(176 days)
Ureteral Dilators: Intended to be used for dilatation of the ureter during ureteroscopic procedures.
Percutaneous Nephrostomy Dilators:
Dilator for tract preparation or splittable working sheath to protect the parenchyma.
Ureteral dilators:
The Ureteral Dilators are hollow rigid tubes made of Polyether Block Amide (PEBA) with tapered tips at the distal and proximal end. Total length is approximately 48 cm.
The dilators are compatible with a 0.038 inch (0.97 mm) guidewire. Outer diameters are either:
- CH FR 08 at one end and CH FR 10 at the other end
- CH FR 12 at one end and CH FR 14 at the other end ●
Percutaneous Nephrostomy (PCN) dilators:
The simple dilators are hollow tubes made in Polyether Block Amide (PEBA), with a tapered distal tip and straight cut proximal end. Total length is approximately 21cm.
The dilators are compatible with a 0.038 inch (0.97mm) guide-wire.
The dilator with splittable sheath consists of a high-density polyethylene (HDPE) dilator fitted with a Polytetrafluoroethylene (PTFE) sheath.
The provided text describes a 510(k) premarket notification for Ureteral Dilators and Percutaneous Nephrostomy Dilators. This document is a regulatory submission for medical devices, where the manufacturer seeks to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device.
Crucially, the provided text DOES NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as typically found in clinical performance studies for AI/software-as-a-medical-device (SaMD).
Instead, this document focuses on bench testing and biocompatibility testing to establish substantial equivalence for a physical medical device. The "summary and conclusions from the nonclinical tests submitted" only mention these two types of tests.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth types, because these elements are not present in the provided 510(k) summary for this type of physical device submission.
The document states: "Substantial equivalence is supported by bench testing comparing Ureteral and Percutaneous Nephrostomy Dilators to the predicate device and biocompatibility testing performed on the Ureteral and Percutaneous Nephrostomy Dilators." This indicates the primary evidence for this submission is related to the physical properties and material safety of the dilators, not an AI algorithm's diagnostic performance.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).