(72 days)
The Fossa Ureteral Stone Sweeper is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder, and/or for the manipulation, capture and removal of urinary calculi.
The Fossa Ureteral Stone Sweeper set consists of a flexible, Piqtail tipped, selfexpanding stent with: Insertion sheath, "Pusher," and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. Short slits along the working length of the stent allow radial device expansion to permit fluid flow through and around the device, and to permit stone passage into the inner stent's lumen.
The provided text is a 510(k) premarket notification for the Fossa Ureteral Stone Sweeper. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on a clinical study with detailed performance metrics. Typically, devices like the Fossa Ureteral Stone Sweeper (ureteral stents/retrieval baskets) are cleared based on performance testing (bench testing) and material equivalence to existing devices, especially when their mechanism of action is well-understood and similar to previously cleared devices.
Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not explicitly stated in this type of 510(k) summary. These types of studies are more common for diagnostic devices or devices with novel mechanisms of action where performance metrics like sensitivity, specificity, or accuracy are critical.
However, based on the provided text, here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with specific performance metrics (e.g., success rates, complication rates, or quantitative measurements) for a clinical study. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" mentioned refers to compliance with FDA guidance for ureteral stents and mechanical lithotripters, which generally involves bench testing.
- Acceptance Criteria (Inferred from 510(k) process): The device must be demonstrated to be "substantially equivalent" in terms of safety and effectiveness to legally marketed predicate devices. This typically means similar technological characteristics, indications for use, and performance that is at least as safe and effective as the predicates, often validated through non-clinical (bench) testing.
- Reported Device Performance (Inferred): "Product performance testing has been provided in support of this 510(k) in accordance with FDA's Guidance for the Content of Premarket Notifications for Ureteral Stents and 510(k) Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastorenterology and Urology." This indicates the device underwent testing relevant to its function as a ureteral stent and a stone removal device, likely including tests for material properties, structural integrity, flow rates, and stone manipulation/retrieval capabilities. However, specific results (e.g., stent fracture rate, stone fragmentation efficiency) are not quantified in this summary.
- Safety and Effectiveness Conclusion: "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Fossa Ureteral Stone Sweeper has been shown to be safe and effective for its intended use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable or not provided. This 510(k) summary does not describe a clinical study with a "test set" in the context of human patients for performance evaluation. The "performance testing" referenced is almost certainly non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable as no clinical study or human performance evaluation with expert-established ground truth is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical study or human performance evaluation is presented.
5. 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 instrument (ureteral stent/retrieval basket), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a device like this, "ground truth" often relates to engineering specifications and material science, verified through bench testing against established standards and predicate device characteristics.
8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable as no training set for an algorithm is mentioned.
Summary of what is provided:
- Device Type: Medical device (ureteral stent/retrieval basket).
- Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
- Basis for Clearance: Comparison to predicate devices (Cook Double Pigtail Polyurethane Stent, Bard Double Pigtail Ureteral Stent, Surgitek Stone Basket, Boston Scientific (Van-Tec) Segura Basket) and non-clinical "product performance testing" in accordance with FDA guidance documents.
- Key Argument: The materials used are identical to those in currently marketed urinary drainage and stone removal devices.
- Conclusion: The device is "safe and effective for its intended use" based on indications, technological characteristics, performance testing, and predicate comparison.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).