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The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder.

The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder. The hydrophilic coating will allow the stent to become 'slippery-when-wet' which will reduce friction. This device will be made from polyurethane, silicone and a hydrophilic coating.

Due to the nature of the provided text, which is an excerpt from a 510(k) Premarket Notification for a medical device (AQ Hydrophilic Stent), it does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment.

The provided text focuses on:

• Submission details: Applicant, date, device name, classification.
• Predicate devices: Stating equivalence to existing devices.
• Device description: Intended use, materials, "slippery-when-wet" property due to hydrophilic coating.
• Substantial Equivalence claim: Based on indications for use, materials, physical construction, manufacturing controls, packaging, and sterilization.

This type of document for a Class II medical device (like a ureteral stent) typically relies heavily on predicate device comparison and bench testing for performance, biocompatibility, and sterilization validation, rather than large-scale clinical studies with acceptance criteria based on metrics like sensitivity, specificity, or reader performance, as would be common for AI/ML-based diagnostic devices.

Therefore, I cannot populate the table or answer the specific questions based on the provided input. The information simply isn't present in this excerpt.

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The Surgitek Classic Double Pigtail Ureteral Stent is an indwelling device used to provide drainage from the kidney to the bladder and stenting of the ureter without external catheters. The stent may be placed using endoscopic, percutaneous or open procedures.

The Circon-Surgitek Classic Double Pigtail Ureteral Stent is a ureteral stent without a hydromer coating. The function of the double pigtail ureteral stent is to provide drainage from the kidney to the bladder and stenting of the ureter without the aid of internal catheters.

The Circon-Surgitek Classic Double Pigtail Ureteral Stent has a flexible pigtail curl at both the proximal (kidney) and distal (bladder) end of the stent. The kidney curl of the double pigtail is similar to the Circon-Surgitek Lubri-Flex™ kidney curl [K905289] while the bladder curl is similar to the Circon-Surgitek Multi-Flex [K913928]. These curls minimize upward and downward migration of the device. The curls at each end are formed in opposite directions from each other. The proximal kidney curl hooks, laterally into the lower colon or renal pelvis while the distal bladder curl curves medially into the bladder. The kidney curl, located at the proximal end of the device, is easily distinguished by the open tapered tip (or tail) which extends beyond the curl. The bladder curl, located at the distal end of the device, is distinguished by its open blunt end which does not extend beyond the curl.

Drainage holes are located at approximately 2.0 cm intervals in a spiral configuration along the mainshaft of the stent.

The Circon-Surgitek Classic Double Pigtail Ureteral Stent is designed for endoscopic or open surgical placement. A medial line is imprinted along the mainshaft of the stent on the side opposite the proximal curl to assist the physician in correctly orienting the curls within the kidney and bladder. The medial line terminates at the axial ring, parallel to the center radius of the distal curl. The axial ring serves as a visual marker to the physician for placement of the stent. The physician advances the stent until the ring is adjacent to the ureterovesical junction. This allows a sufficient amount of the stent to remain in the bladder to fully form the distal curl.

A non-absorbable monofilament trailing suture is provided in the distal curl to assist the physician in stent placement and positioning. To protect the suture, a retaining tube is placed over the tapered end of the stent.

Other currently marketed components to be packaged with the Circon-Surgitek Classic Double Pigtail Ureteral Stent include:

• One (1) Push Catheter .

Here's an analysis of the provided text regarding the acceptance criteria and study for the Circon-Surgitek Classic Double Pigtail Ureteral Stent:

Important Note: The provided document is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with strict acceptance criteria in the way a PMA (Premarket Approval) would. Therefore, the "acceptance criteria" here relate to demonstrating similar performance characteristics to predicate devices. The "study" largely consists of comparisons of material properties and design features.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not explicitly stated for any formal "test set" in the context of clinical performance. The comparison seems to be based on design specifications, material properties, and a general understanding of predicate device performance.
• Data Provenance: The data appears to be primarily from internal testing (for material and mechanical properties comparisons), and references to regulatory submissions (510(k) numbers like K860267, K930731, K905289, K946296) for predicate devices. There is no indication of clinical data from patients for a specific "test set." The information is retrospective since it refers to already cleared devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts: Not applicable. This submission is about substantial equivalence, not establishing clinical "ground truth" through expert consensus on a test set of patient data. The "ground truth" here is the established safety and effectiveness of the predicate devices.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. No clinical test set requiring adjudication is described.

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

• MRMC Study: No MRMC study was done.
• Effect Size: Not applicable. This is not an AI-assisted device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate devices (Microvasive Mardis Stent, Cook Double Pigtail Stent, Circon-Surgitek Lubri-Flex, Circon-Surgitek Quadra-Coil™). The applicant is asserting that their new device is "substantially equivalent" to these already cleared devices, implying similar safety and efficacy. The excerpt from Resnick, "A guide to double-pigtail stents," provides clinical context and suggests general acceptance of ureteral stents for urinary drainage.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable.

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