CONMED LINVATEC OSPREY DRILL SYSTEM

K080444 · Conmed Linvatec · HBC · Apr 2, 2008 · Neurology

Device Facts

• Record ID: K080444
• Device Name: CONMED LINVATEC OSPREY DRILL SYSTEM
• Applicant: Conmed Linvatec
• Product Code: HBC · Neurology
• Decision Date: Apr 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ConMed Linvatec Osprey™ Drill System is intended for cutting, drilling, and manipulation of soft tissue and bone in the following applications: orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic.

Device Story

The ConMed Linvatec Osprey™ Drill System is an electric surgical system designed for cutting, drilling, and manipulating bone and soft tissue. It functions as a powered surgical instrument used by surgeons in various specialties, including neurosurgery, orthopedics, and oral/maxillofacial surgery. The system consists of a handpiece and associated attachments that provide mechanical energy to surgical tools. It is operated by a clinician in a clinical or surgical setting to facilitate bone and tissue removal or modification during procedures. The device provides the mechanical force necessary for surgical access and reconstruction, aiding the surgeon in achieving precise anatomical modifications.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electric surgical system; cranial drill motor; powered handpiece with attachments for bone/tissue manipulation. Operates via electric motor energy source. Class II device (21 CFR 882.4360).

Indications for Use

Indicated for cutting, drilling, and manipulation of soft tissue and bone in orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic surgical procedures.

Regulatory Classification

Identification

An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Predicate Devices

• MicroPower Handpiece System (K072706)
• Microspeed Uni Motor System (K053526)
• MicroAire 1000E System (K014060)
• Anspach eMax Drill (K011444)
• Hall® UltraPower® Drill (K781979)

Submission Summary (Full Text)

{0}------------------------------------------------

K08044

# 510(k) SUMMARY ConMed Linvatec Osprey™ Drill System

APR - 2 2008

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number

#### A. Submitter

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

### Company Contact B.

Sue F. Dauterman Regulatory Affairs Specialist [phone] Telephone [phone] FAX

## C. Device Name

| Trade Name: | ConMed Linvatec Osprey™ Drill System |
|------------------------|----------------------------------------|
| Common Name: | Electric Surgical System |
| Classification Name: | Electric Cranial Drill Motor, 882.4360 |
| Proposed Class/Device: | Class II |
| Product Code: | HBC |

#### D. Predicate/Legally Marketed Devices

| MicroPower Handpiece System | 510(k) # K072706 | ConMed Linvatec |
|-----------------------------|------------------|--------------------------------------------------------------|
| Microspeed Uni Motor System | 510(k) # K053526 | Aesculap, Inc. |
| MicroAire 1000E System | 510(k) # K014060 | MicroAire Surgical Instruments |
| Anspach eMax Drill | 510(k) # K011444 | The Anspach Effort, Inc. |
| Hall® UltraPower® Drill | 510(k) # K781979 | Linvatec Corporation (acquired<br>from AMSCO/Hall® Surgical) |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has a ribbon-like design flowing from its beak.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ConMed Linvatec % Ms. Sue Dauterman Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773

APR - 2 2008

Re: K080444

Trade/Device Name: ConMed Linvatec Osprey™ Drill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: February 13, 2008 Received: February 19, 2008

Dear Ms. Dauterman:

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 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) 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 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 comply 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.

{2}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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.

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): K 0804444

Device Name: ConMed Linvatec Osprey™ Drill System

Indications for Use:

The ConMed Linvatec Osprey™ Drill System is intended for cutting, drilling, and manipulation of soft tissue and bone in the following applications: orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic.

Prescription Use_X AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

NitRL. Sglm
(Division Sign-Off) for mxm

Division of General, Restorative, and Neurological Devices

**510(k) Number** K080444