(47 days)
K941407/S1
K941407/S1
No
The description focuses on material composition and physical characteristics of ear ventilation tubes, with no mention of AI or ML.
Yes
The device is intended to provide ventilation or drainage of the middle ear, which is a therapeutic intervention for medical conditions affecting the ear.
No
This device is described as a ventilation tube for temporary communication of the outer and middle ear to provide ventilation or drainage. Its purpose is therapeutic (ventilation/drainage), not to diagnose a condition.
No
The device description explicitly states it is a "fluoroplastic ACTIVENT tube" and describes its manufacturing process and physical characteristics, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary communication of the outer and middle ear for ventilation or drainage. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a ventilation tube inserted into the ear. This is a physical device used for treatment, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
77 ETD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
outer and middle ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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.
Key Metrics
Not Found
Predicate Device(s)
K941407/S1
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
2222
510(k) Summary Antimicrobial Ventilation (Tympanostomy) Tube
Image /page/0/Picture/2 description: The image shows a handwritten number, K 961873, underlined and circled. The number is written in a simple, clear font, and the circle around it is slightly irregular. The background is plain white, which makes the number stand out. The image appears to be a close-up of the number.
- 1.0 Date Prepared
UL.
2.0 Submitter (Contact)
May 14, 1996
David Timlin Xomed Surgical Products 6743 Southpoint Drive N. Jacksonville, FL 32216-0980 (904) 279-7532
3.0 Device Name
Proprietary Name: Common Name: Classification Name:
ACTIVENT Antimicrobial Ventilation Tubes Tympanostomv (Ventilation) Tube Tube, Tympanostomy
న్నార 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 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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