SILVERSTEIN MICROWICK by MICROMEDICS, INC.

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:

A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria or tests.
Sample size used for the test set and the data provenance: No new test set data is presented.
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.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned or referenced.
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.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
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.

Summary

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AUG 2 6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles Grote Manager of Quality Assurance and Regulatory Affairs Micromedics, Inc. 1285 Corporate Center Drive, Suite 150 Eagan, MN 55121

Re: K991670 Trade Name: Silverstein MicroWick™ Regulatory Class: II Product Code: 77 ETD Dated: May 14, 1999 Received: May 17, 1999

Dear Mr. Grote:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Charles Grote

· This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER: Not known at this time Kag167D

DEVICE NAME: Silverstein MicroWick

STATEMENT OF INDICATIONS FOR USE

CONTINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE -Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off)
Division of Ophthalmic Devices

510(k) Number K991670

2 Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use __

Regulation Number and Section

§ 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.