SILVERSTEIN MICROWICK

K991670 · Micromedics, Inc. · ETD · Aug 26, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K991670
• Device Name: SILVERSTEIN MICROWICK
• Applicant: Micromedics, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Aug 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Silverstein MicroWick is a device for delivering fluids to the middle ear. Used by licensed physicians in clinical settings. Device facilitates therapeutic fluid administration to treat ear disorders. Benefits include targeted delivery of medication to the middle ear space.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluid delivery wick for middle ear application. Device is non-electronic and mechanical in nature.

Indications for Use

Indicated for patients with ear disorders requiring delivery of fluids to the middle ear. Intended for use by or on the order of a licensed physician.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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.

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)

OR

Over-The Counter Use __