(57 days)
The MedNet LOCATOR, INC., bobbin myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
Myringotomy Tube - Bobbin
The provided documents are a 510(k) premarket notification letter from the FDA and the associated "Indications For Use" statement for a medical device. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.
The FDA letter (K971943) simply states that the "Myringotomy Tube - Bobbin" device is substantially equivalent to legally marketed predicate devices and can proceed to market. The "Indications For Use" defines the intended use of the device.
Therefore, I cannot provide a response to your request, as the necessary information is not present in the given text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K97194/3
Judy S. Chandler MedNet Locator, Inc. 7000 Shadow Oaks Memphis, TN 38125 Re: K971943
Myringotomy Tube - Bobbin Dated: July 5, 1997 Received: July 8, 1997 Regulatory Class: II 21 CFR 874.3880/Procode: 77 ETD
Dear Ms. Chandler:
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 scordance 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.
JUL 2 3 1997
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 (QS) 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 the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your ice in the Federal Register. Please note: this response to your premarket notification 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 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 vito 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,
h.T.Hiau Yui
Lillian Yiu, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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K971943 510(k) Number (if known):
Myringotomy Tube - Bobbin Device Name:_
Indications For Use:
The MedNet LOCATOR, INC., bobbin myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ehrich G. Seymon
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
Prescription Use_Y (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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§ 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.