(252 days)
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.
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.
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.
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 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.
The provided FDA 510(k) summary for the Portex® BLUxl™ Extra Length Tracheostomy Tube, BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and BLUxl™ Extra Length Tracheostomy Inner Cannula focuses on establishing substantial equivalence to a predicate device rather than demonstrating the device meets a specific set of primary acceptance criteria through a clinical study.
Therefore, many of the typical elements requested in a description of acceptance criteria and a study proving a device meets them (such as MRMC studies, specific expert qualifications for ground truth, or effect sizes for AI assistance) are not applicable to this type of submission. This document describes a non-clinical performance evaluation to show similarity and safety compared to an already cleared device.
Here's a breakdown of the information that can be extracted and how it relates to your request:
Study Overview and Acceptance Criteria (as applicable for a 510(k) of this nature)
The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating that the subject devices are substantially equivalent (SE) to the predicate devices (Smiths Medical BLUselect® Tracheostomy Tube, BLUselect® Suctionaid® Tracheostomy Tube, and BLUselect® Inner Cannula) in terms of:
- Intended Use
- Technological Characteristics (materials, design, performance features)
- Safety and Effectiveness (demonstrated through non-clinical testing)
The study proving the device meets these "acceptance criteria" is a non-clinical performance evaluation comparing the subject device to the predicate device. The conclusion states: "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."
1. Table of acceptance criteria and reported device performance
Since this is a substantial equivalence submission based on non-clinical testing, the "acceptance criteria" are implied by successful demonstration of performance similar to the predicate and compliance with relevant standards. The "reported device performance" refers to the successful completion of these tests.
| Acceptance Criteria (Implied for SE) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Mechanical Performance: Device components meet specified dimensional and mechanical requirements (e.g., kink resistance, tensile strength, cuff performance, inner cannula cycling, obturator function, marking robustness). | Passed: Testing included: Dimensional requirements (Tracheostomy tube outer diameter, Tube overall length, Tube inner diameter at patient end and 15mm connector taper gauging); mechanical requirements (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, Robustness of product markings). |
| Aging Performance: Device maintains performance after artificial aging, indicative of expected shelf life. | Passed: 6-month, 2-year, 3-year, and 5-year artificially aged samples tested to design requirements. Real-time aging will be carried out for the same periods. |
| MRI Compatibility: Device does not pose an undue risk in an MRI environment. | Rationale Provided: Utilized legacy testing data. (Note: Specific MRI safety levels like "MR Conditional" are typically stated elsewhere but implied by the rationale.) |
| Cleaning Validation: Reusable components can be effectively cleaned. | Passed: Cleaning validation of BLUxl™ Extra Length Tracheostomy Inner Cannula. Cleaning validation of external surface of the BLUxl™ Extra Length Tracheostomy Tube. |
| Biocompatibility: Materials are safe for patient contact and do not elicit adverse biological responses. | Passed: Testing evaluated: Cytotoxicity, Sensitization, Irritation, Acute System Toxicity, Pyrogenicity, Subchronic Toxicity, Genotoxicity, and Implantation, compatible to ISO 10993-1:2009 for the specified contact classifications and duration (up to 29 days, prolonged). |
| Sterilization Efficacy: Device can be effectively sterilized to a minimum Sterility Assurance Level (SAL). | Passed: Validations in accordance with ISO 11135:2014, ISO 11138-1:2017, ISO 11137-1:2018, ISO 11737-2:2020, and ISO 10993-7:2008 demonstrated results indicating acceptability and distribution as sterile at SAL of 10-6. |
| Packaging Integrity: Packaging maintains sterility and product integrity. | Passed: Testing performed to ASTM F2096-11 and ASTM F88-15, with passing results. |
| Overall Substantial Equivalence: Subject device has same intended use, similar technological characteristics, and no new safety/effectiveness issues compared to predicate. | Concluded Substantially Equivalent: "The subject Portex® BLUxl™ Extra Length Tracheostomy Tubes, Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes, and Portex® BLUxl™ 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." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of clinical patient numbers since this was a non-clinical (bench and lab) performance evaluation. The "sample size" would refer to the number of devices or components tested for each mechanical, biocompatibility, sterilization, and packaging validation. These numbers are typically defined by engineering standards and internal quality procedures.
- Data Provenance: The data is from non-clinical laboratory testing and validation conducted by Smiths Medical ASD, Inc. (the manufacturer). The country of origin for the data generation is not explicitly stated but would typically be where the manufacturer's R&D and testing facilities are located (Minneapolis, MN, USA, based on the address). The data is prospective in the sense that the tests were designed and executed to support this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the typical sense of clinical ground truth. For a non-clinical performance evaluation, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM) and internal design specifications validated by skilled engineers, microbiologists, and other technical experts within the manufacturer's organization or through certified testing labs. These are not "experts" establishing a clinical diagnosis or interpretation but rather technical professionals verifying physical and biological properties against predefined criteria.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., subjective image assessment) to resolve discrepancies. For non-clinical performance testing, the results are typically quantitative and objective (e.g., passing/failing a force test, meeting dimensional specifications, biological assay results). Any discrepancies would be resolved through retesting, root cause analysis, or verification against the defined test methods.
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, not done. This type of study is entirely irrelevant to the submission for a tracheostomy tube. MRMC studies are specific to diagnostic devices, particularly those involving image interpretation by human readers, often comparing AI-assisted performance to unassisted performance.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- No, not done. This describes the performance evaluation of an AI algorithm, which is not applicable to a physical medical device like a tracheostomy tube.
7. The type of ground truth used
- The "ground truth" for this device's performance evaluation is based on defined engineering specifications, performance standards (e.g., ISO 11135 for sterilization, ISO 10993 for biocompatibility, ASTM for packaging), and comparison to the predicate device's established safe and effective performance. There is no clinical "ground truth" in terms of disease diagnosis or patient outcomes directly derived for this submission, as clinical testing was not deemed necessary.
8. The sample size for the training set
- Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device and does not involve AI or machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI model.
In summary: This 510(k) submission is for a physical medical device and establishes substantial equivalence through a comprehensive non-clinical performance evaluation. It does not involve clinical studies with human subjects, AI algorithms, or subjective interpretations that would necessitate the study design elements typically seen in diagnostic AI/imaging device submissions. The "acceptance criteria" are the successful demonstration of equivalence in intended use, technological characteristics, and safety/effectiveness via robust non-clinical testing against established engineering and regulatory standards.
§ 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.