LEGEND POWER ADAPTER MODEL: 6475000

K101168 · Medtronic Sofamor Danek · HBB · Aug 24, 2010 · Neurology

Device Facts

• Record ID: K101168
• Device Name: LEGEND POWER ADAPTER MODEL: 6475000
• Applicant: Medtronic Sofamor Danek
• Product Code: HBB · Neurology
• Decision Date: Aug 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2

Intended Use

The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.

Device Story

The LEGEND® Power Adapter is a stainless steel mechanical accessory for the MIDAS REX® LEGEND® System. It functions as a gear reduction unit, providing a 20:1 gear ratio to the system's motor output. It is used in surgical settings by physicians to power rotating surgical cutting tools. The device is provided non-sterile and requires end-user steam sterilization. It does not contain electronic or software components.

Clinical Evidence

Bench testing only. Dynamometer testing was performed to confirm the adapter functions appropriately when attached to the MIDAS REX® LEGEND® Power Systems; the device met all acceptance criteria.

Technological Characteristics

Stainless steel mechanical adapter; 20:1 gear ratio reduction; non-sterile; intended for steam sterilization; no electronic or software components.

Indications for Use

Indicated for use with the MIDAS REX® LEGEND® System to power rotating surgical cutting tools for neurosurgery (craniotomy, spinal surgery), ENT, orthopedic, and general surgical applications (maxillofacial, sternotomy).

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® LEGEND® System Perforator Attachment

Submission Summary (Full Text)

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# LEGEND® Power Adapter 510(k) Summary

### August 2010

Regulatory Affairs Specialist

AUG 2 4 2010

Medtronic Sofamor Danek USA Company: 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: [phone] Fax: [phone] Contact: Jennifer Hackney

II. Proposed Proprietary Trade Name: Common Name: Classification Name(s):

> Classfication: Product Code(s): Regulation No .: Predicate Device:

LEGEND® Power Adapter Power Adapter Surgical instrument motors and accessories/attachments; Class II HBC 882.4360 MIDAS REX® LEGEND® System Perforator Attachment

#### III. Description:

I.

The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power to MEDTRONIC rotating surgical cutting tools. The LEGEND® Power Adapter provides a 20:1 gear ratio reduction when used with the MIDAS REX® LEGEND® System.

### IV. Indications for Use:

The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.

### Technological Characteristics: V.

The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power to MEDTRONIC rotating surgical cutting tools. Both products are manufactured from stainless steel, utilize gears to reduce the output of the MIDAS REX® LEGEND® System, and are provided non-sterile for end user steam sterilization.

### VI. Substantial Equivalence:

Documentation was provided demonstrating that the LEGEND® Power Adapter is substantially equivalent to other commercially available accessories, including those included in the MIDAS REX® LEGEND® System.

Dynamometer testing was performed to confirm that the LEGEND® Power Adapter would function appropriately when attached to the MIDAS REX® LEGEND® Power Systems. The subject adapter successfully met the acceptance criteria.

C2010 Medtronic Sofamor Danek

. '

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 an abstract symbol that resembles an eagle or other bird in flight, represented by three stylized, curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek USA % Ms. Theresa Leister Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

AUG 2 4 2010

Re: K101168

Trade/Device Name: LEGEND® Power Adapter Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic cranial drill motor Regulatory Class: Class II Product Code: HBB. GET Dated: August 18, 2010 Received: August 20, 2010

Dear Ms. Leister:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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## Page 2 - Ms. Theresa Leister

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

sincerely, yours,

Mark A. Mulkersen

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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K10116.8

## 510(k) Number (if known): K101168

Device Name: LEGEND® Power Adapter

### Indications for Use:

ﺴﻴﺴ

..

The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use _ X Per 21 CFR 801.109

Over-The-Counter Use ------

Neil H. Oyler for mxm

ivision Sign-Off) (Division Sign of Surgical, Orthopedic, Ivision of Restorative Devices

510(k) Number K101168