(46 days)
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.
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.
"The provided text contains a 510(k) summary for a Tympanostomy Tube and a letter from the FDA confirming its substantial equivalence. However, it does not include detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the format requested. The document states broadly that ""The Tympanostomy Tube met all performance acceptance criteria.""
To answer your request, I will extract relevant information, but please note that some points you asked for, such as the sample size for test and training sets, the number and qualifications of experts, adjudication methods, MRMC study details, and specific ground truth mechanisms, are not explicitly present in the provided text for a performance study. The submission appears to rely on substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria and outcome metrics for the new device.
Here's the information based on the provided text, with explicit notes where information is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The submission states the device met ""all performance acceptance criteria"" without listing them. | The Tympanostomy Tube met all performance acceptance criteria. The device is substantially equivalent to the predicate devices (MicroMedics Otological Ventilation Tube (K830228), Xomed Activent Ventilation Tube (K941407), Exmoor Plastics Ltd. Donaldson Vent-Mini Tube (K911580)) as confirmed through relevant tests. |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "relevant tests" were conducted, but details on the nature or sample size of these tests are not provided.
- Data Provenance: Not specified.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or AI-assisted study is mentioned. This device is a physical medical device (Tympanostomy Tube), not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for specific performance acceptance criteria. The basis for safety and effectiveness appears to be substantial equivalence to predicate devices through "relevant tests," which would likely compare physical and material characteristics, and possibly functional performance against established standards for tympanostomy tubes.
-
The sample size for the training set:
- Not applicable/Not specified. This is a physical medical device, not an AI or machine learning algorithm requiring a training set in the conventional sense.
-
How the ground truth for the training set was established:
- Not applicable. (See #7).
Summary of the study mentioned (or lack thereof):
The document is a 510(k) premarket notification for a Tympanostomy Tube. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed performance study data in the way one might for a novel diagnostic or AI device. The document explicitly states: "The Tympanostomy Tube met all performance acceptance criteria" and "The Tympanostomy Tube is substantially equivalent to the predicate devices as confirmed through relevant tests."
Therefore, the "study" referred to is likely a set of engineering and bench tests designed to ensure the new device meets the same performance characteristics and safety profile as the predicate devices. These tests would typically cover aspects like material biocompatibility, structural integrity, dimensions, and possibly flow rates or insertion characteristics, rather than diagnostic accuracy or human reader performance. Specific details of these "relevant tests," their methodologies, sample sizes, and expert involvement are not included in this summary document."
{0}------------------------------------------------
SEP 1 9 2008
ﺘ .
| APPENDIX A: 510(k) SUMMARY | |
|---|---|
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
| Contact Person: | Keri YenRegulatory Affairs SpecialistPhone: (650) 687-5874Fax: (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 toprovide ventilation and/or drainage to the middle ear. TheTympanostomy Tube is available in two types: Donaldson andPaparella. |
| 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. |
| TechnologicalCharacteristics: | 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 acceptancecriteria. |
| Summary of SubstantialEquivalence: | The Tympanostomy Tube is substantially equivalent to thepredicate devices as confirmed through relevant tests. |
Acclarent)
{1}------------------------------------------------
Acclarent
:
:
:
{2}------------------------------------------------
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.
{3}------------------------------------------------
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)
Page of of
§ 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.