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The Elation™ Wireguided Balloon Dilation Catheters are intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilation of the Sphincter of Oddi with or without prior sphincterotomy.

The Elation™ Wireguided Balloon Catheters are multi-lumen 7.5F catheters with a dilation balloon on the distal tip. The catheter is designed to pass through the working channel of an endoscope and accept a guidewire through its guidewire lumen. This catheter comes packaged with a floppy tip guidewire preloaded in the guidewire lumen. A guidewire locking device, packaged in the unlocked position, is attached to the guidewire hub of the catheter. The dilation balloon will be available in catheter lengths of 180 cm and 240 cm, balloon length of 5.5 cm and in six balloon sizes. Each balloon size will inflate to at least 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 twelve configurations of multiple lengths and diameters – six are for the Esophageal Pyloric Biliary dilation and six for the Esophageal Pyloric Biliary Colonic dilation.

The document describes the Elation™ Wireguided Balloon Dilation Catheter and its substantial equivalence to a predicate device, but it does not provide acceptance criteria or detailed study results in the format requested.

The document states that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." Instead, performance testing was conducted based on risk analysis and international standards and guidance documents.

The performance testing listed includes Bench tests and Biocompatibility tests, but it does not present specific acceptance criteria or quantitative performance outcomes for the device against those criteria. The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance data against pre-defined acceptance criteria for a new device's efficacy or safety.

Therefore, the requested information cannot be fully extracted from the provided text.

Here's an attempt to answer based only on the provided text, acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document lists performance tests conducted but does not specify the acceptance criteria for each test or the reported performance data in a quantitative manner.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This information is not applicable/provided. The device is a medical catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The device is a medical catheter, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided in the document. Performance testing for a catheter typically involves bench testing against engineering specifications, not "ground truth" as might be used for diagnostic algorithms.

8. The sample size for the training set

This information is not applicable/provided. The device is a medical catheter, not an algorithmic model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided.

Summary of what is present:

The document indicates that performance testing was conducted based on:

• Risk analysis
• International standards and guidance documents (a list is provided on page 5)

Bench Performance Testing Categories Listed (though no criteria or results are given):

• Radiopacity
• Catheter Length
• Tip Perforation
• Guidewire Insertion
• Endoscope Catheter Insertion and Withdrawal
• Radiopaque Marker Band Location
• Balloon Diameter
• Balloon Deflation Time
• Balloon Burst / Freedom from Leakage
• Distal Catheter Joints Tensile
• Proximal Catheter Joints Tensile
• Catheter Pushability
• Catheter Kink
• Kink Recovery

Biocompatibility Testing Categories Listed:

• Cytotoxicity
• Sensitization
• Irritation

The document's purpose is to demonstrate substantial equivalence (K151925) to a predicate device (Boston Scientific's CRE™ Wireguided Balloon Dilatation Catheter, K112994), not to present detailed acceptance criteria and performance data for the Elation™ device as a novel technology.

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