ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · ETD · Jul 1, 1996 · Ear, Nose, Throat
Device Facts
| Record ID | K961873 |
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| Device Name | ACTIVENT ANTIMICROBIAL VENTILATION TUBES |
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| Applicant | Xomed, Inc. |
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| Product Code | ETD · Ear, Nose, Throat |
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| Decision Date | Jul 1, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 874.3880 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended Use
for prescription use only, as a means of temporary communication of the outer and middle ear to provide ventilation or drainage of the middle ear when inserted through an incision in the tympanic membrane.
Device Story
Fluoroplastic tympanostomy tube; contains silver compound additive for bacteriocidal/bacteriostatic properties. Inserted through tympanic membrane incision by otolaryngologist; provides middle ear ventilation/drainage. Device design/sizes mirror existing non-antimicrobial ventilation tubes. Intended for prescription use.
Clinical Evidence
Bench testing only. Evaluations included biocompatibility, silver ion leach testing, and in vitro antimicrobial activity comparisons between fluoroplastic and silicone base materials. No clinical or in vivo testing performed.
Technological Characteristics
Fluoroplastic resin blended with silver compound and colorant. Available in various grommet and shank styles. Bacteriocidal/bacteriostatic properties via silver ion release. Class II device (21CFR 874.3880).
Indications for Use
Indicated for patients requiring temporary ventilation or drainage of the middle ear via tympanostomy tube insertion.
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
- silicone ACTIVENT tubes (K941407/S1)
Related Devices
- K062385 — BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES · Grace Medical, Inc. · Sep 27, 2006
- K992222 — FLUOROPLASTIC VENTILATION TUBES · Gyrus Ent LLC · Aug 26, 1999
- K062672 — GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES · Grace Medical, Inc. · Oct 24, 2006
- K233658 — Biowy Tym Tube (TT) · Biowy Corporation · Feb 16, 2024
- K061058 — NEOZOLINE VENTILATION TUBES · Adept Medical, Ltd. · Jul 12, 2006
Submission Summary (Full Text)
{0}
K 961873
# 510(k) Summary
Antimicrobial Ventilation (Tympanostomy) Tube
## 1.0 Date Prepared
May 14, 1996
JUL - 1 1996
## 2.0 Submitter (Contact)
David Timlin
Xomed Surgical Products
6743 Southpoint Drive N.
Jacksonville, FL 32216-0980
(904) 279-7532
## 3.0 Device Name
Proprietary Name: ACTIVENT Antimicrobial Ventilation Tubes
Common Name: Tympanostomy (Ventilation) Tube
Classification Name: Tube, Tympanostomy
## 5.0 Device Classification
This device was classified by the Ear, Nose and Throat Panel as follows:
Tube, Tympanostomy 77 ETD Class II 21CFR 874.3880
## 6.0 Device Description
Each fluoroplastic ACTIVENT tube will be manufactured from a fluoroplastic resin blended with a silver compound and a colorant. This proprietary process results in ventilation tubes that exhibit bacteriocidal/bacterostatic properties. As with the current silicone ACTIVENT tubes, the new fluoroplastic ACTIVENT will be offered in a wide variety of tube designs and sizes (grommets and shank styles) as currently manufactured and distributed in non-antimicrobial vent tubes.
## 7.0 Intended Use
The intended use of the fluoroplastic antimicrobial vent tube is identical to the currently marketed silicone ACTIVENT tubes: for prescription use only, as a means of temporary communication of the outer and middle ear to provide ventilation or drainage of the middle ear when inserted through an incision in the tympanic membrane.
## 8.0 Substantial Equivalence
The fluoroplastic ACTIVENT vent tubes are substantially equivalent to the currently marketed silicone ACTIVENT vent tubes. This statement is supported by the fact that both devices have the same intended use / indications for use and contain the same active ingredient. Evaluations of biocompatibility, silver ion leach testing and in vitro evaluations of antimicrobial activity were conducted to compare the characteristics of the silicone and fluoroplastic antimicrobial vent tubes. This testing demonstrates that the fluoroplastic tubes display biocompatibility and performance characteristics equivalent to the silicone tubes. Clinical studies or other in vivo testing are considered unnecessary, as the clinical safety and effectiveness of silver as an antimicrobial additive has already been demonstrated with the silicone base material as reported in K941407/S1. The equivalent performance and biocompatibility of the fluoroplastic and silicone base materials with silver additive, do not raise any new issues of safety or effectiveness that would require clinical evaluation to resolve.
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