K Number
K160077
Date Cleared
2016-07-12

(180 days)

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

Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. This set and suggested procedure are particularly well-suited for gaining percutaneous access to an unobstructed, non-dilated collecting system when pursuing a planned course of endourological intervention. Fluoroscopic control is necessary throughout this procedure. Intended for one-time use.

Device Description

The RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. The RetroPerc™ Wire Puncture Set consists of a puncture wire, tip protector sheath with mounted pin-vise actuator, radiopaque exchange catheter, and fascial dilators. A stainless steel puncture wire is advanced within a protective sheath via the working channel of a flexible ureteroscope positioned in the targeted calyx, at which time the puncture wire is advanced through the kidney, perirenal tissue and fascia, until it emerges at the patient's flank skin. An exchange catheter (coaxial catheter in CX set or single lumen catheter in the LX set) is then positioned over the puncture wire at the flank, after which the puncture wire is removed. A standard 0.038 inch wire guide is then advanced through the exchange catheter until it advances out of the urethra. The exchange catheter is then removed, and finally the tract is dilated with fascial dilators, as clinically indicated. The RetroPerc Wire Puncture Set will be available in two configurations: CX and LX. Each set will perform well for the same patient populations and kidney stones, has the same indications, etc. The choice of set will be driven by physician preference: the CX set if the surgeon wishes to use a coaxial exchange catheter, and the LX set if the surgeon wishes to use non-coaxial exchange catheter.

AI/ML Overview

The provided text describes a 510(k) submission for the "RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set," asserting its substantial equivalence to a predicate device, the "Lawson Retrograde Nephrostomy Wire Puncture Set, Cook Medical, K833762."

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The submission claims substantial equivalence based on similarities to the predicate device rather than specific quantitative acceptance criteria being met. The performance data section describes bench testing but does not provide specific numerical outcomes or acceptance criteria.

Acceptance Criteria (Explicitly Stated)Reported Device Performance
N/A (Substantial Equivalence Claim)See below for details on how this was assessed through bench testing and comparisons to the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The text describes bench testing, meaning tests performed in a laboratory setting, not clinical studies involving human or animal subjects that would typically have a "test set" in the context of clinical data. Therefore, details like sample size for a test set and data provenance (country, retrospective/prospective) are not applicable in the usual sense for this submission. The "test set" for the mechanical and dimensional attributes would be the manufactured devices themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided as the submission focuses on substantial equivalence based on material and design similarities, and bench testing, rather than a clinical study requiring expert ground truth assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided and is not applicable given the nature of the bench testing described.

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

This is not applicable. The device is a physical medical instrument (wire puncture set), not an AI diagnostic or assistance tool. Therefore, an MRMC study or AI assistance effectiveness is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench testing, the "ground truth" would be established engineering specifications, material properties, and expected mechanical responses. For biocompatibility, it's compliance with ISO 10993 - Part 1. For sterilization, it's compliance with ISO 11135-1 and validation of shelf life. These are based on established standards and scientific methods rather than expert consensus on clinical findings or pathology.

8. The sample size for the training set

This is not applicable as the submission does not involve a "training set" in the context of machine learning or AI development.

9. How the ground truth for the training set was established

This is not applicable as there is no training set.


Summary of Acceptance Criteria and Proving Device Meets Criteria from the Text:

The RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set seeks clearance through the 510(k) pathway by demonstrating substantial equivalence to a predicate device (Lawson Retrograde Nephrostomy Wire Puncture Set).

Acceptance Criteria (Implied by Substantial Equivalence Claim):

  • Same Intended Use: The device must have the same intended use as the predicate.
  • Same Indications for Use: The device must have same indications for use as the predicate.
  • Comparable Technological Characteristics: The device must have comparable technological characteristics to the predicate device, or any differences must not raise new questions of safety or effectiveness.
  • Safety and Effectiveness: The device must be safe and effective for its intended use. This is primarily demonstrated through bench testing and, as implied, by not raising new safety or effectiveness concerns compared to a legally marketed predicate.
  • Biocompatibility: Compliant with ISO 10993 - Part 1 for a short duration indwelling device (

N/A