(76 days)
The Cook Ureteral Balloon Dilation Catheter Set is used for Dilation prior to stone manipulation or ureteroscopy, and Dilating the intramural ureter. This device is sterile And intended for one-time use.
The Cook Ureteral Balloon Dilation Catheter Set is used for dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon and catheter is nylon with a hydrophilic coating. The Catheter is 7 French in diameter and is 65 cm's in length. The Rated Burst is 20 ATM's. The Set will include the balloon catheter and an inflation device. The product will be sold as sterile and intended for one-time use.
The provided text is a 510(k) summary for a medical device called the "Cook Ureteral Balloon Dilation Catheter Set." It does not contain information about acceptance criteria or a dedicated study proving the device meets specific performance metrics in the way you've described (e.g., sensitivity, specificity, or human improvement with AI).
Instead, this document focuses on establishing substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, without needing to conduct extensive new clinical trials to prove efficacy from scratch.
Here's why the requested information cannot be extracted from this document:
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Acceptance Criteria and Reported Device Performance: This document does not specify quantitative performance acceptance criteria (e.g., a certain percentage of successful dilations or a specific rate of adverse events that the device must achieve). The "Rated Burst is 20 ATM's" is a physical specification, not a clinical performance metric. The "performance" being evaluated here is primarily whether it's functionally similar to predicates, not whether it achieves a specific clinical outcome with a measurable metric.
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Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Studies, Ground Truth for Test Set: These concepts are relevant for studies that assess diagnostic accuracy or clinical efficacy, often involving human readers, and are simply not present in a 510(k) substantial equivalence submission for a device like a ureteral balloon catheter. There's no test set in the sense of a collection of cases to be interpreted or diagnosed.
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Training Set Sample Size and Ground Truth for Training Set: Similarly, for devices that are not AI-driven or diagnostic in nature (like this physical catheter), there is no concept of a "training set" for an algorithm.
What the document does tell us about "proof" and "acceptance":
- Acceptance Criteria (Implicit): The implicit acceptance criterion is substantial equivalence to predicate devices. This means the device must be shown to be as safe and effective as devices already permitted for sale.
- Study That Proves the Device Meets Acceptance Criteria: The "study" in this context is the 510(k) submission itself, which demonstrates substantial equivalence through:
- Comparison of Indications for Use: The proposed device's indications must be the same as or very similar to the predicate devices.
- Comparison of Design and Materials: The design (7 French, 65 cm, nylon with hydrophilic coating) and materials are compared to predicate devices.
- Comparison of Manufacturing and Quality Control: The document states the device "will be manufactured according to specified process controls and Quality Assurance Program" and "will undergo packaging and sterilization procedures similar to devices currently marketed."
- Performance Specifications: The "Rated Burst is 20 ATM's" is a specific performance characteristic, likely compared to predicates to ensure it's within an acceptable range for safe use.
In summary, for this particular document, the requested information (related to AI, diagnostic performance, expert review, sample sizes for test/training sets, etc.) is not applicable because the submission is based on substantial equivalence for a physical medical device, not a diagnostic or AI-driven system.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).