TM MICRO-CATHETERS

K971124 · Xomed, Inc. · ETD · May 16, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971124
• Device Name: TM MICRO-CATHETERS
• Applicant: Xomed, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: May 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Silicone elastomer catheters designed for middle ear fluid delivery. Two configurations: flanged (indwelling) and non-flanged (beveled). Used by clinicians in ENT settings to administer therapeutic fluids. Flanged version provides retention in eardrum for temporary treatment; non-flanged version facilitates immediate, short-term delivery. Device enables targeted medication administration to middle ear space, potentially improving treatment efficacy for ear disorders compared to systemic delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone elastomer tubing; proximal injection port; distal flange (indwelling) or bevel (immediate use).

Indications for Use

Indicated for patients with ear disorders requiring fluid delivery to the middle ear; w/ Flange version for temporary indwelling use (<29 days); w/o Flange version for immediate use (up to 4 hours).

Regulatory Classification

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.

Predicate Devices

• Microtek Irrigation system (K844061)
• Tympanostomy tubes (K820453)
• Butterfly catheters (K810461)

Submission Summary (Full Text)

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MAY 16 1997
Revised April 28,1997
510(k) Summary
K971124

1.0 Date Prepared
March 24, 1997

2.0 Submitter (Contact)
David Timlin, Manager of Regulatory Affairs
Xomed Surgical Products
Jacksonville, FL
[phone] FAX [phone]

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

5.0 Device Classification
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.

6.0 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.

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Revised April 28,1997

7.0 Intended Use
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.

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.

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