← Product Code [ETD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD) · K961873 # ACTIVENT ANTIMICROBIAL VENTILATION TUBES (K961873) _Xomed, Inc. · ETD · Jul 1, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD/K961873 ## Device Facts - **Applicant:** Xomed, Inc. - **Product Code:** [ETD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD.md) - **Decision Date:** Jul 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3880 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Indications for 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). ## Regulatory 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](/device/K941407.md)/S1) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. 45 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD/K961873](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETD/K961873) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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