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K Number
K250448
Device Name
Disposable Percutaneous Nephrostomy Dilatation Kit
Manufacturer
Shenzhen Trious Medical Technology Co., Ltd
Date Cleared
2025-07-03

(135 days)

Product Code
LJE
Regulation Number
N/A
Type
Traditional
Panel
GU
Reference & Predicate Devices
K170531
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Disposable Percutaneous Nephrostomy Dilators:
Dilator for tract preparation and splittable working sheath to protect the parenchyma.

Device Description

The Disposable Percutaneous Nephrostomy Dilators consists of dilator tube and tearing sheath. The body of the tearing sheath is made of polytetrafluoroethylene (PTFE), the tearing handle is made of acrylonitrile-butadiene-styrene copolymer (ABS).

The body of the dilator tube is made of polypropylene (PP), the connector of the dilator tube is made of polypropylene (PP).

The Disposable Percutaneous Nephrostomy Dilators are sterile single use device. EO sterilization, shelf life of 3 years.

These devices must be used in operating theatre, under aseptic environment.

Duration of use for the different components:
Tearing sheath tube:

AI/ML Overview

This document is a 510(k) clearance letter for a medical device called "Disposable Percutaneous Nephrostomy Dilators." It's not a study report or a publication containing detailed information about acceptance criteria or specific performance studies in the way you've outlined for an AI-powered diagnostic device.

The FDA 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific clinical acceptance criteria through extensive clinical trials for new technologies.

Therefore, the input provided does not contain the information requested for an AI-powered device's acceptance criteria and study that proves it meets them. This document is for a Class II medical device (Disposable Percutaneous Nephrostomy Dilators) that is a physical tool, not an AI software.

Here's why the requested information cannot be extracted from this document:

  • Acceptance Criteria & Reported Performance: The document does not define specific performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI diagnostic device. Instead, it lists non-clinical performance tests (e.g., Dimensional Testing, Resistance to Flattening, Biocompatibility tests, Sterility, Shelf-life) for a physical device, and concludes that it is "as safe and as effective" as the predicate device.
  • Sample Size (Test Set) and Data Provenance: Not applicable for this type of device and submission. There is no "test set" of patient data for an AI algorithm.
  • Number of Experts & Qualifications (Ground Truth): Not applicable. Ground truth for an AI diagnostic would involve expert consensus on medical images or pathology. For this physical dilator, "ground truth" refers to established engineering and biological safety standards.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: Not applicable. There is no human reader component to compare with AI for this physical device.
  • Standalone Performance: Not applicable. This is a physical device, not a software algorithm.
  • Type of Ground Truth: For the physical device, ground truth for its performance is based on established engineering standards (e.g., ISO for sterility, dimensional accuracy) and biological safety guidelines (e.g., ISO 10993 for biocompatibility).
  • Sample Size (Training Set): Not applicable. There is no concept of a "training set" for a physical medical device in this context.
  • Ground Truth for Training Set: Not applicable.

In summary, the provided FDA 510(k) clearance letter is for a physical medical device (dilator) and does not describe the kind of acceptance criteria or performance studies relevant to an AI-powered diagnostic device.

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