ULTRABUR

K974174 · Mednet Locator, Inc. · ERL · Mar 10, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974174
• Device Name: ULTRABUR
• Applicant: Mednet Locator, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedNet LOCATOR, INC., ULTRABUR is to be used by ear, nose and throat physicians for forming a hole in the footplate for the placement of middle ear prostheses in stapedectomy procedures.

Device Story

MedNet UltraBur is a pneumatic surgical drill used by ENT physicians during stapedectomy procedures. Device functions as a surgical instrument to form a hole in the footplate of the middle ear to facilitate placement of middle ear prostheses. Operated via pneumatic power; used in clinical/surgical settings. Output is mechanical drilling action; assists surgeon in precise bone removal. Benefits patient by enabling accurate prosthesis implantation for hearing restoration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic surgical drill and bur system. Designed for manual operation by ENT physicians. Class II device (21 CFR 874.4250).

Indications for Use

Indicated for use by ENT physicians to create a hole in the footplate for middle ear prosthesis placement during stapedectomy procedures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Judy Chandler MedNet Locator, Inc. 7000 Shadow Oaks Memphis, TN 38125

Re:

K974174 MedNet UltraBur (Pheumatic Surgical Drill, Surgical Drill and Bur) Dated: February 16, 1998 Received: February 24, 1998 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL

Dear Ms. Chandler:

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 interstatecommerce 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 (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 requirements, 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 the Electronic Product 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/odrh/dsmaldsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

ULTRABUR Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

1

The MedNet LOCATOR, INC., ULTRABUR is to be used by ear, nose and throat physicians for forming a hole in the footplate for the placement of middle ear prostheses in stapedectomy procedures.

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

David G. Severson

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Prescription Use マ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)