Search Results

The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.

The proposed device Balloon Dilatation Catheter is comprised of a pebax balloon mounted at the distal end of a pebax catheter with two ports. The balloon can be inflated to three distinct sizes, 6-7-8mm, 8-9-10mm, 10-11-12mm, 12-13.5-15mm, 15-16.5-18mm, 18-19-20mm diameters; the balloon length can be 30mm, 55mm and 80mm. Radiopaque bands placed at the distal and proximal end of the device provide fluoroscopic visualization of the balloon location. The catheter length is 1800mm, 1950mm, 2100mm and 2400mm with an outer diameter of 1.8mm, 2.0mm or 2.3mm. The two ports correspond to a guide wire port and balloon inflation port. A stopcock is included at the proximal end of the balloon inflation port to control pressure movement into or out of the device. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. The Balloon Dilatation Catheter is EO sterilization and use for single use only.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document explicitly states "The Balloon Dilatation Catheter meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135)". For the other items listed under "Following tests were conducted in our non-clinical bench test," the document states "The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This implies that the acceptance criterion for these tests was to meet their respective design specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the non-clinical bench tests. It also does not provide information on the provenance of data for these tests (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a Balloon Dilatation Catheter, and the assessment relies on engineering and biological performance standards, not expert interpretation of medical images or clinical outcomes that typically require expert ground truth establishment.

4. Adjudication Method

Not applicable. As noted above, this submission focuses on bench testing against established standards and design specifications, not on subjective clinical assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No Clinical test is included in this submission." Therefore, no MRMC study was conducted.

6. Standalone Performance Study

Yes, a standalone performance study in the form of non-clinical bench testing was conducted to evaluate the device against its design specifications and relevant medical device standards. The "Performance Data" section details the various aspects tested (e.g., head tip, connect strength, leakage, balloon fatigue, etc.).

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation was based on:

• Design specifications: The device's performance was compared against its own pre-defined engineering and functional requirements.
• Relevant medical device standards: Specifically, ISO 10993 for biocompatibility and ISO 11135 for sterility. While not explicitly named for other tests, it's implied that recognized engineering and performance standards would be followed.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device and its performance is evaluated through bench testing and conformance to standards, not through machine learning models that require training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no machine learning training set for this device.

Ask a specific question about this device

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.

Ask a specific question about this device