(61 days)
The Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
The family of Peripheral Cutting Balloon (PCB) Catheters has features of a conventional angioplasty catheter with advanced microsurgical capabilities. The PCB family features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. When the PCB device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Angioplasty (PTA) with the PCB device allows dilatation of the target lesion with less pressure, minimizing barotrauma.
This document is a 510(k) summary for the Boston Scientific Peripheral Cutting Balloon catheters. It details the device's indications for use, its description, and its substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance Study:
The document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes for the peripheral cutting balloon.
Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that the device is considered as safe and effective as the predicate device because it has the same intended use and the same technological characteristics, or, if there are differences in technological characteristics, those differences do not raise different questions of safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
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Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided 510(k) summary. The summary focuses on showing equivalence rather than meeting pre-defined performance criteria for a new type of device. -
Sample size used for the test set and the data provenance:
The document does not describe a specific test set, its sample size, or data provenance for performance evaluation. The substantial equivalence argument relies on the inherent similarity to predicate devices. The "proposed device" in the table (Page 3) is the one under review, which is essentially the same as the "predicate device" with minor labeling changes. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/provided as there is no mention of a test set with ground truth established by experts. -
Adjudication method for the test set:
This information is not applicable/provided as there is no mention of a test set. -
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 is not applicable. The device described is a medical device (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/provided as there is no specific performance study requiring ground truth in this submission. The "ground truth" for substantial equivalence is the historical safety and effectiveness data of the predicate devices. -
The sample size for the training set:
This information is not applicable/provided. No training set for an algorithm is mentioned. -
How the ground truth for the training set was established:
This information is not applicable/provided. No training set for an algorithm is mentioned.
Summary of the Document's Content Regarding Equivalence:
The core of this 510(k) submission is the assertion of substantial equivalence based on the following:
- Identical Intended Use: The "Indications for Use" for the proposed device (Peripheral Cutting Balloon catheters for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae) are the same as those of its predicate devices.
- Identical Technological Characteristics (with minor changes): The document states: "There are no changes in design, composition, function or indication of any of the proposed PCB devices compared to their respective predicates." The only change being proposed is "adding a new contraindication and a new warning in the DFU (Directions For Use)." Such labeling changes are generally considered minor and do not alter the fundamental safety and effectiveness of the device itself, thus maintaining substantial equivalence.
Therefore, for this specific 510(k) submission, the "study" demonstrating that the device meets criteria is the comparison to predicate devices, showing that it is fundamentally the same and incorporates only minor, non-performance-altering changes.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).