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510(k) Data Aggregation
(242 days)
Reliant(TM) Multistage Dilatation Balloon Catheter
The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.
The Reliant™ Multistage Dilatation Balloon Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.
The Reliant™ Multistage Dilatation Balloon Catheter is designed to pass through a 2.8mm or greater working channel of an endoscope. It will also accept a 0.035 inch (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 inch (0.89mm) guidewire preloaded in the guidewire lumen. The guidewire is about 20cm longer than the balloon catheter with the excess length extending from single lumen tube.
The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.
This document is a 510(k) summary for the Reliant™ Multistage Dilatation Balloon Catheter, indicating that it is a medical device for endoscopically dilating strictures of the gastrointestinal tract.
Here's an analysis of the provided information regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several design verification tests conducted on the proposed device. For each test, it implicitly states that the device was found to be "substantially equivalent" to the predicate device, meaning it met the acceptance criteria derived from the predicate device's performance or established industry standards. The specific quantitative acceptance criteria values are not provided in this summary, but the successful completion of these tests indicates compliance.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Balloon Appearance Test | Test performed, results indicate substantial equivalence to predicate. |
| Retraction Test | Test performed, results indicate substantial equivalence to predicate. |
| Tensile Strength Testing Test | Test performed, results indicate substantial equivalence to predicate. |
| Balloon Inflation and Deflation Test | Test performed, results indicate substantial equivalence to predicate. |
| Dimension Test | Test performed, results indicate substantial equivalence to predicate. |
| EO Residual Test | Test performed, results indicate substantial equivalence to predicate. |
| Sterility Test | Test performed, results indicate substantial equivalence to predicate. |
| Endoscopic Compatibility Test | Test performed, results indicate substantial equivalence to predicate. |
| Balloon Burst Pressure Test | Test performed, results indicate substantial equivalence to predicate. |
| Balloon Fatigue Testing Test | Test performed, results indicate substantial equivalence to predicate. |
| Radiopacity Test | Test performed, results indicate substantial equivalence to predicate. |
| Biocompatibility Evaluation | Test performed, results indicate substantial equivalence to predicate. |
| ECH Residual Test | Test performed, results indicate substantial equivalence to predicate. |
| Package Integrity Test | Test performed, results indicate substantial equivalence to predicate. |
| Risk analysis (referencing ISO 14971) | Carried out in accordance with established in-house acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the design verification tests. It also does not explicitly state the data provenance (e.g., country of origin or whether data was retrospective or prospective). However, as a 510(k) submission, the tests are typically conducted in a controlled laboratory environment by the manufacturer for regulatory purposes, implying an internal, prospective testing approach.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes device performance testing, not clinical studies involving human or expert interpretation of data. Therefore, the concept of "ground truth" established by experts for a test set, as would be relevant in an AI/diagnostic imaging context, does not directly apply here. The "ground truth" for these engineering tests would be the established specifications and performance limits for the device components.
4. Adjudication Method
Not applicable, as this is device performance testing, not a clinical study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) submission for a physical medical device (a balloon catheter), not an AI/software device that would typically involve MRMC studies to assess human reader improvement with AI assistance. The document explicitly states "No clinical study is included in this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the device performance tests would be based on engineering specifications, industry standards, and regulatory requirements. For example:
- Balloon Burst Pressure: The ground truth is the specified burst pressure beyond which the balloon should not fail.
- Dimensions: The ground truth is the specified dimensional tolerances of the device components.
- Sterility: The ground truth is the standard for sterility, often validated through methods like bacterial endotoxin testing and direct inoculation.
8. The Sample Size for the Training Set
Not applicable. As this is a physical medical device performance evaluation and not an AI/machine learning submission, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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