(162 days)
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.
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.
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.
§ 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.