(81 days)
The VersaTube™ Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.
The VersaTube is a sterile, single use cuffed tracheostomy tube with a disposable inner cannula, and will be manufactured as a 7, 8, or 9 mm ID device (with the inner cannula being either 6, 7, or 8 mm ID). The angle of curvature of the VersaTube is 96° (7, 8 mm ID) or 97 ° (9 mm ID) and ranges from 78 to 98 mm. The neck-plate, 15 mm airway connector, and inner cannula are color coded to marry together the tracheostomy tube with the correctly sized inner cannula. The device is not intended to be used for more than 29 days.
The VersaTube consists of a polyviny1 chloride outer cannula which is tapered at the distal end for smooth insertion. The device also incorporates a low pressure, high volume balloon cuff at the distal end of the device for the purpose of sealing the airway for proper ventilation. Included with the VersaTube are two inner cannulae. Each inner cannula is designed for a close fit to the corresponding size VersaTube.
This document describes a 510(k) premarket notification for the Cook Incorporated VersaTube™ Tapered Tracheostomy Tube with Disposable Inner Cannula. It outlines the device's characteristics and compares it to a predicate device. However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (Portex® Blue Line Ultra® Tracheostomy Tube, K030381), rather than presenting a performance study against specific acceptance criteria for a novel device.
The "verification testing" mentioned is general and serves to confirm the design and performance for substantial equivalence, not to meet specific, quantified acceptance criteria for a clinical or performance study.
Therefore, I cannot answer the request directly as the information is not present in the provided text. To provide the requested information, the document would need to include:
- Specific, quantified acceptance criteria for metrics like "cuff performance," "insertion force," etc.
- Detailed results of primary studies demonstrating whether the device met those criteria, including sample sizes, ground truth establishment, and expert involvement.
Here's what I can extract based on the provided text, highlighting the absence of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance:
Information Not Provided in the Text. The document lists types of verification testing but does not provide specific acceptance criteria (e.g., "Insertion force shall be less than X Newtons") or the quantitative results of those tests.
2. Sample Size Used for the Test Set and Data Provenance:
Information Not Provided in the Text. The text mentions "verification testing" but does not specify sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). These verification tests appear to be engineering/benchmark tests rather than clinical studies with test sets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Information Not Provided in the Text. Since no clinical test set is described, there's no mention of experts establishing ground truth. The verification tests performed appear to be technical assessments of the device's physical properties.
4. Adjudication Method for the Test Set:
Information Not Provided in the Text. No adjudication method is described as there's no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No MRMC comparative effectiveness study was done or mentioned. The document is for a tracheostomy tube, which is a physical medical device, not an AI or imaging diagnostic tool where MRMC studies are typically performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a physical tracheostomy tube, not an algorithm or AI system.
7. The Type of Ground Truth Used:
Information Not Provided in the Text. For the "verification testing" mentioned (Strength of neck-plate, cuff performance, insertion force, etc.), the "ground truth" would implicitly be engineering standards, physical measurements, and biological compatibility test results. However, the exact methods and standards are not detailed.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set, this information is not relevant.
Summary of Study (Verification Testing) Mentioned:
The document briefly lists the following "verification testing" performed to demonstrate reliable design and performance:
- Strength of neck-plate and 15 mm connector attachment to cannula
- Cuff performance
- Insertion force
- Inner cannula extraction force
- Sterilization testing
- Biocompatibility testing
However, no specific study report, methodology, acceptance criteria, or quantitative results for these tests are provided or referenced in the given text. The focus of the 510(k) is to demonstrate substantial equivalence based on technological characteristics and intended use compared to a predicate device.
§ 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.