(46 days)
Not Found
No
The summary describes a simple silicone tube for ventilation and drainage, with no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is described as a "silicone tube that is intended to provide ventilation and/or drainage to the middle ear" for conditions like chronic otitis media and recurrent otitis media, which directly treats or alleviates a medical condition.
No
The device, a Tympanostomy Tube, is an implantable medical device designed to provide ventilation and drainage to the middle ear to treat various ear conditions. It is a therapeutic device, not a diagnostic one, as it does not diagnose a condition but rather treats it.
No
The device description explicitly states it is a "silicone tube," which is a physical hardware component, not software.
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 provide information about a person's health.
- Device Description: The description clearly states the Tympanostomy Tube is a silicone tube intended to provide ventilation and/or drainage to the middle ear. This is a physical device inserted into the body for a therapeutic purpose (ventilation/drainage), not for testing samples.
- Intended Use: The intended use describes conditions related to the middle ear and the purpose of the tube is to address these conditions directly, not to diagnose them through laboratory testing.
Therefore, the Tympanostomy Tube is a surgical implant or device used for treatment, not an IVD.
N/A
Intended Use / Indications for Use
Conditions for which tympanostomy tubes are indicated include:
- Chronic otitis media with effusion (serous, mucoid, or purulent)
- Recurrent otitis media that fails to respond to conventional medical treatment
- A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.
- Retraction pocket of the tympanic membrane.
Product codes (comma separated list FDA assigned to the subject device)
ETD
Device Description
The Tympanostomy Tube is a silicone tube that is intended to provide ventilation and/or drainage to the middle ear. The Tympanostomy Tube is available in two types: Donaldson and Paparella.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The Tympanostomy Tube met all performance acceptance criteria.
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.
MicroMedics Otological Ventilation Tube (K830228), Xomed Activent Ventilation Tube (K941407), Exmoor Plastics Ltd. Donaldson Vent-Mini Tube (K911580)
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.
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
SEP 1 9 2008
ﺘ .
| APPENDIX A: 510(k) SUMMARY | |
|---|---|
| Sponsor/Submitter: | Acclarent, Inc. |
| 1525-B O'Brien Drive | |
| Menlo Park, California 94025 | |
| Contact Person: | Keri Yen |
| Regulatory Affairs Specialist | |
| Phone: (650) 687-5874 | |
| Fax: (650) 687-4449 | |
| Date of Submission: | August 1, 2008 |
| Device Trade Name: | TBD |
| Common Name: | Tympanostomy Tube |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.3880 |
| Classification Name: | Tube, Tympanostomy |
| Product Code: | ETD |
| Predicate Devices: | MicroMedics Otological Ventilation Tube (K830228) |
| Xomed Activent Ventilation Tube (K941407) | |
| Exmoor Plastics Ltd. Donaldson Vent-Mini Tube (K911580) | |
| Device Description: | The Tympanostomy Tube is a silicone tube that is intended to |
| provide ventilation and/or drainage to the middle ear. The | |
| Tympanostomy Tube is available in two types: Donaldson and | |
| Paparella. | |
| Indications for Use: | Conditions for which tympanostomy tubes are indicated include: |
| ○ Chronic otitis media with effusion (serous, mucoid, or purulent) | |
| ○ Recurrent otitis media that fails to respond to conventional medical treatment | |
| ○ A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus. | |
| ○ Retraction pocket of the tympanic membrane. | |
| Technological | |
| Characteristics: | The Tympanostomy Tube, when inserted through the tympanic membrane, is intended to ventilate the middle ear. It also allows for drainage of fluid resulting from otitis media. |
| Performance Data: | The Tympanostomy Tube met all performance acceptance |
| criteria. | |
| Summary of Substantial | |
| Equivalence: | The Tympanostomy Tube is substantially equivalent to the |
| predicate devices as confirmed through relevant tests. |
Acclarent)
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Acclarent
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles, represented by curved lines. The profiles are arranged in a way that suggests a sense of unity and collaboration.
SEP 1 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Acclarent, Inc. c/o Keri Yen 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K082188
Trade/Device Name: Tympanostomy Tube Regulation Number: 21 CFR 874.3880 Regulation Name: Tube, tympanostomy Regulatory Class: II Product Code: ETD Dated: August 1, 2008 Received: August 4, 2008
Dear Ms. Yen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 --Keri Yen
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mahina B. Esguerra, M.D.
Malvina B. Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX B: INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K082188 |
|---|---|
| Trade Name: | TBD |
| Common Name: | Tympanostomy Tube |
| Indications For Use: | Conditions for which tympanostomy tubes are indicated include: Chronic otitis media with effusion (serous, mucoid, or purulent)Recurrent otitis media that fails to respond to conventional medical treatmentA history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.Retraction pocket of the tympanic membrane. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Karen A. Baker
Sign-Off) ാivision of Ophthalmic Ear, Nose and Throat Devises
KO82188 510(k) Number _
(Posted November 13, 2003)
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