(251 days)
The TubaVent balloon dilatation system is intended to dilate the cartilaginous portion of the Eustachian tube for treatment of persistent obstructive Eustachian tube dysfunction in patients 18 years and older.
The TubaVent balloon dilatation system is an Eustachian Tube Balloon Dilatation System consisting of the balloon catheter, the Tubalnsert insertion device and the inflation device. It is used for dilation of the cartilaginous portion of the Eustachian tube in persistent obstructive Eustachian tube dysfunction. The balloon catheter TubaVent is available in two versions where the balloon diameter is different: 3 and 4.5 mm. The insertion device Tubalnsert has an angle of 45° at the distal end.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the TubaVent Balloon Dilatation System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details performance tests that were conducted and states that the device "met all acceptance criteria." However, it does not provide a specific table outlining the acceptance criteria values themselves (e.g., "burst pressure > X bar") alongside the measured performance. Instead, it describes the types of tests performed and a general statement of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | - All tests passed (ISO 10993-5, -10, -11, -23). |
| - Not cytotoxic, does not cause sensitization, irritation, or acute systemic toxicity. | |
| Performance | - All performance tests demonstrated device performs as intended. |
| - Tests included dimensional verification, deflation time, balloon burst pressure, tensile strength, torque, and fatigue. | |
| - Simulation studies (head model, animal cadaver - sheep) ensured function per design specs and intended use. | |
| - Human factors validation testing showed safe use by intended users without serious errors. | |
| Shelf Life | - TubaVent balloon dilatation system: 3 years |
| - TubaInsert insertion device: 5 years | |
| - Tuba inflation devices: 3 years | |
| Sterilization | - Achieves Sterility Assurance Level (SAL) of 10-6. |
| Design Validation | - Performed in a human cadaver study. |
2. Sample Size Used for the Test Set and Data Provenance
- Human Cadaver Study (Design Validation): The text mentions a "human cadaver study" was executed for design validation and to fulfill a special control requirement (874.4180(b)(iv)(6)). It does not specify the sample size (number of cadavers or Eustachian tubes tested) or the provenance (country of origin, retrospective/prospective).
- Simulation Studies: Acknowledges "simulation studies in a head model and in an animal cadaver model (sheep head)" but does not specify sample sizes for these.
- Human Factors Validation Testing: No sample size or details about the participants are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the establishment of a "ground truth" for a test set in the context of expert consensus, pathology, or outcomes data. The studies mentioned (biocompatibility, performance, shelf life, human cadaver, human factors) are primarily engineering and safety evaluations rather than diagnostic accuracy or clinical effectiveness studies requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
Not applicable, as the clinical study type requiring such adjudication (e.g., diagnostic accuracy where experts review cases) was not performed or detailed.
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
Not applicable. This device is a medical instrument (balloon dilatation system), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document primarily relies on engineering specifications, biological safety testing (biocompatibility), and functional performance data. For the human cadaver study, the "ground truth" would likely be the physical integrity and proper function of the device within the anatomical context, assessed through direct observation and measurements, rather than an expert consensus on a pathological finding or clinical outcome.
8. The Sample Size for the Training Set
Not applicable, as this device does not involve machine learning or AI models with training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not involve machine learning or AI models with training sets.
§ 874.4180 Eustachian tube balloon dilation system.
(a)
Identification. A Eustachian tube balloon dilation system is a prescription device that includes a flexible catheter attached to an inflatable balloon. The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Mechanical testing, including tensile and flexural testing of catheter joints and materials.
(ii) Durability testing, including fatigue and burst pressure testing of the balloon materials and components.
(iii) Inflation and deflation characterization testing, including time and pressure measurements, and leak testing of the balloon.
(iv) Verification testing of safety features built into the device must be performed, including the characterization of catheter geometries and distal tip insertion limitation mechanisms.
(2) Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support shelf life by demonstrating continued sterility of the device, package integrity, and device functionality over the identified shelf life.
(6) Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device.
(7) Labeling must include:
(i) Detailed instructions for use.
(ii) A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes.
(iii) A shelf life.