(85 days)
The device is intended for temporary internal drainage from the ureteropelvic junction to the bladder following dilation and or incision of a stricture. Double pigtail ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques.
The Ultrathane Endoureterotomy Stent Set is comprised of a double pigtail endoureterotomy stent and coaxial positioner. The endoureterotomy stent body has a dual diameter design with a larger diameter section tapered to a smaller diameter section. This dual diameter option is available with a 9.5 French to 6.0 French taper or a 14.0 French to 7.0 French taper. The small diameter section has drainage holes along the stent body. The stent body working length is available in 18 to 30 centimeters. Sideports are located along the curl to allow for drainage. The stent (stent body and pigtails) is made of radiopaque polyurethane elastomer.
The coaxial positioner consists of a release sleeve and a stent positioner. The release sleeve is made of radiopaque tetrafluoroethylene. The release sleeve has a 10.0 French outer diameter and a 38 centimeter working length. The release sleeve is able to lock into the stent positioner via a compression fitting consisting of a connector cap and luer lock adapter. The stent positioner is made of polyethylene and has a distal stainless steel marker. The stent positioner has a 7.0 French outer diameter and a 46.1 centimeter working length. The stent positioner accepts a 0.038 inch wire guide.
The set will be supplied sterile and is intended for one-time use. The set is packaged in a peelopen pouch with a three-year shelf life.
This document is a 510(k) summary for the Ultrathane Endoureterotomy Stent Set. It describes the device, its intended use, and performance testing conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Tensile force during proper clinical use should not fracture the Ultrathane Endoureterotomy Stent Set materials and bonds. | "All predetermined acceptance criteria were met." |
| Curl Retention (stent only) | (1) Curl retention during proper clinical use should retain the Ultrathane Endoureterotomy Stent within the intended anatomy. (2) Curl retention strength must allow for removal of the Ultrathane Endoureterotomy Stent within the intended anatomy. | "All predetermined acceptance criteria were met." |
| Magnetic Resonance (MR) Compatibility | The device should be MR conditional under defined conditions. | "All predetermined acceptance criteria were met." (Device is MR conditional based on defined, tested conditions.) |
| Biocompatibility | The device should conform with biocompatibility requirements based on its intended use. | "All predetermined acceptance criteria were met." |
Note: The document explicitly states "All predetermined acceptance criteria were met" for all categories, but it does not provide the specific numerical thresholds for these criteria. For example, it doesn't say "Tensile strength must be >X Newtons" or "Curl retention force must be between Y and Z Newtons."
Study Information
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Sample size used for the test set and the data provenance:
The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The performance data section describes types of testing performed (Tensile Strength, Curl Retention, MR, Biocompatibility), which likely involved specific test articles or samples for each test. However, the exact number of units or samples tested for each criterion is not provided. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described appears to be primarily engineering/materials performance testing (tensile strength, curl retention, MR compatibility) and biocompatibility testing, rather than a clinical study requiring expert assessment of "ground truth" for patient outcomes or diagnostic accuracy. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/provided as the described testing does not involve clinical judgment or adjudication of a test set in the way a diagnostic AI device would. -
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:
No, an MRMC comparative effectiveness study was not done and is not applicable to an endoureterotomy stent. This device is a physical medical device, not a diagnostic AI tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This pertains to a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As mentioned, the testing seems to involve physical and chemical property measurements against predefined engineering and regulatory standards, rather than "ground truth" in a clinical diagnostic sense. For example:- Tensile Strength & Curl Retention: Ground truth would be the physical measurement of these properties compared to required specifications.
- MR Compatibility: Ground truth would be the demonstration that the device performs safely and as intended in an MR environment, likely through controlled laboratory testing.
- Biocompatibility: Ground truth is established through standardized biological testing (e.g., cytotoxicity, sensitization, irritation) against ISO standards.
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The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. -
How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 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).