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K Number
K991670
Device Name
SILVERSTEIN MICROWICK
Manufacturer
MICROMEDICS, INC.
Date Cleared
1999-08-26

(101 days)

Product Code
ETD
Regulation Number
874.3880
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Silverstein MicroWick is intended for use by or on the order of a licensed physician The Shverstelli Microwter is meanseans for the delivery of fluids to the middle ear for patients with ear disorders.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter from the FDA for the Silverstein MicroWick device. It does not contain the detailed information about acceptance criteria or specific study results that you are requesting.

The document states that the FDA has reviewed the 510(k) notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that no new clinical studies were required to prove safety and effectiveness for this specific device. Instead, the manufacturer demonstrated that their device is as safe and effective as a device that was already approved and on the market.

Therefore, for this particular document, I cannot provide the following:

  1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria or tests.
  2. Sample size used for the test set and the data provenance: No new test set data is presented.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set was conducted.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned or referenced.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

What the document does provide:

  • Device Name: Silverstein MicroWick
  • Intended Use: "The Silverstein MicroWick is intended for use by or on the order of a licensed physician. The Silverstein MicroWick is intended for the delivery of fluids to the middle ear for patients with ear disorders."
  • Regulatory Class: II
  • Product Code: 77 ETD
  • 510(k) Number: K991670

To find the information you're looking for, you would generally need to refer to the original 510(k) submission document (if publicly available and containing such details) or, more commonly, a clinical study report for a device that underwent primary clinical evaluation rather than substantial equivalence.

§ 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.