(50 days)
The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopes, percutaneous, or open surgical techniques. The Stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.
The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is a "fube-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" (21 CFR 876.4620).
This document is a 510(k) Special Notification for a medical device called the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent. The purpose of this notification is to expand the product line of an already cleared 4 French ureteral stent by adding larger sizes (5, 6, 7, and 8 French).
The document explicitly states: "No non-clinical or clinical performance data are included in this Special 510(k)." This means that no studies proving device performance against acceptance criteria are presented in this document.
Instead, substantial equivalence is established based on the following:
- Design Controls: The development of the new sizes was done in accordance with 21 CFR 820.30, and compliance with other aspects of Quality Systems Regulation (21 CFR 820) was maintained.
- Validation and Verification Activities: These activities were performed to reflect findings of individual risk analysis. They concluded that any differences in the values of attributes for the larger stents were proportional to those of the cleared/predicate 4 French stent (510(k) K082805).
- Technological Characteristics: The larger sized stents are made of the same raw material, have the same composition and radiopacifier, and use the same manufacturing methods, process parameters, design controls, and quality assurance system as the predicate 4 French device.
- Intended Use and Indications for Use: The proposed stents have the same intended use and indications for use as the cleared predicate, with the exception of removing an upper age limit.
Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets these criteria is not available within this document. This submission relies on the substantial equivalence to a previously cleared device, asserting that the new sizes are sufficiently similar in design, materials, manufacturing, and performance characteristics to the predicate device, and thus do not require new clinical or non-clinical performance data to demonstrate safety and effectiveness.
Since no such study is provided, I cannot populate the table or answer the specific questions about sample size, ground truth, expert opinions, or MRMC studies.
§ 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).