(113 days)
The Bivona® Fixed Neckflange Hyperflex™ Tracheostomy Tube is intended to provide direct airway access for a tracheostomized patient up to 29 days. It may be reprocessed for singlepatient use up to 10 times for adults sizes and up to 5 times for pediatric sizes.
The Bivona® Adjustable Neckflange Hyperflex™ Tracheostomy Tube is not intended for long term use. It is intended to provide temporary airway access for a tracheostomized patient when determining the optimal tube length for a patient. It must be replaced with a fixed neck flange tracheostomy tube when the optimal length is determined.
The Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes with wire reinforcement have been determined to be MR-conditional. They may be used in a static magnetic field of 3-Testa or less with spatial gradient magnetic field of 720-Gauss/cm or less and maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3-W/Kg for 15 minutes of scanning.
The Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes are contraindicated for use with lasers or electrosurgical devices where their output may contact and damage the tube. The Bivona® Adjustable Neckflange Hyperflex™ Tracheostomy Tube is contraindicated for use in home care settings.
The Bivona® Adjustable and Fixed Neckflange Tracheostomy Tubes are sterile, single patient use, silicone tracheostomy tubes. They come in a variety of configurations for adults and pediatrics. They come cuffed (TTS®, Aire-Cuf® or Fome-Cuf®) or cuffless. The tubes are wire reinforced. Each tube is individually packaged in a peel-open tray with an obturator, decannulation cap, twill tape, and a disconnection wedge if appropriate. Additionally, a range of customizable options are offered allowing the clinician to create a tracheostomy tube to meet a specific patient's needs.
The purpose of this submission is to modify the indications for use for these devices to include the use of a properly placed Bivona® Adiustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes in the MRI environment. No changes have been made to the devices themselves.
The medical device described in the provided text is the Bivona® Adjustable and Fixed Neckflange Hyperflex™ Tracheostomy Tubes. The recent submission is a modification to the indications for use to include the use of these tubes in an MRI environment, as no changes were made to the devices themselves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Condition for MR-Conditional) | Reported Device Performance |
|---|---|
| Static magnetic field of 3-Tesla or less | 3-Tesla or less |
| Spatial gradient magnetic field of 720-Gauss/cm or less | 720-Gauss/cm or less |
| Maximum MR system reported whole-body averaged specific absorption rate (SAR) of 3-W/Kg for 15 minutes of scanning | 3-W/Kg for 15 minutes of scanning |
| Temperature rise of less than or equal to 0.4°C | 0.4°C was noted (at stated SAR conditions) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the "sample size" in terms of how many tracheostomy tubes were tested. The testing was bench testing.
- Data Provenance: The study was a non-clinical bench test. There is no information regarding the country of origin, but it can be inferred that the testing was conducted by or for Smiths Medical ASD, Inc., which is an American company. The testing is described as "bench testing," meaning it was conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The ground truth for proving MR-conditional status of a medical device is established through calibrated measurement instruments and adherence to standardized testing protocols (e.g., ASTM standards for MRI safety of medical devices), not through expert consensus on qualitative observations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human readers or expert consensus, not in non-clinical bench testing for physical properties. The bench testing would have yielded quantitative results directly from instruments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for assessing the performance of AI algorithms in diagnostic imaging interpretation and their impact on human readers, which is not the subject of this 510(k) submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
No, a standalone algorithm performance study was not conducted. This submission concerns the MR-conditional status of a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth used was based on objective physical measurements and established scientific principles related to MRI safety (e.g., electromagnetic interference, heating, and magnetic field interactions). The determination of MR-conditional status is based on adhering to predefined limits for temperature rise, artifact generation, and movement within a specified MRI environment.
8. Sample Size for the Training Set
This information is not applicable. This submission does not involve an AI algorithm or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there was no training set for an AI algorithm.
§ 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.