SUPER SILIPLUGS EAR PLUGS

K972923 · Interview Medical Technology Corp. · EWD · Oct 27, 1997 · EN

Device Facts

• Record ID: K972923
• Device Name: SUPER SILIPLUGS EAR PLUGS
• Applicant: Interview Medical Technology Corp.
• Product Code: EWD · EN
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

Super SiliPlugs™ Ear Plugs are used to block water from entering the ear canal.

Device Story

Super SiliPlugs™ Ear Plugs are designed to block water from entering the ear canal. The device is intended for over-the-counter use by individuals seeking to prevent water exposure to the ear canal during activities such as swimming or bathing. The plugs are inserted manually into the ear canal by the user to create a physical barrier against water. The device provides a simple, non-invasive method for ear protection, potentially reducing the risk of water-related ear discomfort or infections.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone-based ear plugs designed for insertion into the ear canal to provide a water-tight seal. Mechanical barrier device; no energy source or software components.

Indications for Use

Indicated for individuals requiring protection of the ear canal from water ingress.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1997

Louis R. Matson President & C.E.O. InterView Medical Technology Corporation 3941 Park Drive, Suite 20-325 El Dorado Hills, CA 95762

Re: K972923 Super SiliPlugs™ Ear Plugs Dated: August 5, 1997 Received: August 8, 1997 Regulatory class: Unclassified Procode: 77 EWD

Dear Mr. Matson:

We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 amouncements 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 Radiation Control provisions, or other Federal laws or regulations.

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 question 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,

N'Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ky7-2422 510(k) Number (if known):_

Device Name: Super SiliPlugs™ Ear Plugs

Indications For Use:

manoutions For Co. Co.
Super SiliPlugs™ Ear Plugs are used to block water from entering the ear canal.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thind h. bejorn
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)