(48 days)
The Invotec Ear Tampon ( wick ) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.
Invotec Ear Tampon (Wick) w/String
The provided documentation pertains to a 510(k) premarket notification for an Invotec Ear Tampon (Wick) w/String and does not contain information about acceptance criteria, device performance metrics, or study details typically associated with demonstrating performance against such criteria for a novel device, especially one involving AI or complex analytical methods.
The document is a letter from the FDA to Invotec International, Inc., confirming that their Ear Tampon (Wick) w/String is substantially equivalent to a legally marketed predicate device. This determination is based on the device's indications for use: "as an ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing."
Since this is a 510(k) clearance for a relatively simple medical device (an ear tampon/wick) where substantial equivalence to a predicate device is the basis for market clearance, a detailed study proving performance against specific acceptance criteria, as one would find for an AI-powered diagnostic device, is not presented or required in this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as existing, similar devices.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not part of the provided FDA 510(k) clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jeffrey L. All President Invotec International, Inc. 11243 St. Johns Industrial Parkway South Jacksonville, Florida U.S.A. 32246
Re: K973578
Invotec Ear Tampon (Wick) w/String Dated: September 17, 1997 Received: September 19, 1997 Regulatory class: Unclassified Procode: 77 MMJ
NOV - 6 1997
Dear Mr. All:
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, 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 (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 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 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.
hĩ 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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Statement Of Indications For Use
The Invotec Ear Tampon ( wick ) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.
Daniel C. Symm
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _ 44
Prescription Use
(Per 21 CFR 801.109)
§ 874.5220 Ear, nose, and throat drug administration device.
(a)
Identification. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.