(313 days)
Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent post-E.S.W.L.
The Kwart Retro-Inject™ Stent Set is intended to be marketed as a set with multiple components. The set is comprised of a double pigtail ureteral stent with tether, inserter, release sleeve, wire guide, and an adapter. The stent is available as a specified length or a multi-length stent with or without hydrophilic coating. The specified lengths are 22, 24, 26, and 28 centimeters with outer diameters of 4.7, 6, and 7 French. The multi-length stent offers a range of 22-32 centimeters with outer diameters of 4.7, 6, 7, and 8.2 French. Both specified and multi-length stents have drainage holes along the kidney loop, and continuing along the stent body extending from the kidney. However, the bladder pigtail and 15 centimeters of the stent body extending from the bladder loop do not have drainage holes. The bladder pigtail has a polyethylene terephthalate tether attached. In addition, both stent types are constructed of radiopaque polyurethane elastomer and have radiopaque ink marks to aid in stent placement. The stents accept either a 0.035 or a 0.038 inch wire guide.
The inserter is made of radiopaque polyurethane and has radiopaque ink markers. The inserter is available in outer diameters of 4.5, 5, or 6 French with a 70 centimeter working length. The inserter accepts a 0.038 inch wire guide. A female luer lock to connector cap adapter may be attached on the inserter to provide injection. The release sleeve is made of radiopaque plasticized polyvinylchloride. The release sleeve has an 8 or 10 French outer diameter and a 38 centimeter working length.
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.
The provided text describes a 510(k) premarket notification for a medical device called the "Kwart Retro-Inject™ Stent Set." This document focuses on demonstrating substantial equivalence to predicate devices through performance testing. However, it does not detail a study involving AI or human readers, but rather physical and material characteristic testing of the stent itself.
Therefore, many of the requested categories relating to AI performance, human reader studies, ground truth establishment for AI, and training sets are not applicable to the information provided.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All predetermined acceptance criteria were met" for the listed tests. However, it does not specify the quantitative acceptance criteria themselves nor the exact reported numerical performance for each test. Instead, it provides a general statement of compliance.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|
| Retention Strength and Break Strength: | Met predetermined acceptance criteria. Retention during proper clinical use and allows for removal. |
| Dynamic Frictional Force Testing: | Characterized the dynamic frictional force for both coated and uncoated stents at time zero and after accelerated aging. (No explicit acceptance criteria or numerical performance provided, only that it was "characterized") |
| Radiopacity: | Subjected to comparative fluoroscopic evaluation. (No explicit acceptance criteria or numerical performance provided, only that it was "assessed") |
| Gravity Flow Rate: | Characterized the gravity flow rate at time zero. (No explicit acceptance criteria or numerical performance provided, only that it was "characterized") |
| Magnetic Resonance (MR): | Met predetermined acceptance criteria. Shows the device is MR conditional based on defined, tested conditions. |
| Biocompatibility: | Met predetermined acceptance criteria. Conforms with biocompatibility requirements based on intended use. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It broadly states "The following testing was performed..." without detailing the number of units tested.
Data provenance is not applicable as this is product performance testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are engineering and material characterization tests, not analyses requiring expert medical adjudication of images or clinical data.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation or adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on the physical and material properties of the stent.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
No, this is about a physical medical device (a stent), not an algorithm or AI.
7. The type of ground truth used
For the physical and material tests, the "ground truth" would be the established engineering and materials standards and specifications against which the device performance was measured. For example, for "Retention Strength and Break Strength," there would be predefined force thresholds that the stent needed to meet to be considered acceptable. These are implied but not explicitly stated.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm study that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm study.
§ 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).