(78 days)
Not Found
No
The device description focuses on the physical design and material of a patch for tympanic membrane perforations, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "a patch to aid coverage of a tympanic membrane perforation," which directly addresses a medical condition (tympanic membrane perforation) and aids in its treatment or management.
No
The document describes the device as a patch to aid coverage of a tympanic membrane perforation, not as a tool to diagnose conditions.
No
The device description clearly states it is comprised of a physical material (silicone elastomer) and has a physical configuration (double flange design). It is a physical implantable device, not software.
Based on the provided information, the Kartush TM Patcher is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Kartush TM Patcher Function: The Kartush TM Patcher is a physical device intended to be implanted or placed within the body (specifically, on the tympanic membrane) to aid in the coverage of a perforation. It does not perform any tests on bodily samples.
The description clearly indicates it's a physical patch made of silicone elastomer, designed to mechanically cover a hole in the eardrum. This falls under the category of a surgical or implantable device, not an IVD.
N/A
Intended Use / Indications for Use
Kartush TM Patcher is intended for use as a patch to aid coverage of a tympanic membrane perforation in a dry ear.
Product codes
Not Classified
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
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.(b)
Classification. Class II.
0
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 Kartush TM Patcher Proprietary Name:
Tympanic Membrane (TM) patch Common Name:
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.
1
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.