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K Number
K013696
Device Name
SILMED NASAL SEPTAL BUTTON
Manufacturer
SILMED, INC.
Date Cleared
2001-11-28

(21 days)

Product Code
LFB
Regulation Number
N/A
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Silmed Nasal Septal Button is indicated for use for non-surgical closure of nasal septum perforations.

Device Description

Silmed, Inc. Nasal Septal Button is indicated for use for non-surgical closure of nasal perforations. The Silmed Nasal Septal Button is designed in three sizes: small, medium and large. The Silmed Nasal Septal Button features two circular flanges centrally comected by a post. The circular flanges come in varying diaments depending on the size of the button. The central post is elliptical in shape and can also be explained as an elongated circular section. The post dimensions vary with size and with the circular flange diameter based on the size of the nasal perforation and can be trimmed at the time of placement.

AI/ML Overview

The provided text is a 510(k) pre-market notification for a medical device called the "Silmed Nasal Septal Button." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing de novo studies with specific acceptance criteria and detailed performance results for the novel device.

Therefore, the document does not contain the information requested regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set or its provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication method for the test set.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
  • Whether standalone performance (algorithm only) was done.
  • The type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

The document primarily focuses on establishing "substantial equivalence" of the Silmed Nasal Septal Button to existing predicate devices (Nasal Septal Buttons from Boston Medical Products, Micromedics Inc., and Hood Laboratories Inc.) based on:

  • Design concept
  • Indications for use: "non-surgical closure of nasal septum perforations."
  • Use of standard materials
  • Feature comparisons
  • Method of manufacture, cleaning, and device packaging

The FDA's decision to clear the device is based on this demonstration of substantial equivalence, not on independent performance testing against specific acceptance criteria for the new device outlined in the request.

N/A