The TM Micro-Catheter w/ Flange is intended for use as a temporary (less than 29 days) indwelling catheter for delivery of fluids in the treatment of patients with ear disorders. The TM Micro-Catheter w/o Flange is indicated for the immediate (up to 4 hours) delivery of fluids into the middle ear in treating ear disorders.

Device Description

The TM Micro-Catheters are formed of silicone elastomer tubing. Connected to the tubing at the proximal end is an injection port. The TM Micro-Catheter w/ Flange (In-dwelling style) has a small distal flange end for retention in the eardrum. The TM Micro-Catheter w/o Flange has a distal end with a bevel.

AI/ML Overview

This document describes a medical device, the "TM Micro-Catheter," and its intended use, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to a performance study or AI/ML model.

This 510(k) summary is for a traditional medical device, not a software or AI/ML-driven device. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use. Therefore, the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this document.

The document primarily discusses:

Device Name: TM Micro-Catheter
Device Description: Formed of silicone elastomer tubing with an injection port. Two styles: with flange (for retention) and without flange (with a bevel).
Intended Use:
- With Flange: Temporary (less than 29 days) indwelling catheter for fluid delivery in ear disorder treatment.
- Without Flange: Immediate (up to 4 hours) fluid delivery into the middle ear for ear disorder treatment.
Substantial Equivalence: Claims equivalence to the Microtek Irrigation system (K844061) for intended use, and to tympanostomy tubes and butterfly catheters (K820453 or K810461) for technological characteristics, stating no new safety or effectiveness issues are raised.

To answer your prompt with the provided input, I would have to state that the information you're asking for is not present in the given text.

Summary

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Revised April 28, 1997

1 6 1997

510(k) Summary

971124

Date Prepared 1.0 March 24, 1997

2.0 Submitter (Contact)

David Timlin, Manager of Regulatory Affairs Xomed Surgical Products Jacksonville, FL (904) 279-7532 FAX 904-281-1057

Device Name 3.0

TM Micro-Catheter Proprietary Name: Common Name: Catheter Percutaneous Catheter Classification Name:

Device Classification 5.0

Xomed believes TM Micro-Catheters to be unclassified and review by the ENT Devices branch is suitable for the intended use. The TM Micro-Catheter is similar to a Tympanostomy Tube; 21CFR 874.3880 which is intended to be implanted into the tympanic membrane.

Device Description 6.0

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7.0 Intended Use

8.0 Substantial Equivalence

The TM Micro-Catheter with Flange and TM Micro-Catheter without Flange described in this notification have the same intended use as the predicate Microtek Irrigation system (K844061) for delivery of fluids into the middle ear . TM Micro-Catheters have the technological characteristics of the predicate tympanostomy tubes and butterfly catheters (K820453 or K810461) and so do not raise any new issues of safety or effectiveness.

Regulation Number and Section

§ 874.3880 Tympanostomy tube.

(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.