(199 days)
The DRG Laryngeal Augmentation Implant Device is indicated for use in moreations for other inn for treatment of patients with unilateral vocal cord paralysis.
Laryngeal Augmentation Implant
I am sorry, but based on the provided document, there is no information about the acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, or any details related to AI/MRMC studies for the Laryngeal Augmentation Implant.
The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the regulation number, product code, and indications for use. However, it does not include the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth without further information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2005
Doctors Research Group, Inc. c/o Mahmud Ahmed Manager Quality/Regulatory Affairs 50 Altair Ave. Plymouth, CT 06782
Re: K051487
Trade/Device Name: Laryngeal Augmentation Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: December 6, 2005 Received: December 7, 2005
Dear Mr. Ahmed:
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 for doe battled in the 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 may of dayses to de 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 any I 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 - Mahmud Ahmed
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and in your he FDA finding of substantial equivalence of your device to a legally prematics noticated. " ce 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 it you dom's spece of Compliance at (301) 827-8910. 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 miorination 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/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting 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 Statement
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
diam
Device Name: Laryngeal Augmentation Implant
Indications for Use: The DRG Laryngeal Augmentation Implant Device is indicated for use in moreations for other inn for treatment of patients with unilateral vocal cord paralysis.
Prescription Use Only (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kuen H. Baker
(Division Sign-Off) (Division of Ophthalmic Ear, Nose and Throat Devises
ാ10(k) Number
(Optional Format 3-10-98)
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.