KARTUSH TM PATCHER
K964484 · Xomed, Inc. · KHJ · Jan 24, 1997 · Ear, Nose, Throat
Device Facts
| Record ID | K964484 |
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| Device Name | KARTUSH TM PATCHER |
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| Applicant | Xomed, Inc. |
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| Product Code | KHJ · Ear, Nose, Throat |
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| Decision Date | Jan 24, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 874.3620 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended Use
Kartush TM Patcher is intended for use as a patch to aid coverage of a tympanic membrane perforation in a dry ear.
Device Story
Kartush TM Patcher; silicone elastomer implant; double-flange collar-button design; no lumen/through-hole. Used by ENT surgeons to cover tympanic membrane (TM) perforations. Device placed in dry ear; flanges conform to TM surface to secure patch over perforation; central shaft provides stability to prevent displacement. Trimmed to size by surgeon. Silicone material biocompatible; similar to existing tympanostomy tubes and nasal septal buttons. Benefits: provides secure coverage of perforation; restores middle ear protection; less invasive than surgical repair. Potential risks: infection, premature extrusion, perforation widening, or granulomatosis reaction.
Clinical Evidence
No clinical data provided. Substantial equivalence based on design, material, and intended use comparison to existing ENT silicone implants.
Technological Characteristics
Silicone elastomer; double-flange collar-button configuration; non-porous (no lumen); soft/pliable for folding and trimming; biocompatible material.
Indications for Use
Indicated for patients with tympanic membrane perforations in a dry ear requiring coverage to aid healing.
Regulatory Classification
Identification
Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.
Predicate Devices
- Tympanostomy tube (21CFR 874.3880)
- Nasal septal button (Procode 77 LFB)
- Silicone sheeting (21CFR 874.3620)
Related Devices
- K071150 — TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE · Heinz Kurz GmbH Medizintechnik · Dec 12, 2007
- K151067 — Ventilation (Tympanostomy) Tubes · Medtronic Xomed, Inc. · Jul 22, 2015
- K992222 — FLUOROPLASTIC VENTILATION TUBES · Gyrus Ent LLC · Aug 26, 1999
- K033796 — KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS · Heinz Kurz GmbH Medizintechnik · Jan 30, 2004
- K232702 — Solo+ Tympanostomy Tube Device (TTD) · Aventamed Dac · May 20, 2024
Submission Summary (Full Text)
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K964484
# 510(k) Summary
## 1.0 Date Prepared
November 6, 1996
JAN 24 1997
## 2.0 Submitter (Contact)
David Timlin
Xomed Surgical Products
Jacksonville, FL
(904) 279-7532
## 3.0 Device Name
Proprietary Name: **Kartush TM Patcher**
Common Name: Tympanic Membrane (TM) patch
Classification Name: Not Classified
## 5.0 Device Classification
The Kartush TM Patcher has not yet been classified. It is similar to a number of current ENT devices: a tympanostomy tube, in that both are intended to be implanted in the tympanic membrane; a nasal septal button, in that both are intended to cover a perforation in mucosal lined tissue; and silicone sheeting, as both are silicone implant material for ENT repairs and both are used for patching TM perforations.
| Tympanostomy Tube | Procode 77 ETD | Class II; 21CFR 874.3880 | Tier 2 |
| --- | --- | --- | --- |
| Nasal Septal Button | Procode 77 LFB | Class II; | Tier 1 |
| Silicone sheeting | Procode 77 KHJ | Class II; 21 CFR 874.3620 | Tier 2 |
## 6.0 Device Description
The Kartush TM Patcher is comprised of a double flange design, using silicone elastomer as the biocompatible material. The configuration is similar to a collar button style tympanostomy tube, with the exception that no through-hole or lumen is present. A variety of sizes or diameters of the TM Patcher will be available for approximating different size perforations. Alternately, the TM Patcher may be trimmed to size by the surgeon to fit the existing perforation. The flange thickness is the same as silicone sheeting currently used to treat TM perforations. The soft, pliable flange, which can conform to the surface of the TM, also easily folds for removal of the device as needed. As with nasal septal buttons, the silicone elastomer material is the same as used in the manufacture of Xomed tympanostomy tubes.
## 7.0 Intended Use
Kartush TM Patcher is intended for use as a patch to aid coverage of a tympanic membrane perforation in a dry ear.
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## 8.0 Substantial Equivalence
The Kartush TM Patcher described in this notification has the same intended use as the currently used silicone sheeting. But silicone sheets, although commonly used, are not designed specifically for TM patching. The TM Patcher, designed and intended specifically for TM patching, draws on the design benefits of the other predicate devices, the tympanostomy tube and the nasal septal button, that have proven to be safe as a TM implant and effective as a nasal perforation patch, respectively. The TM patch functions in the same regard as the silicone sheeting, but the central shaft and inner flange of the TM Patcher provide added security to help reduce displacement. A more secure patch helps to restore the protection of the middle ear effected by the tympanic membrane. Although it is expected that there could be adverse effects similar to the predicate devices, such as infection, premature extrusion, widening or persistent perforation, or granulomatosis reaction; the TM Patcher does not raise any new issues of safety or effectiveness and certainly involves less risk than that associated with a surgical repair.
