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The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.

The proposed CRE™ Balloon Dilatation 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. It is designed to be used through an endoscope having a 2.8mm or larger working channel. A stainless steel core wire extends through the entire length of the shaft. The wire is in tension within the balloon, which facilitates the removal of the catheter from the endoscope following balloon dilatation. The proposed device incorporates a minor material formulation change for the flexible tip of the device.

The provided text describes a Special 510(k) Premarket Notification for the CRE™ Balloon Dilatation Catheter, focusing on demonstrating substantial equivalence to a predicate device after a minor material formulation change. This type of submission generally relies on non-clinical data (e.g., bench testing, biocompatibility) rather than extensive clinical studies with specific acceptance criteria related to accuracy or diagnostic performance.

Therefore, many of the requested categories (e.g., acceptance criteria for device performance, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific submission. The focus is on demonstrating that the revised device performs similarly to the predicate device in terms of safety and basic function, not on demonstrating a new clinical performance claim or diagnostic accuracy.

Here's a breakdown based on the information provided and what is typical for a Special 510(k):

Acceptance Criteria and Device Performance

Study Details (Not Applicable/Not Provided for this Type of Submission)

This submission is a Special 510(k) for a minor change, which primarily focuses on bench testing and comparison to an already cleared predicate. Therefore, detailed clinical study information as requested is not available in this document.

1. Sample size used for the test set and the data provenance: Not applicable for a Special 510(k focused on material change and bench testing. No clinical test set details are provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as part of this type of submission.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.
4. 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: Not applicable. This device is a mechanical medical device (a balloon dilatation catheter), not an AI/imaging diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here is compliance with engineering specifications and biocompatibility standards.
7. The sample size for the training set: Not applicable. This device is a mechanical medical device, not an AI/machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study and Conclusion from the Document:

The "study" described here is primarily a series of pre-clinical tests (biocompatibility and in-vitro functional/mechanical testing) and a design comparison to the predicate device.

• Study Goal: To demonstrate that the proposed CRE™ Balloon Dilatation Catheter with a minor material formulation change to its flexible tip is substantially equivalent in terms of safety and effectiveness to the predicate CRE™ Balloon Dilatation Catheter (K971320).
• Methods:
  • Biocompatibility Testing: Conducted according to AAMI/ANSVISO 10993-1: 2009, including Cytotoxicity, Sensitization, and Intracutaneous Reactivity (Irritation).
  • In-vitro Testing: Performed on components, subassemblies, and/or full devices to ensure they met required specifications for chemical analysis, biocompatibility, and tensile strength (likely referring to mechanical and material integrity tests).
  • Design Comparison: The proposed device's design and manufacturing processes are stated to be identical to the predicate, with the exception of the minor material formulation change.
• Results/Conclusion: Boston Scientific Corporation demonstrated that the proposed device, with its minor modifications, is substantially equivalent to the predicate device. This conclusion was based on the fulfillment of biocompatibility standards and in-vitro functional testing, coupled with the assertion of identical design and manufacturing except for the specified material change. The FDA's letter (K122924) confirms this determination of substantial equivalence.

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