(51 days)
No
The summary describes a passive silicone implant and explicitly states that AI/ML is "Not Found".
No
The device is described as an implant material to aid in surgical repairs and space occupying augmentation, rather than directly treating a disease or condition. Its purpose is structural support/filling.
No
Explanation: The device is described as an implant material used for surgical repairs and augmentation, which is a therapeutic function, not a diagnostic one. It doesn't assess or detect medical conditions.
No
The device description clearly states it is a sterile implant produced from silicone elastomer, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the Silicone Blocks/Strips are for use as an implant material in surgical repairs and augmentation. This is a direct interaction with the patient's body during a surgical procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The description confirms it's a sterile implant made of silicone elastomer, designed to be placed inside the body.
The information provided strongly indicates this is a surgical implant, not a diagnostic device used on samples outside the body.
N/A
Intended Use / Indications for Use
The Silicone Blocks/Strips are intended for use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery.
Product codes
77 ENT
Device Description
Xomed Silicone Block/Strip are sterile, implants produced from silicone elastomer molded into a squares and/or rectangular shapes of various sizes and thicknesses and durometer as specified on each product label.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head & Neck
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Prede
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
MAY - 2 1991
Image /page/0/Picture/1 description: The image shows the logo for XOMED Surgical Products. The logo is in black and white and features the word "XOMED" in large, bold letters. Below the word "XOMED" is the phrase "SURGICAL PRODUCTS" in smaller letters. Below the phrase is a circular design with four arrows pointing outwards.
510(k) Summary
1.0 Date Prepared
March 6, 1997
- Submitter (Contact) 2.0 David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
Proprietary Name:
Silicone Block/Strip Common Name(s):
Classification Name: ENT synthetic polymer material
4.0 Device Classification
21 CFR 874.3620 Tier 3 Class II : Procode 77 ENT : Unclassified General and Restorative:
Xomed Silicone Block/Strip
5.0 Device Description
Xomed Silicone Block/Strip are sterile, implants produced from silicone elastomer molded into a squares and/or rectangular shapes of various sizes and thicknesses and durometer as specified on each product label.
6.0 Intended Use
The Silicone Blocks/Strips are intended for use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery.
7.0 Substantial Equivalence
Both silicone sheeting and silicone block were marketed by Xomed prior to May 16, 1976. A reinforced version of the Silicone Sheeting was introduced in 1995 via 510(k) [K953013]. The Silicone Block and Strip proposed in this submission are substantially equivalent to these predicate products in that they have the same intended use and are made from essentially the same base material. Additionally, the proposed devices are similar to predicate products from other manufacturers, i.e. Implantech Silicone Block (K913882), Dow Silicone Block and McGhan Silicone Block (510k unknown). Again, the intended use and base materials are essentially identical.