DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE

K051487 · Doctor'S Research Group, Inc. · KHJ · Dec 22, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K051487
• Device Name: DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
• Applicant: Doctor'S Research Group, Inc.
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DRG Laryngeal Augmentation Implant Device is indicated for use in treatment of patients with unilateral vocal cord paralysis.

Device Story

Laryngeal Augmentation Implant used for treatment of unilateral vocal cord paralysis. Device implanted by physician to augment vocal cord tissue; restores glottic closure; improves voice quality. Clinical context involves ENT surgical procedures. Benefits include improved phonation and airway protection for patients suffering from vocal cord paralysis.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review.

Technological Characteristics

Synthetic polymer material implant for laryngeal augmentation. Class II device (Product Code: KHJ).

Indications for Use

Indicated for patients with unilateral vocal cord paralysis requiring laryngeal augmentation.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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 [phone]. 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 [phone] or [phone] 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)

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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)