Search Results

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

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

Device Description

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

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

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for performance was established through compliance with recognized international standards (ISO, ASTM) and FDA guidance for medical device testing, rather than expert consensus on a test set of cases.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

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

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

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

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

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

8. The Sample Size for the Training Set

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

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

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

Ask a Question

Ask a specific question about this device

Page 1 of 1