PROMEX ENT TISSUE REMOVAL SYSTEM

K972865 · Promex, Inc. · ERL · Sep 29, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972865
• Device Name: PROMEX ENT TISSUE REMOVAL SYSTEM
• Applicant: Promex, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the removal of soft tissue and bone in the ear, nose & throat.

Device Story

Promex ENT Tissue Removal System is a surgical instrument designed for the mechanical removal of soft tissue and bone during ENT procedures. Operated by a physician in a clinical or surgical setting, the device functions as a powered tissue resection tool. It assists surgeons in clearing anatomical obstructions or performing resections, thereby facilitating surgical access and treatment of ENT conditions. The system provides controlled tissue removal, aiding in the precision of surgical interventions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Powered surgical instrument for tissue and bone removal. Classified under 21 CFR 874.4250 (ENT manual surgical instrument).

Indications for Use

Indicated for the removal of soft tissue and bone in the ear, nose, and throat (ENT) for patients requiring surgical intervention in these areas.

Regulatory Classification

Identification

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1997

Joseph L. Mark Vice President Promex, Inc. 1125 Brookside Ave., Suite G500 Indianapolis, IN 46202

K972865 Re:

Promex ENT Tissue Removal System Dated: July 31, 1997 Received: August 4, 1997 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL

Dear Mr. Mark:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

hJliau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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91128 510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________ Promex ENT Tissue Removal System

Indications For Use:

For the removal of soft tissue and bone in the ear, nose & throat.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segmon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

Ω(k) Number ***_***

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Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

..

(Optional Format 1-2-96)

EN
II