(181 days)
The Bard® Inlay Optima™ Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.
The Bard® (nLay Optima™ Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtall ureteral stent with a monofilament suture loop attached to aid in stent removal. The stent Is available in two forms: a single size or a customizable multi-length size. The following items are included with each stent:
- Ureteral Stont with Suture
- Push Catheter with Radiopaque Tip
- Pigtail Straightener
- 1 Guidewire* (Optional)
*Note: a 4.7 Fr stent Is compatible with a .035" guidewire and a 6,7,and 8 Fr stents are compatible with a .038" guidewire.
The provided document, K022447, is a 510(k) summary for the Bard® InLay Optima™ Ureteral Stent with Suture. This summary primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel device.
The document indicates that the device is "held to the same design, manufacture, and performance specifications as those stents currently manufactured by Bard." It also states that "Performance and functional testing standards are based on the FDA draft 'Guidance for the Content of Premarket Notifications for Ureteral Stents' dated February 10, 1993 and the draft ASTM F.04.70.01, 'Standard Test Method for Ureteral Stents' dated July 9, 1997."
However, there is no specific table of acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or similar outcomes from a clinical study within the provided text. The performance data summary (Section G) explicitly states that the device is based on existing specifications and industry standards, implying that its performance is presumed to be equivalent to the predicate device and meet these established standards.
The document does mention one in vitro test:
- "In vitro testing conducted on the Bard® InLay Optima™ Ureteral Stents and Multi-Length Ureteral Stents indicate reduced accumulation of urine calcium salts as assayed by calcium when compared to a control."
- It also states: "Correlation of in vitro data to clinical outcome has not been established."
Given the nature of a 510(k) submission for substantial equivalence, clinical performance data with detailed acceptance criteria and study results, as might be found for a novel device requiring rigorous clinical validation, are not typically included or required in the summary provided. The primary "study" is the comparison to a legally marketed predicate device (Bard® InLay Lubricious Double Pigtail Ureteral Stent with Suture #K983498) based on technological characteristics and intended use.
Based on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic accuracy).
- Sample sizes used for a test set (clinical data).
- Data provenance (country of origin, retrospective/prospective for clinical data).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm performance study.
- Type of ground truth used (pathology, outcomes data, etc.) for a clinical study.
- Sample size for a training set (as this is not an AI/ML device where a training set is relevant).
- How ground truth for a training set was established.
The document focuses on demonstrating technological equivalence and adherence to existing guidance and standards for ureteral stents.
Summary of available information:
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Table of Acceptance Criteria and Reported Device Performance: Not explicitly provided in terms of clinical outcomes or performance metrics. The device is asserted to meet design, manufacture, and performance specifications comparable to existing Bard stents, and adhere to FDA and ASTM draft guidance for ureteral stents.
- One in vitro test result is mentioned: Reduced accumulation of urine calcium salts as assayed by calcium, compared to a control. No specific quantitative criteria or success rates are given for this in vitro test, nor is a correlation to clinical outcome established.
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Sample sizes used for the test set and the data provenance: Not applicable or not provided, as detailed clinical efficacy or performance studies are not summarized. The comparison is primarily based on technological characteristics.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided.
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Adjudication method for the test set: Not applicable or not provided.
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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 physical medical device (ureteral stent), not an AI/ML diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or not provided for clinical outcomes. The in vitro test used "control" for comparison of calcium salt accumulation.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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).