(86 days)
The largest patient population are children between 4 months and 6 years of age (but not exclusively). Otological ventilation tubes are indicated for patients with:
- Chronic or recurrent otitis media with persistent effusion (OME).
- Recurrent acute otitis media.
- Acute otitis media with complications.
- Eustachian tube dysfunction resulting in one or more of the following: significant and symptomatic hearing loss, otalgia, vertigo, and tinnitus.
- Hearing loss resulting from bilateral chronic middle ear effusion.
Neozoline Ventilation Tubes
The provided document is an FDA 510(k) clearance letter for the "Neozoline Ventilation Tubes" and does not contain information regarding detailed acceptance criteria, device performance studies, or ground truth establishment relevant to AI/ML device evaluation. It is a regulatory document stating that the device is substantially equivalent to a predicate device for its indicated uses.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on:
- Device Name: Neozoline Ventilation Tubes
- Regulation Number/Name: 21 CFR 874.3880, Tympanostomy Tubes
- Regulatory Class: Class II
- Product Code: ETD
- Indications for Use: Chronic or recurrent otitis media with persistent effusion (OME), Recurrent acute otitis media, Acute otitis media with complications, Eustachian tube dysfunction (resulting in hearing loss, otalgia, vertigo, tinnitus), and Hearing loss from bilateral chronic middle ear effusion.
- Target Population: Largest patient population are children between 4 months and 6 years of age (but not exclusively).
To answer your questions about acceptance criteria and device performance studies, a different type of document (e.g., a clinical study report, a comprehensive technical report, or a detailed submission summary that includes performance data) would be required.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Adept Medical c/o Jason Marsh P.O. Box 10075 Dominion Road Auckland, New Zealand
Re: K061058
Trade/Device Name: Neozoline Ventilation Tubes Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tubes Regulatory Class: Class II Product Code: ETD Dated: June 16, 2006 Received June 19, 2006
Dear Mr. Marsh:
This letter corrects our substantially equivalent letter of July 12, 2006.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments or to conninered proc to May 20, 1978, the oncordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may. and Cosmette free the device, subject to the general controls provisions of the Act. The general therefore, manter the act include requirements for annual registration, listing of devices, controls provisions of the receiners, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). if your device is classified (600 above). Existing major regulations affecting your device can be it may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in the Coule of Poucharts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not nean I Trase of advised that I Dris Issualites or our device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of any redital statures and regulations daminders but not limited to: registration and listing (21 Compry with an the Act 3 requirements, news, as and acturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality brovisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely yours,
M.B. Egelman, 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
{2}------------------------------------------------
Indications for Use
K061058 510(k) Number (if known):
Neozoline Ventilation Tubes Device Name:
Indications For Use:
The largest patient population are children between 4 months and 6 years of age (but not exclusively). Otological ventilation tubes are indicated for patients with:
- Chronic or recurrent otitis media with persistent effusion (OME). ।
- Recurrent acute otitis media. -
- Acute otitis media with complications. -
- Eustachian tube dysfunction resulting in one or more of the following: significant and symptomatic hearing loss, otalgia, vertigo, and tinnitus.
- Hearing loss resulting from bilateral chronic middle ear effusion. -
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Klaus Barker
Division Sign-C of Ophthalmic Ear,
510(k) Number K060508
Page 1 of 1 __
§ 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.