(48 days)
The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear that are electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Masker is intended for those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus
electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear.
The provided document is a 510(k) clearance letter from the FDA for a device called "Refuge Tinnitus Masker." This letter primarily communicates the FDA's "substantial equivalence" determination to a legally marketed predicate device, indicating that the new device does not raise new questions of safety or effectiveness.
It does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding development, training sets, or expert ground truths. These types of details are typically found in the 510(k) summary or other sections of the submission, not in the clearance letter itself.
Therefore,Based on the provided document (a FDA 510(k) clearance letter), I am unable to provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter states that the device, "Refuge Tinnitus Masker," has been determined to be "substantially equivalent" to a legally marketed predicate device. This determination is based on the comparison to existing devices and does not typically include a detailed report of novel clinical studies with specific acceptance criteria beyond demonstrating equivalence.
The document only provides:
- Trade/Device Name: Refuge Tinnitus Masker Sound Generator
- Regulation Number: 21 CFR 874.3400
- Regulation Name: Tinnitus masker
- Regulatory Class: Class II
- Product Code: KLW
- Indications For Use: The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear that are electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Masker is intended for those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes its fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus. The target population is the adult population over 18 years of age.
To answer your specific questions, additional documentation from the original 510(k) submission, such as the 510(k) summary, clinical study reports, or performance data, would be required. This letter merely confirms regulatory clearance based on substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 2004
Micro-Ear Technology, Inc. c/o Deborah Shaffer Regulatory Team Leader 3500 Holly Lane North Suite 10 Plymouth, MN 55447
Re: K041302
Trade/Device Name: Refuge Tinnitus Masker Sound Generator Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: May 13, 2004 Received: May 17, 2004
Dear Ms. Shaffer:
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 - Deborah Shaffer
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Akerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Ko41302 510(k) Number (if known):
Device Name: Refuge Tinnitus Masker
Indications For Use:
The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear that are electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Masker is intended for those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus
The target population is the adult population over 18 years of age.
ﺔ ﻳﻊ
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Karen H. Porter
ivision Sign-Division of Ophthalmic B Nose and Throat Devises
510(k) Number K041302
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§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.