(57 days)
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Not Found
No
The summary describes a simple mechanical device (a myringotomy tube) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development or validation.
Yes.
The device is used to ventilate and/or drain the middle ear to treat otitis media, which directly addresses a medical condition to alleviate symptoms and discomfort.
No
Explanation: The device is a myringotomy tube, used for ventilating and/or draining the middle ear to treat otitis media, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states "Myringotomy Tube - Bobbin," which is a physical medical device intended for insertion into the eardrum. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Examples include blood tests, urine tests, and tissue biopsies.
- This device is a surgical implant. The myringotomy tube is inserted directly into the eardrum to provide ventilation and/or drainage. It is a physical device used for treatment and management of a condition, not for analyzing a biological sample to obtain diagnostic information.
The description clearly states its purpose is for insertion into the eardrum for ventilation and/or drainage, which are therapeutic and management actions, not diagnostic ones.
N/A
Intended Use / 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.
Product codes
77 ETD
Device Description
Myringotomy Tube - Bobbin
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eardrum, middle ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ear, nose and throat physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Not Found
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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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