(314 days)
The Venner PneuX™ TT (Tracheostomy Tube) is intended to be inserted into the patient's tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventilation and for the evacuation or drainage of secretions from the subglottic space.
The Venner Pneux TT (Tracheostomy Tube) is a disposable, sterile, single-patient, single-use device. It is a flexible, low volume and low pressure cuffed tracheostomy tube, which is reinforced with a Nitinol wire. The Venner PneuX TT may be used with the Venner PneuX TSM™ to monitor, maintain and regulate cuff pressure. The Venner PneuX TSM was cleared for marketing via 510(k) application K110631.
The Venner PneuX TT is available in three sizes (inner diameters: 7.0, 8.0 and 9.0 mm) and is MRI Conditional. Depth markings indicate the distance to the distal tip of the tube and a printed black line provides a means to orient the tube.
The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation.
A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. A fixation block secures the position of the tube to preventunintended movement during use. A standard connector (15 mm) for universal attachment to a ventilator is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated.
The obturator fits in the airway tube of the TT and guides its placement. Its tip is designed to aid passage through the surgical opening of a tracheostomy stoma. The obturator also has a hole which allows a guidewire to pass through, if clinically required.
The Venner PneuX™ TT (Tracheostomy Tube) is a medical device. The provided text outlines the performance data to establish its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Venner PneuX™ TT are primarily based on established ISO standards for medical devices and specific performance tests, as well as biocompatibility assessments. The reported device performance indicates that the device passed all conducted tests.
| Acceptance Criteria Category | Specific Criteria / Test Performed | Reported Device Performance |
|---|---|---|
| Sterilization, Shelf Life, & Packaging | - Sterility Assurance Level (SAL) of 10⁻⁶ via Ethylene Oxide (EO) sterilization (conformance to ISO 11135:2014 using half-cycle approach). |
- Ethylene oxide residue levels meeting Tolerable Contact Limit (TCL) for prolonged exposure devices (patient contact > 24 hours up to 30 days) according to ISO 10993-7.
- Packaging integrity supporting proposed shelf life through accelerated and real-time aging studies. | Passed (device is provided sterile, met SAL, EO residue levels met TCL, aging studies supported shelf life including packaging integrity). |
| Biocompatibility | - MEM Elution Assay (Cytotoxicity) per ISO 10993-5:2009 & ISO 10993-12:2012. - Intracutaneous Reactivity per ISO 10993-10:2010 & ISO 10993-12:2012.
- Guinea Pig Maximum Sensitization per ISO 10993-10:2010 & ISO 10993-12:2012.
- Acute Systemic Toxicity per ISO 10993-11:2006 & ISO 10993-12:2012.
- Subacute/subchronic Toxicity (14-day) per ISO 10993-11:2006 & ISO 10993-12:2012.
- Genotoxicity – Ames and Mouse Lymphoma Assay per ISO 10993-3:2014 & ISO 10993-12:2012.
- Implantation (4-week) per ISO 10993-6:2007.
- Material-Mediated Pyrogenicity per ISO 10993-11:2006 & ISO 10993-12:2012. | Passed for all listed tests. |
| Performance Testing (Mechanical & Functional) | - Conformance to ISO 5366:2016 (Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors) for dimensions, curvature, cuff diameter, and connectors. - Conformance to ISO 5361:2016 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors).
- Mechanical and functional requirements, including: cuff leakage, cuff herniation, tube collapse, radiopacity, kink resistance, 15mm connector leakage and seal pressure leakage (tested on terminally sterilized unaged and aged samples).
- Cuff inflation, leakage and function.
- Lumen function.
- Pull tests for all joints and connections.
- Bite block resistance.
- Meeting the same acceptance criteria as the predicate device (K100950). | Passed (met all standards and requirements, both unaged and aged, and met predicate device's acceptance criteria). |
| MRI Compatibility | - Magnetically induced displacement force per FDA guidance. - Magnetically induced torque per FDA guidance.
- Heating by radiofrequency fields per FDA guidance.
- Image artifact per FDA guidance.
(Evaluated per FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued December 11, 2014). | Passed (demonstrated MR compatible under specified conditions in labeling). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "Terminally sterilized unaged and aged samples were tested" for mechanical and functional assessments. The various biocompatibility tests would have their own sample size requirements as per the specified ISO standards, but these details are not provided in this summary.
The data provenance is from in-vitro (laboratory) and potentially in-vivo (animal for some biocompatibility tests like sensitization, toxicity, implantation) studies conducted by the manufacturer or contracted labs to demonstrate compliance with recognized standards. There is no mention of human clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable in the context of this device and testing. The "ground truth" for these tests (sterilization, biocompatibility, mechanical performance, MRI compatibility) is established by adherence to pre-defined international standards and scientific methodology, rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be the qualified personnel performing and interpreting the laboratory tests and analyses according to those standards (e.g., microbiologists for sterility, toxicologists for biocompatibility, engineers for mechanical testing).
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly for diagnostic devices where subjective interpretation of results (e.g., imaging) is involved and a consensus among multiple readers is needed to establish ground truth. For the physical and chemical testing performed for this device, results are objective (e.g., pass/fail for a cytotoxicity assay, numerical values within a specified range for dimensions, etc.) and do not require expert adjudication as described.
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
There was no MRMC comparative effectiveness study done. This device is a tracheostomy tube, a physical medical device, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. This device is a physical medical device, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is based on:
- International Standards: Adherence to established ISO standards (e.g., ISO 11135, ISO 10993, ISO 5366, ISO 5361) that define acceptable parameters and test methods for tracheostomy tubes, sterilization, and biocompatibility.
- Predicate Device Equivalence: The new device met the same acceptance criteria as the legally marketed predicate device (K100950), implying that the predicate's established safety and effectiveness forms a basis for comparison.
- FDA Guidance: Compliance with specific FDA guidance documents, particularly for MRI compatibility.
- Pre-defined Specifications: The device successfully passed tests against its own performance specifications (e.g., regarding cuff inflation, leakage, lumen function, pull tests, bite block resistance).
8. The Sample Size for the Training Set
This information is not applicable. Since this is a physical medical device and not an AI/machine learning model, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set, there is no "ground truth for the training set."
§ 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.