(148 days)
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.
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.
This 510(k) premarket notification for the "Hoffman H/A Coated Long-Term Ventilation Tube with Liner" does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document is a summary describing the device, its intended use, and its substantial equivalence to other marketed devices. It focuses on regulatory aspects for market clearance rather than performance evaluation against specific metrics.
Therefore, none of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, adjudication, or ground truth can be extracted from the provided text.
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K96 3727
Image /page/0/Picture/1 description: The image shows the logo for XOMED Surgical Products. The logo is in black and white and features the word "XOMED" in large, bold letters. Below the word "XOMED" is the phrase "SURGICAL PRODUCTS" in smaller letters. Below the phrase is a circular symbol with a cross inside.
FEB 11 1997
510(k) Summary Hoffman Long-Term H/A Coated Ventilation Tube (with Liner)
Date Prepared 1.0
September 5, 1996
2.0 Submitter (Contact)
David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
Hoffman H/A Coated Long-Term Ventilation Tube with Liner Proprietary Name:
Long Term Vent Tube Common Name:
Classification Name: Tympanostomy Tube
Device Classification 5.0
Class II: 21CFR 874.3880 Tier 2 Typanostomy Tube Procode 77 ETD
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.
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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) |
§ 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.