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K Number
K181735
Device Name
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
Manufacturer
Cook Incorporated
Date Cleared
2019-03-27

(268 days)

Product Code
LJE
Regulation Number
N/A
Type
Traditional
Panel
GU
Reference & Predicate Devices
K140085,K854909
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Percutaneous Neonatal Pigtail Nephrostomy Set: This device is intended for percutaneous placement of a pigtail catheter in the renal pelvis for nephrostomy drainage in neonatal patients.
Pediatric Nephrostomy Stent Set: This device is used as a nephrostomy drainage catheter and ureteral stent in pediatric patients 2 years and older.

Device Description

The Percutaneous Neonatal Pigtail Nephrostomy Set comprises a 6.0 French (Fr) pigtail drainage catheter, a 22-gauge trocar needle, an 18-gauge trocar needle, a 5.0-Fr dilator, a 6.0-Fr dilator, a 7.0-Fr dilator, a retention disc and pull tie, a 10-Fr connecting tube, and a 0.038-inch (in) diameter, 30-centimeter (cm) wire guide.
The Pediatric Nephrostomy Stent Set comprises an 8.2-Fr pigtail drainage catheter with 4.7-Fr stent tubing, a retention disc and pull tie, and 10-Fr connecting tube.

AI/ML Overview

This document is a 510(k) Pre-market Notification for medical devices, specifically the "Percutaneous Neonatal Pigtail Nephrostomy Set" and "Pediatric Nephrostomy Stent Set." It asserts substantial equivalence to predicate devices and describes various performance tests. However, it does not contain any information about a study proving the device meets specific acceptance criteria related to an AI/ML algorithm or software.

Therefore, I cannot provide the requested information. The document pertains to traditional medical devices (catheters and stents), not an AI-powered one.

Specifically, the following requested information cannot be extracted from the provided text:

  1. A table of acceptance criteria and the reported device performance: While performance tests are listed (Sterilization, Packaging, Biocompatibility, etc.), no specific acceptance criteria values or results from these tests are provided. More importantly, these are device manufacturing/material performance criteria, not related to an AI/ML algorithm's clinical performance.
  2. Sample size used for the test set and the data provenance: Not applicable as there is no AI/ML algorithm being evaluated.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. 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: Not applicable.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

N/A