(252 days)
Error: Not Found
No
The document describes a physical medical device (tracheostomy tube and inner cannula) and its intended use and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is described as an "artificial airway" intended for "airway maintenance" in tracheostomy patients due to "trauma or medical condition," which directly addresses and supports a physiological function, thus categorizing it as therapeutic.
No.
The device is a tracheostomy tube and inner cannula intended for airway maintenance, not for diagnostic purposes.
No
The device description and testing information clearly indicate that this is a physical medical device (tracheostomy tubes and inner cannulas) and not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text clearly states the device is intended for "airway maintenance of tracheostomy patients" and for providing an "artificial airway." This describes a device used in vivo (within the body) to manage a physical condition.
- Device Description: The description reinforces the use of the device for creating and maintaining an artificial airway in patients.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is a medical device used inside the body to manage a patient's airway.
N/A
Intended Use / Indications for Use
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.
Portex® BLUxI™ Extra Length Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JOH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult population
Intended User / Care Setting
Hospital environments, Home care use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing of the components comprised in each configuration of the 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 and tested appropriately to design controls, i.e. design verification, design validations. The test results conclude that for Portex® BLUxl™ Extra Length Tracheostomy Tube, Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula are to be substantially equivalent to the predicate device described herein. Testing listed below passed and were verified against their requirements:
Mechanical Testing:
Testing included: Dimensional requirements (such as Tracheostomy tube outer diameter, Tube overall length, Tube inner diameter at the patient end and 15mm connector taper gauging) and mechanical requirements (such as 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 and Robustness of product markings).
Artificially Aged Sample Testing:
Testing included: 6-month, 2-year, 3-year and 5-year artificially aged samples tested to design requirements. Additionally, real 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 Inner Cannula. Cleaning validation of external surface of the BLUxl™ Extra Length Tracheostomy Tube.
Biocompatibility:
Testing evaluated: Cytotoxicity, Sensitization, Irritation, Acute System 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.
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 (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
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 PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
6000 Nathan Lane North
Minneapolis, MN 55442
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
Regulation Number: 21 CFR 868.5800
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.
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 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.
Portex® BLUXI™ Extra Length Tracheostomy Tube is indicated for airway
maintenance of tracheostomised patients.
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. |
| Non-clinical
Performance Data: | Non-clinical testing of the components comprised in each configuration of
the 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 and
tested appropriately to design controls, i.e. design verification, design
validations. The test results conclude that for Portex® BLUxl™ Extra Length
Tracheostomy Tube, Portex® BLUXIT™ Suctionaid® Extra Length
Tracheostomy Tube, and Portex® BLUxl™ Extra Length Tracheostomy Inner
Cannula are to be substantially equivalent to the predicate device described
herein. Testing listed below passed and were verified against their
requirements: Mechanical Testing Testing included: Dimensional requirements (such as
Tracheostomy tube outer diameter, Tube overall length, Tube
inner diameter at the patient end and 15mm connector taper
gauging) and mechanical requirements (such as 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 and
Robustness of product markings). Artificially Aged Sample Testing Testing included: 6-month, 2-year, 3-year and 5-year artificially
aged samples tested to design requirements. Additionally, real
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
Inner Cannula. Cleaning validation of external surface of the BLUxI™ Extra
Length Tracheostomy Tube. Biocompatibility Testing evaluated: Cytotoxicity, Sensitization, Irritation, Acute
System 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 Skin
Duration: up to 29 days, prolonged |
| Clinical Performance
Data: | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial
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 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. |
5
6
Substantial Equivalence – Subject vs. Predicate Comparison
| Comparator | Subject Device:
Portex® BLUxl™ Extra
Length Tracheostomy
Tube, Portex® BLUxl™
Suctionaid® Extra Length
Tracheostomy Tube, and
Portex® BLUxl™ Extra
Length Tracheostomy Inner
Cannula | Predicate Device:
BLUselect® Tracheostomy
Tube and BLUselect® with
Suctionaid Tracheostomy
Tube and BLUselect® Inner
Cannula | Substantial
Equivalence
Determination |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Company | Smiths Medical ASD, Inc. | Smiths Medical ASD, Inc. | Identical |
| 510(k) | K210833 | K173384, cleared on April
10, 2018 | N/A |
| Comparator | Subject Device:
Portex® BLUxI™ Extra
Length Tracheostomy
Tube, Portex® BLUxI™
Suctionaid® Extra Length
Tracheostomy Tube, and
Portex® BLUxI™ Extra
Length Tracheostomy Inner
Cannula | Predicate Device:
BLUselect® Tracheostomy
Tube and BLUselect® with
Suctionaid Tracheostomy
Tube and BLUselect® Inner
Cannula | Substantial
Equivalence
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
Length Tracheostomy Tube
is indicated for airway
maintenance of
tracheostomised patients.
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. | Smiths Medical Portex®
BLUselect® Tracheostomy
Tube is indicated for airway
maintenance of
tracheostomised patients.
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. | Identical |
| Contraindications
in Labeling | There are no known
Contraindications
associated with this
product. | There are no known
Contraindications
associated with this
product. | Identical |
| Product Codes | JOH | JOH | Identical |
| Comparator | Subject Device:
Portex® BLUxl™ Extra
Length Tracheostomy
Tube, Portex® BLUxl™
Suctionaid® Extra Length
Tracheostomy Tube, and
Portex® BLUxl™ Extra
Length Tracheostomy Inner
Cannula | Predicate Device:
BLUselect® Tracheostomy
Tube and BLUselect® with
Suctionaid Tracheostomy
Tube and BLUselect® Inner
Cannula | Substantial
Equivalence
Determination |
| Intended Use | Smiths Medical 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.
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. | Smiths Medical Portex®
BLUselect® Tracheostomy
Tube is for patients that
require an artificial airway
due to trauma or medical
condition. Maximum period
of use is 29 days.
(BLUselect® and
BLUselect® Suctionaid®)
The BLUselect® Inner
Cannula is intended to be
used with the Smiths
Medical Portex®
BLUselect® Tracheostomy
Tube for patients that
require an artificial airway
due to trauma or medical
condition. Maximum period
of use is 29 days. | Identical |
| Single Patient Use | Yes | Yes | Identical |
| Patient Population | Intended for adults with
above average height,
weight, and
anthropometrics. | Intended for adults with
average height, weight, and
anthropometrics. | Similar |
| Use Environment | Hospital environments,
Home care use | Hospital environments,
Home care use | Identical |
| Materials | Tracheostomy Tube:
Polyvinyl Chloride
(PVC)with Dioctyl
Terephthalate (DEHT)
plasticizer
Tracheostomy Tube Cuff:
Polyurethane (PU)
Inner Cannula:
Polytetrafluoroethylene
(PTFE) and Low Density
Polyethylene (LDPE)
Obturator: High-density
Polyethylene (HDPE) | Tracheostomy Tube:
Polyvinyl Chloride
(PVC)with Dioctyl
Terephthalate (DEHT)
plasticizer
Tracheostomy Tube Cuff:
Polyvinyl Chloride (PVC)
Inner Cannula: Low
Density Polyethylene
(LDPE) or LDPE with red
colorant (Fenestrated)
Obturator: High-density
polyethylene (HDPE) | Similar |
| Comparator | Subject Device:
Portex® BLUxI™ Extra
Length Tracheostomy
Tube, Portex® BLUxI™
Suctionaid® Extra Length
Tracheostomy Tube, and
Portex® BLUxI™ Extra
Length Tracheostomy Inner
Cannula | Predicate Device:
BLUselect® Tracheostomy
Tube and BLUselect® with
Suctionaid Tracheostomy
Tube and BLUselect® Inner
Cannula | Substantial
Equivalence
Determination |
| Product
Configurations | Uncuffed, Cuffed,
Suctionaid® | Uncuffed, Fenestrated
Uncuffed, Cuffed,
Fenestrated Cuffed,
Suctionaid®, Fenestrated
Suctionaid® | Similar |
| Sizes (Inner
Diameter) | 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 System
Components | Tracheostomy Tube,
Obturator, Uncoupling
Wedge, Tube Holder, Inner
Cannula (x2), Patient
Labels, IFU | Tracheostomy Tube,
Obturator, Uncoupling
Wedge, Tube Holder with
Cleaning Brush, Inner
Cannula (x2), Patient
Labels, IFU | Similar |
| Suctionaid®
Standard System
Component | Vacuum Control Valve | Vacuum Control Valve | Identical |
| Flange Markings | Laser marked product
information with vinyl ink
pad printer color coding
band | Laser marked product
information with vinyl ink
pad printer color coding
band | Identical |
| Maximum Use | Recommended 29 days | Recommended 29 days | Identical |
| Biocompatibility | Materials compatible to
ISO 10993-1:2009 | Materials compatible to
ISO 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 life
Inner Cannula: 5-year shelf
life | Tracheostomy Tube and
Inner Cannula: 5-year shelf
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.