IPC POWEREASE SYSTEM

K111520 · Medtronic Xomed, Inc. · HBE · Oct 26, 2011 · Neurology

Device Facts

• Record ID: K111520
• Device Name: IPC POWEREASE SYSTEM
• Applicant: Medtronic Xomed, Inc.
• Product Code: HBE · Neurology
• Decision Date: Oct 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPC® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC® POWEREASE™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in the placement of screws, or cutting of screws, posts, and rods.

Device Story

IPC® POWEREASE™ System is a powered surgical driver for spinal procedures; performs drilling, tapping, and screw driving; cuts screws, posts, and rods. System comprises Integrated Powered Console (IPC), driver handpiece, and cables. Features quick-connect interface for various working end attachments. Integrates with Medtronic NIM-ECLIPSE® System via external cable to provide nerve stimulation capabilities during surgery. Operated by surgeons in clinical/OR settings. Provides powered mechanical force for bone/tissue manipulation; nerve stimulation output assists in monitoring nerve proximity. Benefits include streamlined surgical workflow and integrated nerve monitoring capability.

Clinical Evidence

Bench testing only. Laboratory testing performed according to IEC 60601 standards demonstrated that the device's performance characteristics are substantially equivalent to the predicate devices.

Technological Characteristics

Powered surgical driver system; includes handpiece, console, and cables. Features quick-connect mechanism for attachments. Nerve stimulation capability enabled via external cable connection to third-party nerve monitoring system. Electrical energy source. Software-controlled via Integrated Powered Console. Complies with IEC 60601 for medical electrical equipment.

Indications for Use

Indicated for patients undergoing spinal surgery, including open and minimally invasive procedures, requiring drilling, tapping, screw driving, or cutting of screws, posts, and rods.

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

• Integrated Powered Console (Electric Drill System) (K081475)
• Stimulating Bur Guard (K063305)
• Stryker Consolidated Operating Room (CORE) System (K032303)
• Orthomon (K061113)
• Eclipse TCD Neurvascular Workstation (K061639)
• XPS 4000 System, Midas Rex Legend EHS System, Integrated Power Console (IPC) (K081277)

Submission Summary (Full Text)

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# 111520

pg 1 of 3

OCT 2 6 2011

### 5. 510(k) Summary

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Medtronic Xomed, Inc. Address of Manufacturer: 6743 Southpoint Drive Jacksonville, FL 32216 [phone] Phone [phone] Facsimile Establishment Registration Number: 1625507 Contact Person: Rishi Sinha Senior Regulatory Affairs Specialist

Date:

Trade or Proprietary Name:

IPC® POWEREASE™ System IPC System with POWEREASE TM POWEREASE™ System

Common usual or Classification Name:

21 CFR 882.4310 - Powered simple cranial drills, burrs, trephines, and their accessories 21CFR 878.4820 - Surgical instrument motors and accessories/attachments 21CFR882.1870 - Evoked Response Electrical Stimulator

## Description:

The purpose of this submission is to add a new driver and an accompanying software module to the IPC® . The new system is the IPC® POWEREASE™System. The IPC® POWEREASE™ System provides a powered driver that performs multiple functions and also has nerve stimulation capabilities. The IPC® POWEREASE™ System consists of the Integrated Powered Console (K081475, 10/17/2008), a driver handpiece, and cables to connect the driver, IPC® and NIM-ECLIPSE® System together. The driver is powered by the previously cleared Integrated Powered Console equipped with the appropriate software to operate the driver. The driver is used for drilling, tapping and driving screws in the pedicle, placing screws, and driving working end attachments capable of breaking set screw heads, cutting posts, and cutting rods during spinal surgery. The POWEREASE™ Driver also has nerve stimulation capabilities when connected to the Medtronic NIM -ECLIPSE® System (K061113 - 05/23/2006; K061639 -11/01/2006). An external POWEREASE™NIM Cable that connects the NIM-ECLIPSE® System to the driver enables the driver to have nerve stimulating capability. It should be noted that the IPC® does not provide the stimulation. The stimulation used with the IPC® POWEREASE™ is provided by the Medtronic NIM-ECLIPSE® System.

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K111520

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The driver is equipped with a quick connect feature which allows for easy and secure attachment of different working end attachments compatible with the IPC® POWEREASE™ Driver to perform the various functions mentioned above.

## Indications for Use:

The IPC® is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC® POWEREASE™ System is also used in the placement of screws, or cutting of screws, posts, and rods.

### Predicate Device Identification:

The Medtronic IPC® POWEREASE™ System is substantially equivalent to the following predicate devices:

| Device | Manufacturer | 510(k)<br>Number | Clearance<br>Date |
|------------------------------------------------------------------------------------|-----------------------|------------------|-------------------|
| Integrated Powered Console (Electric<br>Drill System) | Medtronic Xomed, Inc. | K081475 | 10/17/2008 |
| Stimulating Bur Guard | Medtronic Xomed, Inc. | K063305 | 11/29/2006 |
| Stryker Consolidated Operating Room<br>Equipment (CORE) System | Stryker Instruments | K032303 | 1/16/2004 |
| Orthomon | Axon Systems, Inc. | K061113 | 05/23/2006 |
| Eclipse TCD Neurvascular Workstation | Axon Systems, Inc. | K061639 | 11/01/2006 |
| XPS 4000 System, Midas Rex Legend<br>EHS System, Integrated Power Console<br>(IPC) | Medtronic Xomed, Inc. | K081277 | 09/05/2008 |

Table 1: Predicate Devices for the IPC® POWEREASE™ System

#### Comparison to Predicate Device:

The IPC® POWEREASE™ System is similar in device design, function, intended use and fundamental scientific technology to the previously cleared devices listed above.

| Features | IPC® POWEREASE™ System | IPC® System (K081475) |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The IPC® is indicated for the incision /<br>cutting, removal, drilling, and sawing of<br>soft and hard tissue and bone, and<br>biomaterials in Neurosurgical (Cranial,<br>Craniofacial), Orthopedic, Arthroscopic,<br>Spinal, Sternotomy, and General<br>surgical procedures.<br><br>The IPC® POWEREASE™ System is<br>indicated for drilling, tapping and driving | The IPC® is indicated for the incision /<br>cutting, removal, drilling, and sawing of<br>soft and hard tissue and bone, and<br>biomaterials in Neurosurgical (Cranial,<br>Craniofacial) Orthopedic, Arthroscopic,<br>Spinal, Sternotomy, and General surgical<br>procedures |

Table 2: Comparison of Subject Device to Predicate Device

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K111520

| | screws and working end attachments<br>during spinal surgery, including open<br>and minimally invasive procedures.<br>The IPC® POWEREASE™ System is<br>also used in the placement of screws,<br>or cutting of screws, posts, and rods. | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Handpiece<br>Driver<br>Compatibility | Drills including the POWEREASE™<br>Driver, Saws, Microdebriders. All Class<br>II devices in the IPC® System other<br>than the POWEREASE™ Driver are<br>cleared via K081475. | Drills, Saws, Microdebriders - All Class II<br>devices cleared via K081475 |
| Nerve<br>Monitoring<br>Capability | Yes - allows for connection to nerve<br>monitoring systems | Yes - allows for connection to nerve<br>monitoring systems |

#### Testing:

Laboratory bench testing conducted on the POWEREASE™ System demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market. Testing was performed according to IEC 60601 Medical Electrical Equipment.

# Conclusion/Summary:

Based upon the laboratory bench test summaries, intended use, and the successful completion of design control activities; the IPC® POWEREASE™ System has been shown to be substantially equivalent to currently marketed predicate devices.

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

OCT 2 6 2011

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

Re: K111520

Trade/Device Name: IPC POWEREASE System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: Class II Product Code: HBE, HWE, GWF Dated: September 29, 2011 Received: October 03, 2011

- Dear Mr. Sinha:

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, Trug 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 and warranties. We remind you; however, that device labeling must be truthful and not muclery,

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 – Mr. Rishi Sinha

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 yours,
Erine Keith

Jos 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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4. Indications for Use Statement

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K111520

510(k) Number (if known):

® 2024 Experian

Device Name: IPC® POWEREASE™ System

Indications for Use:

The IPC® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in the placement of screws, or cutting of screws, posts, and rods.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nail RPE Ogden for uxm
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111520

Medtronic IPC® POWEREASE™ System