HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER

K963727 · Medtronic Xomed · ETD · Feb 11, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K963727
• Device Name: HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
• Applicant: Medtronic Xomed
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xomed Hoffman H/A Coated Long-Term Ventilation Tube with Liner is intended for prescription use only, as a means of communication of the outer and middle ear to provide long-term ventilation or drainage of the middle ear when inserted under the tympanic membrane.

Device Story

Tympanostomy tube for long-term middle ear ventilation/drainage; surgically placed under tympanic membrane by otolaryngologist. Device consists of outer titanium tube with polished inner lumen and partial exterior Hydroxylapatite (H/A) coating for bony ear canal contact; removable fluoroplastic inner liner allows for clearing of occlusions. Liner design prevents internal migration into middle ear. Surgeon removes/replaces liner as needed. Benefits include sustained middle ear aeration and reduced need for repeat surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Materials: Titanium (outer tube), Hydroxylapatite (coating), fluoroplastic (liner). Design: Two-component system with removable inner liner. Function: Passive ventilation/drainage. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring long-term ventilation or drainage of the middle ear via insertion under the tympanic membrane.

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

• Xomed Silverstein Permanent Aeration Tube (SPAT) (Preamendment)
• Jahn Hydroxylvent™ Tube w/ fluoroplastic liner (K900267)
• Fluoroplastic/Titanium Ventilation Tubes (Unknown)

Submission Summary (Full Text)

{0}

XOMED
K963727
FEB 11 1997

# 510(k) Summary
## Hoffman Long-Term H/A Coated Ventilation Tube (with Liner)

1.0 Date Prepared

September 5, 1996

2.0 Submitter (Contact)

David Timlin
Xomed Surgical Products
Jacksonville, FL
[phone]

3.0 Device Name

Proprietary Name: Hoffman H/A Coated Long-Term Ventilation Tube with Liner
Common Name: Long Term Vent Tube
Classification Name: Tympanostomy Tube

5.0 Device Classification

Typanostomy Tube Procode 77 ETD Class II; 21CFR 874.3880 Tier 2

6.0 Device Description

The Xomed Hoffman H/A Coated Long-Term Ventilation Tube is comprised of two components, using three biocompatible materials. One component of the device is an outer titanium tube with a polished inner lumen. A Hydroxylapatite (H/A) coating covers a portion of the exterior surface of the outer tube where it is positioned against the bony wall of the ear canal when surgically placed. The second component is a removable inner tube made of fluoroplastic. This liner can be removed and replaced by the surgeon should occulsion of the liner lumen occur. The liner design precludes the internal migration of the polymer liner into the middle ear space.

6743 Southpoint Dr. N., Jacksonville, Florida 32216-0980 • 904-296-9600 Customer Service 1-800-874-5797

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## 7.0 Intended Use

The Xomed Hoffman H/A Coated Long-Term Ventilation Tube with Liner is intended for prescription use only, as a means of communication of the outer and middle ear to provide long-term ventilation or drainage of the middle ear when inserted under the tympanic membrane.

## 8.0 Substantial Equivalence

The Hoffman H/A Coated Long-Term Ventilation Tube with Liner is substantially equivalent to other currently marketed long-term ventilation tubes in that it has the same intended use, the same materials and/or equivalent design characteristics as shown in the predicate device labeling. The substantially equivalent ventilation tubes are as follows:

| Xomed Silverstein Permanent Aeration Tube (SPAT)
[Xomed Surgical Products, Inc] | (Preamendment) |
| --- | --- |
| Jahn Hydroxylvent™ Tube w/ fluoroplastic liner
[Smith & Nephew/Richards] | (K900267) |
| Fluoroplastic/Titanium Ventilation Tubes
[Smith & Nephew/Richards] | (Unknown) |