(38 days)
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Not Found
No
The summary describes a physical medical device (ventilation tube) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, a "Tympanostomy Ventilation Tube," is used to treat conditions like "Chronic otitis Media with effusion," "Recurrent acute ofitis Media," and "persistent high negative A record of with associated middle ear pressure," which are medical conditions, thus making it a therapeutic device.
No
Explanation: The device, a Tympanostomy Ventilation Tube, is described as a treatment for conditions like chronic otitis media with effusion and recurrent acute otitis media, implying a therapeutic rather than diagnostic function.
No
The device description clearly identifies the device as a "Tympanostomy Ventilation Tube-TVT 800," which is a physical medical device (a tube inserted into the ear). 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:
- Intended Use: The intended use describes a device used to treat conditions related to the ear (specifically, Eustachian tube dysfunction and otitis media) by being surgically inserted. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a "Tympanostomy Ventilation Tube," which is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a treatment.
N/A
Intended Use / Indications for Use
Ventilation tubes are indicated where cases of enstachian tube dysfunction fails to respond conventional therapy. This includes : · Chronic otitis Media with effusion (serous , mucoid, or pur ulent). Recurrent acute ofitis Media . persistent high negative A record of with associated middle ear pressure, hearing conductive Symptomatic otalgia, vertige and for timmitas brangia, version of the tympanic membraine.
Product codes
77 ETD
Device Description
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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
Ear
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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 consists of a stylized human figure with three lines representing the body, arms, and legs. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
MAY 2 9 1997
Robert E. Ellis Vice President, Operations Ikonos Corporation 320 Southwest Sixth Avenue Second Floor Portland, Oregon 97204-1749 Re: K971454
Tympanotomy Ventilation Tube-TVT 800 Dated: April 17, 1997 Received: April 21, 1997 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD
Dear Mr. Ellis:
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 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 probibitions against misbranion.
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51. through 542 of the Act for devices under the Electronic Product 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 production 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) 594-4591 for Radiology devices, or 594-4613 for Eac, Nose and Throat devices. 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 water 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,
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
1
K971454 510(k) Number (if known): Device Name: Tympanostomy Ventilation Tube - TVT 800 Indications For Use: Ventilation tubes are indicated where cases of enstachian tube dysfunction fails to respond conventional therapy. This includes : · Chronic otitis Media with effusion (serous , mucoid, or pur ulent). Recurrent acute ofitis Media . persistent high negative A record of with associated middle ear pressure, hearing conductive Symptomatic otalgia, vertige and for timmitas brangia, version of the tympanic membraine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gerrit A. Lykken
(Division Sign-Off)
Division of Reproductive, Abdominal, El and Radiological Devices V4710 0(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)