcomes directly derived for this submission, as clinical testing was not deemed necessary.

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device and does not involve AI or machine learning algorithms.

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

Not applicable. As above, no training set for an AI model.

In summary: This 510(k) submission is for a physical medical device and establishes substantial equivalence through a comprehensive non-clinical performance evaluation. It does not involve clinical studies with human subjects, AI algorithms, or subjective interpretations that would necessitate the study design elements typically seen in diagnostic AI/imaging device submissions. The "acceptance criteria" are the successful demonstration of equivalence in intended use, technological characteristics, and safety/effectiveness via robust non-clinical testing against established engineering and regulatory standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 26, 2021

Smiths Medical ASD, Inc. Nancy Deangelo Manager, Regulatory Affairs 6000 Nathan Lane North Minneapolis, Minnesota 55442

Re: K210833

Trade/Device Name: Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUx1 Extra Length Tracheostomy Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: July 30, 2021 Received: October 25, 2021

Dear Nancy Deangelo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210833

Device Name

Portex® BLUxI™ Extra Length Tracheostomy Inner Cannula

Indications for Use (Describe)

The Portex® BLUxI™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxI™ Extra Length 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 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) K210833

Device Name

Portex® BLUxITM Extra Length Tracheostomy Tube

Indications for Use (Describe)

Portex® BLUxI™ Extra Length Tracheostomy Tube is indicated for airway maintenance of tracheostomised 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 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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5 510(k) Summary

Sponsor:	Smiths Medical ASD, Inc.6000 Nathan Lane NorthMinneapolis, MN 55442763.383.3000
Date Prepared:	March 17, 2021 (revised November 22, 2021)
Proprietary Name:	Portex® BLUxl™ Extra Length Tracheostomy Tube, Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula
Classification Name:	JOH- Tube, Tracheostomy Tube and Tube Cuff
Classification:	Class: IIRegulation Number: 21 CFR 868.5800Product Code: JOH - Tube, Tracheostomy Tube and Tube Cuff
Predicate device:	Smiths Medical BLUselect® Tracheostomy Tube, BLUselect® Suctionaid® Tracheostomy Tube and BLUselect® Tracheostomy Tube Inner Cannula (K173384, cleared on April 10, 2018).
Device Description:	Portex® BLUxl™ Extra Length Tracheostomy Tubes and BLUxl™ Suctionaid® Extra Length 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.Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tubes and Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes. The inner cannulas are single use only.A detailed description of the Portex® BLUxl™ Extra Length Tracheostomy Tube, Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is provided in Section 10 Device Description.
Intended Use:	Portex® BLUxl™ Extra Length Tracheostomy Tube is for the adult patient category that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.200/710, 720 and 730/xxx are extra proximal length (y measurement) tracheostomy tubes and are indicated for use in patients with excessive skin surface to anterior tracheal wall distance as frequently seen in obesity.200/715, 725 and 735/xxx are extra distal length (x measurement) tracheostomy tubes and are indicated for use in patients with normal skin surface to anterior tracheal wall distance and require the distal length of the tracheostomy tube to extend more caudally within the trachea.
Indications for use:	The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intendedto be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube forpatients that require an artificial airway due to trauma or medical condition.Maximum recommended period of use is 29 days.Portex® BLUXI™ Extra Length Tracheostomy Tube is indicated for airwaymaintenance of tracheostomised patients.The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intendedto be used with the Portex® BLUxl™ Extra Length Tracheostomy Tubeindicated for airway maintenance of tracheostomy patients.
Non-clinicalPerformance Data:	Non-clinical testing of the components comprised in each configuration ofthe subject devices, Portex® BLUxl™ Extra Length Tracheostomy Tube,Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and Portex®BLUxl™ Extra Length Tracheostomy Inner Cannula were assessed andtested appropriately to design controls, i.e. design verification, designvalidations. The test results conclude that for Portex® BLUxl™ Extra LengthTracheostomy Tube, Portex® BLUXIT™ Suctionaid® Extra LengthTracheostomy Tube, and Portex® BLUxl™ Extra Length Tracheostomy InnerCannula are to be substantially equivalent to the predicate device describedherein. Testing listed below passed and were verified against theirrequirements: Mechanical Testing Testing included: Dimensional requirements (such asTracheostomy tube outer diameter, Tube overall length, Tubeinner diameter at the patient end and 15mm connector tapergauging) and mechanical requirements (such as Tube kinkresistance, Tensile strength of flange, Cuff inflation/deflation,Cuff resting diameter, Cuff herniation, Cuff attachment, Cuffburst, puncture and leak resistance, Inner Cannulainsertion/removal cycling, Obturator insertion and fallout andRobustness of product markings). Artificially Aged Sample Testing Testing included: 6-month, 2-year, 3-year and 5-year artificiallyaged samples tested to design requirements. Additionally, realtime aging will be carried out for the same time periods. Magnetic Resonance Imaging (MRI) Rationale provided utilizing legacy testing data. Cleaning Instruction Validation Cleaning validation of BLUxl™ Extra Length TracheostomyInner Cannula. Cleaning validation of external surface of the BLUxI™ ExtraLength Tracheostomy Tube. Biocompatibility Testing evaluated: Cytotoxicity, Sensitization, Irritation, AcuteSystem Toxicity, Pyrogenicity, Subchronic Toxicity,Genotoxicity and Implantation.
	Sterilization Validations, in accordance with ISO 11135:2014, ISO 11138-1:2017, ISO 11137-1:2018, ISO 11737-2:2020, and ISO 10993-7:2008 have been completed demonstrating results which indicate the subject devices are acceptable and can be distributed sterile to meet with the minimum sterility assurance level (SAL) of 10-6 per ISO 11135. Packaging Testing was performed to ASTM F2096-11 and ASTM F88-15, with passing results.
Biocompatibility	Contact classifications: Externally Communicating - Tissue, Surface Device – Mucosal Membrane, Surface Device – Intact SkinDuration: up to 29 days, prolonged
Clinical PerformanceData:	Clinical testing was not necessary for the determination of substantial equivalence.
SubstantialEquivalence:	Smiths Medical considers the subject devices, Portex® BLUxl™ Extra Length Tracheostomy Tube, BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and BLUxl™ Extra Length Tracheostomy Inner Cannula to be substantially equivalent to the predicate device, Smiths Medical BLUselect® Tracheostomy Tube, BLUselect® Suctionaid Tracheostomy Tube and BLUselect® Inner Cannula because there are no significant differences between the devices in intended use, mechanical and functional performance and all utilize the same functional scientific technology. The predicate 510(k) Summary is provided in Attachment 3 .Smiths Medical has demonstrated there are no new issues of safety and effectiveness raised due to the similarities and/or differences between the subject and predicate/commercialized devices, as each are used to treat the same clinical conditions and represent a similar/basic design concept.The table below provides a substantial equivalence summary, between the BLUselect devices and the predicate devices.

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Substantial Equivalence – Subject vs. Predicate Comparison

Comparator	Subject Device:Portex® BLUxl™ ExtraLength TracheostomyTube, Portex® BLUxl™Suctionaid® Extra LengthTracheostomy Tube, andPortex® BLUxl™ ExtraLength Tracheostomy InnerCannula	Predicate Device:BLUselect® TracheostomyTube and BLUselect® withSuctionaid TracheostomyTube and BLUselect® InnerCannula	SubstantialEquivalenceDetermination
Company	Smiths Medical ASD, Inc.	Smiths Medical ASD, Inc.	Identical
510(k)	K210833	K173384, cleared on April10, 2018	N/A
Comparator	Subject Device:Portex® BLUxI™ ExtraLength TracheostomyTube, Portex® BLUxI™Suctionaid® Extra LengthTracheostomy Tube, andPortex® BLUxI™ ExtraLength Tracheostomy InnerCannula	Predicate Device:BLUselect® TracheostomyTube and BLUselect® withSuctionaid TracheostomyTube and BLUselect® InnerCannula	SubstantialEquivalenceDetermination
Image	Image: Portex® BLUxI™ Extra Length Tracheostomy Tube, Portex® BLUxI™ Suctionaid® Extra Length Tracheostomy Tube, and Portex® BLUxI™ Extra Length Tracheostomy Inner Cannula	Image: BLUselect® Tracheostomy Tube and BLUselect® with Suctionaid Tracheostomy Tube and BLUselect® Inner Cannula	N/A
Indications	Portex® BLUxI™ ExtraLength Tracheostomy Tubeis indicated for airwaymaintenance oftracheostomised patients.The Portex® BLUxI™ ExtraLength Tracheostomy InnerCannula is intended to beused with the Portex®BLUxI™ Extra LengthTracheostomy Tubeindicated for airwaymaintenance oftracheostomy patients.	Smiths Medical Portex®BLUselect® TracheostomyTube is indicated for airwaymaintenance oftracheostomised patients.Smiths Medical Portex®BLUselect® Suctionaid®Tracheostomy Tube isindicated for airwaymaintenance oftracheostomised patients.Suctionaid® allowsaspiration of contaminatedmucous and subglotticsecretions that collect andbuild up between thetracheostomy tube cuff andthe glottis.The BLUselect® InnerCannula is intended to beused with the SmithsMedical Portex®BLUselect® TracheostomyTube indicated for airwaymaintenance oftracheostomy patients.	Identical
Contraindicationsin Labeling	There are no knownContraindicationsassociated with thisproduct.	There are no knownContraindicationsassociated with thisproduct.	Identical
Product Codes	JOH	JOH	Identical
Comparator	Subject Device:Portex® BLUxl™ ExtraLength TracheostomyTube, Portex® BLUxl™Suctionaid® Extra LengthTracheostomy Tube, andPortex® BLUxl™ ExtraLength Tracheostomy InnerCannula	Predicate Device:BLUselect® TracheostomyTube and BLUselect® withSuctionaid TracheostomyTube and BLUselect® InnerCannula	SubstantialEquivalenceDetermination
Intended Use	Smiths Medical Portex®BLUxl™ Extra LengthTracheostomy Tube is forthe adult patient categorythat require an artificialairway due to trauma ormedical condition.Maximum recommendedperiod of use is 29 days.The Portex® BLUxl™ ExtraLength Tracheostomy InnerCannula is intended to beused with the Portex®BLUxl™ Extra LengthTracheostomy Tube forpatients that require anartificial airway due totrauma or medicalcondition. Maximumrecommended period of useis 29 days.	Smiths Medical Portex®BLUselect® TracheostomyTube is for patients thatrequire an artificial airwaydue to trauma or medicalcondition. Maximum periodof use is 29 days.(BLUselect® andBLUselect® Suctionaid®)The BLUselect® InnerCannula is intended to beused with the SmithsMedical Portex®BLUselect® TracheostomyTube for patients thatrequire an artificial airwaydue to trauma or medicalcondition. Maximum periodof use is 29 days.	Identical
Single Patient Use	Yes	Yes	Identical
Patient Population	Intended for adults withabove average height,weight, andanthropometrics.	Intended for adults withaverage height, weight, andanthropometrics.	Similar
Use Environment	Hospital environments,Home care use	Hospital environments,Home care use	Identical
Materials	Tracheostomy Tube:Polyvinyl Chloride(PVC)with DioctylTerephthalate (DEHT)plasticizerTracheostomy Tube Cuff:Polyurethane (PU)Inner Cannula:Polytetrafluoroethylene(PTFE) and Low DensityPolyethylene (LDPE)Obturator: High-densityPolyethylene (HDPE)	Tracheostomy Tube:Polyvinyl Chloride(PVC)with DioctylTerephthalate (DEHT)plasticizerTracheostomy Tube Cuff:Polyvinyl Chloride (PVC)Inner Cannula: LowDensity Polyethylene(LDPE) or LDPE with redcolorant (Fenestrated)Obturator: High-densitypolyethylene (HDPE)	Similar
Comparator	Subject Device:Portex® BLUxI™ ExtraLength TracheostomyTube, Portex® BLUxI™Suctionaid® Extra LengthTracheostomy Tube, andPortex® BLUxI™ ExtraLength Tracheostomy InnerCannula	Predicate Device:BLUselect® TracheostomyTube and BLUselect® withSuctionaid TracheostomyTube and BLUselect® InnerCannula	SubstantialEquivalenceDetermination
ProductConfigurations	Uncuffed, Cuffed,Suctionaid®	Uncuffed, FenestratedUncuffed, Cuffed,Fenestrated Cuffed,Suctionaid®, FenestratedSuctionaid®	Similar
Sizes (InnerDiameter)	6.0mm, 7.0mm, 8.0mm,9.0mm	6.0mm, 7.0mm, 7.5mm,8.0mm, 8.5mm, 9.0mm,9.5mm, 10.0mm	Similar
System Overview
Standard SystemComponents	Tracheostomy Tube,Obturator, UncouplingWedge, Tube Holder, InnerCannula (x2), PatientLabels, IFU	Tracheostomy Tube,Obturator, UncouplingWedge, Tube Holder withCleaning Brush, InnerCannula (x2), PatientLabels, IFU	Similar
Suctionaid®Standard SystemComponent	Vacuum Control Valve	Vacuum Control Valve	Identical
Flange Markings	Laser marked productinformation with vinyl inkpad printer color codingband	Laser marked productinformation with vinyl inkpad printer color codingband	Identical
Maximum Use	Recommended 29 days	Recommended 29 days	Identical
Biocompatibility	Materials compatible toISO 10993-1:2009	Materials compatible toISO 10993-1:2009	Identical
Sterilization	Ethylene Oxide (EO)Sterilized – SAL 10-6	Ethylene Oxide (EO)Sterilized - SAL 10-6	Identical
Shelf Life	Tracheostomy Tubes: 3-year shelf lifeInner Cannula: 5-year shelflife	Tracheostomy Tube andInner Cannula: 5-year shelflife	Similar

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K210833

Smiths Medical ASD, Inc.
Traditional 5 10(k) for Portex® BLUx1™ Extra Length Tracheostomy Tube

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K210833

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K210833

Conclusion: The subject Portex® BLUxI™ Extra Length Tracheostomy Tubes, Portex® BLUxI™ Suctionaid® Extra Length Tracheostomy Tubes, and Portex® BLUxI™ Extra Length Tracheostomy Inner Cannulas has the same indications for use and technological characteristics compared to the predicate devices. The non-clinical performance data included in this submission supports that any differences in technological characteristics from the predicate device do not raise any new questions of safety and effectiveness. It is concluded that the information provided in this submission supports substantial equivalence.

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.