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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.

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