(162 days)
No
The document describes a physical medical device (tracheostomy tube) and its components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on bench testing, biocompatibility, sterilization, and human factors, not algorithmic performance.
Yes
The device is a tracheostomy tube and aids in airway maintenance for patients, which is a therapeutic function. The Suctionaid version also allows for the aspiration of contaminated mucous and subglottic secretions, providing further therapeutic benefits.
No
Explanation: The device is a tracheostomy tube designed for airway maintenance and secretion management, which are therapeutic functions, not diagnostic.
No
The device description clearly outlines physical components such as a tracheostomy tube, tube holder, cleaning brush, inner cannula, obturator, disconnection wedge, and vacuum control valve, all manufactured from medical grade materials. The performance studies also focus on bench testing and validation of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "airway maintenance of tracheostomised patients" and "aspiration of contaminated mucous and subglottic secretions." This is a therapeutic and supportive function related to managing a patient's airway, not for diagnosing a condition or analyzing a sample in vitro (outside the body).
- Device Description: The description details a physical tube and accessories used to maintain an airway. It mentions contact with "patient tissue/bodily fluids/secretions," but this is in the context of the device's function within the body, not for analyzing these substances for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (markers of disease, etc.)
- Providing information for diagnosis, monitoring, or screening of a medical condition.
The device is clearly a medical device used for direct patient care and airway management.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BTO
Device Description
The Smiths Medical Portex® BLUselect and BLUselect Suctionaid Tracheostomy Tubes are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. BLUselect Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect Tracheostomy Tubes. The subject device package consists of a tracheostomy tube, a tube holder, cleaning brush, an inner cannula, obturator, disconnection wedge, and a vacuum control valve (with Suctionaid® tubes only) and a maximum recommended period of use is 29 days; intended to be used critical care settings, acute care settings, long term care facilities, and for home use. The tube is manufactured with a flange, inflation line, suction line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for safe use when in-contact with patient tissue/bodily fluids/secretions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway, trachea, anterior neck
Indicated Patient Age Range
adult patient population
Intended User / Care Setting
critical care settings, acute care settings, long term care facilities, and for home 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 comprising each configuration of the subject devices Smiths Medical Portex® BLUselect, BLUselect Suctionaid Tracheostomy Tubes and BLUselect Inner Cannula were assessed and tested appropriately to design controls; i.e. design verification, design validations. The test results conclude the subject products are substantially equivalent to the predicate devices described herein (above). Testing listed below:
- Bench Testing was conducted per ISO 5366:2016 to ensure the BLUselect devices meets the essential requirements for paediatric tracheostomy tubes.
- Bench Testing was conducted per ISO 5356-11 to ensure the BLUselect devices is compatible with breathing system connection via 15mm connector; which are used for standard anesthetic and respiratory equipment.
- Bench Testing was conducted per ISO 18190 to ensure the BLUselect devices is safe and effective when used as an airway device and/or equipment.
- Magnetic Resonance Environment use was assessed per SSTM F2052-15 and MRI Conditional marking per ASTM F2503 to ensure BLUselect devices are safe for Magnetic Resonance Imaging (MRI).
- Cleaning Instruction Validation for the BLUselect Inner Cannula was conducted per the FDA Guidance, AAMI TIR 30, AAMI TIR12 and AAMI TIR34. The inner cannula is a single-patient use and can be effectively cleaned for re-use with the IFU instructions.
- Tube External Maintenance instructions for the BLUselect device to remove secretions or debris from the external surfaces of the accessible portion of the device, will the device is in-situ. Instructions comply too the common practice in a healthcare or home care setting: similar to cleaning instructions of the predicate devices.
- Design Validation / Human Factors per ISO 62366 was conducted to ensure the subject device(s) performance is acceptable for its intended use.
- Sterilization/Microbiology Validation was conducted to ensure the subject device product sterility to the end user for ISO 11135. AAMI TIR28 and ISO 11747 is acceptable.
- Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the subject devices materials are biocompatible and equivalent with the same base materials of the predicate devices. The following end-points were evaluated: cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subchronic toxicity, and implantation.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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April 10, 2018
Smiths Medical ADS, Inc. Donna Semlak Principal Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K173384
Trade/Device Name: Smiths Medical Portex® BLUselect® Tracheostomy Tube Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: BTO Dated: March 2, 2018 Received: March 5, 2018
Dear Donna Semlak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K173384
Device Name Smiths Medical Portex® BLUselect® Tracheostomy Tube
Indications for Use (Describe)
Smiths Medical Portex® BLUselect® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
K173384
Device Name Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube
Indications for Use (Describe)
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.
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
Indications for Use
510(k) Number (if known)
K173384
Device Name Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula
Indications for Use (Describe)
The BLUselect® Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect® Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart |
ion 300 (Part 2: 3.11.00: Support B)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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."
5
smiths medical
bringing technology to life
510(k) SUMMARY
BLUselect® Devices
Date of Summary Preparation:
Submitter:
Establishment Registration Number:
Company Contact (Primary):
Trade Name(s):
Device Names(s):
Device Classification:
Regulation Number and Product Code(s):
April 9, 2018 (revised)
Smiths Medical 6000 Nathan Lane Minneapolis, MN 55442 USA
3012307300 (Minneapolis)
Donna M. Semlak Principal Regulatory Affairs Specialist Email: donna.semlak@smiths-medical.com Office: 763-383-3076
Tracheostomy Tube
- · Smiths Medical Portex® BLUselect® Tracheostomy Tube
- · Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube
- · Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula
Class II
21 CFR § 868.5800 Tracheostomy, Tube вто
6
Purpose
The purpose of this premarket notification Traditional 510(k) is to obtain FDA clearance for adult patient population requiring an artificial airway for breathing. This submission is submitted to establish substantial equivalence and obtain 510(k) clearance for the following:
- Smiths Medical Portex® BLUselect® Tracheostomy Tube .
- Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube ●
- Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula ●
Predicate Device(s) for Smiths Medical Portex® BLUselect® Devices
Information for the predicate device is provided in the table below for the subject devices. BLUselect®, BLUselect® Suctionaid®, and BLUselect® Inner Cannula.
| Predicate
Device Name | FDA 510(k)
Number and
Clearance Date | Classification | Primary Code |
|-----------------------------------------------------------|-------------------------------------------------------------------|----------------|------------------------|
| Portex Blue Line Ultra
Suctionaid
Tracheostomy Tube | K030570
Sept 17, 2003
Original Applicant:
Portex Limited | Class II | BTO
21 CFR 868.5800 |
Reference Devices for Smiths Medical Portex® BLUselect® Devices
| Reference
Device Name | FDA 510(k)
Number and
Clearance Date | Classification | Primary Code |
|-------------------------------------------------------------------|---------------------------------------------------------------------|----------------|------------------------|
| Portex UniPerc
Percutaneous Dilation
Tracheostomy Kit | K083031
August 18, 2009
Original Applicant:
Smiths Medical | Class II | BTO
21 CFR 868.5800 |
| Bivona Tracheostomy
Tubes
MRI Labeling | K083641
Feb 23, 2009
Original Applicant:
Smiths Medical | Class II | JOH
21 CFR 868.500 |
| Blue Line Ultra
Tracheostomy Tube
Includes inner
cannula | K030381
Aug 23, 2003
Original Applicant:
Portex Limited | Class II | BTO
21 CFR 868.5800 |
General Device Description
Smiths Medical Portex® BLUselect®, BLUselect® Suctionaid®, and BLUselect® Inner Cannula:
The Smiths Medical Portex® BLUselect and BLUselect Suctionaid Tracheostomy Tubes are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation
7
for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. BLUselect Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect Tracheostomy Tubes. The subject device package consists of a tracheostomy tube, a tube holder, cleaning brush, an inner cannula, obturator, disconnection wedge, and a vacuum control valve (with Suctionaid® tubes only) and a maximum recommended period of use is 29 days; intended to be used critical care settings, acute care settings, long term care facilities, and for home use.
The tube is manufactured with a flange, inflation line, suction line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for safe use when in-contact with patient tissue/bodily fluids/secretions.
| Smiths Medical Product Name | Indications For Use |
|---|---|
| Smiths Medical Portex® BLUselect® | |
| Tracheostomy Tube | Smiths Medical Portex® BLUselect® Tracheostomy |
| Tube is indicated for airway maintenance of | |
| tracheostomised patients. | |
| Smiths Medical Portex® BLUselect® | |
| Suctionaid® Tracheostomy Tube | 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. | |
| Smiths Medical Portex® BLUselect® | |
| Tracheostomy Inner Cannula | The BLUselect® Inner Cannula is intended to be used |
| with the Smiths Medical Portex® BLUselect® | |
| Tracheostomy Tube indicated for airway maintenance | |
| of tracheostomy patients. |
Indications for Use:
Summary of Technological Characteristics:
The Smiths Medical Portex® BLUselect subject devices shares the similar technological characteristics as their 510(k) cleared predicates, Blue Line Ultra devices. These characteristics include the same intended use of 29 days for the adult patient population, same overall design, same base materials, and same range of sizes, Also, both the subject device and the predicate devices meet the ISO 5366 and ISO 5356 standards and requirements for tracheostomy tubes; including ISO 18190 for airway equipment; which concludes substantially equivalent performance characteristics.
The BLUselect subject device and the Blue Line Ultra Tracheostomy Tube predicate device are manufactured with the same type of material, Polyvinyl Chloride (PVC). The BLUselect Inner Cannula and Blue Line Ultra Inner Cannula predicate device material is a medical grade polyethylene.
The subject devices and the predicate devices are designed to aid the adult population with an artificial airway due to trauma, a medical condition or airway maintenance. Both have 15mm connectors for attachment to airway circuits. which are compatible with standard healthcare systems for use of humidification and/or ventilation equipment. Both, the subject and predicate devices provide a neck strap (tube holder) for use to secure the tracheostomy tube placement to the patient.
8
The surqical procedure is the same for BLUselect; anterior surgical approach of the patient's trachea anatomy. An invasive incision is made at the tracheal anatomy, in which a surgical stoma is created for the tracheostomy tube insertion. Both the subject and predicate devices are manufactured with a radio-opaque material, which assists the physician for device placement with x-ray.
The BLUselect trach tubes, subject device(s) and predicate devices are by prescription only, for single use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user.
The BLUselect inner cannula and predicate inner cannula are intended to be used with the tracheostomy tube and are by prescription only, for single-patient use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user. The inner cannula cleaning instructions allows for re-use with the same patient.
Principle of Operation
The Smiths Medical Portex® BLUselect and BLUselect Suctionaid Tracheostomy Tubes and BLUselect Inner Cannula are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction.
A tracheotomy is a surgical procedure in which a direct airway is established by creating an opening in the anterior neck and placing a tracheostomy tube through the anterior neck into the trachea to secure the airway.
Summary of Performance Testing:
The Smiths Portex® Medical BLUselect and BLUselect Suctionaid Tracheostomy Tubes and BLUselect Inner Cannula incorporates the same indications for use, similar technological characteristics, including MRI conditional labeling and the similar tube sizes as the legally marketed primary predicate device the Blue Line Ultra Tracheostomy Tubes, K030381, 510(k) clearance issued August 27, 2003: Blue Line Ultra Suctionaid Tracheostomy Tube with reusable inner cannula, K030570; 510(k) clearance issued Sept 17, 2003. MRI Conditional labeling primary predicate device is the Bivona Tracheostomy Tubes, K083641; 510(k) clearance issued Feb 23, 2009.
Non-clinical testing of the components comprising each configuration of the subject devices Smiths Medical Portex® BLUselect, BLUselect Suctionaid Tracheostomy Tubes and BLUselect Inner Cannula were assessed and tested appropriately to design controls; i.e. design verification, design validations. The test results conclude the subject products are substantially equivalent to the predicate devices described herein (above). Testing listed below:
Smiths Medical Portex® BLUselect Tracheostomy Tubes / Inner Cannula:
- . Bench Testing was conducted per ISO 5366:2016 to ensure the BLUselect devices meets the essential requirements for paediatric tracheostomy tubes.
9
- Bench Testing was conducted per ISO 5356-11to ensure the BLUselect devices is . compatible with breathing system connection via 15mm connector; which are used for standard anesthetic and respiratory equipment.
- . Bench Testing was conducted per ISO 18190 to ensure the BLUselect devices is safe and effective when used as an airway device and/or equipment.
- Magnetic Resonance Environment use was assessed per SSTM F2052-15 and MRI Conditional marking per ASTM F2503 to ensure BLUselect devices are safe for Magnetic Resonance Imaging (MRI).
- . Cleaning Instruction Validation for the BLUselect Inner Cannula was conducted per the FDA Guidance, AAMI TIR 30, AAMI TIR12 and AAMI TIR34. The inner cannula is a single-patient use and can be effectively cleaned for re-use with the IFU instructions.
- Tube External Maintenance instructions for the BLUselect device to remove secretions or debris from the external surfaces of the accessible portion of the device, will the device is in-situ. Instructions comply too the common practice in a healthcare or home care setting: similar to cleaning instructions of the predicate devices.
- . Design Validation / Human Factors per ISO 62366 was conducted to ensure the subject device(s) performance is acceptable for its intended use.
- . Sterilization/Microbiology Validation was conducted to ensure the subject device product sterility to the end user for ISO 11135. AAMI TIR28 and ISO 11747 is acceptable.
- I Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the subject devices materials are biocompatible and equivalent with the same base materials of the predicate devices. The following end-points were evaluated: cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subchronic toxicity, and implantation.
| | BLUselect
Component(s) | Contact Type | Duration of Use |
|------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------|---------------------|
| Tracheostomy Tube Components | 15mm
connector | Externally
Communicating –
Tissue | ≤29 days, prolonged |
| | Tube with
molded
flange | Tube: Externally
Communicating –
Tissue
Flange: Surface Device
– Compromised
Surface | ≤29 days, prolonged |
| | Soft-seal cuff | Surface Device –
Mucosal Membrane | ≤29 days, prolonged |
| | Inflation line | Surface Device –
Mucosal Membrane | ≤29 days, prolonged |
- . Patient Contacting Components
1 ISO 5356 - Smiths complies with revision 2004 and 2015 Smith Medical K173384/003 510k Summary
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| BLUselect
| Component(s) | Contact Type | Duration of Use |
|---|---|---|
| Pilot line | Surface Device - Intact Skin | ≤29 days, prolonged |
| Inflation line | ||
| Valve assembly | Surface Device - Intact Skin | ≤29 days, prolonged |
| Suction line | Surface Device - Mucosal Membrane | ≤29 days, prolonged |
| Suction connector | Surface Device - Intact Skin | ≤29 days, prolonged |
| Valve guard | Surface Device - Intact Skin | ≤29 days, prolonged |
| Inner Cannula | Externally Communicating - Tissue | ≤29 days, prolonged |
Substantial Equivalence
Smiths Medical considers the subject devices performance to be substantially equivalent to the predicate device(s), because these devices are intended for same patient population that require an artificial airway due to trauma, a medical condition and/or airway maintenance.
Subject Devices:
- Smiths Medical Portex® BLUselect® Tracheostomy Tube
- Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube ●
- Smiths Medical Portex® BLUselect® Tracheostomy Inner Cannula ●
There are no significant differences in the intended use, mechanical and functional performance and functional scientific technology. Overall and including the difference in the material change for the tracheostomy tube, Smiths Medical demonstrations there are no new issues of safety and effectiveness are raised due to the similarities/differences between the subject and predicate/commercialized devices, as each are used to treat the same clinical condition and represent a similar/basic design concept.
Table 3 below provides a substantial equivalence summary of the subject device and predicate devices, including device pictures.
Table 3: Substantial Equivalence Summaries:
11
BLUselect / Suctionaid / Inner Cannula
| Product
Component | Subject Device
BLUselect Tracheostomy Tube
w/wo Suctionaid and
Inner Cannula | Predicate Device
K030570
Blue Line Ultra/Suctionaid | Compare |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | BTO | BTO | Same |
| Product
Classification | Class II | Class II | Same |
| Device Classification
Name and 21 CFR | Tracheostomy tube and tube cuff
§ 868.5800 | Tracheostomy tube and tube cuff
§ 868.5800 | Same |
| Invasive or Non-
Invasive | Surgically Invasive | Surgically Invasive | Same |
| Patient Population | Adults with average height, weight,
and anthropometrics. | Adults with average height, weight,
and anthropometrics. | Same |
| Intended Use | For use with patients that require an
artificial airway due to trauma or
medical condition. | For use with patients that require an
artificial airway due to trauma or
medical condition. | Same |
| Maximum Use | Recommended 29 Days | Recommended 29 Days | Same |
| Indications for Use
Tracheostomy Tube | Smiths Medical Portex®
BLUselect® and Suctionaid
Tracheostomy Tube is indicated for
airway maintenance of
tracheostomised patients. | Portex® Blue Line Ultra® and
Suctionaid Tracheostomy Tube is
indicated for airway maintenance of
tracheostomised patients. | Same |
| Indications for Use
Suctionaid | 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. | Portex® Blue Line Ultra®
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. | Same |
| Indications for Use
Inner Cannula | The BLUselect® Inner Cannula
is intended to be used with the
Smiths Medical Portex®
BLUselect® Tracheostomy Tube
indicated for airway maintenance
of tracheostomy patients. | Portex® Blue Line Ultra
Tracheostomy Inner Cannula is
intended to be used with the Smiths
Medical Portex® Blue Line Ultra
Tracheostomy Tube indicated for
airway maintenance of tracheostomy
patients.
(not included in IFU) | Same |
| Functionality | Smiths Medical Portex®
BLUselect® Tracheostomy Tube is
intended for airway maintenance and
is optionally available with a range of
secondary features including cuff,
Suctionaid®, and fenestrations in a
size range from 6.0mm to 10.0mm
for adult patients | Portex® Blue Line Ultra®
Tracheostomy Tube is intended for
airway maintenance and is optionally
available with a range of secondary
features including cuff, Suctionaid®,
and fenestrations in a size range
from 6.0mm to 10.0mm for adult
patients | Same |
| Sterilization | Ethylene Oxide (EO) Sterile SAL 10-
6 to End User | Ethylene Oxide (EO) Sterile SAL 10-
6 to End User | Same |
| Product
Component | Subject Device
BLUselect Tracheostomy Tube
w/wo Suctionaid and
Inner Cannula | Predicate Device
K030570
Blue Line Ultra/Suctionaid | Compare |
| Biocompatibility | Compatibility materials
ISO 10993-1: 2009 | Compatibility materials
ISO 10993-1: 2009 | Same |
| MRI Conditional | Yes | Yes | Same |
| Shelf Life | 5-year shelf life intended | 5-year shelf life | Same |
| Single Use
Single Patient Use | Yes | Yes | Same |
| Environment of Use | Critical care settings, Acute care
settings, Long term care facilities | Critical care settings, Acute care
settings, Long term care facilities | Same |
| Home Care Use | Yes | Yes | Same |
| Tracheostomy Tube
Materials (Flexible
PVCs) | Main Tube Body: DEHT PVC
Inflation Line: DEHT PVC
Pilot Balloon: DEHT PVC
Suction Line: DEHT PVC
Cuff Bonding Cement: DEHT PVC
All other materials of Construction
are equivalent | Main Tube Body: DEHP PVC
Inflation Line: DEHP PVC
Pilot Balloon: DEHP PVC
Suction Line: DEHP PVC
Cuff Bonding Cement: DEHP PVC
All other materials of Construction
are equivalent | Different |
| Flange Marking
Color Coding | Laser Marked Product Information
with Vinyl Ink Printed Color Coding
Band
Image: tracheostomy tube with the text '7.0' on it | Clear Embossed Mark
Image: tracheostomy tube | Different |
| Suctionaid feature | Available | Available | Same |
| Varied Components | Included | Included | Same |
| Inner Cannula | Included | Included | Same |
| Cleaning Instructions | Included | Included | Same |
| IFU | Included | Included | Same |
12
Conclusion
Smiths Medical's evaluation concludes that the subject devices are substantially equivalent to the predicate device.