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510(k) Data Aggregation
(273 days)
Portex Blue Line Ultra Paediatric Tracheosomy Tube
Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients.
The Portex® Blue Line Ultra® Paediatric Tracheostomy Tube (Blue Paeds) is designed for the paediatric population who require an artificial airway due to trauma or medical condition. It is indicated for patients who require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. The subject device package consists of a paediatric tracheostomy tube and cotton tape (neck strap) and a maximum recommended period of use is 29 days.
The tube is manufactured with a flange, blue line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for use when in-contact with patient tissue/bodily fluids/secretions.
This document describes the Portex Blue Line Ultra Paediatric Tracheostomy Tube (BLU PAEDS) and asserts its substantial equivalence to predicate devices, thus demonstrating that it meets acceptance criteria for its intended use. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BLU PAEDS are established by demonstrating compliance with relevant ISO standards and comparable performance to the predicate devices. The document frames this as "substantial equivalence" rather than explicit numeric acceptance criteria for each characteristic.
| Acceptance Criteria Category (implied by testing) | Reference/Standard | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Performance | ISO 5366-3, ISO 5366:2016 (with one exception) | Bench testing confirmed the BLU PAEDS device meets essential requirements for paediatric tracheostomy tubes, addressing the 90-degree curve design difference from predicates. |
| Breathing System Connection Compatibility | ISO 5356-1 | Bench testing confirmed compatibility with breathing system connections via the 15mm connector, ensuring it works with standard anesthetic and respiratory equipment. |
| Airway Device Evaluation | ISO 18190 | Bench testing evaluated the device for its intended use as an airway device. |
| Material Properties | Radiopacity, cleaning agents compatibility, MRI compatibility | Material bench testing confirmed radiopacity (blue line of radio-opaque material), compatibility with cleaning agents (consistent with IFU), and MRI safety (verified per ASTM F2503-13, as materials are nonconductive, nonmetallic, and nonmagnetic). |
| Human Factors/Usability | ISO 62366 | Design Validation / Human Factors study conducted to ensure the device's performance is acceptable for its intended use. (Details of metrics not provided). |
| Sterility | ISO 11135, ISO 11747 | Sterilization/Microbiology Validation conducted to ensure product sterility to the end user, achieving a Sterility Assurance Level (SAL) of 10-6. |
| Biocompatibility | ISO 10993-1:2009 | Biocompatibility assessment confirmed that the subject device materials (Medical Grade Polyvinyl Chloride (PVC) with non-phthalate plasticizer (DEHT)) are biocompatible and equivalent to the base materials of the Shiley predicate device, addressing the difference from the silicone Bivona predicate. |
| Shelf Life | Not explicitly referenced, but tested | 5-year shelf life, similar to the primary predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each bench test conducted. Instead, it states: "Non-clinical testing of the components comprising each configuration of the subject BLUE PAEDS were assessed and tested appropriately to design controls; i.e. design verification, design validations." This implies sufficient samples were used to meet the requirements of the standards cited.
The data provenance is prospective, non-clinical bench testing performed by the manufacturer, Smiths Medical. The "country of origin of the data" is not explicitly stated but would typically be the location of Smith Medical's testing facilities, likely within the USA given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by the specifications and criteria outlined in the relevant ISO standards and internal design requirements, rather than expert consensus on a test set in the way one might see for diagnostic AI.
4. Adjudication Method for the Test Set
This information is not provided. As "ground truth" for non-clinical bench testing is based on device specifications and standard compliance, a formal adjudication method by external experts (like 2+1 or 3+1) is not typically applicable or described in this context.
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
No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (tracheostomy tube), not a diagnostic AI system or an assistive technology that improves human "reading" performance. Therefore, this type of study is not relevant to its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the Portex Blue Line Ultra Paediatric Tracheostomy Tube. It is a physical medical device, not an algorithm, and does not have "standalone" performance in the context of AI. Its performance is inherent to its design and material properties.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of this device is primarily based on:
- Compliance with established international standards (e.g., ISO 5366-3, ISO 5366, ISO 5356-1, ISO 18190, ISO 10993-1, ISO 11135, ISO 11747, ASTM F2503-13).
- Engineering specifications and design controls to ensure the device performs as intended for airway maintenance in paediatric patients.
- Comparison to legally marketed predicate devices to establish substantial equivalence in safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
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