MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM

K020069 · Medtronic Midas Rex · HBB · Mar 18, 2002 · Neurology

Device Facts

• Record ID: K020069
• Device Name: MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
• Applicant: Medtronic Midas Rex
• Product Code: HBB · Neurology
• Decision Date: Mar 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Device Story

Modular, pneumatically powered surgical instrument system; consists of motor (handpiece) and accessories (adapters, spindles, burrs, drills, cutters). High-pressure gas (air or nitrogen) drives motor to rotate cutting tools. Used in OR by surgeons for bone dissection/cutting in neurosurgical, ENT, orthopedic, and general surgical procedures. Provides mechanical power for tissue/bone removal; assists surgeon in performing precise surgical cuts. Benefits include modularity and high-speed performance for various surgical applications.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Modular pneumatic high-speed instrument system. Powered by high-pressure gas (air or nitrogen). Includes handpiece, adapters, spindles, burrs, drills, and cutters. Mechanical energy source. No software or electronic components.

Indications for Use

Indicated for patients undergoing neurosurgery (craniotomy, spinal surgery), ENT, orthopedic, and general surgical procedures (maxillofacial, craniofacial, sternotomy) requiring bone dissection or cutting.

Regulatory Classification

Identification

A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Predicate Devices

• Midas Rex Classic
• Midas Rex III Instrumentation Systems
• Mednext 1000 Bone Dissecting System

Submission Summary (Full Text)

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

Premarket Notification [510(K)] Summary

MAR 1 8 2002

1/2

KO20069

(per 21 CFR 807.92)

### Submitted by: 1.

Medtronic Midas Rex
4620 North Beach Street
Fort Worth, TX 76137

| Contact Person: | Greg Cannedy<br>Director of Regulatory Affairs |
|-----------------|------------------------------------------------|
| Telephone: | 817-788-6400 |
| Facsimile: | 817-788-6222 |

January 7, 2002 Date Prepared:

### Device Name 2.

Trade/Proprietary Name: Common/Usual Name: Classification Name:

Midas Rex Legend System Surqical drill motors with accessories Pneumatic cranial drill motors for neurosurgery (HBB) Surgical drill for Ear, Nose & Throat (ERL) Surgical Ear. Nose & Throat bur (EQJ) Pneumatic motor for orthopedic surgery (HSZ) Pneumatic motor for general surgery (GET) Pneumatically powered saw (KFK) Powered simple cranial drills, burrs, and accessories (HBE) Blades, saw, surqical cardiovascular (DWH)

### 3. Predicate Device:

The Medtronic Midas Rex Legend System is substantially equivalent to the Midas Rex Classic and Midas Rex III Instrumentation Systems, and the Mednext 1000 Bone Dissecting System.

### 4. Intended use of the device

The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

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

K02 0069 2/2

### Description of the Device 5.

The Medtronic Midas Rex Legend System is a modular, pneumatic, highspeed instrument system consisting of a motor (handpiece) and accessories/attachments, including but not limited to adapters, spindles, burrs, drills, cutters, and other dissecting tools.

### Summary of the technological characteristics of the device 6. compared to the predicate device.

The intended use of the Medtronic Midas Rex Legend System have not changed to the intended uses of the Midas Rex Classic, Midas Rex III, and Mednext 1000 systems. The modified device and the predicate devices have the same technological characteristics, the same operating principles, use the same patient contacting materials, and have similar performance characteristics. These systems utilize a high-pressure gas source (either air or nitrogen) to power the motors and drive the cutting tools for use during surgical applications.

### 7. Testing

Performance testing on the Medtronic Midas Rex Legend System confirms that the device operates as intended, and is substantially equivalent to the Midas Rex Classic, Midas Rex III, and Mednext 1000 Instrumentation Systems.

### 8. Conclusions

Based upon the testing and comparison to the predicate devices, the Medtronic Midas Rex Legend System performs as intended and raises no new safety or effectiveness issues.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 8 2002

Medtronic Midas Rex Mr. Greg Cannedy Director of Regulatory Affairs 4620 North Beach Street Fort Worth, Texas 76137

Re: K020069

Trade Name: Midas Rex Legend System Regulation Number: 882.4370 Regulation Name: Pneumatic Cranial Drill Motor Regulatory Class: II Product Code: HBB Dated: January 8, 2002 Received: January 9, 2002

Dear Mr. Cannedy:

We have reviewed your Section 510(k) premarket 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) 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, controls provisions or actice, 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.

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

Page 2 – Mr. Greg Cannedy

This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow your to ocgin mading of substantial equivalence of your device to a legally premaired predicated 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 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF F Far 659. Additionally, for questions on the promotion and advertising of Compliance at [phone] Compliance at [phone]. Also, please note the your devices, preads offically by reference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

iriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Statement of Indications for Use

Page 1 of 1

KO20069 510(k) Number (if known):

Medtronic Midas Rex® Legend™ Instrumentation System Device Name:

Indications For Use:

The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; ins well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (per 21 CFR 801.109) OR

Over the Counter Use: (Optional Format 1-2-96)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K020069