(80 days)
Super SiliPlugs™ Ear Plugs are used to block water from entering the ear canal.
Super SiliPlugs™ Ear Plugs
I am sorry, but the provided text from the FDA 510(k) K972923 for "Super SiliPlugs™ Ear Plugs" does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.
The document is a clearance letter from the FDA, stating that the device is "substantially equivalent for the indications for use" to devices marketed prior to May 28, 1976. This indicates that the device's acceptable performance is based on its similarity to existing legally marketed devices, rather than a specific set of new performance metrics and a study to achieve them.
Therefore, I cannot provide the requested table or the detailed study information because it is not present in the given text. The clearance process for this type of device, particularly in 1997, often relied on substantial equivalence demonstration rather than extensive novel performance studies.
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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 (301) 594-4613. Additionally, for question 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,
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)
N/A