K Number

Device Name

Manufacturer

COOK UROLOGICAL, INC.

Date Cleared

1996-07-18

(62 days)

Product Code

LJE

Regulation Number

N/A

Type

Traditional

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures.

Device Description

The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures. The materials used in this device are slicone, polyvinylchloride and polypropylene. Biocompatibility testing has been performed on the silicone. Results show the nuterial to meet the requirements of these tests. The polyvinylchloride and polypropylene do not come into contact with body tissue.

AI/ML Overview

This 510(k) Premarket Notification for the Circle Nephrostomy Catheter Set does not contain any information about acceptance criteria or a study proving device performance using the metrics you've outlined.

The document is a summary for regulatory submission, focusing on substantial equivalence to existing predicate devices. It primarily addresses:

Device Identification: Trade name, classification name.
Predicate Devices: Identifying similar devices already on the market.
Device Description: Intended use, materials, basic design.
Substantial Equivalence Argument: How the new device is similar to predicates regarding indications for use, materials, physical construction, manufacturing controls, packaging, and sterilization.

The entire submission is built on the premise that because the new device is "substantially equivalent" to already approved devices, it can be marketed without requiring new clinical performance studies or specific acceptance criteria for metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot populate the table or answer your specific questions related to acceptance criteria, sample sizes, ground truth, expert opinions, or MRMC studies because this information is not present in the provided text. The device's approval hinges on its similarity to older, already-approved devices, not on proving new performance metrics.

Summary

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510(k) Premarket Notification Circle Nephrostomy Catheter Set Cook Urological, Incorporated

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS J.

Submitted By:

Rick Lykins Cook Urological, Incorporated 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 May 16, 1996

K961933

JUL 18 1995

Device:

Trade Name:

Circle Nephrostomy Catheter Set

Proposed Classification Name: Catheter, Nephrostomy, General & Plastic Surgery 79 GBO

Predicate Devices:

The Circle Nephrostomy Cathere Set is substantially equivalent to predicate circle nephrostomy catheter sets in terms of indications for use, design, construction and materials equivalence. Predicate devices include:

. Silastic® U-Tube Nephrostomy Kit manufactured by Dow Corning Corporation.
. Circle Nephrostomy Tube manufactured by Mentor Urology

Device Description:

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Urological, Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed by Cook Urological, Incorporated. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

Regulation Number and Section

N/A