(54 days)
Not Found
Not Found
No
The summary describes a physical medical device (myringotomy tube) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The text explicitly states the intended use is to "ventilate and/or drain the middle ear in the case of mild to chronic otitis media," which is a therapeutic action aimed at treating a medical condition and alleviating symptoms.
No
The document describes a myringotomy tube used for ventilation and drainage of the middle ear, which is a therapeutic procedure, not a diagnostic one.
No
The device description clearly states "Myringotomy Tube - Pediatric," which is a physical medical device (a tube inserted into the eardrum). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states the device is a "pediatric myringotomy tube" intended for "insertion into the eardrum for the purpose of ventilating and/or draining the middle ear." This is a surgical implant/device used within the body for a therapeutic purpose (ventilation and drainage), not for performing diagnostic tests on samples.
The information provided aligns with a surgical device used for treatment, not a diagnostic test performed in a lab setting.
N/A
Intended Use / Indications for Use
The MedNet LOCATOR, INC., pediatric 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 - Pediatric
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
Pediatric
Intended User / Care Setting
ear, nose and throat physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 1997
Judy S. Chandler MedNet Locator, Inc. 7000 Shadow Oaks Memphis. TN 38125 Re: K972126 Myringotomy Tube - Pediatric Dated: May 22, 1997 Received: June 5, 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 accordance 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.
If your device is classified (see above) into either 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 QS 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 vou 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 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,
W.Lilian Yu
Lilian 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
1
_of_1 Page
K972126 510(k) Number (if known):
Device Name: Myringotomy Tube - Pediatric
Indications For Use:
The MedNet LOCATOR, INC., pediatric 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K972126 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|---|---|
| --------------------------------------- | ------------------------------------- |
(Optional Format 1-2-96)