Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula

K210833 · Smiths Medical Asd, Inc. · JOH · Nov 26, 2021 · Anesthesiology

Device Facts

• Record ID: K210833
• Device Name: Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
• Applicant: Smiths Medical Asd, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Nov 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

Extra-length tracheostomy tubes and inner cannulas designed for adult patients with specific anthropometric needs (obesity or need for distal tracheal extension). Tubes provide artificial airway for patients requiring prolonged mechanical ventilation, secretion management, or relief of upper airway obstruction. Suctionaid variants include a vacuum control valve for aspiration of subglottic secretions. Devices are used in hospital or home care settings. Healthcare providers insert the tube to maintain airway patency; the inner cannula is used for maintenance and secretion clearance. Output is a patent airway; clinical decision-making relies on patient respiratory status and anatomical requirements. Benefits include improved airway access for patients with challenging anatomy.

Clinical Evidence

No clinical data provided. Substantial equivalence determined via non-clinical bench testing, including dimensional requirements, kink resistance, tensile strength, cuff performance (inflation/deflation, leak, burst), insertion/removal cycling, and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, implantation).

Technological Characteristics

Materials: PVC (tube), PU (cuff), PTFE/LDPE (inner cannula), HDPE (obturator). Sensing/Actuation: Mechanical airway maintenance. Energy: None. Connectivity: None. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 11135:2014, ISO 11138-1:2017, ISO 11137-1:2018, ISO 11737-2:2020, ISO 10993-7:2008, ISO 10993-1:2009, ASTM F2096-11, ASTM F88-15.

Indications for Use

Indicated for airway maintenance in adult tracheostomized patients requiring artificial airways due to trauma or medical conditions, including prolonged mechanical ventilation, inability to manage secretions, or upper airway obstruction. Contraindications: None known.

Regulatory Classification

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.

Predicate Devices

• Smiths Medical BLUselect® Tracheostomy Tube, BLUselect® Suctionaid® Tracheostomy Tube and BLUselect® Tracheostomy Tube Inner Cannula (K173384)

Submission Summary (Full Text)

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

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

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

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 ([e-mail]) or phone [phone] 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

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

# 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 [e-mail]

"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}------------------------------------------------

# 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.*

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."

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

#### 5 510(k) Summary

| Sponsor: | Smiths Medical ASD, Inc.<br>6000 Nathan Lane North<br>Minneapolis, MN 55442<br>763.383.3000 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: II<br>Regulation Number: 21 CFR 868.5800<br>Product 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.<br>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.<br>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.<br>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.<br>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 intended<br>to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube for<br>patients that require an artificial airway due to trauma or medical condition.<br>Maximum recommended period of use is 29 days.<br>Portex® BLUXI™ Extra Length Tracheostomy Tube is indicated for airway<br>maintenance of tracheostomised patients.<br><br>The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended<br>to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube<br>indicated for airway maintenance of tracheostomy patients. |
| Non-clinical<br>Performance Data: | Non-clinical testing of the components comprised in each configuration of<br>the subject devices, Portex® BLUxl™ Extra Length Tracheostomy Tube,<br>Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and Portex®<br>BLUxl™ Extra Length Tracheostomy Inner Cannula were assessed and<br>tested appropriately to design controls, i.e. design verification, design<br>validations. The test results conclude that for Portex® BLUxl™ Extra Length<br>Tracheostomy Tube, Portex® BLUXIT™ Suctionaid® Extra Length<br>Tracheostomy Tube, and Portex® BLUxl™ Extra Length Tracheostomy Inner<br>Cannula are to be substantially equivalent to the predicate device described<br>herein. Testing listed below passed and were verified against their<br>requirements: Mechanical Testing Testing included: Dimensional requirements (such as<br>Tracheostomy tube outer diameter, Tube overall length, Tube<br>inner diameter at the patient end and 15mm connector taper<br>gauging) and mechanical requirements (such as Tube kink<br>resistance, Tensile strength of flange, Cuff inflation/deflation,<br>Cuff resting diameter, Cuff herniation, Cuff attachment, Cuff<br>burst, puncture and leak resistance, Inner Cannula<br>insertion/removal cycling, Obturator insertion and fallout and<br>Robustness of product markings). Artificially Aged Sample Testing Testing included: 6-month, 2-year, 3-year and 5-year artificially<br>aged samples tested to design requirements. Additionally, real<br>time 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 Tracheostomy<br>Inner Cannula. Cleaning validation of external surface of the BLUxI™ Extra<br>Length Tracheostomy Tube. Biocompatibility Testing evaluated: Cytotoxicity, Sensitization, Irritation, Acute<br>System Toxicity, Pyrogenicity, Subchronic Toxicity,<br>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 Skin<br>Duration: up to 29 days, prolonged |
| Clinical Performance<br>Data: | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial<br>Equivalence: | 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 <b>Attachment 3</b> .<br><br>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.<br><br>The table below provides a substantial equivalence summary, between the BLUselect devices and the predicate devices. |

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

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

## Substantial Equivalence – Subject vs. Predicate Comparison

| Comparator | Subject Device:<br>Portex® BLUxl™ Extra<br>Length Tracheostomy<br>Tube, Portex® BLUxl™<br>Suctionaid® Extra Length<br>Tracheostomy Tube, and<br>Portex® BLUxl™ Extra<br>Length Tracheostomy Inner<br>Cannula | Predicate Device:<br>BLUselect® Tracheostomy<br>Tube and BLUselect® with<br>Suctionaid Tracheostomy<br>Tube and BLUselect® Inner<br>Cannula | Substantial<br>Equivalence<br>Determination |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Company | Smiths Medical ASD, Inc. | Smiths Medical ASD, Inc. | Identical |
| 510(k) | K210833 | K173384, cleared on April<br>10, 2018 | N/A |
| Comparator | Subject Device:<br>Portex® BLUxI™ Extra<br>Length Tracheostomy<br>Tube, Portex® BLUxI™<br>Suctionaid® Extra Length<br>Tracheostomy Tube, and<br>Portex® BLUxI™ Extra<br>Length Tracheostomy Inner<br>Cannula | Predicate Device:<br>BLUselect® Tracheostomy<br>Tube and BLUselect® with<br>Suctionaid Tracheostomy<br>Tube and BLUselect® Inner<br>Cannula | Substantial<br>Equivalence<br>Determination |
| 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™ Extra<br>Length Tracheostomy Tube<br>is indicated for airway<br>maintenance of<br>tracheostomised patients.<br>The Portex® BLUxI™ Extra<br>Length Tracheostomy Inner<br>Cannula is intended to be<br>used with the Portex®<br>BLUxI™ Extra Length<br>Tracheostomy Tube<br>indicated for airway<br>maintenance of<br>tracheostomy patients. | Smiths Medical Portex®<br>BLUselect® Tracheostomy<br>Tube is indicated for airway<br>maintenance of<br>tracheostomised patients.<br>Smiths Medical Portex®<br>BLUselect® Suctionaid®<br>Tracheostomy Tube is<br>indicated for airway<br>maintenance of<br>tracheostomised patients.<br>Suctionaid® allows<br>aspiration of contaminated<br>mucous and subglottic<br>secretions that collect and<br>build up between the<br>tracheostomy tube cuff and<br>the glottis.<br>The BLUselect® Inner<br>Cannula is intended to be<br>used with the Smiths<br>Medical Portex®<br>BLUselect® Tracheostomy<br>Tube indicated for airway<br>maintenance of<br>tracheostomy patients. | Identical |
| Contraindications<br>in Labeling | There are no known<br>Contraindications<br>associated with this<br>product. | There are no known<br>Contraindications<br>associated with this<br>product. | Identical |
| Product Codes | JOH | JOH | Identical |
| Comparator | Subject Device:<br>Portex® BLUxl™ Extra<br>Length Tracheostomy<br>Tube, Portex® BLUxl™<br>Suctionaid® Extra Length<br>Tracheostomy Tube, and<br>Portex® BLUxl™ Extra<br>Length Tracheostomy Inner<br>Cannula | Predicate Device:<br>BLUselect® Tracheostomy<br>Tube and BLUselect® with<br>Suctionaid Tracheostomy<br>Tube and BLUselect® Inner<br>Cannula | Substantial<br>Equivalence<br>Determination |
| Intended Use | Smiths Medical Portex®<br>BLUxl™ Extra Length<br>Tracheostomy Tube is for<br>the adult patient category<br>that require an artificial<br>airway due to trauma or<br>medical condition.<br>Maximum recommended<br>period of use is 29 days.<br>The Portex® BLUxl™ Extra<br>Length Tracheostomy Inner<br>Cannula is intended to be<br>used with the Portex®<br>BLUxl™ Extra Length<br>Tracheostomy Tube for<br>patients that require an<br>artificial airway due to<br>trauma or medical<br>condition. Maximum<br>recommended period of use<br>is 29 days. | Smiths Medical Portex®<br>BLUselect® Tracheostomy<br>Tube is for patients that<br>require an artificial airway<br>due to trauma or medical<br>condition. Maximum period<br>of use is 29 days.<br>(BLUselect® and<br>BLUselect® Suctionaid®)<br>The BLUselect® Inner<br>Cannula is intended to be<br>used with the Smiths<br>Medical Portex®<br>BLUselect® Tracheostomy<br>Tube for patients that<br>require an artificial airway<br>due to trauma or medical<br>condition. Maximum period<br>of use is 29 days. | Identical |
| Single Patient Use | Yes | Yes | Identical |
| Patient Population | Intended for adults with<br>above average height,<br>weight, and<br>anthropometrics. | Intended for adults with<br>average height, weight, and<br>anthropometrics. | Similar |
| Use Environment | Hospital environments,<br>Home care use | Hospital environments,<br>Home care use | Identical |
| Materials | Tracheostomy Tube:<br>Polyvinyl Chloride<br>(PVC)with Dioctyl<br>Terephthalate (DEHT)<br>plasticizer<br>Tracheostomy Tube Cuff:<br>Polyurethane (PU)<br>Inner Cannula:<br>Polytetrafluoroethylene<br>(PTFE) and Low Density<br>Polyethylene (LDPE)<br>Obturator: High-density<br>Polyethylene (HDPE) | Tracheostomy Tube:<br>Polyvinyl Chloride<br>(PVC)with Dioctyl<br>Terephthalate (DEHT)<br>plasticizer<br>Tracheostomy Tube Cuff:<br>Polyvinyl Chloride (PVC)<br>Inner Cannula: Low<br>Density Polyethylene<br>(LDPE) or LDPE with red<br>colorant (Fenestrated)<br>Obturator: High-density<br>polyethylene (HDPE) | Similar |
| Comparator | Subject Device:<br>Portex® BLUxI™ Extra<br>Length Tracheostomy<br>Tube, Portex® BLUxI™<br>Suctionaid® Extra Length<br>Tracheostomy Tube, and<br>Portex® BLUxI™ Extra<br>Length Tracheostomy Inner<br>Cannula | Predicate Device:<br>BLUselect® Tracheostomy<br>Tube and BLUselect® with<br>Suctionaid Tracheostomy<br>Tube and BLUselect® Inner<br>Cannula | Substantial<br>Equivalence<br>Determination |
| Product<br>Configurations | Uncuffed, Cuffed,<br>Suctionaid® | Uncuffed, Fenestrated<br>Uncuffed, Cuffed,<br>Fenestrated Cuffed,<br>Suctionaid®, Fenestrated<br>Suctionaid® | Similar |
| Sizes (Inner<br>Diameter) | 6.0mm, 7.0mm, 8.0mm,<br>9.0mm | 6.0mm, 7.0mm, 7.5mm,<br>8.0mm, 8.5mm, 9.0mm,<br>9.5mm, 10.0mm | Similar |
| System Overview | | | |
| Standard System<br>Components | Tracheostomy Tube,<br>Obturator, Uncoupling<br>Wedge, Tube Holder, Inner<br>Cannula (x2), Patient<br>Labels, IFU | Tracheostomy Tube,<br>Obturator, Uncoupling<br>Wedge, Tube Holder with<br>Cleaning Brush, Inner<br>Cannula (x2), Patient<br>Labels, IFU | Similar |
| Suctionaid®<br>Standard System<br>Component | Vacuum Control Valve | Vacuum Control Valve | Identical |
| Flange Markings | Laser marked product<br>information with vinyl ink<br>pad printer color coding<br>band | Laser marked product<br>information with vinyl ink<br>pad printer color coding<br>band | Identical |
| Maximum Use | Recommended 29 days | Recommended 29 days | Identical |
| Biocompatibility | Materials compatible to<br>ISO 10993-1:2009 | Materials compatible to<br>ISO 10993-1:2009 | Identical |
| Sterilization | Ethylene Oxide (EO)<br>Sterilized – SAL 10-6 | Ethylene Oxide (EO)<br>Sterilized - SAL 10-6 | Identical |
| Shelf Life | Tracheostomy Tubes: 3-<br>year shelf life<br>Inner Cannula: 5-year shelf<br>life | Tracheostomy Tube and<br>Inner Cannula: 5-year shelf<br>life | Similar |

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

### K210833

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

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

### K210833

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

#### 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.