(147 days)
The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.
The NuVent™ Eustachian Tube Dilation Balloon is composed of a sterile, single use balloon handpiece and stopcock valve. The balloon is used in conjunction with the NuVent™ inflator, which is packaged with extension tubing to connect the inflator to the stopcock valve. The NuVent™ Inflator was cleared as a part of the NuVent™ EM Sinus Balloon Dilation System, 510(k) cleared under K132297.
A pre-angled flexible balloon section promotes easy access and insertion into the Eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the Eustachian tube and surrounding tissues during insertion. The rigid shaft and handle extending to the flexible balloon section provides stability and tactile feedback when moving the balloon through the nasal passages and into the Eustachian tube canal.
Mounted near the distal end of the balloon handpiece is a flexible balloon section. Once the balloon section is advanced into the target Eustachian tube the 6mm diameter/16 mm long rigid balloon is inflated using the separate NuVent™ inflator, expanding the Eustachian tube canal tissue and cartilage.
The provided text is a 510(k) Summary for the NuVent Eustachian Tube Dilation Balloon. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. The information supplied in this document focuses on mechanical and functional performance testing to prove substantial equivalence, rather than a clinical study evaluating the device's impact on human readers or clinical outcomes in the way a diagnostic AI device might be.
Therefore, many of the requested items (e.g., number of experts for ground truth, MRMC study, effect size of human improvement with AI, standalone performance, training set details) are not applicable to this type of device and the information provided in this 510(k) summary.
However, I can extract the acceptance criteria and performance data for the mechanical and functional tests that were performed to support the device's substantial equivalence.
Here's the information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document states that "All samples passed testing and met acceptance criteria." While the specific numerical acceptance criteria for each test are not explicitly detailed (e.g., "tensile strength must be > X N"), the general statement indicates that the device met pre-defined requirements for these performance characteristics. The table below lists the performance tests conducted, implying that the acceptance criterion for each was successful completion without failure, demonstrating performance comparable to or better than the predicate devices and ensuring safety and effectiveness.
| Performance Test Category | Reported Device Performance (Acceptance Criteria Met) |
|---|---|
| Mechanical/Functional Testing | |
| Wire dislodgement | Passed (met acceptance criteria) |
| Balloon inflation | Passed (met acceptance criteria) |
| Balloon deflation | Passed (met acceptance criteria) |
| Stopcock holding pressure without leaking | Passed (met acceptance criteria) |
| Pressure indicator button functionality | Passed (met acceptance criteria) |
| System does not leak or burst under use conditions in cyclic testing | Passed (met acceptance criteria) |
| Handpiece does not leak at the rated burst pressure in cyclic testing | Passed (met acceptance criteria) |
| Tensile strength of balloon, balloon bonds and tip | Passed (met acceptance criteria) |
| Torsional testing of balloon system | Passed (met acceptance criteria) |
| Usability testing, including simulated use | Passed (met acceptance criteria) |
| Flexibility testing (comparing subject and predicate devices under axial, angular, and torsional loading of balloon sections) | Passed (met acceptance criteria), demonstrating that the NuVent device is as safe and effective as the primary and secondary predicates. |
| Biocompatibility | Complies with ISO 10993-1 and FDA guidance (met requirements for intended use) |
| Sterilization | Achieved minimum sterility assurance level (SAL) of 10^-6 (validated to ISO 11135, ISO 11138-2, ISO 11737-1, ISO 11737-2) |
| Shelf Life Testing | All samples passed testing and met acceptance criteria of design inputs for device and packaging system following accelerated aging. Real-time aging is ongoing. |
Study Information Specifics:
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Sample Size Used for the Test Set and Data Provenance:
- The document states "All samples passed testing," but does not specify the sample size (N) used for each of the performance tests.
- The data provenance is from non-clinical tests conducted by Medtronic Xomed, Inc. This testing is typically done in a lab setting, not on human subjects.
- The data is prospective in the sense that the tests were designed and executed to evaluate the new device.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- N/A. This device's testing involves mechanical and functional performance, not diagnostic interpretation requiring expert ground truth in the context of a medical imaging or AI study. The ground truth for these tests is based on engineering specifications and physical measurements/observations of device performance against predefined criteria.
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Adjudication Method for the Test Set:
- N/A. Since this involves mechanical/functional tests against engineering specifications, there is no "adjudication" in the sense of reconciling human expert opinions. Test results are objectively measured or observed.
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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:
- N/A. This device (Eustachian Tube Dilation Balloon) is not an AI-powered diagnostic tool, nor does it assist human readers in interpreting medical images. It is a surgical device.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm-only" performance component. It is a physical medical device.
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The Type of Ground Truth Used:
- The ground truth used for this type of device relies on engineering specifications, physical measurements, and adherence to established performance standards (e.g., ISO, ASTM, internal Medtronic criteria). For example, a "passed" result for tensile strength means it met a minimum force before breaking, or "passed" for inflation means it inflated to the specified dimensions without bursting within a given pressure range.
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The Sample Size for the Training Set:
- N/A. There is no "training set" in the context of this device's mechanical and functional testing, as it is not an AI/machine learning model.
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How the Ground Truth for the Training Set was Established:
- N/A. This question pertains to AI/machine learning model development, which is not relevant to the type of device and testing described in this 510(k) summary.
§ 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.