TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE

K121264 · Medtronic Surgical Technologies · HBE · Aug 27, 2012 · Neurology

Device Facts

• Record ID: K121264
• Device Name: TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
• Applicant: Medtronic Surgical Technologies
• Product Code: HBE · Neurology
• Decision Date: Aug 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPC System with the TRITON Electric High-Torque Handpiece 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

TRITON Electric High Torque Handpiece is a line extension for the Integrated Power Console (IPC) System. Device functions as an electric-powered surgical instrument; motor rotates to drive interchangeable attachments (saws, drills, drivers) for bone/tissue manipulation. Operated by surgeons in clinical settings (OR). IPC console provides power and control; software module enables recognition and control of handpiece position, torque, and direction. Output is mechanical rotation of attachments. Benefits include precise tissue/bone removal and screw/wire placement during spinal, cranial, and orthopedic procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Laboratory bench testing demonstrated performance characteristics substantially equivalent to predicate devices.

Technological Characteristics

Electric-powered handpiece; connects to IPC console. Features interchangeable attachments for drilling, sawing, and driving. Software-controlled torque, position, and direction. Duty cycle: 20s on/20s off; max torque 3.1 Nm (with attachment). Thermal safety: max surface temperature <51°C (<1 min) and <48°C (<10 min).

Indications for Use

Indicated for incision, cutting, removal, drilling, and sawing of soft/hard tissue, bone, and biomaterials in neurosurgical (cranial, craniofacial), orthopedic, arthroscopic, spinal, sternotomy, and general surgical procedures.

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

• XPS 4000 System, Midas Rex Legend EHS System, Integrated Power Console (IPC) (K081475)
• XPS 4000 System, Midas Rex Legend EHS System, Integrated Power Console (IPC) (K081277)
• IPC POWEREASE System (K111520)

Submission Summary (Full Text)

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K12/264

# 5. 510(k) Summary

# AUG 2 7 2012

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

| Address of Manufacturer: | Medtronic Powered Surgical Solutions<br>4620 North Beach Street<br>Fort Worth, TX 76137<br>[phone] Phone |
|--------------------------|-----------------------------------------------------------------------------------------------------------------|
|--------------------------|-----------------------------------------------------------------------------------------------------------------|

[phone] Facsimile

Establishment Registration Number: 1625507

Contact Person:

Date:

Trade or Proprietary Name:

Jeffrey Henderson VP, Quality, Clinical & RA

August 10, 2012

TRITON Electric High Torque Handpiece and Software Module

IPC System with the TRITON High Torque Handpiece

Common usual or Classification Name:

21 CFR 882.4360, Product Code HBC, Class II - Electric cranial drill motor

21 CFR 882.4310, Product Code HBE, Class II - Powered simple cranial drills, burrs, trephines, and their accessories

21 CFR 888.1100, Product Code HRX, Class II - Arthroscope

21CFR 878.4820, Product Code HWE, Class I - Surgical instrument motors and accessories/attachments

### Description:

The purpose of this submission is to add a new handpiece and an accompanying software module as a line extension to the current Integrated Power Console IPC® System. The handpiece is powered by the previously cleared integrated Powered Console. In order to operate the TRITON Electric Handpiece, the IPC will be equipped with the appropriate software module to drive the handpiece. The handpiece is used for sawing, drilling, driving and placing screws, wires and pins when used in conjunction with various attachments previously cleared for use during spinal surgery.

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The TRITON Electric High Torque Handpiece has the identical attachment connecting interfacing components as the handpiece cleared under K870157. As a result, the TRITON Electric High Torque Handpiece utilizes the same Attachments and Blades as those cleared under K870157.

# Indications for Use:

The TRITON Electric High-Torque Handpiece 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.

# Predicate Device Identification:

The Medtronic TRITON Electric High Torque Handpiece and Software Module is substantially equivalent to the following predicate devices:

| Device | Manufacturer | 510(k) Number | Clearance Date |
|------------------------------------------------------------------------------------|-----------------------|---------------|----------------|
| XPS 4000 System, Midas Rex<br>Legend EHS System, Integrated<br>Power Console (IPC) | Medtronic Xomed, Inc. | K081475 | 10/17/2008 |
| XPS 4000 System, Midas Rex<br>Legend EHS System, Integrated<br>Power Console (IPC) | Medtronic Xomed, Inc. | K081277 | 09/05/2008 |
| IPC® POWEREASETM System<br>510(k) K111520 | Medtronic Xomed, Inc. | K111520 | 10/26/2011 |

#### Table 1: Predicate Devices for the IPC System with TRITON High Torque Handpiece

### Comparison to Predicate Device:

The TRITON Electric High Torque Handpiece and Software Module are similar in device design, function, intended use and fundamental scientific technology to the previously cleared devices listed above.

Table 2: Comparison of Subject Device to Predicate Device

| Feature | Proposed IPC TM System w/ TRITON<br>High Torque Handpiece | Predicate Devices |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Integrated Powered Console System w/<br>TRITON Handpiece<br>The IPC® system is indicated for the<br>incision / cutting, removal, drilling, and<br>sawing of soft and hard tissue and<br>bone, and biomaterials in<br>Neurosurgical (Cranial, Craniofacial)<br>Orthopedic, Arthroscopic, Spinal,<br>Sternotomy, and General surgical<br>procedures. The IPC® provides power<br>to various drills and saws to drive | Integrated Powered Console - K081475<br>The IPC® system is indicated for the<br>incision / cutting, removal, drilling, and<br>sawing of soft and hard tissue and bone,<br>and biomaterials in Neurosurgical<br>(Cranial, Craniofacial) Orthopedic,<br>Arthroscopic, Spinal, Sternotomy, and<br>General surgical procedures. The IPC®<br>provides power to various drills and saws<br>to drive attachments and tools during<br>surgical procedures. |
| Feature | Proposed IPC™ System w/ TRITON<br>High Torque Handpiece | Predicate Devices |
| | attachments and tools during surgical<br>procedures. | |
| Indication for<br>Use | Integrated Powered Console w/<br>TRITON Handpiece<br>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 | Integrated Powered Console - K081475<br>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 |
| Operating<br>Principle | Integrated Powered Console w/<br>TRITON Handpiece<br>The IPC® System is an electric<br>powered instrument system consisting<br>of multiple handpieces which are<br>powered by the IPC® console. The<br>handpieces are intended to drive<br>various types of interchangeable<br>attachments and instruments used in<br>various surgical procedures. When<br>active, the motor of the handpiece<br>rotates to drive the connected<br>attachment. | Integrated Powered Console - K081475<br>The IPC® System is an electric powered<br>instrument system consisting of multiple<br>handpieces which are powered by the<br>IPC® console. The handpieces are<br>intended to drive various types of<br>interchangeable attachments and<br>instruments used in various surgical<br>procedures. When active, the motor of the<br>handpiece rotates to drive the connected<br>attachment. |
| Software | Integrated Powered Console w/<br>TRITON Handpiece<br>The IPC software is designed to<br>recognize and control position, torque<br>and direction of the following<br>handpieces, POWEREASE Driver,<br>Stylus, Stylus Touch, EHS, Visao,<br>Skeeter and Indigo drills, the<br>Oscillating, Reciprocating and Sagittal<br>saws, and Triton driver and the M4,<br>SC1 microdebriders and the TRITON<br>High Torque Handpiece. | Integrated Powered Console - K081475<br>The IPC software is designed to<br>recognize and control position, torque and<br>direction of the following handpieces,<br>Stylus, Stylus Touch, EHS, Visao,<br>Skeeter and Indigo drills, the Oscillating,<br>Reciprocating and Sagittal saws, and<br>Triton driver and the M4 and SC1<br>microdebriders |

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# Handpiece Comparison

| Metric | IPC® with TRITON Electric High Torque<br>Handpiece | | Predicate Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: Free Run | Image: With<br>Attachment | |
| Maximum<br>Applied Torque | 1.6 Nm | 3.1 Nm(1) | 7 Nm |
| Range of<br>Speed | 0 to max free run speed of<br>1250 - 1800 rpm | 0 - 250 rpm | 0 - 250 rpm |
| Range of Safe<br>Working<br>Temperatures | Max temperature through the entire operating<br>range at any external surface location on<br>handpiece shall be less than 51 °C for less than<br>1 minute and shall not exceed 48 °C for less<br>than 10 minutes | | 48°C max |
| Duty Cycle | Cycle Time: 20 seconds on maximum / 20<br>seconds off minimum<br>Maximum number of cycles before resting<br>handpiece: 6<br>Maximum number of cycles before resting<br>attachment: 3<br>Minimum rest period: 25 minutes | | Continuous Operation |
| Intended Use | The TRITON Electric High Torque Handpiece is<br>intended to remove hard and soft tissue, drill<br>pilot holes, drive screws, wires, and pins<br>during, but not limited to, spinal, cranial, and<br>small bone surgical procedures. The TRITON<br>Electric High Torque Handpiece is intended to<br>be used in both open and minimally invasive<br>surgical procedures. | | The IPC® POWEREASE™ System<br>is indicated for drilling, tapping, and<br>driving screws and working end<br>attachments during spinal surgery,<br>including open and minimally<br>invasive procedures. It is also used<br>in the placement of screws, or<br>cutting of screws, posts, and rods. |

ក្រុង

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# Testing:

Laboratory bench testing conducted on the IPC System with the TRITON Electric High Torque Handpiece demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market.

# Conclusion/Summary:

Based upon the laboratory bench test summaries, intended use, and the successful completion of design control activities; the IPC System with the TRITON Electric High Torque Handpiece and software module is shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

AUG 27 2012

Medtronic Surgical Technologies c/o Mr. Jeffrey Henerson VP, Quality, Clinical & RA 4620 North Beach Street Fort Worth, TX 76137

Re: K121264

Trade/Device Name: TRITON Electric High Torque Handpiece and Software Module Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBE, HRX, HWE Dated: August 10, 2012 Received: August 13, 2012

Dear Mr. Henderson:

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.

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#### Page 2 - Mr. Jeffrey Henerson

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); 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/ResourcesforYou/Industry/default.htm.

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<http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm>.

Sincerely vours.

Kesia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4. Indications for Use Statement

K121264 510(k) Number (if known):

Device Name: __ TRITON Electric High Torque Handpiece and Software Module

Indications for Use:

The IPC System with the TRITON Electric High-Torque Handpiece 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.

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)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121264

Prescription Use (Per 21 CFR 801.109)

Medtronic TRITON Electric High-Torque Handpiece

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