(72 days)
Not Found
Not Found
No
The summary describes a physical medical device (tympanostomy tube) and its intended use, with no mention of software, image processing, AI, or ML.
Yes.
The device, a Tympanostomy Tube, is used to treat medical conditions such as chronic otitis media with effusion, recurrent acute otitis media, persistent high negative middle ear pressure, and atelectasis. These are therapeutic indications as they are intended to alleviate or cure a disease or medical condition.
No
Explanation: The device described is a Tympanostomy Tube, which is an implantable medical device used for treatment (insertion into the tympanic membrane) rather than for diagnosing a condition. Its indications for use describe conditions for which it would be implanted, not conditions it would identify or measure.
No
The device description explicitly states "Tympanostomy Tube," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that this is a tympanostomy tube, which is a device inserted into the tympanic membrane (eardrum) to drain fluid from the middle ear. This is a surgical procedure performed directly on the patient's body, not an examination of a specimen taken from the body.
- The description focuses on a physical device and its surgical application. There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant or device, not an IVD.
N/A
Intended Use / Indications for Use
Indications for insertion of a tympanostomy tube into an incision in the tympanic membrane include any of the following:
- . Chronic otitis media with effusion characterized as either serous, mucoid, or purulent
- . Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
- . A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistant or recurrent otalgia, persistent or recurrent vertigo and/or tinnitus
- . Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction
Product codes
77 ETD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane, middle ear
Indicated Patient Age Range
Not Found
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 1998
Anthony D. Prescott Grace Medical, Inc. 31 Highway 70 Suite 107 Bartlett, TN 38133
Re:
K981575 Tympanostomy Tube (see enclosure) Dated: April 30, 1998 Received: May 4, 1998 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD
Dear Mr. Prescott:
We have reviewed your Section 510%) 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 Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 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 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 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 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/dsmam.n.html".
Sincerely yours,
Kilian Yin
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
ENCLOSURE
:
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neammaalstop post the productions of
| Grace
Catalog # | Description | 510(k)
page | Inner
Diameter |
|--------------------|-------------------------------------|----------------|-------------------|
| 1 | Goode T-Tube | 21 | 1.14 |
| 2 | Goode T-Tube | 21 | 1.32 |
| 3 | Butterfly Vent Tube | 23 | 1.27 |
| 4 | Goode T-Grommet Vent Tube | 25 | 1.25 |
| 5 | Cohen T-Grommet Vent Tube | 26 | 1.25 |
| 6 | Baxter T-Grommet Vent Tube | 27 | 1.25 |
| 7 | Paparella Type Vent Tube | 29 | 1.02 |
| 8 | Paparella Type Vent Tube | 29 | 1.27 |
| 9 | Paparella Type Vent Tube | 29 | 2.03 |
| 10 | Per-Lee Vent Tube | 30 | 1.57 |
| 11 | Donaldson Vent Tube | 32 | 1.14 |
| 12 | Armstrong Beveled Grommet Vent Tube | 34 | 1.14 |
| 13 | Armstrong Beveled Vent Tube | 35 | 1.14 |
| 14 | Parasol/Umbrella Vent Tube | 37 | 1.02 |
| 15 | Parasol/Umbrella Vent Tube | 37 | 1.52 |
| 16 | Parasol/Umbrella Vent Tube | 37 | 2.03 |
| 17 | Shepard Grommet Vent Tube | 38 | 1.14 |
| 18 | Baxter Beveled Vent Tube | 40 | 1.27 |
| 19 | Baxter Beveled Vent Tube | 40 | 0.97 |
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2
510(k) Number (if known):
Device Name: Tympanostomy Tube
Indications For Use:
Indications for insertion of a tympanostomy tube into an incision in the tympanic membrane include any of the following:
Kax 1575
- . Chronic otitis media with effusion characterized as either serous, mucoid, or purulent
- . Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
- . A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistant or recurrent otalgia, persistent or recurrent vertigo and/or tinnitus
- . Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR
Over-The-Counter Use
David H. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .