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The Device is intended for placement of the Foley catheter in the bladder for drainage when there is difficulty in negotiating the urethra

The Rusch Inc. Simplastic Councill Tip Catheter may be supplied as a stand alone device or may be accompanied with accessories including a filiform and follower. The Simplastic Councill Tip Catheter consists of a 2-way PVC Foley catheter with a 5 ml balloon and an open tip to fit over a guide. The catheter can be supplied with a lubricious coating to facilitate insertion. The guide will be a flexible PVC shaft with standard threaded male Philips connector for attachment of a detachable filiform. The filiform also consists of a PVC shaft with a standard threaded female Philips connector. The catheter and accessories are supplied sterile. Sterility is by Ethylene Oxide Sterilization.

This document does not contain the information needed to answer your request. It is a 510(k) summary for a medical device (a catheter) and primarily focuses on establishing substantial equivalence to a predicate device. It defines the device, its intended use, and confirms FDA clearance.

Specifically, the document does not include:

• Acceptance criteria for device performance.
• Results from any studies proving the device meets acceptance criteria.
• Information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or details about training sets.

The information provided in this document is purely regulatory clearance related, not performance study related.

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