(56 days)
- Chronic otitis media with effusion (serous, mucoid, or purulent) .
- Recurrent episodes of acute otitis media despite conventional medical treatment .
- A record of persistent high negative middle ear pressure associated with one or more of the . following system:
-
- Conductive hearing loss that is symptomatic
-
- Persistent or recurrent otalgia
-
- Persistent or recurrent vertigo, tinnitus, or both
-
- Retraction pocket of the tympanic membrane .
The Fluoroplastic Ventilation Tubes are substantially equivalent to the current fluoroplastic tubes marketed by Smith & Nephew, Inc., ENT Division, and the fluoroplastic tubes marketed by Xomed.
The provided text is a 510(k) summary for Fluoroplastic Ventilation Tubes. This type of document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with statistical endpoints.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training sets is not available in the provided document.
The document states:
- "The Fluoroplastic Ventilation Tubes are substantially equivalent to the current fluoroplastic tubes marketed by Smith & Nephew, Inc., ENT Division, and the fluoroplastic tubes marketed by Xomed."
- "Differences between the Fluoroplastic Ventilation Tubes and the predicate devices should not affect the safety or effectiveness."
This indicates that the main "proof" presented is the assertion of substantial equivalence based on manufacturing materials and intended use, not a clinical study demonstrating performance against a specific set of acceptance criteria.
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AUG 26 1999
992222
510(k) Summary of Safety and Effectiveness
| Trade Name: | Fluoroplastic Ventilation Tubes |
|---|---|
| Common Name: | Tympanostomy Tubes |
| Classification Name: | Tympanostomy Tubes (CFR 21 § 874.3880) |
| Official Contact: | Alicia E. Farage |
| Senior Regulatory Affairs Specialist | |
| Smith & Nephew, Inc. | |
| ENT Division | |
| 2925 Appling RoadBartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 373-0242 |
| Date Prepared: | July 2, 1999 |
The Fluoroplastic Ventilation Tubes are substantially equivalent to the current fluoroplastic tubes marketed by Smith & Nephew, Inc., ENT Division, and the fluoroplastic tubes marketed by Xomed.
These devices have the same indications for use: to ventilate the middle ear subsequent to otitis media.
Differences between the Fluoroplastic Ventilation Tubes and the predicate devices should not affect the safety or effectiveness.
{1}------------------------------------------------
Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the human profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 26 1999
Ms. Alicia E. Farage Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. ENT Division 2925 Appling Road Barlett, TN 38133
Re: K992222 Trade Name: Fluoroplastic Ventilation Tubes Regulatory Class: II Product Code: 77 ETD Dated: June 30, 1999 Received: July 1, 1999
Dear Ms. Farage:
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 II (Special Controls) or 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 requirements, 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 you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Ms. Alicia E. Farage
· · 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/dsmamain.html".
Sincerely yours,
A Robert Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Food and Drug Administration 510(k) Notification - Fluoroplastic Ventilation Tubes June 30, 1999
510(k) Number: Device Name:
K9999922 Fluoroplastic Ventilation Tubes
Indications for Use:
- Chronic otitis media with effusion (serous, mucoid, or purulent) .
- Recurrent episodes of acute otitis media despite conventional medical treatment .
- A record of persistent high negative middle ear pressure associated with one or more of the . following system:
-
- Conductive hearing loss that is symptomatic
-
- Persistent or recurrent otalgia
-
- Persistent or recurrent vertigo, tinnitus, or both
-
- Retraction pocket of the tympanic membrane .
Prescription Use
(Per 21 CFR 801.109)
ﺎ ﻣ
8/20/99
(Division Sign-Off)
(Division Sign-Off Division of Ophthalmic Devices 510(k) Number _ E 992229
§ 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.