ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]

K081475 · Medtronic Xomed, Inc. · HBE · Oct 17, 2008 · Neurology

Device Facts

• Record ID: K081475
• Device Name: ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
• Applicant: Medtronic Xomed, Inc.
• Product Code: HBE · Neurology
• Decision Date: Oct 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

Device Story

Electric surgical drill/saw system comprising power console, footswitches, cables, irrigation tubing, remote irrigation control, and various handpieces. Drives burs, blades, drills, rasps, and saw blades. Functions as endoscope lens cleaning system. Used in OR by surgeons for tissue/biomaterial removal. System provides mechanical power to surgical attachments; surgeon controls operation via footswitch. Enables precise tissue resection and bone cutting; facilitates surgical access and procedural efficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered motor system. Components include power console, handpieces, footswitches, and irrigation accessories. System supports multiple surgical attachments (burs, blades, drills). Connectivity includes cable-based power and control interfaces. Sterilization requirements apply to reusable attachments.

Indications for Use

Indicated for incision, cutting, removal, drilling, and sawing of soft/hard tissue and biomaterials in neurosurgical, orthopedic, arthroscopic, spinal, sternotomy, and general surgical procedures. No specific age or gender restrictions noted.

Regulatory Classification

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Predicate Devices

• Medtronic Xomed XPS system (K073255)
• Midas Rex Legend EHS system (K935567)
• Midas Rex Legend EHS system (K012453)
• Midas Rex Legend EHS system (K012456)
• Midas Rex Legend EHS system (K012457)
• Linvatec Advantage Drive Electric System (K002523)

Submission Summary (Full Text)

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K081475 Pg 1 of

# 510(k) Summary

| 510(k) Owner | OCT 1 7 2008<br>Medtronic Xomed, Inc<br>6743 Southpoint Drive North<br>Jacksonville, Florida 32216-0980 USA<br>904-296-9600<br>904-296-2386 (FAX) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Antoine Kouchakjy<br>Senior Regulatory Affairs Specialist<br>Medtronic Xomed, Inc |
| Date Summary Prepared | May 20, 2008 |
| Proprietary Name | Electric Surgical Drill / Saw System<br>(XPS 4000 System, Midas Rex Legend Drill System,<br>Integrated Power Console (IPC)) |
| Common Name(s) | · Instrument, Surgical, Orthopedic, AC-Powered Motor<br>and Accessory / Attachment (HWE)<br>· Arthroscope (HRX)<br>· Motor, Drill, Electric (HBC)<br>· Drills,Burrs,Trephines&Accessories(Simple,Powered)<br>(HBE) |
| Classification Name(s) | · Surgical instrument motors and accessories/attachments<br>(21 CFR 878.4820, Product Code HWE, Class I)<br>· Arthroscope<br>(21 CFR 888.1100, Product Code HRX, Class II)<br>· Electric cranial drill motor<br>(21 CFR 882.4360, Product Code HBC, Class II)<br>· Powered simple cranial drills, burrs, trephines, and their<br>accessories<br>(21 CFR 882.4310, Product Code HBE, Class II) |

### Marketed device claiming equivalence to

The electric drill system is equivalent to the Medtronic Xomed XPS system K073255, the Midas Rex Legend EHS system (K935567, K012453, K012456, K012457), and to the Linvatec Advantage Drive Electric System (K002523).

### Device Description

The electric drill system consists of a power console, footswitches, connection cables, irrigation / cooling tubing sets, a remote irrigation control unit, and assorted handpieces to drive various burs, blades, drills, rasps, and saw blades. The system can also function as an endoscope lens cleaning system.

#### Intended Use / Indications for use

The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 7 2008

Medtronic Xomed, Inc. % Mr. Antoine Kouchakjy Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K081475

Trade/Device Name: Electric Drill System [XPS4000, Midas Rex EHS system, Integrated Power Console] Regulation Number: 21 CFR 882.4310 Regulation Name: Powered compound cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE, HBC, HWE, HRX Dated: September 15, 2008 Received: September 16, 2008

Dear Mr. Kouchakjy:

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.

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Page 2 - Mr. Antoine Kouchakjy

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 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 M. Milliman

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

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Device Name.
Electric Drill System [XPS4000, Midas Rex EHS system, Integrated Power Console (IPC)]

Indications for Use:

The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Sorthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Mcoyle firmin

(Division Sign Division of General, Restorative, and Neurological Devices

**510(k) Number** K081475