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The FLASH Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.

The FLASH Mini Ostial System is a 0.014" guidewire-compatible, rapid exchange (RX) coronary angioplasty balloon catheter with a working length of 135cm. The FLASH Mini Ostial System uses a dual balloon design that features a complaint Proximal Balloon which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

The FLASH Mini Ostial System is packaged with two accessory syringes. A standard 10cc syringe intended for use in deflation of the Proximal Balloon and a 1.0cc syringe with a pressure relief feature intended for use in inflation of the Proximal Balloon. The pressure relief feature is intended to improve patient safety by limiting the maximum achievable pressure in the Proximal Balloon if the user attempts to inflate the Proximal Balloon when incorrectly positioned.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them based on the provided text.

The text describes a 510(k) premarket notification for a modification to an existing medical device, the FLASH Mini Ostial System. Specifically, it details the addition of a pressure relief feature to a 1.0cc accessory syringe. While it mentions that performance data was collected for this modification, it does not explicitly list the acceptance criteria or elaborate on the results of the study that proves these criteria were met.

Here's what the document indicates regarding new performance data:

• Focus of new performance data: Functionality of the pressure relief feature and ensuring syringe compatibility with the balloon catheter.
• Tests performed for Pressure Relief Syringe: Minimum Expansion Pressure, Maximum Expansion Pressure, Freedom from Leakage.
• Tests performed for Balloon Catheter Compatibility: Proximal Balloon Inflation Time, Simulated Use and Proximal Balloon Inflation Port Compatibility.
• Conclusion: "All test results demonstrate that the pressure relief feature does not impact the use of the device under normal operating conditions. Additionally, the test result demonstrates that the Pressure Relief Syringe consistently limits the maximum pressure that can be achieved in the Proximal Balloon." And "All test results demonstrated that the accessory Pressure Relief Syringe component of the FLASH Mini Ostial System meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the Pressure Relief Syringe."

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for the test set.
3. Number or qualifications of experts, or adjudication methods for ground truth.
4. Information about MRMC or standalone studies.
5. Details on the type of ground truth used.
6. Sample size for the training set (as this appears to be a physical device modification, not an AI/ML-based device).
7. How ground truth for the training set was established.

The document refers to "predetermined design verification and validation acceptance criteria," but does not explicitly state what those criteria are or the specific performance values achieved against them.

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