(192 days)
The Venner Pneux ™ ETT (Endotracheal Tube) is intended to be used for patients undergoing tracheal intubation during routine anesthesia or over extended periods (not more than 30 days) and for the evacuation or drainage of secretion from the subglottic space.
The Venner PneuX ETT (Endotracheal Tube) is a disposable, sterile, single-patient, single-use device. It is a straight, flexible cuffed (low volume, low pressure) Nitinol wire-reinforced tracheal tube with a Murphy Eye. When a patient is intubated with a Venner PneuX ETT and inflated by standard techniques, it can be attached to the Venner PneuX TSM™M via the Venner PneuX™ Extension Tube, to monitor, maintain and regulate cuff pressure. The Venner Pneux TSM, a cuff pressure controller, was cleared for marketing via 510(k) application K110631 and the Venner PneuX Extension Tube is a class I, 510(k) exempt device.
The Venner PneuX ETT is available in four sizes (inner diameters: 6.0, 7.0, 8.0 and 9.0 mm) and is MRI compatible. Depth markings indicate 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. An integrated bite block with fixation block provides a protective covering and secures the position of the tube to preventunintended movement duringuse. A standard connector (15mm)for universal attachment to a ventilator or anesthesia equipment 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 provided text does not describe a study involving an AI/ML device, but rather a medical device, the Venner PneuX™ ETT (Endotracheal Tube). Therefore, the information requested in the prompt, such as acceptance criteria for AI algorithm performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to the provided document.
The document focuses on demonstrating substantial equivalence of the Venner PneuX™ ETT to a predicate device (K093135) through performance testing, biocompatibility evaluation, and material/design comparisons.
Here's the relevant information about the device's acceptance criteria and study proving it meets them, based on the provided text:
Device: Venner PneuX™ ETT (Endotracheal Tube)
Acceptance Criteria and Reported Device Performance (based on this document, primarily focused on equivalence to predicate and relevant standards):
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Explicit from document) | Reported Device Performance |
|---|---|---|
| Premarket Clearance | Substantial Equivalence to Predicate Device (K093135) | Determined as Substantially Equivalent (K192120) |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 (via EO) | Met (conformance to ISO 11135:2014) |
| Ethylene Oxide (EO) Residue Levels meet Tolerable Contact Limit (TCL) for prolonged exposure | Met (according to ISO 10993-7) | |
| Shelf Life & Packaging Integrity | Support proposed shelf life (1 year) | Met (supported by accelerated and real-time aging studies) |
| Biocompatibility | Safe, biocompatible, and suitable for intended use (conformance to ISO 10993 & FDA Guidance) | All seven tests (MEM Elution Assay, Intracutaneous Reactivity, Guinea Pig Maximum Sensitization, Acute Systemic Toxicity, Subacute/subchronic Toxicity, Genotoxicity – Ames, Material-Mediated Pyrogenicity) "Pass". |
| Dimensional Conformance | Conformance to ISO 5361:2016 for dimensions (bevel angle, curvature, cuff diameter, connectors, murphy eye size/placement) | Met the standard. |
| Mechanical & Functional Performance | Conformance to ISO 5361:2016 for mechanical and functional requirements (cuff leakage, cuff herniation, tube collapse, radiopacity, kink resistance, 15mm connector leakage, seal pressure leakage) | Met the standard for both unaged and aged samples. |
| Pass internal performance specifications for: cuff inflation, leakage and function; lumen function; pull tests for all joints and connections; bite block resistance. | Successfully passed each test, meeting its performance specifications. | |
| Meet the same acceptance criteria as the predicate device for functional and mechanical tests. | Met the same acceptance criteria as the predicate device. | |
| MRI Compatibility | MR compatible under conditions identified in device labeling (conformance to FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment") | Demonstrated to be MR compatible (tests performed: magnetically induced displacement force, magnetically induced torque, heating by radiofrequency fields, and image artifact). |
Regarding the non-applicable questions due to the nature of the device (not an AI/ML diagnostic system):
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the medical device, not a data set for an AI algorithm. The document doesn't specify the number of units tested for each performance test, only that "samples" or "device" units were tested. Data provenance typically refers to the origin of data for AI/ML models (e.g., patient demographics, clinical sites), which is not relevant here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for this type of conventional medical device. Performance is measured against engineering specifications and industry standards.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus for labelling data for AI, which is not relevant here.
- 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 is for AI-assisted diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for this device's performance is adherence to industry standards (e.g., ISO 5361, ISO 10993) and established engineering specifications.
- The sample size for the training set: Not applicable. There is no AI training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a premarket notification for a conventional medical device, the Venner PneuX™ ETT, demonstrating its substantial equivalence to a predicate device by meeting various performance, material, and safety standards through physical testing, not through AI/ML model validation.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).