(137 days)
The VenSure™ Balloon Dilation System is used to access and treat the frontal ostia/recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian in adult patients using a transnasal approach.
The VenSure™ Nav Balloon Dilation System is additionally intended for use in conjunction with the Cube Navigation System during ENT procedures when surgical navigation or image-guided surgery may be necessary to locate the Eustachian tube or to locate tissue, bone or cartilaginous tissue surrounding the drainage of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.
The VenSure™ Light Balloon Dilation System is additionally used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.
The VenSure Balloon Dilation Systems combine features of a malleable suction and a malleable probe with the tissue expansion effect of balloon dilation. The distal end of the device includes an atraumatic tip and can be shaped to fit the Frontal, Maxillary, Sphenoid sinuses, and Eustachian tube using the Bending Tool provided with the device. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and the Eustachian tube within the same patient. The devices come in an EO sterilized tray sealed inside of a Tyvek pouch with the bending tool, inflation device, and extension line included in the trav.
All VenSure versions enable a physician to track the device into the sinuses and eustachian tube using endoscopic visualization.
The VenSure™ Nav allows additionally for image-guided visualization when connected to the Cube Navigation System (manufactured by Fiagon). The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "blug and play" tracking capability when used with the Fiagon Navigation System. The sensor carrier containing localizer elements detects a signal within a low-energy magnetic field delivered from the navigation unit. The navigation software then displays the location of the dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the balloon of the dilation device can be inflated with saline solution, using the inflation device to expand the outflow track of the targeted structure.
The VenSure™ Light additionally allows for LED light confirmation of the VenSure balloon through transillumination across nasal and sinus structures. The VenSure™ Light has an integrated flexible light fiber with battery powered LED light source designed to emit red light from the distal end of the VenSure balloon.
The VenSure™ ET is a 45°- pre-bent configuration of the basic VenSure (with straight balloon tip). The pre-bend to 45°bemt of the VenSure ET facilitates the use of the device when only used for treatment in the eustachian tube. The device however can also be reshaped to fit to the sinuses using the Bending tool.
The provided text describes the VenSure™ Balloon Dilation System, including the VenSure™ Light, VenSure™ Nav, and VenSure™ ET variants. These devices are used for balloon dilation of frontal ostial recesses, sphenoid sinus ostia, maxillary ostia/ethmoid infundibula, and the Eustachian tube in adults.
Here's an analysis of the acceptance criteria and the study information as requested:
1. A table of acceptance criteria and the reported device performance
| Performance Testing | Acceptance Criteria (Criteria for SE justification) | Reported Device Performance |
|---|---|---|
| Balloon dimensional integrity | The dimensions of the balloon are as specified and in accordance with the properties of the predicates. | All tests met the predefined acceptance criteria. |
| Balloon pressure stability / Balloon fatigue conditioning | The burst pressure at end of lifetime is above the rated in use pressure and within the specifications of the predicates. | All tests met the predefined acceptance criteria. |
| Balloon Inflation/Deflation times | The balloon inflates and deflates at end of lifetime of the device within the specifications of the predicates. | All tests met the predefined acceptance criteria. |
| Balloon burst pressure | The burst pressure is well above the rated in use pressure and within the specifications of the predicates. | All tests met the predefined acceptance criteria. |
| Mechanical integrity | Mechanical properties all met predefined acceptance criteria. It can be demonstrated that the minor differences in dimensions to the secondary predicate do not raise new concerns of safety and effectiveness and can be rated as substantial equivalent. | All tests met the predefined acceptance criteria. |
| Catheter and distal tip geometries characterization | The specified catheter and distal tip geometries are within the range of the primary predicate devices. | All tests met the predefined acceptance criteria. |
| Simulated use testing in clinical model | Same design safety features and mechanically functionality as primary predicate device can be demonstrated. | All tests met the predefined acceptance criteria. |
| Navigation compatibility (VenSure™ Nav only) | Navigation accuracy is within the rating of the secondary predicate. | Test results demonstrate functionality and compatibility. |
| LightGuide compatibility and performance | Dimensions and light output performance are within the ratings of the secondary predicate. | All tests met the predefined acceptance criteria. |
| Biocompatibility | Compliance with FDA recognized consensus standard ISO 10993-1:2018 (cytotoxicity, irritation, sensitization, acute systemic toxicity testing). | All tests successfully met the required acceptance criteria. |
| Sterilization & Stability | Compliance with ISO 11135-1 for sterilization validation. Shelf life and packaging testing to support labeled shelf life. | All tests were successfully completed. |
| Electromagnetic compatibility and Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2. | Testing was conducted per standards (implied successful). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Bench testing" and "Simulated use testing in clinical model." However, it does not specify sample sizes for the test sets used in performance data. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The reference to "clinical model" suggests a simulated environment rather than actual patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The studies described are primarily bench testing and simulated use, not those requiring expert interpretation of medical images or patient outcomes for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as the described studies do not involve expert adjudication of results in a clinical context.
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 is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device in question is a physical medical device (balloon dilation system) and not an AI/software product requiring human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an AI/software device. The VenSure™ Balloon Dilation System is a physical medical device. While the VenSure™ Nav includes "image-guided visualization" and "navigation software," the document does not describe "standalone" algorithm-only performance in the context of an FDA-cleared AI/software device. The navigation functionality is an aid for the physician using the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" implicitly refers to engineering specifications and established physical properties (e.g., "dimensions of the balloon are as specified," "burst pressure at end of lifetime is above the rated in use pressure"). For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-1:2018). For sterilization, the ground truth is sterilization validation standards (ISO 11135-1). For navigation compatibility, it's about functionality and compatibility with the Fiagon Navigation system meeting accuracy ratings of the predicate. This is based on objective, measurable physical and engineering endpoints rather than clinical ground truth (like pathology or expert consensus on a diagnosis).
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical medical device, not an AI/machine learning model that typically requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no mention of a training set for an AI/machine learning model.
§ 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.