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The Edwards Balloon Catheter is indicated for balloon pulmonic valvuloplasty.

The Edwards Balloon Catheter is used for balloon pulmonic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (polyether block amide) multi-durometer braided shaft with 130 cm working length, platinum/iridium radio-detectable markers, and a polycarbonate y-connector that consists of a balloon inflation port and guidewire lumen. The effective length of the balloon is 4 cm and is offered in 16 mm, 20 mm, 23 mm and 25 mm diameters.

The provided text does not contain information about specific acceptance criteria, reported device performance metrics, or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for the Edwards Balloon Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on the available information:

• Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document states that "Non-clinical testing was completed to demonstrate that the Edwards Balloon Catheter meets the established performance characteristics, and to verify that design requirements are satisfied," but it does not list these specific characteristics or the quantitative results.

• Sample size used for the test set and the data provenance: Not applicable as no specific clinical or performance test sets with sample sizes are detailed. The testing mentioned is non-clinical (bench testing).

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set requiring expert ground truth is described.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set requiring adjudication is described.

• 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 medical catheter, not an AI-driven diagnostic or assistive device.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical catheter, not an AI algorithm.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The testing described is non-clinical (bench testing) to assess device integrity and function, not diagnostic accuracy against a ground truth.

• The sample size for the training set: Not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.

• How the ground truth for the training set was established: Not applicable as this is a physical medical device, not a machine learning algorithm.

Summary of Non-Clinical Testing (from the document):

The document lists the following non-clinical tests that were performed:

• Biocompatibility evaluation per ISO 10993-1
• Ethylene oxide sterilization validation
• Package qualification
• Device functional testing:
  • Surface/visual Inspection
  • Dimensional inspection
  • Radiopacity
  • Balloon diameter
  • Insertion force into sheath
  • Balloon inflation/deflation time
  • Balloon compliance
  • Catheter kink test
  • Balloon catheter retrieval force
  • Balloon fatigue and burst
  • Leakage test
  • Bond testing

The document concludes that "The Edwards Balloon Catheter is substantially equivalent to the predicate device, the NuMed Z-MED™ Balloon Dilatation Catheter" based on these non-clinical tests, and that "The differences between the subject and predicate devices do not have an adverse impact on safety or effectiveness, as demonstrated by bench testing." However, the specific quantitative acceptance criteria for each test and the precise performance results are not detailed in this public FDA letter.

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