(197 days)
The Chin-Up Strip promotes and enhances nasal breathing to help Breathe Right nasal strips to reduce or eliminate snoring.
The Chin-Up Strip supports the chin (mandible) during sleep, thereby promoting and reducing mouth breathing and oral venting.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a device called "Chin-Up Strip", indicating that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Dale Miller, Inc. - The Chin-Up Company c/o Dale Miller, JD President and CEO 1820 Ridgemill Terrace Dacula, GA 30019
Re: K040491
Trade/Device Name: Chin-Up Strip® Regulation Number: 21 CFR 874.3900 Regulation Name: Nasal dilator Regulatory Class: Class I Product Code: LWF Dated: August 24, 2004 Received: August 25, 2004
Dear Mr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device w on a review your your 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 for use sualed in the encreat 1976, the enactment date of the Medical Device Amendments, or to eonimores pror to Tray 2011-01-11 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 I ou mayy arous 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 or uny I vature buttator t's requirements, including, but not limited to: registration and listing eonly) with an an an all a rear 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 - Dale Miller, JD
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse of substantial equivalence of your device of your device to a legally promance noticate 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 11 you t 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 other general mionmation on Joan 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,
A. Kelpi 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
K040491 510(k) Number:
Chin-Up Strip Device Name:
Indications for Use:
"The Chin-Up Strip promotes and enhances nasal breathing to help Breathe Right nasal strips to reduce or eliminate snoring."
"The Chin-Up Strip supports the chin (mandible) during sleep, thereby promoting and "The Chur-Op Birfy supports week ing mouth breathing and oral venting."
Prescription Use (21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Karen Baker
510(k) Number K040491
§ 874.3900 Nasal dilator.
(a)
Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.