(105 days)
The Elation™ Pulmonary Balloon Dilation Catheter is intended to endoscopically dilate strictures of the trachea and bronchi.
The Elation™ Pulmonary Balloon Dilation Catheter is a multi-lumen catheter with a dilation balloon on the distal tip. The catheter is designed to pass through the working channel of an endoscope and accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. Two redundant inflation lumens are used to inflate and deflate the dilation balloon. The dilation balloon will be available in a 7.5F catheter with a length of 100 cm, balloon lengths of 2.0 cm, 3.0 cm or 5.5 cm and in six balloon diameter ranges from 6 mm to 20 mm. Each balloon size will inflate to three different diameters for the specified inflation pressures. The balloon will be identifiable with both endoscopic and radiopaque marker bands. A glow-in-the-dark tag that can be read in low light conditions is attached to the catheter shaft. The tag indicates diameter and corresponding pressure of the balloon. The balloon will be available in eleven configurations of multiple lengths and diameters. The balloon will be identifiable with both endoscopic and fluoroscopic markers and will be provided sterile.
This document pertains to the Elation™ Pulmonary Balloon Dilation Catheter, a medical device. The information provided describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness for determining substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly quantified in terms of specific performance thresholds (e.g., minimum tensile strength value, maximum deflation time). Instead, the document lists various safety and performance tests performed. The reported performance is generally stated as having "passed" or "met requirements," indicating successful completion of the tests and compliance with the specified standards.
Since no specific numerical acceptance criteria or performance metrics are provided in the document, a table with quantitative values cannot be generated. However, the types of tests conducted serve as the de facto acceptance criteria.
Key Performance Areas Tested:
- Mechanical Integrity and Functionality:
- Balloon Diameter
- Balloon Deflation Time
- Balloon Burst / Freedom from Leakage
- Tip Perforation
- Guidewire Pushability
- Simulated Bronchoscope Catheter Insertion and Withdrawal
- Distal Catheter Joints Tensile
- Proximal Catheter Joints Tensile
- Catheter Pushability
- Catheter Kink
- Kink Recovery
- High Tensile Load Balloon Deflation
- Radiological Properties:
- Radiopacity
- Sterilization and Biocompatibility:
- Sterilization Validation (Ethylene Oxide)
- Biocompatibility (Cytotoxicity, Sensitization, Irritation)
- Packaging and Shelf-Life:
- Seal Peel Strength
- Burst Strength
- Visual Inspection
- Bubble Emission
- Dye Penetration
- Shelf Life Validation (Accelerated aging and real-time studies for 6 months initially, with ongoing real-time studies for longer shelf life)
Reported Device Performance:
The document consistently states that the device "meets the requirements" and has successfully completed the specified tests. For example:
- "Performance testing of the subject Elation™ Pulmonary Balloon Dilation Catheter was conducted based on the risk analysis and based on the requirements of the following international standards and guidance documents..." (page 5)
- "Validation and annual revalidation have demonstrated a robust program that exceeds the minimum sterility assurance level of 10-6 as well as limiting residual sterilant levels to within limits established in EN ISO 10993-7:2008..." (page 6)
- "All samples tested passed the tests listed below [packaging tests]." (page 7)
- "Based on the indications for use, design, safety and performance testing, the subject Elation™ Pulmonary Balloon Dilatation Catheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device..." (page 8)
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the individual performance and safety tests. It generally refers to "tests" or "studies" conducted.
The data provenance is from Merit Medical Systems, Inc., the manufacturer of the device. The studies are prospective in the sense that they were conducted for the purpose of demonstrating substantial equivalence for this specific device before its marketing. The country of origin of the data is not explicitly stated beyond being generated by the US-based manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes bench testing, sterilization, biocompatibility, and packaging validation, not studies requiring expert interpretation of diagnostic images or clinical data to establish ground truth. Therefore, information regarding experts for ground truth establishment is not applicable to the type of testing described here.
4. Adjudication Method for the Test Set
As the studies are primarily engineering and laboratory-based tests (e.g., tensile strength, burst test, cytotoxicity, sterility), an adjudication method in the context of clinical interpretation (like 2+1 or 3+1 for medical image ground truth) is not applicable. The results of these tests are typically objective measurements or pass/fail determinations based on predefined criteria in the test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This document focuses on demonstrating the substantial equivalence of the Elation™ Pulmonary Balloon Dilation Catheter through engineering, biocompatibility, and sterilization testing, not through clinical comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable because the device described is a physical medical catheter, not an AI algorithm or software device.
7. The Type of Ground Truth Used
For the various tests conducted:
- Mechanical/Performance Tests: The "ground truth" is typically defined by the physical properties and performance characteristics as measured against established engineering specifications, relevant ISO/ASTM standards, and internal design requirements. These are objective instrumental measurements.
- Sterilization Validation: The ground truth is the achievement of a Sterility Assurance Level (SAL) of 10^-6, as verified by biological indicators and validated sterilization cycles according to ISO 11135:2014.
- Biocompatibility Testing: The ground truth is the absence of adverse biological reactions (cytotoxicity, sensitization, irritation) as per the requirements of ISO 10993 series of standards.
- Packaging Performance: The ground truth is the maintenance of sterile barrier integrity against specified physical challenges (e.g., burst strength, seal integrity).
In essence, the ground truth for these tests is based on objective, measurable criteria defined by established standards and validated test methods.
8. The Sample Size for the Training Set
This question is not applicable because the device is a physical medical catheter, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of device.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.